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New Drug Approvals by FDA & EMA (Mid-2020 Recap)

In case you thought Covid-19 had slowed down US Food and Drug Administration’s New Drug Approvals, you’re in for a pleasant surprise — the FDA appears to be more active than ever before. By the end of June, the FDA had already approved 33 new drugs which put the approval activities within the ballpark of the past two years — 62 novel drugs were approved in 2018, while 54 were approved in 2019. FDA’s Center for Drug Evaluation and Research (CDER) approved 25 new molecular entities and new therapeutic biological products, of which almost half — 12 out of 25 — were oncology drugs, while the rest of the novel therapies were approved by the Center for Biologics Evaluation and Research. The European Medical Agency (EMA) was also busy as the regulator issued a positive opinion for 41 drugs, of which 27 were classified as novel treatments. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Conditional Approval for Gilead’s Remdesivir Gilead’s Remdesivir has certainly been one of the most talked about drugs this year. While it is still under clinical evaluation, the FDA, EMA and the Japanese Ministry of Health, Labour and Welfare (MHLW) found ways of providing market access to this drug as a treatment against Covid-19. On May 1, 2020, based on the totality of scientific evidence available to the FDA, the agency issued an Emergency Use Authorization (EUA), as it believed that remdesivir may be effective in treating Covid-19 and that the known and potential benefits of remdesivir, when used to treat Covid-19, outweigh the known and potential risks of such products. On June 25, 2020, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of conditional marketing authorization for Veklury (remdesivir). The demand for remdesivir is such that the US bought more than 500,000 doses, which is all of Gilead’s production for July and 90 percent of production for August and September, leaving almost no stock of remdesivir for the UK and Europe. In 127 poor or middle-income countries, Gilead is allowing generic drugmakers to supply remdesivir. It has signed non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to further expand the supply of the antiviral drug. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Vertex’s Kaftrio bags EMA approval Earlier this year, PharmaCompass published its compilation of the sales forecasts for the new drugs approved by the FDA in 2019. The list was led by Vertex’s cystic fibrosis treatment — Trikafta — which is expected to have sales of US$ 3.935 billion by 2024. Trikafta is a combination of ivacaftor, tezacaftor and elexacaftor and its stellar clinical data made the FDA approve the drug within three months of Vertex’s application filing and five months before FDA’s action date. In June 2020, EMA’s CHMP adopted a positive opinion, recommending the granting of a marketing authorization for Vertex’s combination which will be marketed as Kaftrio. EMA also adopted positive opinions on other drugs which were previously approved by the FDA in 2019, such as Novartis’ Zolgensma and Piqray, Pfizer’s Staquis and Daurismo among many others. Immunomedic’s antibody-drug conjugate (ADC) — Trodelvy (sacituzumab govitecan-hziy) — was approved by the FDA for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. Trodelvy follows remdesivir in our list of FDA approved drugs in 2020 with the highest sales potential. The current forecast for Trodelvy sales is US$ 2.151 billion by 2026. FDA’s approval of Lundbeck’s Vyepti (eptinezumab) and Biohaven’s Nurtec ODT (rimegepant) for migraine headaches brought additional CGRP-targeted products to the market. It will be interesting to see how Nurtec ODT is accepted given it is a small molecule drug, which makes administration easier. It was recently promoted on social media by Khloe Kardashian. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Covid-19 impacts drug launches The pandemic has, however, started taking a toll on drug launches. One of the most anticipated drug approvals of the year, Bristol-Myers Squibb’s multiple sclerosis (MS) treatment — Zeposia (ozanimod) — was approved in both the US and Europe. However, the launch of the drug would be delayed due to the coronavirus outbreak. The drug was added to BMS’s portfolio through its US$ 74 billion acquisition of Celgene last year. Its approval was one of the three conditions set for a potentially higher payout for Celgene investors. Analysts have high hopes from ozanimod. Its average peak sales for 2024 have been predicted to be at US$ 1.62 billion by Cortellis, though the Covid-19 pandemic may weigh in there as well. