Seqens Seqens

X
menu

    Market Place

    Market Place

    Post Enquiry

    Post Enquiry
    menu

    Find PharmaFlow Article for Apixaban

    Client Email Product

    Apixaban

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    PRICE INFORMATION

    INTERMEDIATES

    DOSSIERs // Finished Dosage Formulations

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS

    ANALYTICAL SOLUTION(s)

    DIGITAL CONTENT

    PharmaCompass
    Related ProductsRelated Products
    API SUPPLIERS
    API Suppliers

    API Suppliers

    114
    US DMFs Filed

    US DMFs Filed

    49
    CEP/COS Certifications

    CEP/COS Certifications

    0

    JDMFs Filed

    JDMFs Filed

    0

    Other Certificates

    Other Certificates

    25
    Other Suppliers

    Other Suppliers

    88
    API REF. PRICE (USD / KG)
    5,813

    API Market Place

    29
    INTERMEDIATES
    94
    DOSSIERS // FDF
    USA (Orange Book)

    USA (Orange Book)

    36
    Europe

    Europe

    26
    Canada

    Canada

    36
    Australia

    Australia

    8
    South Africa

    South Africa

    4
    Uploaded Dossiers

    Uploaded Dossiers

    29
    GLOBAL SALES (USD Million)

    U.S. Medicaid

    41,070.00

    Annual Reports

    9,871.00

    FDF Market Place

    9
    EXCIPIENTS
    146
    PATENTS & EXCLUSIVITIES

    USFDA Orange Book Patents

    15

    USFDA Exclusivities

    0

    DIGITAL CONTENT

    Blog #PharmaFlow

    15

    News

    177
    REF STANDARD

    EDQM

    0

    USP

    0

    JP

    0

    Other Listed Suppliers

    24
    SERVICES

    0

    BlogBlog
    Full View ScreenFull Screen View
    Company Tracker: Pfizer turns to acquisitions as Covid products’ sales nosedive

    Company Tracker: Pfizer turns to acquisitions as Covid products’ sales nosedive

    Over the last five years, a lot has changed for Pfizer Inc, one of the world’s leading pharmaceutical companies based on pharma sales revenue. From entering into an agreement with German biotechnology company BioNTech SE in August 2018 for joint research and development of mRNA-based influenza vaccines to merging its off-patent branded and generic drug business, known as Upjohn, with Mylan to form Viatris and launching Covid-19 vaccine Comirnaty and antiviral drug Paxlovid during the pandemic, the New York-headquartered pharma giant has witnessed substantial transformation in the recent past.The launch of Covid products was undoubtedly the biggest event for the 174-year-old drugmaker, propelling it to the number 1 slot in 2021 with a turnover of US$ 81.3 billion, surpassing competitors such as AbbVie, Johnson & Johnson, Novartis, Roche, Bristol Myers Squibb, Merck, and several others. In 2022, Pfizer further consolidated its position, with revenues exceeding US$ 100 billion, largely due to the success of its Covid products. This success of Covid products filled Pfizer’s coffers, allowing it to expand through the acquisition of smaller companies. Pfizer’s new brand identity and logo, unveiled in 2021, signaled the company's shift from "commerce to science".Pfizer commercially operates through two segments — Biopharma, or its innovative science-based biopharmaceutical business that posted revenues worth US$ 98.98 billion in 2022, and Pfizer CentreOne (PC1), a global contract development and manufacturing organization as well as a leading supplier of specialty active pharmaceutical ingredients (APIs) with US$ 1.3 billion in 2022  revenues.Pfizer’s core therapeutic areas are inflammation and immunology, internal medicine, oncology, rare diseases, vaccines and anti-infectives.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel)Pfizer in acquisition overdrive: Buys Seagen for US$ 43 bn, Biohaven for US$ 11.6 bnPfizer has been utilizing its war chest generated during the pandemic in acquiring companies that would help grow the business when Covid is behind us and its other best-selling drugs (such as Ibrance, Vyndaqel/Vyndamax, Xeljanz and Xtandi) face expiration of patents. In November 2021, Pfizer snapped up Trillium Therapeutics for US$ 2.22 billion. Trillium is a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer. In March 2022, Pfizer acquired Arena Pharmaceuticals for US$ 6.7 billion, a company that develops novel therapies to treat immune-inflammatory ailments. Then, in Oct 2022 it completed the US$ 11.6 billion buyout of migraine specialist Biohaven. This brought Biohaven’s leading oral migraine drug in the US – Nurtec ODT (rimegepant) – into Pfizer’s fold. In June 2022, Pfizer completed the acquisition of ReViral Limited, gaining access to its experimental drugs used to combat respiratory syncytial virus (RSV) infections. In October, Pfizer paid US$ 5.4 billion for blood disorder drugmaker Global Blood Therapeutics (GBT). Through this buyout, Pfizer has added GBT’s approved drug, Oxbryta, along with two other sickle cell medicines – GBT601 and inclacumab (both in mid- to late-stage testing) – to its portfolio.And this month, Pfizer announced it will acquire Seattle-based cancer specialist Seagen for US$ 43 billion, its biggest acquisition in the recent past. “We are not buying the golden eggs,” Albert Bourla, CEO of Pfizer, said post the announcement. “We are acquiring the goose that is laying the golden eggs.”The Pfizer-Seagen deal is also the largest biopharma acquisition since 2019, when BMS bought Celgene for US$ 74 billion. Seagen is a leader in antibody-drug conjugate (ADC) technology. This deal will bring four commercial medicines (Adcetris, Padcev, Tukysa and Tivdak) and a deep pipeline of ADC candidates to Pfizer’s fold.Seagen is likely to post US$ 2.2 billion in revenues this year, which is expected to grow to over US$ 10 billion (risk-adjusted) by 2030. Earlier this year, Bourla had said the company has planned to use its “extraordinary firepower” to buy products that will deliver US$ 25 billion in incremental revenue by 2030. While Seagen will bring in US$ 10 billion, another US$ 10.5 billion will come from Arena, Biohaven, GBT and ReViral.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Diminishing demand for Covid products, expiring patents to drag turnover downPfizer’s turnover has nearly doubled since 2018, when it was at US$ 53.6 billion. In July 2019, Pfizer had announced the plan to combine Upjohn with Mylan to form a new company — Viatris. With the separation of the Upjohn business and the formation of a consumer healthcare joint venture with GSK in 2019, Pfizer transformed into a more focused player in innovative medicines and vaccines. However, this restructuring measure also led to a drop in its turnover to US$ 51.8 billion in 2019 and to US$ 41.9 billion in 2020. From the number three slot in 2018 (behind J&J and Roche), Pfizer’s ranking fell to eight in 2020. However, Covid turned its fortunes yet again and its turnover increased to US$ 81.3 billion in 2021.When we split Pfizer’s 2022 revenues of US$ 100.3 billion, we notice that its portfolio has 10 products with sales greater than US$ 1 billion. These include the Covid-19 vaccine Comirnaty with US$ 37.8 billion in revenues, Paxlovid with US$ 18.9 billion, anticoagulant Eliquis with US$ 6.5 billion, and the Prevnar family of pneumococcal vaccines with US$ 6.3 billion in revenues. Pfizer's partner BMS recorded sales of US$ 11.8 billion for Eliquis in 2022.With a drop in Covid cases, demand for Comirnaty and Paxlovid has decreased significantly. In 2023, Comirnaty’s revenue is likely to drop 64 percent to around US$ 13.5 billion, and Paxlovid’s revenue is likely to plummet by around 58 percent to around US$ 8 billion.Pfizer expects its 2023 revenues to be between US$ 67 billion and US$ 71 billion, reflecting an operational decline of over 30 percent. However, when we exclude the revenues of Covid products, we are likely to see a growth in revenues of around 7 to 9 percent, coming primarily from new product launches, recently acquired products and Pfizer’s in-line portfolio.“Pfizer expects 2024 sales of Covid products to stabilize, then starting in 2025 and continuing in 2026 and beyond, it expects to see an increase in Covid-19 vaccination rates, assuming the successful development and approval of a Covid-flu combination product,” said Bourla. Last December, Pfizer and BioNTech received fast track designation from the US Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and Covid-19, which aims to help prevent two respiratory diseases with a single injection.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Stars in Pfizer’s pipeline — RSV, pneumococcal and meningococcal vaccinesIn 2022, Pfizer spent US$ 11.4 billion in research and development, up 12 percent from its R&D spend in 2021. It has a power-packed pipeline with 110 programs, including 72 new molecular entities. Out of the 110 programs, 33 are in oncology, 23 in inflammation and immunology, 19 in vaccines, 15 in internal medicines, 12 in rare diseases and eight in anti-infectives.However, the stars in Pfizer’s pipeline are its vaccine candidates. Pfizer’s RSV vaccine candidate RSVpreF is being developed for pregnant women (to help protect their babies from RSV after birth) and individuals 60 years of age or older for the prevention of lower respiratory tract disease caused by RSV. The vaccine recently received support from the FDA's advisory committee, and a decision on its use for older adults is expected by May 2023.The agency has also granted priority review to the maternal RSV vaccine, with an action date of August 2023. If approved, it would be the first vaccine for pregnant women to help protect against the complications of RSV disease in infants from birth through six months.Recently, FDA also designated Prevnar 20 for priority review in children aged six weeks through 17 years. Six months ago, Merck’s Vaxneuvance had received pediatric approval. The Merck vaccine defends against 15 serotypes, as compared to 13 strains covered by Pfizer’s Prevnar. However, Merck’s edge could be short-lived as Prevnar’s next-generation vaccine protects against 20 serotypes. The US regulatory agency has also accepted the BLA (biologics license application) review of Pfizer’s pentavalent meningococcal vaccine candidate — MenABCWY — in adolescents with the PDUFA date of October 2023. Moreover, the company has announced positive top-line results from a phase 3 study of its hemophilia B gene therapy candidate, fidanacogene elaparvovec.Besides this vaccines and therapies, FDA is going to decide on several other Pfizer drugs in 2023, such as ritlecitinib for alopecia, elranatamab for multiple myeloma, etrasimod for ulcerative colitis, and Abrilada, a biosimilar of AbbVie’s blockbuster Humira (adalimumab).View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Our viewAs of today, the sweet spot of US$ 100.3 billion in 2022 revenues posted by Pfizer surely looks like a one-off. Though the drug behemoth’s vaccine pipeline looks promising, its shopping list reflects a huge reliance on oncology for future growth.While only time can tell which of those bets will work and which won’t, it looks like Pfizer has capitalized on the lead the pandemic granted it to race ahead of competition.(All financial and drug pipeline-related information has been taken from the Pfizer website.)

