API SUPPLIERS

API Suppliers

45

US DMFs Filed

23

CEP/COS Certifications

0

JDMFs Filed

0

Other Certificates

0

Other Suppliers

28

API REF. PRICE (USD / KG)

969,472

API Market Place

14

INTERMEDIATES

0

DOSSIERS // FDF

USA (Orange Book)

1

Europe

5

Canada

3

Australia

0

South Africa

5

Uploaded Dossiers

6

GLOBAL SALES (USD Million)

U.S. Medicaid

Annual Reports

EXCIPIENTS

6

PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

0

USFDA Exclusivities

0

DIGITAL CONTENT

Blog #PharmaFlow

5

News

137

REF STANDARD

EDQM

0

USP

0

JP

0

Other Listed Suppliers

1

SERVICES

0

Blog

Full Screen View

DMF submissions in 2021: India, China continue to top filings

The year 2021 was eclipsed by the Covid-19 pandemic. In our update for the first half of 2020, we had mentioned that Covid-19 has not slowed down the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA). That trend continued in 2021, when the speed of DMF submissions to the agency remained similar to that witnessed in the previous years. In fact, Type II DMFs, or DMFs for active pharmaceutical ingredients (APIs), were higher in 2021 as compared to previous years. In the first quarter, FDA received 164 Type II DMF submissions, which rose to 165, 166 and 172 submissions over the next three quarters. In all, 667 Type II DMFs were filed in 2021, as opposed to 662 in 2020, 633 in 2019 and 644 in 2018. DMFs are submissions made to the FDA by manufacturers who provide the agency with confidential, detailed information about facilities, processes or articles used in manufacturing, processing, packaging and storing of human drug products. Overall, 2021 saw a total of 913 DMFs (Type II, III, IV and V) being submitted. In comparison, FDA had received 931 DMF submissions in 2020, 894 in 2019 and 979 in 2018. View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) India continues to lead DMF filings, followed by China Country-wise data on DMF filings at the FDA tells us the potential of a country in the field of pharmaceuticals. At the company-level, with each DMF filing, a firm commits itself to manufacturing drugs in a facility that is aligned to the FDA’s rules and regulations. This year too, DMFs filed from India and China were significantly higher than those from other countries. Expectedly, India continued to lead with 376 DMF filings. Submissions from India were over twice that of DMF filings from China (at 159). This is not surprising since the two countries have the maximum number of API manufacturing facilities registered with the FDA. As compared to this, the United States had 52 DMF filings, Italy had 10, Spain and Taiwan had 9 each, and countries like Canada, Israel, Japan and UK had five DMF filings each. View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) India’s MSN Labs leads DMF count As in the past, India's MSN Laboratories continued to lead the DMF filings by a single company with 43 submissions. MSN was followed by five other Indian companies — Dr. Reddy’s Laboratories filed 15 submissions, Hetero Group and Aurobindo Pharma 14, Metrochem API 13 and Aurore Life Sciences filed 12 DMF submissions. The only Chinese company in the top 10 by DMF count was Brightgene Bio-Medical Technology Limited with nine DMF submissions. The maximum number of DMF filings were for semaglutide (eight), followed by favipiravir (seven), apalutamide (six), sitagliptin phosphate (six) and tofacitinib citrate (six). Others like acalabrutinib, elagolix sodium, lenalidomide, liraglutide and pantoprazole sodium had five DMF filings each. View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) Slow assessment review, higher GDUFA fee Although there were 667 Type II DMFs filed with the FDA, only 194 (or 29 percent) had their review completed. The GDUFA (short for Generic Drug User Fee Amendments) fee associated with a DMF assessment review for 2021 was considerably higher — at US$ 69,921 — as opposed to US$ 57,795 for 2020. For FY 2022, the GDUFA fee has been revised upward to US$ 74,952 (an increase of US$ 5,031). There are 42 products for which a DMF was filed for the first time. Among the patented products which should expect generic competition are avatrombopag, encorafenib, esketamine hydrochloride, siponimod fumaric acid, tedizolid phosphate and vorapaxar sulfate. In fact, DMFs were also filed for products that are yet to receive an FDA approval. Some of these products are imeglimin, aviptadil, gimeracil, linzagolix choline, meglumine antimoniate, roluperidone hydrochloride and teneligliptin. View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) Our view The Covid-19 pandemic revealed how the global supply chain for pharmaceuticals is excessively dependent on India and China. As a result, many countries across the world are making investments into expanding their API production capacities. This should translate into more Type II DMF filings from countries other than India and China. Moreover, as the pandemic begins to wane and the FDA increases its inspections — both domestic and international — compliance issues are bound to increase. The US is planning to run a pilot program soon that will test a system of unannounced inspections in India and China. Companies in both India and China will need to increase their focus on compliance if they wish to continue to be major contributors to the global supply chain for pharmaceuticals. We can certainly expect more regulatory news in 2022.View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available)