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) First non-statin cholesterol drug bags FDA approval This year also witnessed the first non-statin treatment to be cleared for sale in the US in nearly 20 years. The drug, bempedoic acid, is made by Esperion Therapeutics Inc. This cholesterol-lowering drug is aimed at helping millions of people who can’t tolerate or don’t get enough help from widely used statin pills like Lipitor and Crestor. This new drug is to be used as an add-on treatment with statins. It lowers bad cholesterol or low-density lipoprotein (LDL) by inhibiting its synthesis in the liver. It targets patients with high cardiovascular risk. Esperion also won approval of bempedoic acid in combination with ezetimibe, another cholesterol-lowering drug. In January last year, Daiichi Sankyo Europe had entered into an exclusive licensing agreement with Esperion Therapeutics for Daiichi Sankyo Europe to market bempedoic acid and bempedoic acid/ezetimibe combination tablet in the European Economic Area and Switzerland. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Approvals not granted to almost 20 drugs There were setbacks too, and not everything rolled smoothly. This year, almost 20 drug approvals were not granted. Among the major setbacks were Bristol Myers Squibb and bluebird bio, Inc announcing that they have received a Refusal to File letter from the FDA regarding the Biologics License Application (BLA) for their CAR-T therapy, idecabtagene vicleucel (ide-cel), for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020. Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the BLA requires further detail to complete the review. No additional clinical or non-clinical data have been requested or are required. Two years after Intarcia Therapeutics received a CRL for its matchstick-sized, long-term drug implant for type 2 diabetes, the FDA issued a second CRL to the company for its ITCA-650 implant. The implant is designed to be a small, osmotic pump which can be slipped under the skin and deliver a continuous, six-month dose of the GLP-1 agonist exenatide. The FDA also did not approve Intercept Pharmaceuticals’ obeticholic acid to treat NASH (or nonalcoholic steatohepatitis, a liver condition in which the buildup of fat progressively scars the organ), as it wasn’t convinced that its benefits outweighed the potential risks. After acquiring Allergan for US$ 63 billion, one of the first drugs which AbbVie was expecting approval for was Abicipar pegol, their experimental DARPin therapy for patients with neovascular (wet) age-related macular degeneration (nAMD). However, FDA’s review indicated the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of wet AMD. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Our view While everyone’s attention is on the Covid-19 pandemic, the industry is certainly busy working towards getting new drugs to market. At the halfway mark, the FDA and EMA seem to be on track to set approval records this year, since the number of drugs approved by June are almost twice the number that were approved at the same time last year. However, it remains to be seen how companies adapt their sales and marketing strategies in a world where mobility is likely to get restricted and interpersonal contact is set to reduce dramatically. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available)

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23 Jul 2020

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Analyzing over US$ 90 billion of Medicare Prescription Drug (Part D) Spending in 2016

This week, PharmaCompass reviews the recently released data on prescription drugs paid for under the Medicare Part D Prescription Drug Program in the United States in calendar year 2016. But first, let’s understand what is Medicare. Medicare is the federal health insurance program in the US. In 2017, it covered 58.4 million people — 49.5 million aged 65 and older, and 8.9 million disabled. Prescription drug coverage under this program was started in 2006, and is known as Medicare Part D. As part of this coverage, the Centers for Medicare & Medicaid Services (CMS) contracts insurance companies and other private companies, known as plan sponsors, that offer prescription drug plans to their beneficiaries with varying drug coverage and cost-sharing requirements. In 2017, the Congressional Budget Office (CBO) had estimated that spending on Medicare Part D would reach US$ 94 billion, or about 16 percent of all Medicare expenditures for the year. Click here