    Impressions: 2708

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/company-tracker-pfizer-turns-to-acquisitions-as-covid-products-sales-nosedive

    #PharmaFlow by PHARMACOMPASS
    23 Mar 2023
    Share Share
    DMF submissions rise 12.1% in 2022; India sees 10.6% drop in Type II filings

    DMF submissions rise 12.1% in 2022; India sees 10.6% drop in Type II filings

    In 2022, the world finally began to emerge out of Covid-related restrictions. Though 2020 and 2021 saw several travel-related curbs, there was no let up in the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA). In the four years between 2018 and 2021, the number of Type II DMF submissions (i.e. submissions for drug substance, drug substance intermediate, and material used in their preparation, or drug product) remained steady at over 630 per year.In 2022, the DMF submissions rose at an impressive pace of 12.1 percent. A total of 1,024 DMFs (Types II, III, IV and V) were submitted in 2022, as opposed to 913 in 2021.Last year, Type II DMF submissions increased by 7.2 percent — a total of 715 Type II DMFs were submitted in 2022 as opposed to 667 in 2021. However, of the 715 DMFs filed with the FDA, only 190 (26 percent) had their reviews completed.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available) DMF submissions from India dip 10.6%, China’s filings increase 45%As always, DMFs filed from India and China were significantly higher than DMFs from other countries. However, the year saw DMF submissions from India drop by 10.6 percent. Overall DMF submission from India stood at 336, as opposed to 376 in 2021. In comparison, China’s DMF filings increased by 45 percent to 231 in 2022, as opposed to 159 in 2021. Interestingly, FDA had issued 31 Form 483s in 2022 out of which 15 were issued to Indian drugmakers. Out of 15, seven Form 483s were issued to manufacturing units belonging to four Indian API manufacturers — Lupin, Aurobindo Pharma, Torrent and Biocon Biologics.While DMFs are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products, a Form 483 is a notification sent by the FDA to a drugmaker regarding objectionable conditions at a facility. A Form 483 is issued at the conclusion of an inspection, when an investigator finds regulatory violations and/or non-compliance of good manufacturing practices. January 2023 saw a spate of Form 483s issued to Indian drugmakers, raising concerns within the pharma industry.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available)   India’s Metrochem API tops DMF submissionsIndia’s Metrochem API led the list of companies with the highest number of DMF submissions at 19. MSN Labs stood second with 16 submissions.Other top Indian companies were Aurobindo Pharma (15), Biophore India (15), Hetero Group (11) and Cipla (10), followed by two Chinese companies — BrightGene Bio-Medical Technology and Changzhou Pharmaceutical Factory — with 9 submissions each.The maximum number of DMF filings were for elagolix sodium (11), empagliflozin (eight), tofacitinib citrate (six), revefenacin (six), apixaban (five), brivaracetam (five), cannabidiol (five), followed by mirabegron (five) and tafamidis (five).A total of 79 DMFs were filed for the first time for 64 products, of which 28 had their GDUFA  (Generic Drug User Fee Amendments) review completed. These include revefenacin (six), migalastat hydrochloride (three), cupric sulfate (three), ivosidenib (two), upadacitinib (one) and voxelotor (one). Revefenacin is losing its marketing exclusivity this year.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available)   Our viewIn our last (H1 2022) review of DMF submissions, we had mentioned that less than half of the 350 Type II DMFs filed by the FDA had been reviewed, as the user fee program had not been reauthorized.FDA published the New GDUFA III fee structure at the eleventh hour — on September 30, 2022. GDUFA III includes several enhancements to the abbreviated new drug application (ANDA) assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality and affordable generics.With the GDUFA III, the US government has made clear its intent to lower generic drug prices. In future, more drugs are likely to go off-patent and we are likely to see the number of DMF submissions rise even further.In the second quarter of 2022, FDA resumed unannounced inspections in India. The regulator has also stepped up onsite inspections. FDA wants cheaper drugs, but not at the cost of quality. There are no short-cuts for generic and bulk drug manufacturers wanting to export to the US.(This article has been updated to accurately reflect the information on Metrochem API and MSN Labs.) 

    Impressions: 2214

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/dmf-submissions-rise-12-1-in-2022-india-sees-10-6-drop-in-type-ii-filings

    #PharmaFlow by PHARMACOMPASS
    02 Feb 2023
    Share Share
    America’s drug price hike conundrum in backdrop of 2019 Medicare Part D data

    America’s drug price hike conundrum in backdrop of 2019 Medicare Part D data

    Nearly every year, drugmakers ring in the new year with drug price increases in the US. This year too, prices of over 450 prescription medicines increased by an average of around 5 percent at the start of January. This, when high drug prices have been one of the biggest political issues in the US over the last few years. PharmaCompass decided to usher in 2022 with a review of the US Medicare Part D Prescription Drug data recently released by the Centers for Medicare and Medicaid Services (CMS) for calendar year 2019. Using the available data, we have developed our own dashboard to show recent trends in consumption of prescription drugs. With this analysis, we hope our readers will get a better understanding of the world’s largest market for pharmaceuticals, as also a fix on where it may be headed. View US Medicare Part D 2019 Drug Spending (Free Excel Available) Rising healthcare, drug spends in US Over the last several years, we have repeatedly heard political leaders in the US complain about high drug prices. Yet, drug prices and healthcare spends have risen unabated. America’s National Health Expenditure Accounts (NHEA) includes annual expenditures on healthcare goods and services, public health activities, the net cost of health insurance, and investment related to healthcare. In 2019, America’s national health expenditure (NHE) grew by 4.6 percent to US$ 3.8 trillion, accounting for 17.7 percent of the gross domestic product (GDP). During the year, prescription drug spend increased by 5.7 percent to US$ 369.7 billion. In comparison, Medicare spend grew 6.7 percent to US$ 799.4 billion. President Joe Biden recently stressed on the need to cap the prices of essential drugs, and said that the average American pays the highest prices for prescription drugs anywhere in the world. Americans pay 10 times as much as other countries for life-saving insulin — the top selling prescription drug covered by the Part D program.  Pharma companies, on the other hand, have vehemently argued against any price cuts in the US, saying price cuts would hinder drug research and development for all diseases. View US Medicare Part D 2019 Drug Spending (Free Excel Available)  Patented drugs account for 80.3 percent of total Part D spend Medicare is the US federal government’s program that provides health insurance to most people who are 65 years or older. Medicare’s Part D plan provides outpatient drug coverage through private insurance companies that have contracts with the federal government. Eligible people have to choose and enroll in a private prescription drug plan for Part D coverage. Medicare Part B, on the other hand, covers a wide variety of medically necessary outpatient services and some preventative services. Prescription drug coverage under Part D reached US$ 183 billion in 2019 — a growth of around 9 percent over 2018, when spending was US$ 168 billion. Spending on patented drugs in 2019 accounted for around US$ 147 billion or 80.3 percent of the total spend for the year. Generic drugs made up for the remaining 19.7 percent (approximately US$ 36 billion). In 2018, generic drugs worth US$ 35.8 billion were sold under Part D, accounting for 21 percent of the total spend under the program. View US Medicare Part D 2019 Drug Spending (Free Excel Available)   Eliquis ranks highest on Medicare’s brand drug spend Under Part D, endocrinology and oncology were the two therapeutic areas that generated maximum revenue for pharma companies, driving home sales of over US$ 31.8 billion and US$ 23.5 billion, respectively. Neurology drugs generated sales of around US$ 22.9 billion. Among branded drugs, Bristol Myers Squibb’s anticoagulant Eliquis (apixaban) was the most selling drug in 2019 under Part D, notching up about US$ 7.3 billion in sales — a rise of US$ 2.3 billion or 46 percent over 2018. Celgene’s cancer drug Revlimid (lenalidomide) roped in US$ 4.7 billion (up by 14.6 percent), while another anticoagulant drug Xarelto (rivaroxaban) by Janssen Pharma — a unit of Johnson & Johnson — fetched US$ 4.1 billion (up 20.6 percent) in sales through Part D. AbbVie’s anti-rheumatic drug Humira and Sanofi’s diabetes drug Lantus saw sales of around US$ 3.7 billion each under the program. Amongst generics, the largest selling drug under Part D (by dosage units) was metformin (diabetes), followed by gabapentin (seizure), PEG3350 with electrolyte (gastroenterology), metoprolol (hypertension) and atorvastatin (cholesterol). In 2019, the overall dosage units sold also jumped higher by 2.25 billion units to 111.35 billion.  The sales ranking of Part D does bare some similarities with the global ranking of highest selling drugs. In 2020, Humira had retained its position as the highest selling drug in the world, generating sales of US$ 20.4 billion. Both Eliquis and Revlimid had retained their ranking as the third and fourth most selling drugs, bringing home US$ 14.1 billion and US$ 12.1 billion in global sales in 2020. View US Medicare Part D 2019 Drug Spending (Free Excel Available)  Medicare’s inability to negotiate prices costs American taxpayers billions of dollars Over the years, drug companies have used Medicare’s inability to negotiate prices under Part D to increase the prices of their drugs significantly and rip off huge profits, a three-year-long US House Oversight Committee investigation has revealed. US taxpayers could have saved over US$ 25 billion in five years if the prices of just seven drugs — Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog and Lyrica — were negotiated by Medicare. Another US$ 16.7 billion could have been saved between 2011 and 2017 on insulin products manufactured by Eli Lilly, Novo Nordisk and Sanofi, which control 90 percent of the insulin market in the US, the committee’s report revealed.   Elsewhere in the world, the same drugmakers are bending over backwards to get into medical insurance programs. For instance, China reported that several international pharma firms, many of them headquartered in the US, slashed the prices of their drugs by up to 94 percent to get into the country’s national medical insurance coverage. In the US — which accounted for around 46 percent of the global share of drugs in 2020 — senior citizens may have to pay more for medicines as the government announced a large hike in Medicare premiums for 2022 if an expensive Alzheimer’s drug, Aduhelm, is included in the list. In order to ensure inclusion in Medicare, Biogen slashed the price of Aduhelm by half — from US$ 56,000 to US$ 28,200 — just weeks before a crucial meeting called by the CMS. Clearly, this has set a precedent in an industry which is known for rampant price hikes and rarely for any price cuts. This could also be put forth as an example of what Medicare could achieve if it receives negotiation rights. View US Medicare Part D 2019 Drug Spending (Free Excel Available)  Our view President Biden's Build Back Better legislation, which the House passed last month, is up for vote in the Senate. The legislation contains provisions that would allow Medicare to negotiate the prices of some expensive drugs, penalize drugmakers who raise prices faster than inflation and cap out-of-pocket costs for insulin at US$ 35 per month. However, chances of the bill being passed in its present form are slim. Even if the Senate passes the bill, Medicare would be able to negotiate the prices of only 10 prescription drugs and insulin products in 2025. The number would increase over the years, reaching 100 in six years, and hence forth grow by 20 drugs a year. It seems like 2022 won’t be the last year when January 1 will be braced with price hikes in the US by drugmakers. Looks like they will continue to make hay while the sun shines.  View US Medicare Part D 2019 Drug Spending (Free Excel Available)    

    Impressions: 2622

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/america-s-drug-price-hike-conundrum-in-backdrop-of-2019-medicare-part-d-data

    #PharmaFlow by PHARMACOMPASS
    06 Jan 2022
    Share Share
    Top drugs and pharmaceutical companies of 2019 by revenues

    Top drugs and pharmaceutical companies of 2019 by revenues

    Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues.  Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.  Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$  50.3 billion however this week it announced that the coronavirus  pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.  GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion).   US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths  — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021.  View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.  Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)   

    Impressions: 54752

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues

    #PharmaFlow by PHARMACOMPASS
    29 Apr 2020
    Share Share
    US market offers niche opportunities, reveals manufacturer sales data from Medicare Part D

    US market offers niche opportunities, reveals manufacturer sales data from Medicare Part D

