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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.)

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23 Mar 2023

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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)

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29 Apr 2020

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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!

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08 Dec 2016

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Sanofi’s rough week; Quality snags at Pfizer; FDA warns against commonly used drug

This week, Phispers delves into Pfizer’s acquisition of Medivation and its impact on Sanofi. There is also news on antipsychotic drug Abilify, besides snippets on a lawsuit against Valeant, Mylan’s price hikes and more quality snags that were unveiled at Pfizer’s plant near Chennai. Read on. Rough week for Sanofi as FDA delays its diabetes drugs, while Pfizer walks away with Medivation Pfizer agreed to pay US $14 billion in cash for Medivation in a deal that adds the prostate cancer drug Xtandi to its product portfolio. Medivation was one of the few independent companies with a cancer treatment that is selling well. Xtandi currently generates about US $ 2 billion a year in annual sales. The acquisition has come as a setback for French drug maker Sanofi that spent five months pursuing Medivation. At one point, Sanofi even attempted to replace Medivation’s board and force a deal. There was another setback for Sanofi, as it saw the launch of its diabetes combination medicine get delayed until November this year. Sanofi spent US $ 245 million on a priority review voucher to beat Danish drug maker Novo Nordisk to market with a diabetes drug that pairs its best-selling medicine Lantus (a basal insulin) with lixisenatide. However, the FDA’s fast-track review pushed out the launch of the combination till at least November. The FDA asked Sanofi for more data on the dual-drug delivery pen – a device that triggered debate during an FDA advisory panel review in May this year. The FDA decision on Novo’s product is due next month. With this unexpected delay, Novo could get more than a two months’ head start over Sanofi. FDA warns against the use of antipsychotic drug Abilify In the US, patients taking the antipsychotic drug Abilify have reported uncontrollable urges to gamble, binge eat, shop, and have sex, according to the FDA. The regulator issued a warning this week on the drug, which is one of the top-selling prescription medications in the United States. Other serious side effects of the drug include a higher chance of developing diabetes and hyperglycemia, and increased risk of suicide among patients under the age of 24. Also known as aripiprazole, the drug is used to treat schizophrenia, and can be used in combination with other drugs to treat depression. In the US, 1.6 million patients received Abilify prescriptions last year. The warning comes amid pending class-action lawsuits against the manufacturer of Abilify – Otsuka America Pharmaceutical. The class-action suits allege the company didn’t properly warn patients about the possibility of impulse-control issues. However, these problems are rare. In the 13 years since the drug was approved, there have been only 167 reports of patients experiencing significant impulse-control problems, according to the FDA. Counterfeit pills may have killed the late singer Prince A little over a year ago, the Drug Supply Chain Security Act (or Drug Quality and Security Act) became effective in the United States. The law was introduced to secure the supply chain of medicines and restrict counterfeit drugs – an industry estimated to be bigger than Pfizer and GSK put together. It seems that regulatory agencies still have a lot of work to do in this area. A mis-labelled bottle of pills found in the home of the late singer Prince contained the powerful painkiller fentanyl, a synthetic opioid 50 times more powerful than heroin. Prince died on April 21 this year. According to sources close to the investigation, the pills were found in a bottle of Aleve, an over-the-counter medication sold in the US that contains the painkiller naproxen. Two dozen pills, found in one bottle, were falsely labelled as ‘Watson 385’ – an identifier for a mix of acetaminophen (paracetamol) and hydrocodone. Valeant mired in trouble with a lawsuit and faltering sales of female sexual dysfunction drug According to a lawsuit filed last week, Valeant Pharmaceuticals refilled patient prescriptions without their permission and directed them to buy expensive drugs in order to boost sales. The lawsuit provides insight into how a mail-order pharmacy – Philidor Rx Services – assisted Valeant in directing prescriptions to its brand-name medicines over cheaper generic versions. Meanwhile, Valeant hired Paul Herendeen as its new chief financial officer, luring the executive away from Zoetis, the