Impressions: 5380

Subscribe

Excel Download

#PharmaFlow by PHARMACOMPASS

17 Feb 2022

Share

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

Subscribe

Excel Download

#PharmaFlow by PHARMACOMPASS

29 Apr 2020

Share

Big changes at Teva; FDA approves one of the world’s costliest drugs

This week, Phispers brings you news about hefty pay packages at AstraZeneca and Mylan; FDA’s Form 483 observations at three of India’s leading pharma companies and news about changes at a debt-ridden Teva. Plus, there is news on Japanese drug makers Takeda and Otsuka. Read on. Shareholders protest against AstraZeneca CEO’s pay package Last week, AstraZeneca suffered a setback from its shareholders in the form of protest over the US$ 17.3 million (£13.4 million) package for its chief executive — Pascal Soriot. In what seemed to be a repeat of a similar episode three years back, nearly 40 percent of investors voted against the pharmaceutical group’s 2016 remuneration report at its annual meet in London. This is about the same percentage of investors who raised objections to remuneration numbers in 2014. Back then, the package in question was to the tune of US$ 4.31 million (£3.34 million), plus potential performance awards of US$ 5.62 million (£4.35 million). Soriot’s US$ 17.3 million package included a long-term incentive plan and other rewards. However, the 39 percent vote against AstraZeneca’s 2016 compensation report has no direct consequences. It’s only an advisory. Mylan chairman’s $97.6 million pay package: Similarly, Mylan chairman’s pay package made headlines this week, after much furor last year over the skyrocketing price of Mylan’s life-saving EpiPens. Mylan chairman, Robert Coury, received a compensation of US$ 97.6 million in 2016. And that doesn’t include an additional US$ 66.3 million in other retirement benefits and payments that Coury received last year as part of a transition from executive chairman to a ‘non-employee chairman role’. Coury will also continue to receive a US$ 1.8 million per year ‘cash retainer’ by virtue of a deal made with Mylan last year. Big changes at Teva: Cancer drug portfolio being put on the market Rumors about big changes at Teva have been around for quite sometime. But recently, an earlier report about longtime CFO Eyal Desheh being eased out got confirmed. Following the report about Desheh, there was another Bloomberg report that said the company’s specialty cancer drug portfolio is being put on the market. Attributing to sources, the report said Teva is speaking with financial advisers about the possible sale of the oncology business, which includes treatments for leukemia and a slow-growing form of lymphoma. Teva acquired the generics business from Allergan for US$ 40.5 billion last year. This left the company with a heavy debt and underperforming divisions. And after the exit of CEO Erez Vigodman more than two months ago, the rumor mills are abuzz with talk of “thousands of job cuts”. There have been reports that 6,000 jobs are being cut, but the company has denied them. GSK’s new CEO wants bigger launches British drug major GlaxoSmithKline's new chief executive — Emma Walmsley (47) — aims to improve returns in drug development, and wants fewer but bigger new medicine launches in the future. According to a Reuters report, Walmsley said recently that her priority was the pharmaceuticals unit, where she wants commercial considerations to be given greater weight in early investment decisions. Speaking post the announcement of first-quarter results, Walmsley said: “We’d like to have probably fewer and more focused priorities, to have bigger launches.” According to her, this would involve tough choices and the closure of some research programs. Novo to settle probe related to marketing of diabetes drugs Novo Nordisk has agreed to settle a probe in the US into the marketing of its diabetes drugs. According to a whistle-blower lawsuit, Novo allegedly disguised salespeople as medical educators and paid kickbacks to persuade doctors to prescribe its medicines, including its diabetes drug Victoza that is covered by federal health-insurance programs. These allegations were disclosed when the lawsuit was unsealed by a judge. The investigation dates back to 2011. According to Novo’s 2016 annual report, the investigation focuses on claims of illegal marketing of Novo’s top-selling Victoza diabetes drug and other products. “We’ve reached an agreement in principle to settle certain claims related to this investigation,” Ken Inchausti, a US-based spokesman for Novo, said. FDA okays BioMarin’s Brineura; Bayer’s Stivarga approved for liver cancer Last week, the US Food and Drug Administration (FDA) gave nod to BioMarin Pharmaceutical Inc’s drug — Brineura. It is a treatment for a rare genetic disorder — a form of Batten disease — that ravages the nervous system and can cause symptoms ranging from seizures to trouble coordinating muscles to vision loss. The disease can affect both adults and children. The list price of BioMarin’s Brineura is a whopping US $ 702,000. This makes this the second most-expensive drug after Horizon Pharma’s Ravicti (priced at US $ 793,632). Bayer’s Stivarga gets nod for liver cancer: The FDA also expanded the approved use of Stivarga (regorafenib) to include treatment of patients with hepatocellular carcinoma (liver cancer), who were previously being treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer since the approval of sorafenib in 2007. Produced by Bayer, Stivarga is a kinase inhibitor that works by blocking several enzymes that promote growth of cancer. The drug is already approved for treatment of colorectal cancer and gastrointestinal stromal tumors that are no longer responding to previous treatments. What’s in a name? Billions of dollars in tech costs for biosimilars A new US FDA guidance on how biological products licensed under the Public Health Service Act (PHS Act) need to be named is playing havoc with a number of healthcare organizations. According to this naming convention, the nonproprietary name designated for “each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.” According to the healthcare organizations, this step will cost the health care system billions of dollars in technology costs. According to a healthcare data provider — Wolters Kluwer Health — healthcare organizations (such as hospitals, insurers, and physician practices, as well as government agencies) will “collectively, spend billions of dollars to redesign and reprogram information technology systems to accommodate this new mandate.” The organization mentioned this in a letter to the White House Office of Management Budget. Decision on relocation of EMA from London likely in October The European Union will be taking a decision in October this year on where to relocate the European Medicines Agency (EMA), currently based in London, after Brexit. According to the Romanian President, Klaus Iohannis, EU leaders met in Brussels last week and talked about the relocation issue “for five minutes”. The European Council President Donald Tusk proposed that EU leaders should agree in June on the criteria to be used for the relocation of the EMA. The final decision should be taken in fall, Iohannis said. Takeda’s US $5.2 billion buy begins to pay off; Will Otsuka be next? Takeda’s US$ 5.2 billion gamble in the form of a buyout of Ariad paid off recently when the US FDA approved the late-stage cancer drug brigatinib, that Takeda acquired via this buyout. The FDA has approved brigatinib for ALK-positive cases of non-small cell lung cancer. Takeda had acquired Ariad in January this year. Takeda can now realize its projections of over US$ 1 billion in annual sales from brigatinib — which will be marketed as Alunbrig. Analysts, however, have predicted US$ 500 million to US$ 800 million in sales for brigatinib. It seems Japanese drugmaker Otsuka Pharmaceutical maybe next in line for receiving pay-offs from its investments. Last year, Ostuka had spent over a billion dollars to partner with Akebia on its experimental anemia drug — Vadadustat — in the US market. But the pact was only a starting point. Last week, Otsuka came back to grab Europe, China, Russia and much of the rest of the world, by paying another US$ 208 million in committed capital. There is more action at Otsuka. India accounts for about 25 percent of the world’s tuberculosis cases. And Otsuka plans to apply for approval of its TB drug — delamanid — in India within three months, a senior company official said. FDA Form 483 observations for India’s Aurobindo, Lupin and DRL Aurobindo Pharma: The US FDA recently handed an inspection report (Form 483) with six observations to major generic drugmaker Aurobindo Pharma.The inspection at Aurobindo Pharma’s Hyderabad facility was held during April 10 to 18 this year. The six observations relate to the company's laboratory system, including a repeat observation from an inspection the year before. The company’s “laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures,” the FDA said. And similar to observations we have seen in other recent inspections, FDA investigators found that Aurobindo’s quality control unit did not adequately investigate out-of-specification (OOS) test results. Lupin: Similarly, Lupin’s Goa facility also received a form 483 from the US FDA, that cited three observations related to violation of good manufacturing practices (GMPs) following an inspection of the site between March 27 and April 7, 2017. The FDA observed that Lupin failed to review and investigate unexplained discrepancy and OOS components of a product batch at the facility. “From January 2016 to March 2017, your firm has invalidated several initial out of specification (product) results…You invalidated the initial results without adequate investigation, performed re-testing using new samples and reported the average results of replicate re-tests,” the FDA said in the Form 483. Similar problems have been cited in past inspections at the Goa facility. Dr. Reddy’s: Last week, drug major Dr Reddy's Laboratories (DRL) said the US FDA has issued it a Form 483 with 11 observations after inspecting its manufacturing plant in Hyderabad. “The observations by the US FDA are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems,” Dr Reddy’s said in a statement. The audit of the plant was completed last week and the company said it will address the observations comprehensively and respond to the regulator within the stipulated time. Zero observations for Strides Shasun: Strides Shasun announced that its API manufacturing facility at Cuddalore (in Tamil Nadu, India) was recently inspected by US FDA. The company has successfully completed the US FDA inspection without any Form 483 observations.