    This week, PharmaCompass reviews the recently released data of the Medicare Part D Prescription Drug Program in the United States for calendar year 2017. The US market is the world’s largest and most important pharmaceutical market, accounting around 45 percent of the global share of drugs, and was valued at US$ 466 billion in 2017. View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available) What is Medicare?   Medicare is the federal health insurance program in the US which covered 58.4 million people in 2017 — 49.5 million aged 65 and older, and 8.9 million disabled.  The National Health Expenditure (NHE) in the US grew 3.9 percent to US$ 3.5 trillion in 2017 and accounted for 17.9 percent of the gross domestic product (GDP). As a result, Medicare spending grew 4.2 percent to US$ 705.9 billion in 2017, or 20 percent of the total NHE. Prescription drug spending in the US increased to US$ 333.4 billion in 2017 while prescription drug coverage under the Medicare program, known as Medicare Part D, reached US$ 151.6 billion in 2017, a little less than half of the total prescription drug spending in the United States. View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available) Why has Medicare been in news?   The Medicare Part D drug benefit is delivered by private drug plans, which are mostly chosen by the program’s participants. Under Part D, drug prices are determined primarily through negotiations between Part D plans and providers (such as pharmacies and drug manufacturers). A key factor that helps Part D plans lower drug costs are rebate payments that the plans negotiate with drug manufacturers. With drug pricing debate raging in the United States, these rebate payments have come under a lot of scrutiny. View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available) During the hearing of Big Pharma executives summoned by the Senate Financing Committee last month, Sanofi’s CEO Olivier Brandicourt detailed a chart showing Sanofi and Genzyme's US sales from 2018, explaining how as much as 55 percent of Sanofi’s gross sales were given back to payers as rebates. The chart showed how out of Sanofi’s US$ 21.6 billion in gross sales in 2018, US$ 4.5 billion was given back in mandatory rebates to government payers and US$ 7.3 billion in discretionary rebates. Earlier this month, the Trump administration unveiled a budget that would reduce spending in Medicare as well as Medicaid by hundreds of billions of dollars compared to the current law. View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available) What are the insights available from the 2017 US Medicare Part D data?   The Medicare Drug Spending dashboards were updated earlier this month to include data for 2017, providing more data and transparency to better identify trends and track consumption and price changes over time.  Using the available data, PharmaCompass has developed its own dashboard to show recent trends in consumption of prescription drugs under Medicare D. Our dashboard also helps identify drugs with limited to no competition. The data reveals that while almost 60 percent of the Medicare spend (nearly US$ 90 billion) is for drugs with only one manufacturer, i.e. mostly patented drugs, there is another US$ 12 billion spend on drugs which have only two manufacturers. The next highest spend — of US$ 4 billion — is on drugs with as many as five manufacturers.  This clearly indicates that if the market can support up to five manufacturers for established products, increased generic competition will significantly help Medicare reduce its Part D prescription drug spending. View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available) Medicare’s highest spend was on Insulin Glargine (US$ 4.7 billion) followed by patented drugs Celgene’s Revlimid (lenalidomide), Bristol-Myers Squibb’s Eliquis (apixaban), Merck’s Januvia (sitagliptin phosphate) and AbbVie’s Humira (adalimumab).   Drugs with limited to no competition can be identified using the dashboard by sorting for drugs with few manufacturers.  Information is also provided on drug uses and clinical indications, thereby enabling comparison between different medications for a given condition. View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available)  

    Impressions: 4699

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/us-market-offers-niche-opportunities-reveals-manufacturer-sales-data-from-medicare-part-d

    #PharmaFlow by PHARMACOMPASS
    28 Mar 2019
    Share Share
    Top drugs by sales in 2017: Who sold the blockbuster drugs?

    Top drugs by sales in 2017: Who sold the blockbuster drugs?

    The year 2017 was a landmark year for pharmaceutical industries in the US and Europe, with a sharp increase in the number of new molecular entities (NMEs) being approved in both geographies. The US Food and Drug Administration (USFDA) approved 46 NMEs in 2017, the second highest since 1996 when 53 NMEs were approved. In Europe, the European Medicines Agency (EMA) approved 35 drugs with a new active substance, up from 27 in 2016. Sales for most major pharmaceutical companies continued to grow in 2017. Earnings forecasts for 2018 have been raised due to the recent US tax reform that has generated investor hopes for accelerated dividend growth and share buyback plans. This week, PharmaCompass brings you a compilation of the top drugs of 2017 by sales revenue. Click here to Access All the 2017 Data (Excel version available) for FREE! Top-sellers: Humira races ahead, despite launch of biosimilars; Enbrel a distant second   There wasn’t any upheaval at the top of the pharma drug sales charts. AbbVie’s anti-TNF (tumor necrosis factor) giant Humira (adalimumab), which is approved to treat psoriasis and rheumatoid arthritis, added almost another US $3 billion to its 2016 sales and posted nearly US $19 billion in revenues. Last year, AbbVie’s raised expectations for Humira’s earnings to reach US $21 billion in global sales by 2020. The company believes this drug will continue to be a significant cash contributor until 2025 and the US $21 billion sales forecast by 2020 is about US $3 billion higher than its expectation two years ago. In 2016, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita (adalimumab-atto) — a biosimilar of Humira. And in 2017, another Humira biosimilar — Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) — received approval from the FDA and European authorities.  Click here to Access All the 2017 Data (Excel version available) for FREE! Enbrel (etanercept), the longest-used biologic medicine for the treatment of rheumatism around the world, was the second best-selling drug with US $8.262 billion in 2017 sales. The sales of the drug were down from US $9.366 billion in 2016 owing to lower selling prices and increased competition, which in turn hurt demand.  Since it was first approved in the United States in 1998, Enbrel has been approved in over 100 countries and the drug is promoted by Amgen, Pfizer and Takeda in different geographies. Novartis’ biosimilar copy of Enbrel, which got approved by the FDA in August 2016 for the treatment of patients with rheumatoid arthritis (RA), plaque psoriasis, ankylosing spondylitis (AS) and other diseases is still not on the market because of a patent-protection challenge from Amgen. Amgen is arguing in the US federal court that its drug has patent protection until 2029. Click here to Access All the 2017 Data (Excel version available) for FREE! Fast-growing drugs: Eylea and Revlimid bring fortunes for Regeneron and Celgene   Regeneron’s flagship eye treatment, Eylea (aflibercept) which is marketed by Bayer outside the United States, added another US $1 billion in annual sales last year to record US $8.260 billion in total sales. Eylea net sales grew 11 percent year-on-year in the US and 19 percent year-over-year outside the US. The company believes much of the recent growth in the US was driven by demographic trends with an aging population as well as an overall increase in the prevalence of diabetes. These demographic trends are expected to continue in the coming years, providing an opportunity for continued growth. Eylea sales alone contribute 63 percent to Regeneron’s total sales.  Click here to Access All the 2017 Data (Excel version available) for FREE! Celgene’s Revlimid (lenalidomide) — a thalidomide derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in an additional US $1.2 billion in 2017 sales and had total revenues of US $8.187 billion.  Revlimid continues to contribute more than 60 percent to the company’s total sales of US $13 billion. Celgene received a setback this month as the USFDA refused to consider Celgene’s application for ozanimod, an experimental treatment for relapsing multiple sclerosis. The treatment was being seen as a key to the company’s fortunes as Celgene had said ozanimod is worth US $4 billion to US $6 billion a year in peak sales. Click here to Access All the 2017 Data (Excel version available) for FREE! Gilead’s Hepatitis C franchise enters free fall   Gilead Sciences’ blockbuster hepatitis C drugs franchise that includes Sovaldi and Harvoni continue to feel the competitive heat as they registered US $9.137 billion in 2017 sales, down from US $14.834 billion the previous year. While reporting 2017 results, Gilead provided guidance for 2018 and said its sales of Hepatitis C drugs could fall further to US $3.5 billion - US $4 billion. At their peak in 2015, Gilead’s Sovaldi and Harvoni had together generated US $19.1 billion in sales. One of the major reasons for this drop is AbbVie’s launch of its new treatment Mavyret at a deep price discount to the competition. AbbVie also claims to have the shortest treatment course at eight weeks, compared with 12 weeks or longer for other treatments.  AbbVie reported US $1.274 billion in Hepatitis C drug sales in 2017, down from US $1.522 billion in 2016. Click here to Access All the 2017 Data (Excel version available) for FREE! Novartis’ Gleevec, Merck’s cardiovascular drugs, GSK’s Advair face generic heat   Novartis’ Gleevec (imatinib), which had at one point become the best-selling drug for Novartis and had brought in US $3.323 billion for the company in 2016, started facing generic competition last year and the anti-cancer drug lost US $1.380 billion in sales to bring in ‘only’ US $1.943 billion last year.  The US patents of  Merck’s cardiovascular drugs — Zetia (Ezetimibe) and Vytorin (Ezetimibe and Simvastatin) — expired in April 2017. In May 2010, Merck and Glenmark Pharmaceuticals entered into an agreement that allowed Glenmark to launch a generic version of Zetia in late 2016. The drugs that had combined sales of US $3.701 billion in 2016 felt the generic heat in 2017 and the sales were US $1.606 billion lower at US $2.095 billion. Click here to Access All the 2017 Data (Excel version available) for FREE! GSK’s Advair, which was expected to encounter generic competition in 2017, continued to breathe easy as the FDA found deficiencies in the applications of Hikma, Mylan and Sandoz. All three failed to get the FDA nod for their generic versions of Advair, a drug used in the management of asthma and chronic obstructive pulmonary disease that generated sales worth US $4.431 billion (£3.130 billion) in 2017.  Top 15 drugs by sales   Here is PharmaCompass’ compilation of the best-selling drugs of 2017. This is based on information extracted from annual reports and US Securities and Exchange Commission (SEC) filings of major pharmaceutical companies. If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version. Click here to access all the 2017 data (Excel version available) for FREE! S. No. Company / Companies Product Name Active Ingredient Main Therapeutic Indication 2017 Revenue in Millions (USD) 1 AbbVie Inc., Eisai Humira® Adalimumab Immunology (Organ Transplant, Arthritis etc.) 18,946 2 Amgen, Pfizer Inc., Takeda Enbrel® Etanercept Immunology (Organ Transplant, Arthritis etc.) 8,262 3 Regeneron, Bayer Eylea Aflibercept Ophthalmology 8,260 4 Celgene Revlimid Lenalidomide Oncology 8,187 5 Roche MabThera®/Rituxan® Rituximab   Oncology 7,831 6 Johnson & Johnson, Merck, Mitsubishi Tanabe Remicade®  Infliximab Autoimmune Disorders 7,784 7 Roche Herceptin® Trastuzumab Oncology 7,435 8 Bristol-Myers Squibb, Pfizer Inc. Eliquis®  Apixaban Cardiovascular Diseases 7,395 9 Roche Avastin®  Bevacizumab Oncology 7,089 10 Bayer, Johnson & Johnson XareltoTM Rivaroxaban Cardiovascular Diseases 6,590 11 Bristol Myers Squibb, Ono Pharmaceutical Opdivo Nivolumab Oncology 5,815 12 Sanofi Lantus Insulin Glargine Diabetes 5,731 13 Pfizer Inc. Prevnar 13/Prevenar 13 Pneumococcal 7-Valent Conjugate Anti-bacterial 5,601 14 Pfizer Inc., Eisai Lyrica Pregabalin Neurological/Mental Disorders 5,318 15 Amgen, Kyowa Hakko Kirin Neulasta® Pegfilgrastim Blood Disorders 4,553 Sign up, stay ahead In order to stay informed, and receive industry updates along with our data compilations, do sign up for the PharmaCompass Newsletter and you will receive updated information as it becomes available along with a lot more industry analysis. Click here to Access All the 2017 Data (Excel version available) for FREE!  

    Impressions: 58408

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-in-2017-who-sold-the-blockbuster-drugs

    #PharmaFlow by PHARMACOMPASS
    29 Mar 2018
    Share Share
    FDA announces generic drug user fees for FY18; Gilead acquires Kite for US$ 12 billion

    FDA announces generic drug user fees for FY18; Gilead acquires Kite for US$ 12 billion