animal health products maker. While Valeant is busy battling challenges on various fronts, its US $ 1 billion acquisition of Sprout Pharmaceuticals of Addyi – the first medicine to combat female sexual dysfunction – is turning out of be a bust, as it has reported meagre sales. Pfizer’s plant in Chennai faces more compliance issues Earlier this month, Pfizer had to halt production at a plant near Chennai in India, after a Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) joint inspection highlighted quality concerns. The other regulators in the PIC/S inspection were the Medicines and Healthcare products Regulatory Agency of the UK (MHRA), the United States Food and Drug Administration (USFDA), Therapeutic Goods Administration of Australia (TGA) and Health Canada. Three years ago, the plant was first cited with an FDA warning letter. Last year, when Pfizer acquired the plant from Hospira, it was well aware of the quality issues. But Pfizer was probably not aware of the extent of troubles that awaited it. Last week, a GMP non-compliance report posted by European Medicines Agency (EMA) listed that an inspection by the MHRA uncovered a variety of critical issues, raising doubts on whether the injectable products coming out of the facility are sterile or not. MHRA inspectors found that employees were using aseptic processes that could allow for microbial contamination. Pfizer’s investigations into issues were not getting to root causes of problems, they said. All of the plant’s shortcomings were linked to employees who lacked the “scientific knowledge” to know what to do. The MHRA withdrew the plant’s GMP certificate and has halted imports to the European Union of six injected antibiotics until the problems get addressed. Mylan’s outrageous drug price hikes for EpiPen come under scrutiny The EpiPen auto-injector, which reverses life-threatening allergic reactions, is under scrutiny. In 2015, the drug had generated US $ 1.2 billion in sales for Mylan. The EpiPen has been around since 1977, but Mylan acquired the auto-injector in 2007. The EpiPen precisely calibrates the dosage of epinephrine. The patient now pays about 400 percent more for this advantage to receive a dollar’s worth of the life-saving drug. EpiPens were sold for about US $ 57 when Mylan acquired it. Today, it is being sold at US $ 500 or more in the US. Meanwhile, Senator Amy Klobuchar (District Minnesota) has asked the US Federal Trade Commission and the Senate Judiciary Committee to investigate price hikes undertaken by Mylan. Klobuchar is the ranking member of Senate Judiciary Antitrust Subcommittee. And Senator Richard Blumenthal (District Connecticut) wrote to the company for data about assistance programs for patients and first responders. He also demanded that Mylan lower its price. Last year, Mylan raised the price on EpiPen — its biggest-selling product — twice by 15 percent (each time). Due to lack of competition, the price hikes were easy. Korea’s Celltrion ships first batch of biosimilar Remicade to US Last week, a day after winning a lawsuit in the US, Korean pharmaceutical firm Celltrion shipped the first batch of its biosimilar medicine -- Remsima – to the country. The lawsuit was on the sale of Remsima – an autoimmune disorder drug – in the US, the world’s largest pharmaceutical market. Celltrion said that the move will accelerate the US launch of Remsima, a biosimilar version of Janssen's Remicade. Remsima has been on sale in Europe since 2013. Pfizer will take charge of sales of Remsima in the US. The drug will soon be available to patients in the US suffering from rheumatoid arthritis and ulcerative colitis under the brand name of Inflectra. Remicaid’s sales were in excess of US $ 8 billion in 2015. Celltrion CEO Kim Hyoung-ki has projected that the company will earn more than US $ 1.7 billion in the US market next year, assuming a double-digit market share. Four healthcare CEOs on the world’s top 20 severance packages list Even though the Pfizer-Allergan US $ 160 billion merger did not go through, Allergan CEO’s Brent Saunders has little to complain. In a recent Bloomberg compilation, his severance package of US $ 140 million ranks in the top 20 of all S&P 500 CEOs. Joining him in the top 20 are other CEOs of healthcare companies such as McKesson (with a severance package of US $ 198 million), Aetna (US $ 91 million) and Regeneron (US $ 90 million). McKesson Corporation is an American company distributing pharmaceuticals at a retail sale level and providing health information technology, medical supplies, and care management tools. Aetna is an American managed health care company, which sells traditional and consumer directed health care insurance plans and related services, such as medical, pharmaceutical, dental, behavioral health, long-term care, and disability plans. Regeneron is a US-based biotechnology company with four FDA approved products and over US $ 4 billion in revenues in 2015.

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