Impressions: 4132

Subscribe

Excel Download

#Phispers by PHARMACOMPASS

04 May 2017

Share

India steps up efforts to improve drug quality; Allergan vows to limit price hikes

This week, Phispers has two news items that demonstrate Indian government’s keenness to improve drug quality and reduce bribing of doctors by drug companies. There is more news on Mylan’s EpiPen and Novo Nordisk’s combination drug for diabetes. Read on. Indian government takes steps to improve drug quality standardsThe Indian government is firm on improving the quality standards in the pharmaceutical industry. As a first step, it is working on enhancing the skills of the workforce employed in the industry. Through a notice issued last week by the Central Drugs Standards Control Organization (CDSCO) under the Ministry of Health and Family Welfare, the government has made it “imperative that all personnel employed in pharmaceutical manufacturing units undergo certification programs developed by the Life Science Skill Sector Development Council”. With effect from January 1, 2018, no person shall be employed in any pharmaceutical manufacturing unit unless the person has obtained a formal diploma or degree in the relevant area, the notice said.Meanwhile, the CDSCO is planning to recruit 500 drug inspectors in the coming year in order to double its manpower by the end of 2017. The organization has already recruited 147 drug inspectors, who will enhance inspections of manufacturing units in line with current Good Manufacturing Practices (cGMP) In EpiPen aftermath, Allergan CEO promises to limit price hikesIn the wake of Mylan’s EpiPen fiasco, Allergan’s CEO Brent Saunders has committed to rebuilding its “social contract” with patients by promising to avoid price gouging and limiting price hikes on brand-name medicines.In a blog posted on the company website this week, Saunders said Allergan would not raise prices more than once a year. And that any price hike will be limited to single-digit percentage increases.Saunders also said the company will avoid “major” price hikes without any corresponding increases in costs as products near patent-expiration. Condemning price gouging, Saunders said: “Recently, the actions of these outliers have shifted attention away from the increasingly vibrant medical innovation ecosystem focused on finding new medicines, improving outcomes for patients and, by doing so, lowering the overall cost of disease.” Mylan now under antitrust investigation over marketing of EpiPens to schools It seems more trouble awaits Mylan Pharmaceuticals over the EpiPen price increase. Mylan is now being investigated by the New York attorney general for potential antitrust violations involving the marketing of these allergy auto-injectors to schools. The attorney general’s office began looking into this matter last week and has issued subpoenas to Mylan for information about its policy of offering discounted EpiPens to schools on the condition that these schools would not purchase competitive products.Since 2004, the price of EpiPens has been increased by 450 percent, after adjusting for inflation. A two-pack now sells for more than US $ 600. Mylan has announced several steps to reduce the cost of EpiPen, including introducing a generic version. But it continues to face political flak.According to an analyst at Sanford C. Bernstein & Co, Mylan’s financial incentive plans are to be blamed for its EpiPen price hike. In 2014, Mylan announced it would reward some 100 employees and executives for not only hitting, but exceeding aggressive profit targets. The company’s top five executives could earn as much as US $ 82 million through the price increases.According to another news report, Mylan has increased its branded ad spending on the EpiPen by 357 percent over five years. During the same time, it hiked the price of EpiPen by 179 percent. FDA puts off decision on Novo’s combination diabetes drug The competition between Sanofi and Novo Nordisk over FDA approval for their combination diabetes drugs is getting interesting. Two weeks after the FDA put off approval of Sanofi’s insulin-plus-GLP-1 combo, the FDA has put off a decision on Novo Nordisk’s combination drug too. The FDA will now review Novo’s drug in December. The drug – which is a marriage