    This week, Phispers brings you the FY18 user fee schedule under GDUFA II, posted by the USFDA, with significantly higher fee for several applications.  There is news on an old drug getting approved for treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease, and a new study revealed benefits of blood thinners — Xarelto and Brilinta. Meanwhile, Gilead acquired Kite Pharma to access a new kind of cancer therapy. Read on. USFDA announces generic user fees for FY18; ANDAs, APIs, devices to pay higher fee   This week, the US Food and Drug Administration (FDA) posted the FY18 user fee schedule for the Generic Drug User Fee Amendments. Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) applications to market generic drugs, known as abbreviated new drug applications (ANDAs), will see fee increases of more than US$ 100,000 —  from US$ 70,480 in 2017 to US$ 171,823 in 2018. The fees were set based on negotiations between the pharmaceutical industry and the USFDA as part of a new five-year reauthorization of the FDA user fee programs signed into law earlier this month. In the fee schedule, a US$ 15,000 foreign differential applies to all non-US facilities, for both finished dosage form (FDF) and active pharmaceutical ingredients (API). This is the first year when pure CMO (contract manufacturing organization) facilities will pay a ‘reduced’ facility fee — one-third of the fee for a non-CMO. This year an ANDA holder fee, also known as program fee, was introduced. This fee has three tiers: entities that hold 20+ approved ANDAs, entities that hold six-19 approved ANDAs, and entities that hold one to five approved ANDAs. ANDAs pending approval are not added to this count, just as facilities that are only referenced in pending ANDAs are not subject to a facility fee. GDUFA II fee for FY 2018 in US dollar One-time application fee   ANDA 171,823 DMF 47,829 Recurring fee for facilities   Domestic API facility 45,367 Foreign API facility 60,367 Domestic FDF facility 211,087 Foreign FDF facility 226,087 Domestic CMO facility 70,362 Foreign CMO facility 85,362 Recurring GDUFA program fee   (20+ANDAs) Large size operation generic drug applicant program 1,590,792 (6-19 ANDAs) Medium size operation drug applicant program 636,317 (1-5 ANDAs) Small business generic drug applicant program 159,079 The fee is applicable from October 1, 2017, until September 30, 2018. Decades old drug — amantadine — wins FDA approval to treat dyskinesia in Parkinson’s   Adamas Pharmaceutical got the nod from the USFDA last week to sell its therapy ADS-5102 — an extended-release version of the generic amantadine. The agency approved it for treatment of a side effect (dyskinesia) caused by a commonly prescribed Parkinson’s drug — levodopa. Amantadine was able to beat a placebo in significantly reducing the side effects of levodopa. This generic drug is already used off label for dyskinesia. This is the first drug cleared by the FDA to control levodopa-induced dyskinesia (LID). According to Adamas, around 200,000 people in the US suffer from LID. LID leads to involuntary movements, mostly non-rhythmic, purposeless and unpredictable, making life all the more difficult for a patient of Parkinson’s disease. The disease is progressive and debilitating, causing tremors, rigidity, extreme slowness of movement, impaired balance, and difficulties in swallowing and speaking.   After GSK, Novartis picks its chief digital officer from retail; Pfizer’s swanky new HQ Last month, GlaxoSmithKline appointed former Walmart chief information officer — Karenann Terrell — as its chief digital and technology officer. And last week, Swiss drug major Novartis followed suit — it appointed Bertrand Bodson, who is currently the chief digital and marketing officer for Sainsbury’s Argos retail chain, as its new chief digital officer. Bodson will assume office on January 1, 2018. These two appointments point to the growing challenges drug companies face from the digital world. For instance, mobile applications offer patients new ways to monitor their health. And clinicians increasingly communicate with their patients using the digital media. Bodson’s appointment is also an indication that Novartis intends to use technology for nearly everything — from drug discovery to interactions between clinicians and patients around the world. Bodson’s job also entails automating business processes. Bodson holds a degree from the Harvard Business School. He has also co-founded the social network site — bragster.com. Pfizer’s new HQ in New York: Pharma giant Pfizer has chosen the skyscraper — The Spiral — for its new headquarters in New York. The Spiral is a 1,005-foot-tall office tower in the Hudson Yards district of Manhattan’s Midtown West. According to New York Post, Pfizer has taken up nearly 800,000 square feet of space in this building. The 65-story, 2.85-million square-foot building is designed by Danish architect Bjarke Ingels. FDA approves first CAR-T therapy for cancer; Gilead bets big on it by acquiring Kite   California-headquartered biopharma company Gilead Sciences is acquiring Kite Pharma for US$ 11.9 billion. The acquisition points to Gilead’s increased focus on a new kind of cancer therapy, known as chimeric antegen receptor (CAR) T-cell therapy (or CAR-T) According to Gilead, Kite is an industry leader in cell therapy — a treatment that uses the patient’s own immune cells to fight cancer. Kite’s most advanced CAR-T therapy candidate, axicabtagene ciloleucel (axi-cel), is currently under priority review by the USFDA. The FDA has set a target action date of November 29, 2017 under the Prescription Drug User Fee Act (PDUFA). For Gilead, Kite could bring in the much-needed growth. Gilead has been witnessing falling sales of its hepatitis C treatments. It generates most of its sales from anti-infective therapies. Therefore, the acquisition will diversify Gilead’s portfolio. It will also boost Gilead’s emerging oncology drug franchise. For the biotech sector, this acquisition is a big endorsement of the immuno-oncology segment. CAR-T inhibitors allow doctors to create a “personalized” drug tailored to each cancer patient by harvesting their T-cells and modifying them in a laboratory to make them more efficient at combating and killing cancer cells. Though critics say Gilead has overpaid for Kite, Gilead’s CEO, John Milligan, justified the purchase. “It is certainly our hope that as we are able to drive down manufacturing costs, and as or if these indications broaden to larger patient populations, that we would be able to drive down the prices over time through manufacturing efficiency,” he said. “CAR-T has the potential to become one of the most powerful anti-cancer agents for hematologic cancers,” Arie Belldegrun, president and CEO of Kite, said. Just days after Gilead’s announcement of its acquisition, the FDA approved Novartis’ Kymriah (tisagenlecleucel), the first CAR-T gene therapy, for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). The list price of Kymriah is US$ 475,000 for a one-time treatment. Bayer-J&J, AZ post promising data on their blood thinners; AZ to expand UK operations   At the annual meeting of the European Society of Cardiology held in Barcelona this week, studies brought to fore several benefits of blood thinners like Johnson & Johnson and Bayer’s Xarelto, and AstraZeneca’s Brilinta. A study published in the New England Journal of Medicine revealed that the combination of a low dose of Xarelto and aspirin cut the risk of heart attacks by 14 percent, strokes by 42 percent, and death by 18 percent. Forty-one out of every 1,000 people who took the Xarelto-and-aspirin combo would be expected to have a heart attack, stroke, or heart-related death compared to 54 among those who got aspirin alone. Next generation anticoagulants, such as Eliquis, had been giving Xarelto a run for its money. Similarly, a sub-analysis from the Pegasus clinical trial, which first reported positive results in 2015, showed that AstraZeneca’s blood-thinner Brilinta cuts the risk of cardiovascular death by 29 percent in patients with a history of heart attacks who keep taking it beyond the standard 12-month initial period. The sub-analysis also showed a risk reduction of 20 percent in all causes of death. The finding comes as a shot in the arm for AstraZeneca, which had suffered several clinical failures last year. AstraZeneca to invest in UK facility: Meanwhile, AstraZeneca is making huge investments into its Macclesfield campus in England in order to ramp up production. This is Astra’s biggest manufacturing site. The investment — expected to run into tens of millions of pounds – is set to be announced soon. This investment is likely to take investors by surprise. A month back, Astra’s CEO Pascal Soriot had said he is putting all capital investment decisions on hold due to the uncertainty around Brexit. The decision comes amid calls for the UK government to do more to support the sector ahead of Brexit. Recently, drugmakers, including AstraZeneca, published a paper calling on the public sector to invest up to US$ 181 million (£140 million) in three new drug manufacturing “centers of excellence” to stimulate the industry and help reverse a long-term decline in UK’s drug exports.    

    Impressions: 2485

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/fda-announces-generic-drug-user-fees-for-fy18-gilead-acquires-kite-for-us-12-billion

    #Phispers by PHARMACOMPASS
    31 Aug 2017
    Share Share
    Investors up ante against Mylan board; More Ipca products banned from the US

    Investors up ante against Mylan board; More Ipca products banned from the US

    This week, Phispers looks at fresh troubles brewing at Mylan, as rebel investors intensify their demand for remaking the board, and a low-cost rival for EpiPen gets FDA nod. Meanwhile, BMS sold off its API plant in Ireland to South Korea’s SK Biotek and Baxter tied up with CRO Dorizoe for speedier development of generic injectables. There is more news on Dr. Reddy’s, Ipca and CROs this week. Read on.  Tough time for Mylan as camp to oust directors grows; Adamis to launch EpiPen rival   The war at Mylan — with rebel investors on one side, and the management on the other side — intensified last week as another proxy firm joined hands with the rebel investors looking to remake the board. Egan-Jones Proxy Services joined ISS, Glass Lewis and a group of rebel shareholders in pushing for the ouster of the board members. Together, they feel Mylan shareholders should vote against the re-election of six directors. Mylan shareholders will meet in Amsterdam on Thursday, June 22, 2017. The investors are not just disturbed over Chairman Robert Coury’s US$ 97 million pay package for 2016, but are also upset that Mylan turned away potential acquirer Teva. And that government investigations over pricing went beyond the EpiPen, and involved its generic drugs as well. However, Mylan’s CEO Heather Bresch shot back by blaming the company’s problems on external pressures, as opposed to internal missteps. Meanwhile, Mylan received another setback last week when Adamis Pharmaceuticals received approval for selling its emergency epinephrine syringes in the US. Adamis’ epinephrine syringes will prove to be a lower cost alternative to Mylan’s widely used EpiPen. Epinephrine treats severe allergic reactions. Adamis is reportedly looking for a marketing partner and would set a price for the product before its launch sometime in the second half of 2017. Its pre-filled epinephrine syringes would be sold under the brand name Symjepi. Trump’s volte-face: Pharma executive order to have positive impact on industry   President Donald Trump has repeatedly spoken about being tough on the drug industry. Yet, his administration is yet to take any measure that lives up to his promise of lowering drug prices. On the contrary, news reports suggest that Trump administration’s plan to lower prescription drug prices may end up being friendly to drug companies. The 'Drug Pricing and Innovation Working Group’, a group of officials from the Trump administration, have been meeting every two weeks to discuss drug pricing. The group is led by Joe Grogan, an associate director at the Office of Management and Budget who worked for Gilead Sciences until March this year. Gilead has been repeatedly criticized for pricing its hepatitis C drugs at US$ 1,000 per pill. To solve the crisis of high drug prices, the group discussed strengthening the monopoly rights of pharmaceuticals overseas, ending discounts for low-income hospitals and accelerating drug approvals by the US Food and Drug Administration (FDA). According to Kaiser Health News, the policies wouldn't ease the cost of prescription drugs, and might even increase them. The Trump administration is preparing the executive order, which could be signed within weeks. According to another news report, the executive order was originally expected to have a negative impact on the drug industry, but the policies now under consideration would not do so. For instance, the Trump administration is said to be considering direct federal agencies to pursue value-based purchasing contracts for drugs. Another policy under discussion would instruct agencies to pursue trade policies that would strengthen the intellectual property rights of drug companies. The industry too expects a positive impact. Allergan CEO Brent Saunders recently said the executive order on drug pricing could have a positive impact and he believes his company is well-positioned to handle any changes. BMS sells its API plant in Ireland to Korea’s SK Biotek   Bristol-Myers Squibb (BMS) is selling off its API plant in Ireland to South Korea’s SK Biotek. The divestment is in line with BMS’ shift in focus towards biologics manufacturing. SK Biotek is a unit of South Korea’s third largest conglomerate, SK Holdings. The company has been a BMS ingredient supplier for a decade. Though the terms of the deal are not known, it is likely to close in the last quarter of 2017. SK Biotek will continue to manufacture products BMS currently makes at the plant, which includes the API for BMS and Pfizer’s anticoagulant Eliquis.  SK Biotek will use this plant for its contract development and manufacturing business, which is growing at a healthy pace. It plans to add marketing and R&D operations at the site, as well as invest in boosting capacity. “This transaction is an important step to achieve our goal of becoming a leading global CDMO (contract development and marketing organization),” Junku Park, CEO, SK Biotek, said in a statement. Ipca’s products banned from US; Dr. Reddy’s provides positive inspections updates   Of late, Dr. Reddy’s has been providing positive inspection updates. On June 16, the company said it received one US FDA observation for its Srikakulam formulation plant, which the company is addressing. However, the company didn’t disclose the nature of the observation.  Three days prior, on June 13, Dr.Reddy’s had received an Establishment Inspection Report (EIR) for its Miryalaguda plant, indicating closure of the FDA audit. The API plant was inspected by the US regulator in February this year, and had received three Form 483 observations. The Miryalaguda plant was one among the three plants for which the company received FDA’s warning letter in November 2015. The warning letter mentioned deviations in good manufacturing practices (GMPs). Meanwhile, the FDA banned entry of products of Ipca Lab in the US due to non-compliance with manufacturing norms at three of its facilities. All drugs manufactured at facilities in Ratlam, Indore SEZ and Silvassa will be refused admission in the US until the company can demonstrate that products from these sites are in compliance with prescribed norms. The company’s API plant at Ratlam and formulations units at Indore SEZ and Silvassa have been under FDA import alert since 2015 for violation of GMPs. However, few products were exempted from the ban to avoid shortages in the US market. Now, only one API product, chloroquine phosphate manufactured at Ratlam facility, is exempted from the import ban. Baxter in agreement with Dorizoe to speed up development of generic injectables   Global medical products company Baxter International Inc announced it had entered into an agreement with Dorizoe Lifesciences Limited (Dorizoe), a full-service global contract research and development organization headquartered in Ahmedabad (India). The agreement will speed up the development of more than 20 generic injectable products—including anti-infectives, oncolytics and cardiovascular medicines.  “This partnership extends Baxter’s growing pipeline of generic injectables, further strengthening our portfolio with a broad range of high-quality essential medicines,” Robert Felicelli, president, Pharmaceuticals, Baxter, said. Baxter has been in an expansion mode. In December last year, Baxter had announced the acquisition of Claris Injectables Limited (Claris) for US$ 625 million. The acquisition of Claris, which is expected to close in the second half of 2017, will provide Baxter with a portfolio of molecules in anesthesia and analgesics, renal, anti-infectives and critical care. Recently, Baxter also announced a strategic partnership with ScinoPharm Taiwan, a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. The partnership is for developing, manufacturing and commercializing five generic injectables used in cancer treatment, with an option to add up to 15 additional injectable molecules. After AMRI, Parexel International — gets acquired by a PE firm for US$ 4.5 billion   This appears to be a month when private equity firms are continuing to pick up stake in pharma contract research organizations or CROs. On June 6, global asset manager, the Carlyle Group (CG) and GTCR LLC (a private equity firm), acquired Albany Molecular Research (AMRI), a global contract research and manufacturing organization, for about US$ 922 million in cash. And this week, Parexel International Corp, a US drug research services provider, got acquired by Pamplona Capital Management LLP in a US$ 4.5 billion deal. There was pressure from investors, including Starboard Value LP, on Parexel to explore a sale. They argued the company’s profit margins have consistently fallen behind those of its peers. Headquartered near Boston, Massachusetts, Parexel provides a range of services to the pharma industry, such as drug development, regulatory consulting, clinical pharmacology, clinical trials management and reimbursement.  