to access the compilation of Medicare Part D Prescriber Summary Report According to the CBO, Medicare Part D is the most significant expansion of the Medicare program since it was created by Congress in 1965. With more than 1.48 billion claims from beneficiaries enrolled under the Part D prescription drug benefit program under its umbrella, our analysis of Medicare Part D provides valuable insights into how elderly Americans use prescription drugs. Top 10 drugs by cost: The ones that bore the highest cost burden for Medicare As in 2015, in 2016 too Gilead’s Hepatitis C treatment — Ledipasvir/Sofosbuvir (Harvoni) — remained the single drug highest payout under the Medicare Part D Prescription Drug Program with a total cost of US$ 4.4 billion. As Gilead continued to face competition from AbbVie and Merck in the Hepatitis C space, the spending on Harvoni was down 37 percent from US$ 7.03 billion in 2015. Click here to access the compilation of Medicare Part D Prescriber Summary Report Celgene’s cancer treatment, Lenalidomide (Revlimid), Sanofi and Merck’s diabetes treatments and AstraZeneca’s Crestor (Rosuvastatin Calcium) for cholesterol followed Harvoni. All together, they cost the Medicare program over US$ 10 billion. Generic Name Number of Medicare Part D Claims Number of Medicare Beneficiaries Number of Prescribers Aggregate Cost Paid for Part D Claims (In USD) LEDIPASVIR/ SOFOSBUVIR (HARVONI) 141,665 52,782 12,097 4,398,534,465 LENALIDOMIDE 239,049 35,368 10,382 2,661,106,127 LANTUS SOLOSTAR (INSULIN GLARGINE, HUM.REC.ANLOG ) 5,028,485 1,075,248 245,447 2,526,048,766 SITAGLIPTIN PHOSPHATE 4,742,505 864,442 206,223 2,440,013,513 ROSUVASTATIN CALCIUM 6,012,444 1,560,050 249,981 2,322,724,007 FLUTICASONE/SALMETEROL 5,194,391 1,196,007 275,442 2,319,808,482 PREGABALIN 4,940,115 852,497 267,532 2,098,953,250 RIVAROXABAN 4,403,332 807,820 252,141 1,954,748,890 APIXABAN 4,455,782 826,969 231,631 1,926,107,484 TIOTROPIUM BROMIDE 4,153,162 903,494 235,564 1,818,857,361 Click here to access the compilation of Medicare Part D Prescriber Summary Report Top 10 drugs by claims: The most commonly used drugs of 2016 With 46.6 million claims, the thyroid hormone deficiency treatment — Levothyroxine Sodium — retained its position of being the most claimed product under Medicare’s Part D Prescription Drug Program in 2016. The number of Medicare Part D claims includes original prescriptions and refills. Following Levothyroxine Sodium was the lipid-lowering agent — Atorvastatin Calcium — which had 44.5 million Medicare Part D claims that were filed by almost 9.4 million beneficiaries. Generic Name Number of Prescribers Number of Medicare Part D Claims Number of Medicare Beneficiaries LEVOTHYROXINE SODIUM 669,999 46,617,109 8,091,785 ATORVASTATIN CALCIUM 494,973 44,595,686 9,435,633 AMLODIPINE BESYLATE 497,017 39,913,468 7,802,905 LISINOPRIL 490,452 39,469,840 8,009,954 OMEPRAZOLE 492,951 32,909,236 7,001,160 METFORMIN HCL 611,700 31,007,932 6,394,014 SIMVASTATIN 380,560 29,687,947 6,201,911 HYDROCODONE/ACETAMINOPHEN 660,617 28,595,150 7,265,882 FUROSEMIDE 488,352 27,878,243 5,421,598 GABAPENTIN 555,997 27,627,466 5,363,382 Click here to access the compilation of Medicare Part D Prescriber Summary Report Top 10 drugs by prescribers: Medicines that were most popular with doctors Among the prescribers, albuterol sulfate (salbutamol) and Diltiazem had over 900,000 unique providers (or doctors) prescribing the drug. Albuterol (salbutamol) is used to provide quick relief from wheezing and shortness of breath while Diltiazem is used to prevent chest pain (angina). Also on the list of popular drugs with prescribers is Hydrocodone-Acetaminophen. With more doctors prescribing Hydrocodone-Acetaminophen (an opioid) than commonly used antibiotics, such as Cephalexin, Ciprofloxacin and Amoxicillin, the series of new FDA initiatives to combat the epidemic of opioid misuse and abuse should change the position of opioids in the top 10 drugs by prescribers in the coming years. Click here to access the compilation of Medicare Part D Prescriber Summary Report Generic Name Number of Prescribers Number of Medicare Part D Claims Number of Medicare Beneficiaries ALBUTEROL SULFATE 985,427 13,100,354 5,417,718 DILTIAZEM HCL 931,159 8,142,004 1,982,550 POTASSIUM CHLORIDE 879,491 18,945,969 4,278,000 PEN NEEDLE, DIABETIC 677,210 5,281,778 1,795,046 LEVOTHYROXINE SODIUM 669,999 46,617,109 8,091,785 HYDROCODONE/ACETAMINOPHEN 660,617 28,595,150 7,265,882 METFORMIN HCL 611,700 31,007,932 6,394,014 CEPHALEXIN 597,647 5,603,879 3,933,373 CIPROFLOXACIN HCL 594,129 7,000,081 4,851,657 AZITHROMYCIN 