of Tresiba and Victoza – has already been approved in the EU as Xultophy. Sanofi’s LixiLan is a combination of Lixisenatide and Lantus.Both Xultophy and LixiLan have prospects of becoming blockbuster drugs, with a US $ 6 billion market potential between them. Both companies are counting on these drugs to increase sales, since their diabetes products are being subject to increased competition and pricing pressure. However, a decision on Sanofi’s combination drug is expected to be taken before Novo’s Xultophy. This news has come at nearly the same time as news about its long-time CEO, Rebien Sorensen, stepping down. From January, Sorensen will be succeeded by Lars Fruergaard Jorgensen, currently executive vice president and head of corporate development. India plans penal provisions to deter drug companies from bribing doctors The Indian government plans to deter pharmaceutical companies from bribing doctors with freebies by replacing the voluntary code, brought into place in January 2015, with a strong mandatory code that has penal provisions.The voluntary code was to expire in June 2015. But it has been given four extensions, even though it wasn’t deterring drug companies from giving freebies to doctors. According to a report published in The Economic Times, the chemicals and fertilizers ministry is reworking on the toothless voluntary code to come out with a mandatory one, with penal provisions. The ministry has sought legal opinion on the new code, which will be applicable to both pharmaceutical and medical devices companies. Gilead urged to drop legal action against generic Sovaldi in UkraineIn June, Gilead Sciences had filed a claim against a Ukrainian drug wholesaler, the Ukrainian Drug Regulation Authority, and the Ministry of Health, alleging several of its patents prevent generic drug makers from marketing a version of its Hepatitis C drug – Sovaldi – for the next few years.This week, International humanitarian-aid non-governmental organization – Doctors Without Borders – has urged Gilead Sciences to drop the case that prevents Pharco Pharmaceuticals – a generic drug maker – from selling a copycat version of Gilead’s Sovaldi in Ukraine.If Gilead wins the case, generic versions of Sovaldi will not be available in Ukraine. According to the World Health Organization, more than 1.3 million people are believed to be infected with Hepatitis C in Ukraine.In a letter, dated September 5, the organization has urged Gilead to “reconsider its business strategy in high-burden, middle-income countries, especially Ukraine,” since its strategies “threaten sustainable access to Hepatitis C treatment in a number of countries” where the advocacy group treats patients. A hearing in this case is scheduled for September 12.In March 2015, a US $ 10 version of Sovaldi was made available in Bangladesh by Incepta Pharmaceuticals. Sovaldi sells for US $1 ,000 a pill in the US. FDA’s letters to Pan Drugs and Zhejiang Hisoar explain reasons behind import alerts India’s Pan Drugs had two of its facilities placed on FDA’s import alert list last year. Recently, the FDA posted the warning letter issued to Pan Drugs on its website. The letter explains why the finished formulations unit failed an inspection.For instance, Pan Drugs’ quality unit allowed the use of adulterated API ‘dated May 25–31, 2015’ which was manufactured at Pan Drugs’ Nandesari facility. The Nandesari facility was placed on FDA import alert on May 5, 2015, for egregious cGMP deviations. “Your firm used this API for the manufacture of drugs which were then shipped to the US market from October 7 to November 23, 2015,” the warning letter said.Additionally, the quality unit of Pan Drugs approved certificates of analysis for several API as well as finished products, prior to conducting all quality control and release testing. The production manager “falsified the documents,” the warning letter said.In the case of Hisoar, whose facility was also placed on import alert, FDA investigators discovered that the facility lacked basic laboratory controls to prevent changes to its electronically-stored data and paper records. “When you encountered suspect and out-of-specification (OOS) results, you retested samples until you obtained desirable results,” the warning letter said.