    Impressions: 2695

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/investors-up-ante-against-mylan-board-more-ipca-products-banned-from-the-us

    #Phispers by PHARMACOMPASS
    22 Jun 2017
    Share Share
    Chemical entities SHINE in the top 10 fastest-growing drugs of 2016

    Chemical entities SHINE in the top 10 fastest-growing drugs of 2016

    Global pharmaceutical companies are increasingly focusing on the development of new biologics. In fact, in 2016, nine out of the top 15 pharmaceutical drugs by sales were of biologic origin. This makes us wonder what the future holds for manufacturers specializing in drugs that originate from chemical synthesis. This week, PharmaCompass continued its analysis of the top pharma drugs by sales to evaluate the drugs that registered large sales growth in 2016. Click here to Access All the 2016 Data (Excel version available) for FREE! Please note that these are not the top-selling drugs, but are the top 10 drugs that registered the maximum growth in global sales over 2015. Interestingly, things didn’t appear that bad for drugs originating from chemical synthesis — while the top two drugs on the list were biologics, the remaining originated from chemical synthesis.  Here’s a list of drugs that witnessed the largest sales growth in 2016: 1. Opdivo (nivolumab) – Bristol-Myers Squibb   2016 sales: US$ 3,774 million 2015 sales: US$ 942 million Sales growth: US$ 2,832 million First approved in 2014, Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda — also known as checkpoint inhibitors — continued to stay on track to be among the top 20 best-selling drugs in the world by 2020. They represent the hot new field of immunotherapy and are known to have given 90-year old Jimmy Carter (former President of the United States) hope in his fight against cancer. With a sales growth of US$ 2.832 billion, Opdivo registered the highest sales growth of any single drug in 2016. However, Bristol-Myers Squibb received a nasty surprise last year when Opdivo did not demonstrate the desired slowdown in the progress of advanced lung cancer in a trial, as compared to conventional chemotherapy. While Bristol-Myers’ stock price plunged on this news, Merck announced that not only did Keytruda succeed in a clinical trial as an initial treatment for advanced non-small cell lung cancer, but patients actually lived longer. Although Keytruda did not make it to our list of top 10 drugs by sales growth in 2016, it did register a sales increase of US$ 836 million, as its sales grew from US$ 566 million to US$ 1,402 million. Click here to Access All the 2016 Data (Excel version available) for FREE! 2. Humira (adalimumab) – AbbVie   2016 sales: US$ 16,078 million 2015 sales: US$ 14,012 million Sales growth: US$ 2,066 million Abbvie’s Humira (adalimumab) juggernaut continued as it not only remained the best-selling drug in the world, but also added another US$ 2 billion to its 2015 sales by generating record sales of US $16.078 billion in 2016. Last year, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita™ (adalimumab – atto) — a biosimilar of Humira®. Therefore, it remains to be seen if Humira will be able to sustain the momentum. Amjevita was approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis. 3. Epclusa (sofosbuvir and velpatasvir) – Gilead   2016 sales: US$ 1,752 million (new launch) Gilead’s third sofosbuvir-based regimen — Epclusa (sofosbuvir and velpatasvir) was approved by the US FDA in June 2016. It is the first and only all-oral, pan-genotypic single tablet regimen for chronic Hepatitis C virus infection. While Epclusa registered an impressive start, Gilead's other two sofosbuvir-based treatments — Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and lepidasvir) — saw their combined sales decline by almost US$ 6 billion. Click here to Access All the 2016 Data (Excel version available) for FREE! 4. Imbruvica (ibrutinib) — Johnson & Johnson / AbbVie   2016 sales: US$ 3,083 million 2015 sales: US$ 1,443 million Sales growth: US$ 1,640 million Abbvie’s 2015 US$ 21 billion buy of Pharmacyclics seems to be paying off. The Pharmacyclics buy was a way to get access to Imbruvica (ibrutinib), a cancer drug which is co-marketed with Johnson & Johnson. It generated sales of US$ 3.083 billion in 2016. Imbruvica works by blocking a specific protein called Bruton’s tyrosine kinase (BTK). In December 2011, Johnson & Johnson said it would pay Pharmacyclics as much as US$ 975 million to fund getting the drug to market in exchange for half the profits generated globally. 5. Eliquis (apixaban) - Bristol-Myers Squibb / Pfizer   2016 sales: US$ 3,342 million 2015 sales: US$ 1,860 million Sales growth: US$ 1,483 million Although apixaban was the third-to-market novel oral anticoagulant (NOAC), which is co-promoted by Pfizer and Bristol-Myers Squibb as Eliquis, it continues to unseat Johnson & Johnson’s Xarelto (rivaroxaban) as the leader in its class based on total prescriptions. Rivaroxaban's total 2016 sales were US$ 5.392 billion. While Pfizer’s reports its sales as part of Alliance revenues, and exact sales are not known, Bristol-Myers Squibb results alone put Eliquis in the top 10 list. Generics are hot on their tail as, last month, Pfizer and Bristol-Myers’ filed suits against 16 generic makers to uphold their patents for apixaban. 6. Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) — Gilead   2016 sales: US$ 1,484 million 2015 sales: US$ 45 million Sales growth: US$ 1,439 million Genvoya has been the most successful HIV treatment launch since the introduction of Atripla (the first single-tablet regimen launched a decade ago). Gilead is the dominant HIV player in the US market and has the top three most-prescribed HIV regimens in the US.  Genvoya adds Tenofovir Alafenamide (TAF) to already known treatments. TAF based drugs have demonstrated a better safety profile. They would also allow Gilead to maintain its dominance in the HIV market. Click here to Access All the 2016 Data (Excel version available) for FREE! 7. Ibrance (palbociclib) — Pfizer   2016 sales: US$ 2,135 million 2015 sales: US$ 723 million Sales growth: US$ 1,412 million Discovered in Pfizer laboratories and approved by the US FDA in February 2015, Ibrance is used in combination with Letrozole as a first-line treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer. 8. Triumeq (abacavir, dolutegravir, lamivudine) – GlaxoSmithKline   2016 sales:US$ 2,151 million 2015 sales: US$ 905 million Sales growth: US$ 1,246 million GlaxoSmithKline's HIV drugs business — ViiV Healthcare — has been enjoying sales growth with the introduction of Triumeq ® in its portfolio. While GSK is the major shareholder in ViiV Healthcare, Pfizer and Shionogi also have a stake. Triumeq® is the company’s first fixed-dose combination tablet for a once-daily single pill regimen that combines dolutegravir, an integrase inhibitor, with the nucleoside reverse transcriptase inhibitors — abacavir and lamivudine. 9. Revlimid (lenalidomide) – Celgene   2016 sales: US$ 6,974 million 2015 sales: US$ 5,801 million Sales growth: US$ 1,173 million Celgene’s Revlimid (lenalidomide) — a thalidomide-derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in US$ 5.8 billion in 2015, and grew another 20 percent this year, to US $6.974 billion. Revlimid now contributes more than 60 percent to Celgene's total sales of US$ 11.229 billion. 10. Xarelto (rivaroxaban) – Johnson & Johnson (US) and Bayer   2016 sales: US$ 5,392 million 2015 sales: US$ 4,255 million Sales growth: US$ 1,137 million Bayer’s Xarelto, which is promoted by Johnson & Johnson in the United States, provided patients with an alternative to the old-guard therapy — warfarin. While rivaroxaban is competing with other novel oral anticoagulants (NOAC) like Eliquis (apixaban) and Pradaxa (dabigatran), rivaroxaban has the class lead in indications. Xarelto recently posted positive results in a large-scale Phase 3 study —COMPASS, involving 27,402 patients, that assessed the effect of the blood thinner in preventing major adverse cardiac events (MACE). The trial was stopped a year early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE (which includes cardiovascular death, myocardial infarction and stroke) reached its pre-specified criteria for superiority over aspirin.  Click here to Access All the 2016 Data (Excel version available) for FREE! Our view   In QuintilesIMS Institute’s new annual drug spending report, analysts have forecasted that over the coming five years the industry should continue to receive 40 to 45 new drug approvals every year. A quarter of all the drugs in late-stage development are now focused on oncology. The rate of oncology drug development has hit such a rapid pace that new drugs are superseding old ones in a matter of a few years. It’s clear that this compilation will see radical changes next year. However, with eight out of the 10 fastest-selling drugs coming from chemical synthesis, traditional generic manufacturers still have a lot of opportunities to explore. Sign up, stay ahead    In order to stay informed, and receive industry updates along with our data compilations, do sign up for the PharmaCompass Newsletter and you will receive updated information as it becomes available along with a lot more industry analysis. Click here to Access All the 2016 Data (Excel version available) for FREE!  