591,028 7,958,625 5,734,122 What does the future hold? Although the Part D Prescriber PUF (public use file) has a wealth of information on payment and utilization for Medicare Part D prescriptions, the dataset has a number of limitations. Of particular importance is the fact that the data may not be representative of a physician’s entire practice or all of Medicare as it only includes information on beneficiaries enrolled in the Medicare Part D prescription drug program (i.e., approximately two-thirds of all Medicare beneficiaries). Click here to access the compilation of Medicare Part D Prescriber Summary Report Last month, the Office of the Inspector General (OIG) reviewed the Part D claims data for the years 2011 to 2015 for brand-name drugs. The OIG’s report found that the total reimbursement for all brand-name drugs in Part D increased 77 percent from 2011 to 2015, despite a 17-percent decrease in the number of prescriptions for these drugs. With soaring drug prices being an issue for regular debate in the Unites States and President Trump announcing that his team will use strategies to strengthen the negotiating powers under Medicare Part D and Part B, it remains to be seen how the data on prescription drugs paid for under the Medicare Part D Prescription Drug Program will change in the coming years. Click here to access the compilation of Medicare Part D Prescriber Summary Report

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05 Jul 2018

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Pfizer exits China venture with Hisun; FDA mulls more steps to increase generic drug competition

This week in Phispers, we look at the measures US FDA announced last week to increase competition in generics, which in turn would reduce the increases in their prices. Pfizer exited its JV with Hisun in China, while Albert Bourla became its new COO. We also look at a digital pill for mental illnesses from Japanese drugmaker Otsuka that obtained the FDA’s nod this week. Meanwhile, the EU plans to change patent rules for APIs to give an impetus to its manufacturing sector. After Brazil, Pfizer exits Chinese venture plagued with data-integrity concerns In July this year, Pfizer had bowed out of Brazil with the sale of its stake in Laboratório Teuto Brasileiro. The reason — the historic recession in Brazil, because of which the joint venture never really took off. Last week, Pfizer sold its 49 percent equity stake in the joint venture — Hisun-Pfizer Pharmaceutical to Sapphire I (HK) Holdings Limited. Though the company did not give a reason in its statement, we suspect data integrity concerns to be the key reason behind this exit. The joint venture between Pfizer Inc and Zhejiang Hisun Pharmaceuticals Company Ltd had been formed in 2012 to develop, manufacture and commercialize branded generic pharmaceutical products in China and in the global markets. In September 2015, PharmaCompass had covered how the United States Food and Drug Administration (FDA) had placed Zhejiang Hisun Pharma on its import alert list after a March 2015 inspection uncovered “systemic data manipulation across your facility” The transfer of Pfizer’s equity stake will allow both Hisun and Pfizer to focus on their core strengths, a Pfizer statement said. “After Pfizer’s equity share transfer, the joint venture will change its name but will retain its current rights to manufacture, sell and distribute all of Hisun-Pfizer Pharmaceutical’s currently marketed and pipeline products in China,” it added. Pfizer has been facing problems with its acquisitions. Last week, PharmaCompass reported on Pfizer facing supply shortages for products from the legacy Hospira portfolio. Pfizer had acquired Hospira in 2015 for US$ 15 billion. Meanwhile, Pfizer has promoted Albert Bourla to the newly created post of chief operating officer. This way, America’s largest drug maker hopes to free up its CEO Ian Read to focus more on long-term strategy and in engaging with the government and industry leaders. Bourla, who had joined Pfizer in 1993, will assume the COO post next year. FDA okays Otsuka’s Abilify MyCite, a digital ingestible pill for mental illness Back in September 2015, PharmaCompass had covered ingestible sensors in a story on Abilify (aripiprazole), a combination product embedded with a Proteus ingestible sensor. Japanese drugmaker Otsuka Pharmaceutical Company’s Abilify is a drug used to treat a variety of mental illnesses. It uses Proteus Digital’s ingestible sensor that can be incorporated into a tablet, placed inside a hard gelatin capsule, or attached to the surface of a tablet/capsule using