Impressions: 2654

Subscribe

Excel Download

#Phispers by PHARMACOMPASS

08 Sep 2016

Share

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: 56503

Subscribe

Excel Download

#PharmaFlow by PHARMACOMPASS

10 Mar 2016

Share

Find PharmaFlow Article for Liraglutide

Liraglutide

Liraglutide

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

45 API Suppliers

23 USDMF

18 NDC API

28 Listed Suppliers

DEVELOPMENTS

5 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

DOSSIERs // Finished Dosage Formulations

20 Dossiers

1 FDA Orange Book

5 Europe

3 Canada

5 South Africa

6 Listed Dossiers

RELATED EXCIPIENT COMPANIES

Suppliers

2 Actylis

1 Nanjing Well Pharmaceutical

1 BASF

1 Finar

1 Kerry

EXCIPIENTS BY APPLICATIONS

3 Parenteral

2 Film Formers & Plasticizers

2 Topical

1 Controlled & Modified Release

1 Thickeners and Stabilizers

1 Fillers, Diluents & Binders

1 Coating Systems & Additives

1 Solubilizers

GLOBAL SALES INFORMATION

12 US Medicaid Prescriptions

3 Finished Drug Prices

MARKET PLACE

14 APIs

4 DOSSIERS // FDF

PATENTS

6 Health Canada Patents

ANALYTICAL SOLUTION(s)

1 Other Ref. Standards

DIGITAL CONTENT

5 Data Compilations & Company Tracker #PharmaFlow

137 News

API SUPPLIERS

API REF. PRICE (USD / KG)

INTERMEDIATES

DOSSIERS // FDF

GLOBAL SALES (USD Million)

EXCIPIENTS

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

REF STANDARD

SERVICES

DMF submissions in 2021: India, China continue to top filings

Top drugs and pharmaceutical companies of 2019 by revenues

Big changes at Teva; FDA approves one of the world’s costliest drugs

India steps up efforts to improve drug quality; Allergan vows to limit price hikes

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

What are you looking for?