    Impressions: 9289

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/chemical-entities-shine-in-the-top-10-fastest-growing-drugs-of-2016

    #Phispers by PHARMACOMPASS
    17 May 2017
    Share Share
    More bad news engulfs Teva; India to bring laws so that doctors prescribe generics

    More bad news engulfs Teva; India to bring laws so that doctors prescribe generics

    This week, Phispers brings you news about Teva — which received a warning letter from the FDA for its China facility and a setback from the Mexican regulator in its ongoing legal battle with Rimsa. Also, there is news on how Aspen employees allegedly destroyed stocks of life-saving drugs, along with news on Eli Lilly, Korea’s Hanmi and Pfizer-BMS. Read on.   FDA issues warning letter to Teva’s China facility; Mexico regulator supports Rimsa   In a difficult week for Teva, the world’s largest manufacturer of generic drugs reported that its facility in China got a warning letter from the US Food and Drug Administration (FDA).The warning letter came in on April 10, based on a regulatory inspection carried out in September last year. Teva said they are in the process of addressing the concerns raised by the FDA and will respond to the regulator by May 1. The FDA referenced several deficiencies at Teva’s active pharmaceutical (API) plant pertaining to production controls and sampling techniques and processes. To make matters worse for the Israeli drugmaker, Mexico’s pharmaceutical regulator — Federal Commission for the Protection against Sanitary Risk (COFEPRIS) — issued a memorandum that appears to undermine the claims of Teva against drugmaker Representaciones e Investigaciones Medicas SA, known as Rimsa, which it acquired for US $2.3 billion in 2015. In the memorandum, COFEPRIS says it found no “unexpected adverse effects” in 147 drugs produced by Rimsa. It said the drugs were safe. Teva is engaged in a legal battle against Rimsa for allegedly selling defective products and duping regulators. In September 2016, the former owners of Rimsa had filed a legal suit in a New York State court against Teva’s subsidiary Lemery SA, saying Teva was suffering from “a classic case of buyers’ remorse” and was therefore alleging that the former owners fraudulently induced it to purchase the Rimsa companies. Teva has had issues with the FDA since last year. And these have affected its operations. The company has received two warning letters in just six months, say news reports. Aspen’s staff plotted to destroy stocks of life-saving drugs   Employees at Africa’s leading drug company — Aspen Pharmacare — reportedly plotted to destroy stocks of life-saving medicines during a price dispute with the Spanish health service in 2014. In fact, leaked internal emails suggest that employees at Aspen called for a “celebration” over price hikes of cancer drugs, an investigation has revealed. In October last year, Italian antitrust authorities fined Aspen nearly US $ 5.5 million for halting supplies of several cancer drugs. The authorities viewed this as a negotiating tactic to hike the prices of these cancer drugs by as much as 1,500 percent. The price-gouging episode began after Aspen purchased five different cancer drugs from GlaxoSmithKline. It then began negotiations with the Italian Medicines Agency over pricing for the cancer medicines. This news from Aspen comes at a time when Baxter’s possible price fixing of intravenous (IV) saline has led to an employee being subpoenaed. Baxter said the subpoena, obtained by federal investigators, is “pursuant to a criminal investigation”. It calls for the employee to produce documents and testimony related to pricing, shortages of Baxter's IV solutions “and communications with competitors regarding the same,” the company said. BMS, Pfizer hope to slow generic competition to Eliquis through patent suits   Pfizer and Bristol-Myers Squibb have filed 16 patent infringement suits against generic drug makers over the last fortnight. And these include legal suits against companies like Mylan, Dr. Reddy’s Laboratories and Accord Healthcare. With these patent infringement lawsuits, the two companies hope to slow the advance of generic versions of their shared blockbuster Eliquis. Eliquis is a stroke and blood clot preventer that brought in about US $3.3 billion for BMS last year, up nearly 60 percent from the US $1.9 billion earned the year before. Pfizer, on the other hand, earned US $1.6 billion from this drug. The two companies have gone to great lengths to protect and promote this drug — which is a top-selling product for both companies. Pfizer spent US $174 million on direct-to-consumer advertising for Eliquis last year. Modi says India may bring legal framework for doctors to prescribe generics   India is keen on encouraging cheaper generics over branded drugs. India’s Prime Minister Narendra Modi on Monday indicated that his government may bring in a legal framework under which doctors will have to prescribe generic medicines to their patients, which are cheaper than the corresponding branded drugs. The government has brought in a health policy after 15 years and capped the prices of medicines and stents, which has angered some pharmaceutical companies, Modi said. “Doctors write prescriptions in such a way that poor people do not understand the handwriting, and he has to buy that medicine from private stores at high prices,” Modi said. “It is the government’s responsibility that everybody should get health services at minimal price,” he added. FDA tells Lilly to do more work on its new rheumatoid arthritis drug   Eli Lilly was not able to pacify FDA’s concerns over the safety risks of its much anticipated rheumatoid arthritis drug — baricitinib. The Indianapolis-based drug company and its partner Incyte were expecting an approval for baricitinib. Instead, they received a complete response (CRL) letter from the FDA, which said they need to do more work on the drug. FDA wants to see additional clinical data to get the doses right and to better characterize safety concerns for the once-daily oral medication for moderate-to-severe rheumatoid arthritis (RA), Eli Lilly said. More trials will increase the time and money that Eli Lilly and Incyte spend on baricitinib before its approval. Incyte and Lilly both said they are committed to working with the agency to get approval. “We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA,” Christi Shaw, president of Lilly Bio-Medicines, said in a statement. “We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the US,” Shaw added. Controversy around Korea’s Hanmi and the death of a patient   Korean drug maker Hanmi is involved in a controversy pertaining to its cancer drug — olmutinib. A Korean patient taking this drug died from a rare case of Stevens-Johnson syndrome. And the death was reported after 14 months to the country’s health authorities. As a result, Hanmi’s partner — Boehringer Ingelheim — abruptly withdrew from their US $730 million partnership for olmutinib. The death of the patient occurred in July 2015, when the patient was taking olmutinib and two other drugs. The physicians involved in the case said it was triggered by the other drugs and reported the case to a monitoring agency. But it was not reported as an unexpected serious adverse event. Hanmi and the agency finally reported the death to health officials in September, 2016. According to Korean officials, Hanmi broke two medical laws related to monitoring and reporting clinical trials. The opposition party in Korea said the influential Hanmi had intentionally delayed reporting the death so it could get the drug approved in Korea. But investigators say they found no evidence of that.  

    Impressions: 2986

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/more-bad-news-engulfs-teva-india-to-bring-laws-so-that-doctors-prescribe-generics

    #Phispers by PHARMACOMPASS
    20 Apr 2017
    Share Share
    US DMF filings indicate a robust API industry, with multiple first-to-file challenges

    US DMF filings indicate a robust API industry, with multiple first-to-file challenges

    This week, PharmaCompass brings you a compilation of the Drug Master Files (DMFs) updates at the US Food and Drug Administration (FDA) over the past two quarters. These applications provide an overview of the products active pharmaceutical ingredient (API) manufacturers are investing in. And, they also give a sneak preview into the next possible first-to-file (FTF) generic challenges to patented drugs.  Here are some key findings from our compilation of the FDA’s DMF updates over the second and third quarter of 2016, details of which were provided in July and October: India leads the pack, as the number of filings remain the same Over the period, there were a total of 379 updates of DMFs at the FDA. This number indicates a pace in filings that is nearly the same as the previous quarters. We had seen 180 DMFs updates in the last quarter (Q4) of 2015 and 190 in the first quarter (Q1) of  2016. During the last two quarters, the DMF updates were led by Indian companies, such as Macleods Pharmaceuticals (14 DMFs), MSN Labs (13 DMFs), Hetero (12 DMFs), Lupin (9 DMFs), Cipla and Biophore. The other prominent companies were Mylan and Teva. Companies with compliance issues stay away Unlike previous quarters, where companies with compliance problems continued to submit DMFs, the last two quarters were slightly different, since companies like Zhejiang Hisun and Ipca Laboratories did not submit DMFs. However, Emcure Pharmaceuticals — whose Pune facility was inspected by the FDA last year and a warning letter was issued to the company for violations of current good manufacturing practices (cGMPs) in March this year — submitted one DMF (for Phytonadione) While China shut down antibiotic manufacturing in the Shijiazhuang city, raising concerns about the global supply chain’s dependence on China, Sinopharm Weiqida Datong Pharmaceutical, located about 300 kilometers away from Shijiazhuang, filed DMFs for the key building blocks of antibiotic manufacturing — 6-APA and 7-ACA. Once again, this filing reinforces the dependence of global antibiotic manufacturing on China. Click here to view all the updates of the second and third quarter of 2016 (Excel version available) for FREE! Imminent FTF challenges The FTF challenges to Alvimopan Dihydrate (Merck’s Entereg), Apremilast (Celgene’s Otezla), Bosutinib (Pfizer’s Bosulib), Daclatasvir Dihydrochloride (Bristol-Myer Squibb’s Daklinza), Elvitegravir (an ingredient in Gilead’s Vitekta, Stribild, Genvoya), Ibrutinib (AbbVie’s Imbruvica), Ospemifene (Shionogi’s Osphena), Perampanel (Eisai’s Fycompa), Pomalidomide (Celgene’s Pomalyst), Regorafenib (Bayer’s Stivarga), Tofacitinib (Pfizer’s Xeljanz) and Vortioxetine Hydrobromide (Takeda’s Trintellix) seem to be imminent in view of the recent filings of DMFs. Roche’s 2014 acquisition of InterMune for US $ 8.3 billion to gain rights to Esbriet (pirfenidone) is likely to come under attack as three more DMFs were submitted during the period under review. The ink wasn’t dry on the deal papers of Pfizer’s US $1 4 billion acquisition of Medivation in August this year, when two more companies — Watson Pharma (now Allergan) and Scinopharm — submitted filings for Enzalutamide, the product for which Pfizer paid all that money. This takes the total number of US submissions for this product to seven. Apixaban and Canagliflozin are most actively filed products The most actively updated DMFs in the past six months were for the APIs of Bristol-Myer Squibb’s new-age anticoagulant Eliquis (Apixaban) and Johnson & Johnson’s diabetes treatment Invokana (Canagliflozin). Sixteen DMFs were submitted for Apixaban along with nine for Canagliflozin. Products like Dimethyl Fumarate and Teriflunomide — which were the most frequently filed DMFs in our previous reports — continued to see vigorous filing activity.  Synbias Pharma made a submission for Nelarabine, the only submission for a Novartis product that was approved in 2005 and for which the only listed patent is expiring in June 2017. Similarly DSM’s submission of Dexpanthenol is the only DMF listed for a product used in a variety of injectable and intravenous solution products. Established pharmaceutical companies like Quimica Sintetica and Piramal Healthcare made submissions for products — Benznidazole and Norprostol — which are currently not approved in the United States, indicating the possibility of development projects being underway. Our view With drug filings ranging from multiple FTFs to cannabis derivatives, updates over the two quarters have shown that regardless of the compliance news, activity in the API industry is extremely robust. You can view the PharmaCompass compilation of the new DMF filings by clicking here or simply by sending us an email to get your own Excel version of the new submissions. Click here to view all the updates of the second and third quarter of 2016 (Excel version available) for FREE!    

    Impressions: 4464

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/us-dmf-filings-indicate-a-robust-api-industry-with-multiple-first-to-file-challenges

    #PharmaFlow by PHARMACOMPASS
    08 Dec 2016
    Share Share
    Top drugs by sales revenue in 2015: Who sold the biggest blockbuster drugs?

    Top drugs by sales revenue in 2015: Who sold the biggest blockbuster drugs?