an edible adhesive layer. This week, the US FDA approved Otsuka’s Abilify MyCite. This is the first drug with a digital ingestion tracking system to be approved in the United States. The product has been approved for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults, the FDA said. It uses digital tracking to record if the medication was taken. The system sends a message from the pill’s sensor to a wearable patch, which then transmits the information to a mobile application, so that patients can track the ingestion of the medication on devices such as a smart phone. However, Abilify MyCite is not approved to treat patients with dementia-related psychosis. AstraZeneca continues to struggle; GSK gets new R&D chief at sky-high salary Last week, it was AstraZeneca’s turn to announce third quarter results. The company saw its drug sales drop yet again, due to generic competition to its erstwhile blockbuster pills, such as cholesterol pill Crestor. The good news was that the pace of decline had slowed down, as the company turned towards new cancer treatments to revive its fortunes. Astra’s product sales were down 3 percent compared to an 11 percent fall during the first half of the year. Growth came from emerging markets, such as China. According to CEO Pascal Soriot, Astra has reached a turning-point — its pipeline of new medicines should start delivering soon, and the impact of patent losses should also recede. Forecasts also point to a recovery in sales and profits from next year. Astra’s total revenues rose 9 percent to US$ 6.23 billion in the quarter, helped by a US$ 997 million payment from Merck, which struck a cancer drug partnership deal with Astra in July. GSK’s new R&D chief: Meanwhile, GSK has replaced the outgoing chief science officer Patrick Vallance with the president of research and development at Calico, Hal Barron. And if the grapevine is to be believed, Barron’s pay package could be higher than that of GSK CEO, Emma Walmsley. Vallance is to leave GlaxoSmithKline next year to take the job of chief scientific adviser to the UK government. Barron will take up his new job on January 1, and will be based in San Francisco and Stevenage in the UK. The hiring is Walmsley’s third key appointment, the previous two being hiring of Luke Miels from AstraZeneca as head of pharmaceuticals and hiring Karenann Terrell (from Wal-Mart) as chief digital and technology officer. FDA mulls more steps to increase generic drug competition and fight price hikes The US is trying to bring more low-cost competition in the generic market in order to bring down the prices of drugs. The US FDA Commissioner Scott Gottlieb said at a Federal Trade Commission (FTC)-sponsored conference that the agency intends to smoothen generic drug development, so that generic drugs get to market faster. According to a report released by the FTC and the FDA at the conference, titled Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics, “generic competition consistently and substantially lowers prescription drug prices.” Looking out for unfair practices: Gottlieb said the FDA is on the lookout for brand drugmakers that deliberately slow collaboration on risk strategies to delay generics from coming to market. Drug companies have used the terms of Risk Evaluation and Mitigation Strategies (REMS) to restrict generic competition by delaying generic manufacturers from purchasing drug products needed to run bioequivalence or bioavailability studies that are required for FDA approval. Acting FTC Chairman Maureen Ohlhausen said her agency will vigorously watch for unfair practices among drugmakers. Expanding ANDAs that seek priority review: Gottlieb also indicated that the agency will expand which abbreviated new drug applications (ANDA) will see priority reviews. “Earlier this year we made changes to how we prioritize the agency’s generic drug submissions. The goal was to prioritize the review of generic applications until the FDA has approved three generic versions of each particular drug,” Gottlieb said in a statement. “Today we’re expanding this competition-focused policy to prioritize any application that can meet the FDA’s approval standards at the point when the 180-day exclusivity period expires on a first generic entrant to a branded medicine.” The shift could accelerate generic competitors to market more quickly and help bring down costs. Trump’s HHS Secy candidate for lowering drug prices: The US President Donald Trump is nominating former pharmaceutical executive and industry lobbyist Alex Azar to serve as US Health and Human Services secretary. According to Trump, Azar