    The year 2015 has gone down in history as a record year for mergers and acquisitions in the pharmaceutical and biotech space with deals worth US $ 300 billion being announced. The highlight of the year was the Pfizer-Allergan mega-merger – the biggest-ever pharma transaction worth more than US $ 160 billion.  Pharma Letter tracked transactions through the year and found the number of deals exceeding US $1 billion at 30 in 2015, as compared to 26 in 2014 and 20 in 2013. In all, a total of 166 M&A deals were announced in 2015 (out of which some are yet to be completed), compared to 137 in 2014.   This week, PharmaCompass brings you a compilation of the top drugs of 2015 by sales revenue and growth. Sofosbuvir – the outright winner of 2015 2015 was the year of Sofosbuvir – the revolutionary active ingredient used for the treatment of hepatitis. Together, through the sale of drugs Harvoni and Sovaldi, Sofosbuvir brought in sales of almost US $ 19 billion. The PharmaCompass prediction that Harvoni (a combination of Ledipasvir and Sofosbuvir; and used for the treatment of infectious diseases like hepatitis and HIV) would become the best-selling drug ever in 2015 fell slightly short of expectations as its sales of US $ 13.864 billion were marginally less than AbbVie’s rheumatoid arthritis treatment – Humira. Humira retained its place as the best-selling drug with US $ 14.012 billion in sales in 2015. However, with sales growth of US $ 11.737 billion in a single year, Harvoni is poised to become the best-selling drug by the end of 2016. Top 20 Drugs by Sales Here is PharmaCompass’ compilation of the best-selling drugs of 2015. This is based on information extracted from annual reports and US Securities and Exchange Commission (SEC) filings of major pharmaceutical companies. If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version. Click here to access all the 2015 data (Excel version available) for FREE!   Product Active Ingredient Main Therapeutic Indication Company 2014 Revenue in Millions (USD) 2015 Revenue in Millions (USD) 2015 Sales Difference Millions (USD) 1 Humira Adalimumab Immunology (Organ Transplant, Arthritis etc.) AbbVie 12,543 14,012 1,469 2 Harvoni Ledipasvir and Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead Sciences 2,127 13,864 11,737 3 Enbrel Etanercept Immunology (Organ Transplant, Arthritis etc.) Amgen / Pfizer 4,688 8,697 4009 4 Remicade Infliximab Immunology (Organ Transplant, Arthritis etc.) Johnson & Johnson / Merck 6,868 8,355 1487 5 MabThera/Rituxan Rituximab Oncology Roche 5,659 7,115 1,456 6 Lantus Insulin Glargine Diabetes Sanofi 6,978 7,029 51 7 Avastin Bevacizumab Oncology Roche 6,481 6,751 270 8 Herceptin Trastuzumab Oncology Roche 6,338 6,603 265 9 Revlimid Lenalidomide Blood Related Disorders Celgene Corpoartion 4,980 5,801 821 10 Sovaldi Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead Sciences 10,283 5,276 (5,007) 11 Seretide / Advair Salmeterol Respiratory Disorders GlaxoSmithKline 6,005 5,227 (778) 12 Crestor Rosuvastatin Calcium Cardiovascular AstraZeneca 5,512 5,017 (495) 13 Lyrica Pregabalin Neuroscience and Mental Health Pfizer Inc. 5,168 4,839 (329) 14 Neulasta Pegfilgrastim Blood Related Disorders Amgen 4,596 4,715 119 15 Gleevec / Glivec Imatinib Oncology Novartis 4,746 4,658 (88) 16 Xarelto Rivaroxaban Anticoagulants Bayer / Johnson & Johnson 3,369 4,345 976 17 Copaxone Glatiramer Neuroscience and Mental Health Teva 4,237 4,023 (214) 18 Januvia Sitagliptin Diabetes Merck & Co 3,931 3,863 (68) 19 Abilify Aripiprazole Neuroscience and Mental Health Bristol-Myers Squibb/ Otsuka Holdings 6,485 3,804 (2681) 20 Tecfidera Dimethyl Fumarate Neuroscience and Mental Health Biogen 2,909 3,638 729 Click here to access all the 2015 data (Excel version available) for FREE! A year of record FDA approvals 2015 was also the year when the US Food and Drug Administration (FDA) approved 45 novel drugs, another all-time record high. In January this year, PharmaCompass had compiled a list of novel drugs approved by the FDA in 2015. We also extensively covered the new dosage forms of existing drugs approved in 2015. Do go through the article published on January 14, 2016, for more information. PharmaCompass’ compilation of sales forecasts of novel drugs indicated a significant variation in estimates.  However, in our view, drugs that saw highest sales growth in 2015 are likely to do well this year as well. Top 20 drugs by sales growth (in USD, millions)   Product Active Ingredient Main Therapeutic Indication 2014 Revenue in Millions (USD) 2015 Revenue in Millions (USD) 2015 Sales Difference Millions (USD) 1 Harvoni Ledipasvir and Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) 2,127 13,864 11,737 2 Viekira Pak Ombitasvir/Paritaprevir/Ritonavir Infectious Diseases (HIV, Hepatitis etc.) 48 1,639 1,591 3 Humira Adalimumab Immunology (Organ Transplant, Arthritis etc.) 12,543 14,012 1,469 4 Hepatits C Franchise Daclatasvir and Asunaprevir Infectious Diseases (HIV, Hepatitis etc.) 256 1,603 1,347 5 Imbruvica Ibrutinib Chronic lymphocytic leukemia 200 1,443 1,243  6 Cubicin Daptomycin Anti-bacterial 25 1,127 1,102 7 Eliquis Apixaban Anticoagulants 774 1,860 1,086 8 Triumeq Abacavir, Dolutegravir and Lamivudine Infectious Diseases (HIV, Hepatitis etc.) - 1,037 1,037 9 Xarelto Rivaroxaban Anticoagulants 3,369 4,345 976 10 Opdivo Nivolumab Oncology 6 942 936 11 Revlimid Lenalidomide Blood Related Disorders 4,980 5,801 821 12 Tecfidera Dimethyl Fumarate Neuroscience and Mental Health 2,909 3,638 729 13 Xtandi Enzalutamide Oncology 480 1,207 727 14 Ibrance Palbociclib Oncology - 723 723 15 Invokana / Invokamet Canagliflozin Type 2 diabetes 586 1,308 722 16 Victoza Liraglutide Diabetes 2,014 2,704 690 17 Stribild Cobicistat, Elvitegravir, Emtricitabine and Tenofovir Disoproxil Fumarate Infectious Diseases (HIV, Hepatitis etc.) 1,197 1,825 628 18 Levemir Insulin Diabetes 2,133 2,745 612 19 Votrient Pazopanib Oncology 565 565 20 Perjeta Pertuzumab Oncology 927 1459 532   Hepatitis C products, which had three of the four highest sales growths in 2015, clearly show the impact these revolutionary treatments will have on the global healthcare landscape in time to come. Cancer immunotherapy treatments, a new generation of blood thinners and novel diabetes treatments were some of the others which demonstrated stellar growth in 2015. Vaccines from Pfizer and Sanofi also displayed tremendous sales growth although they have not been included in the compilation of drugs. Click here to access all the 2015 data (Excel version available) for FREE!   Sign Up, Stay Ahead While some companies like Boehringer and Valeant are yet to release their annual reports. In order to stay informed, do sign up for the PharmaCompass Newsletter and you will receive updated information as it becomes available along with a lot more industry analysis. Click here to access all the 2015 data (Excel version available) for FREE!   CORRECTION, April 12, 2016: An earlier version of this compilation did not account for cases where the same drug is sold by multiple companies (e.g. Enbrel, Remicade, Xarelto etc.). As an outcome, a re-ranking of the Top 20 Drugs by Sales and Sales Growth has been done.   

    Impressions: 56504

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-revenue-in-2015-who-sold-the-biggest-blockbuster-drugs

    #PharmaFlow by PHARMACOMPASS
    10 Mar 2016
    Share Share
    The Next Generic Attack: Brilinta® (Ticagrelor), Xarelto® (Rivaroxaban), Tradjenta® (Linagliptin) and…

    The Next Generic Attack: Brilinta® (Ticagrelor), Xarelto® (Rivaroxaban), Tradjenta® (Linagliptin) and…

    With almost 30,000 Drug Master Files (DMFs) submitted to the FDA, reviewing the filings of only the first quarter of 2015, provides an indicator on the current areas of focus of generic pharmaceutical companies. A detailed evaluation of the 241 filings for active pharmaceutical ingredients only, made us find some interesting trends worth sharing. European Blockbuster battle! Of the 241 DMFs, 21 APIs had more than one DMF filing and accounted for 25% of the total filings. Interestingly, 20 DMFs  were for only three APIs: AstraZeneca’s blood thinner Brilinta® (Ticagrelor), with 2014 sales of $476 million, already had DMF filings from Dr. Reddy’s, Mylan, Polpharma and Zhejiang Hisun at the end of last year. With a maximum of 9 new filings from players like Teva, Alembic, Lek and others, AstraZeneca should brace itself for some serious generic onslaught.  While the 9 filings for Ticagrelor were the most for any single compound, not far behind is Bayer’s own blood thinner: Xarelto® (Rivaroxaban). With 7 submissions, the focus of the generic companies is understandable as Rivaroxaban had sales in excess of $3 billion and year-on-year growth in excess of 70%. However, patents currently protect the product till 2020, so patience is needed before generics can access this golden opportunity. Interestingly, 4 filings for Linagliptin (Boehringer’s antidiabetic Tradjenta®) make it yet another European pharma giant lead the list of products being subjected to generic competition, and make us wonder why European blockbusters are preferred over others? Exclusive but not patented There are products, which have no patent protection, but the market is protected by FDA granted exclusivities (learn more on patents and exclusivities from the FDA website). An opportunity for generic companies to gain significant market share of a multi-hundred million dollar market, without any litigation risk or cost is something companies dream about.  As the time of exclusivity expiry nears, Clobazam, Tetrabenazine, Hydroxyprogesterone Caproate, Deferiprone and Trypan Blue will all see increased generic activity as their Drug Master Files have been submitted. Fragmented Activity More than 80% of the DMF submissions were made by companies who filed only a single product. While the products varied from simple compounds like Sodium Chloride to biologics like Plasmid DNA, over 140 companies filed DMFs in the first quarter with almost 30 submitting a DMF for the first time. An expanding list of suppliers who support DMFs increases options for sourcing managers.  However, a fragmented supplier base limits the industrial scale companies can achieve and raises concerns regarding how many can successfully sustain compliance standards under increased regulatory scrutiny? The Next Generic Wave Blood thinners are an opportunity few generic companies wish to pass on. Boehringer’s (Dabigatran Etexilate), Bristol-Myers Squibb’s (Apixaban) and Bayer’s (Rivaroxaban) are novel compounds in this category which had combined sales in excess of $5 billion last year.  While Dagibatran saw a flurry of activity over the last two years with almost 15 DMF filings, there were no additional filings this year. On the other hand, Apixaban, which generated $774 million for Bristol-Myers Squibb in 2014, has only one DMF filing at the moment and that too was done over a year ago. The export data out of India, reviewed on PharmaCompass, for Apixaban, indicates that product development is already complete so it is just a matter of time before the filings begin.   Conclusion: Product and supplier selection is a critical component of every generic company’s strategy. The PharmaCompass database is designed to assist professionals in business development, marketing and sourcing to take more informed decisions. If you would like us to share our shortlist of 241 DMFs, we will be happy to send it to you by email (click here). You can also access our compilation of the 2014 annual reports of major pharmaceutical companies to review the various products along with their revenues (click here): Table: Products with more than one DMF filing in Q1 2015 PRODUCT NAME DMF FILINGS TICAGRELOR 9 RIVAROXABAN 7 LINAGLIPTIN 4 APREPITANT 3 CINACALCET HYDROCHLORIDE 3 ATAZANAVIR SULFATE 2 ATORVASTATIN CALCIUM TRIHYDRATE 2 CLOBAZAM 2 CLOFARABINE 2 DEFERASIROX 2 DIMETHYL FUMARATE 2 EZETIMIBE 2 ICATIBANT ACETATE 2 LURASIDONE HYDROCHLORIDE 2 MELPHALAN HYDROCHLORIDE 2 OLANZAPINE 2 OLMESARTAN MEDOXOMIL USP 2 PRASUGREL HYDROCHLORIDE 2 RIVASTIGMINE USP 2 ROSUVASTATIN CALCIUM 2 SOLIFENACINE SUCCINATE 2

    Impressions: 8782

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/the-next-generic-attack-brilinta-ticagrelor-xarelto-rivaroxaban-tradjenta-linagliptin-and

    #PharmaFlow by PHARMACOMPASS
    13 May 2015
    Share Share
    Who has the biggest one? Sales of the top pharma products by revenue.

    Who has the biggest one? Sales of the top pharma products by revenue.

    We always knew math was fuzzy, but never imagined addition could get so complicated.  A recent publication on 2014 Global Prescription Medication Statistics listed the top pharmaceutical corporations by revenues, the best selling products along with the top therapy areas. The list, based on data published by IMS Health, caught us by surprise since a previous publication by FiercePharma had a completely different order when ranking the top 15 pharmaceutical companies.  As the difference in revenues of the top-10 companies was in excess of $60 billion and IMS Health’s data is an industry standard for decision making, we dug deeper to analyze the correlation between the information in the annual reports and IMS Health’s statistics. Which pharmaceutical company is the largest? Simply put, the answer is, ‘it depends’ on how you define a pharmaceutical company.  Should divisions like diagnostics, animal health, vaccines, consumer health be counted when determining the size of a pharmaceutical company? FiercePharma, in their analysis, used the total revenue of all divisions of the organizations to determine the largest organization; in their case it is Johnson & Johnson. IMS determines their numbers by measuring “prescription sales and dispensing” and hence, excludes divisions like diagnostics, consumer health and animal health, making Novartis the largest company. As currency exchange rate fluctuations have their own, big role, in determining the size of organizations, we believed it would be best to share the revenues, as presented, so that you can draw your own conclusions. Table 1/ Sales comparison for top pharmaceutical companies in 2014 from different sources (IMS, Fierce Pharma and Annual Reports)  Big Pharma IMS Rank IMS Sales (US $Mn) Fierce Pharma Rank Fierce Pharma Sales (US $Mn) Group Sales based on the Annual Report (Currency as reported, Mn)    Novartis 1 51,307 2 57,996 USD 57,996 Pfizer 2 44,929 4 49,605 USD 49,605 Sanofi 3 40,037 5 43,070 Euro 33,770 Roche 4 37,607 3 49,866 CHF 49,866 Merck & Co 5 36,550 6 42,237 USD 42,237 Johnson & Johnson 6 36,422 1 74,331 USD 74,331 AstraZeneca 7 33,313 8 26,095 USD 26,095 Glaxo SmithKline 8 31,470 7 37,960 GBP 23,006 Teva 9 26,001 11 20,272 USD 20,272 Gilead Sciences 10 23,673 10 24,474 USD 24,890 Amgen 11 20,473 12 20,063 USD 20,063 Lilly 12 19,909 14 19,615 USD 19,615 AbbVie 13 19,049 13 19,960 USD 19,960 Bayer 14 18,347 9 25,470 Euro 42,239 Bristol-Myers Squibb Not in Top 20 15 15,879 USD 15,879 NB: Mn is million Click here to access and download all the 2014 data (Excel version available) for FREE! Since each group has multiple divisions, we further split the sales for you to brainstorm: Table 2/ Sales comparison of the different divisions of top pharmaceutical companies in 2014 (Annual Reports in Mn)  Big Pharma Pharma Division Vaccine Division Generics Consumer Health Other Divisions Medical Devices/ Diagnostics Division Animal Health Division Divestures/ Other adjustments Novartis USD 31,791   Sandoz USD 9,562   Alcon USD 10,827     USD 5,816 Pfizer USD 45,708     USD 3,446 USD 451       Sanofi Euro 22,578 Euro 3,974 Euro 1,805 Euro 3,337     Euro 2,076   Roche CHF 38,969         CHF 10,897     Merck & Co USD 30,740 USD 5,302     USD 6,195       Johnson & Johnson USD 32,313     USD 14,496   USD 27,522     AstraZeneca USD 26,095               Glaxo SmithKline GBP 18,670     GBP 4,336         Teva USD 10,458   USD 9,814           Gilead Sciences USD 24,474             USD 416 Amgen USD 19,327       USD 736       Lilly USD 16,481       USD 788   USD 2,346   AbbVie USD 19,960               Bayer Euro 12,052     Euro 7,923       Euro 22,264 Bristol-Myers Squibb USD 15,879               Click here to access and download all the 2014 data (Excel version available) for FREE! Not sure that it adds any extra clarity on what should define a global pharmaceutical company… Since the various divisions make companies complicated to assess, what about product sales? The good news is that we have a winner!  Humira®, AbbVie’s monoclonal antibody Adalimumab, used to treat rheumatoid and other types of arthritis, is the highest selling product globally. IMS reported Humira’s annual sales for 2014 at $11,844 million, while AbbVie mentions their sales of Humira at $12,543 million, the difference: a mere $700 million! However, with IMS gathering data across various points of the supply chain, and the recent volatility of the currency markets, we believe that a difference of 5.5% of total sales is within range of reason. Unfortunately, things stopped making sense the moment we reached the number-two product on the IMS list. Lantus®, Sanofi’s insulin glargine, recorded sales of Euro 6,344 million (based on Sanofi’s 2014 annual report), while IMS mentions Lantus sales were $10,331 million last year. In addition, Sanofi has an 11% growth rate reported while IMS indicates a growth of 30%.   So unless the Euro/Dollar exchange rate moves back towards the 1.5 range, there seems to be a serious difference in the way the product sales are calculated by companies and by IMS.    Using information available in the annual reports and other company declarations, we attempted to compare IMS’ Top 20 Global Products 2014 with available public information, to only find more complications! Table 3/ Sales comparison of the top pharmaceutical products in 2014 (IMS vs Annual Reports) Products IMS Rank IMS Sales (US $Mn) Annual Reports Sales (US $Mn) Pharma Compass Rank Big Pharma Currency Annual Reports Sales in Mn Marketing Partner Marketing Partner Annual Report Sales (US $Mn) Humira® 1 11,844 12,543 1 Abbvie USD 12,543     Lantus® 2 10,331 7,676 5 Sanofi Euro 6,344     Sovaldi® 3 9,375 10,283 2 Gilead Sciences USD 10,283     Abilify® 4 9,285 7,556 6 Bristol Myers-Squibb USD 2,020 Otsuka 5,536 Enbrel®   5 8,707 8,538 4 Amgen USD 4,688 Pfizer 3,850 Seretide® 6 8,652 6,589 8 GSK GBP 4,229     Crestor® 7 8,473 5,512 11 AstraZeneca USD 5,512     Remicade®   8 8,097 9,880 3 Johnson & Johnson USD 6,868 Merck & Co. 2,372 Mitsubishi Tanabe 640 Nexium® 9 7,681 3,655 19 AstraZeneca USD 3,655     Mabthera®   10 6,552 6,936 7 Roche CHF 5,603 Roche 1,305 Avastin®   11 6,070 6,449 9 Roche CHF 6,417     Lyrica® 12 6,002 5,168 12 Pfizer USD 5,168     Herceptin®   13 5,564 6,306 10 Roche CHF 6,275     Spiriva® 14 5,483 3,917 17 Boehringer Euro 3,237     Januvia® 15 4,991 3,931 16 Merck & Co. USD 3,931     Copaxone® 16 4,788 4,237 14 Teva USD 4,237     Novorapid® 17 4,718 2,835 20 Novo Nordisk DKK 17,449     Neulasta® 18 4,627 4,596 13 Amgen USD 4,596     Symbicort® 19 4,535 3,801 18 AstraZeneca USD 3,801     Lucentis®   20 4,437 4,152 15 Novartis USD 2,441 Roche 1,711 Click here to access and download all the 2014 data (Excel version available) for FREE! It’s clear that the methods used to determine product sales are considerably different between IMS and the pharmaceutical companies, however there is a range of consistency as well. How accurate is each information really depends on the analyst’s point of view. Our take: With over $350 billion in total sales, we have provided our raw data for your review since we are certain that there are opportunities worth capitalizing upon and others, which may not be worthwhile to pursue. While the assessment of pharmaceutical sales is far more complicated than what we had originally imaged, the focus of Big Pharma on small molecules is on Hepatitis C drugs (Sofosbuvir,­ Olysio, AbbVie Hep C), blood thinners, Eliquis® (Apixaban), Xarelto®(Rivaroxaban) and of course ‘tinib’ cancer treatments. Table 4/ Growth of ‘tinib’ cancer treatments in 2014 (Annual Reports) Products Big Pharma Sales (US $Mn) 2013 Sales (US $Mn) 2014 Growth (%) Ibrutinib Pharmacyclics, Inc (now AbbVie) 14 492 3414% Dasatinib Bristol-Myers Squibb 1280 1493 17% Trametinib GSK 10 68 580% Nilotinib Novartis 1266 1529 21% Ruxolitinib Novartis 163 279 71% Ceritinib Novartis Not launched 31   Sunitinib Maleate Pfizer 1204 1174 -2% Crizotinib Pfizer 282 438 55% Axitinib Pfizer 319 410 29% Tofacitinib Citrate Pfizer 114 308 170% Click here to access and download all the 2014 data (Excel version available) for FREE! However, Big Pharma is now all about biologics. IMS’s data indicates that the top 10 products have only 5 biologics, while our calculations have 8 out of the top 10 products as biologics. The future strategy is best summed up by the statement in Bristol-Myers Squibb’s annual report “Just 5 years ago, we had about 40% of our development projects in biologics. If we look forward 3-5 years, we believe that number could potentially grow to about 75%”.  The barriers of entry for generic competition and potential windfalls have made rivals come together to co-market Synagis® (AbbVie & AstraZeneca), Remicade® (Johnson & Johnson, Merck and Tanabe), Xolair® and Lucentis® (Roche & Novartis). Our pharmaceutical whisper (phisper): join the bio-age or bio-degrade!  

    Impressions: 12778

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/who-has-the-biggest-one-sales-of-the-top-pharma-products-by-revenue

    #PharmaFlow by PHARMACOMPASS
    23 Apr 2015
    Share Share
    Fondaparinux –An Opportunity Worth Developing

    Fondaparinux –An Opportunity Worth Developing

    A recent study published in the Journal of the American Medical Association (JAMA) showed that patients who received the anticoagulant fondaparinux (Arixtra®) and had experienced a certain type of heart attack had a lower risk of major bleeding events and death, both in the hospital and after six months, compared to patients who received low-molecular-weight heparin (LMWH). The authors analyzed data from a Swedish registry, which included 40,616 patients who had experienced an NSTEMI (non-ST-segment elevation myocardial infarction). A certain pattern on an electrocardiogram following the heart attack was observed, and 14,791 patients (36.4 percent) received fondaparinux, while 25,825 (63.6 percent) received LMWH.  Fondaparinux, an injectable blood thinner that fights clots in the legs (deep vein thrombosis – DVT) and lungs (pulmonary embolism – PE), is a synthetic pentasaccharide, which is difficult to manufacture on a commercial scale.   Arixtra belonged to GSK as recently as 2013, when it was sold off to the South African company Aspen Global Incorporated. Due to Aspen’s lack of a sales representative in the US, they were forced to enter into a $300 million agreement with Mylan for the US market, through which Mylan would pay Aspen $225 million upon completion of the transaction, and an additional $75 million would be held in escrow until certain conditions were met. Apotex had previously been given the rights to sell the authorized generic of Arixtra, the rights of which would eventually transfer to Mylan, which was scheduled to occur by the end of 2014.  Arixtra and the authorized generic of Arixtra had US sales of approximately $18.8 million and $95.3 million, respectively, for the 12 months ending on June 30, 2014, according to IMS Health.  Currently, the only approved product on the US market, other than Mylan’s, is that of Dr. Reddy’s, which was approved in 2011. Dr. Reddy’s entered into a partnership with the Australian company Alchemia, who claims to have been granted patents over novel synthetic pathways that prevent others from using Alchemia’s proprietary process to manufacture fondaparinux until at least 2022.  The regulatory filing review on PharmaCompass shows two suppliers of the key intermediates who have submitted USDMFs, along with multiple API DMF fillings indicating increased availability of the drug substance. This should overcome a major barrier to entry into the Fondaparinux business.  What makes us believers in Fondaparinux? Here are some facts:  $150 million – This is the size of the market in the United States alone.  There are only 2 approved US marketing authorization holders (Mylan and Dr. Reddy’s).  There are alternative API supply sources emerging other than Aspen (through Sanofi’s Sisteron site and Alchemia). Blood thinners are a booming opportunity. Pfizer’s Eliquis, Bayer’s Xarelto, and Boehringer Ingelheim’s Pradaxa are all expected to achieve sales of more than $1 billion each. There has been limited development activity in India as demonstrated by the trade data. The high development costs will keep this market niche in the long run. The recently published study data is extremely positive and will increase sales.   

    Impressions: 5023

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/fondaparinux-an-opportunity-worth-developing

    #Phispers by PHARMACOMPASS
    11 Mar 2015
    Share Share
    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty
    polpharma Apixaban

    Access Virtual Booth

    Contact Supplier

    View Presentation

    DRL Apixaban

    Access Virtual Booth

    Contact Supplier

    View Presentation

    Post Enquiry
    POST ENQUIRY

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search