would push to lower the price of medicines. If confirmed, Azar would also take the lead in implementing Trump’s campaign promise to dismantle Obamacare (the Affordable Care Act). Incentivizing pediatric research: The US FDA is taking various steps to increase the number of therapies for children, approved by the agency. Some 60 percent of drugs that are used in children are not approved for pediatric use, as these drugs have not been successfully tested in pediatric clinical trials. In fact, in the case of neonates, the FDA-approved options is even smaller with 90 percent of drugs used in this population unapproved for neonatal use. According to a blog written by Susan McCune, FDA’s Director, Office of Pediatric Therapeutics, the FDA is issuing awards to the Institute for Advanced Clinical Trials for Children (IACT for Children) and Duke University in order to facilitate pediatric clinical trials and pediatric trial-related research. “Each awardee will receive US$ 1 million for this year under the Global Pediatric Clinical Trials Network Cooperative Agreement,” she said in the blog. Europe seeks to change patent rules for APIs to bolster manufacturing sector The European Union is working towards bolstering the competitiveness of its manufacturing sector. One of the means it is looking at is to waive supplementary protection certificates or SPCs — an intellectual property right that serves as an extension to a patent right. As a first step in that direction, the European Commission has issued a public consultation to obtain feedback on a proposal that allows for such a waiver for SPCs. The public consultation is open until January 4, 2018. Through this SPC manufacturing waiver, the EU hopes to fix unintended side effects of the SPC by allowing developers of generic and biosimilar medicines to produce during the SPC period in order to supply unprotected markets, soon after the protections expire. SPCs provide an incentive in the EU that extends the protection of patented medicines by up to five years to compensate the time lost in obtaining regulatory approval of the drug. During this period, European manufacturers of generic and biosimilar medicines cannot produce their medicines in the EU. Groups, such as Medicines for Europe, the industry association representing generic-drug manufacturers in Europe, have advocated for a SPC manufacturing waiver to promote a strong manufacturing base in Europe. SPCs is an issue for European API manufacturers, as they limit the time in which they can begin development of generics. With this consultation, the European Commission is seeking public input to evaluate the current legislation and assess the impact of any modification to the SPC and patent-exemption framework in the EU.

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16 Nov 2017

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Trumpcare receives a blow; EMA to suspend 300 drugs due to clinical data integrity violations in India

This week, Phispers takes you to the US, where President Trump’s efforts to repeal and replace Obamacare received a setback. There is also news that the EMA has recommended suspending over 300 drugs due to data integrity concerns at a CRO based in Chennai — Micro Therapeutics — along with news on drug makers like Teva, Pfizer and Stada. Read on. More scrutiny for Pfizer as injectable facility in India comes under FDA lens Pfizer’s fill/finish manufacturing facility in the United States recently received a warning letter from the US Food and Drug Administration (USFDA). In February 2015, Pfizer had acquired the site in McPherson (Kansas) through its US $17 billion acquisition of Hospira. Pfizer was aware of Hospira's manufacturing record when it struck the deal, as the company was issued FDA warning letters on four of the seven continents — Europe, North America, Asia and Australia. Last week, a Hospira facility in Visakhapatnam in India, set up to manufacture specialty injectables at an anticipated cost of US $375-450 million, received 11 observations from the US drug regulator. An inspection by the US FDA took place at the sterile injectables manufacturing unit between March 9 and 17 this year. An initial audit had taken place in 2015, during which 14 observations had been found. The company responded to the observations in March 2015 and submitted additional support documentation by the end of May 2015. “The inspection was found to be acceptable following the FDA's review of the company's responses and support documentation. The company has begun limited commercial production at the facility,” the company had said. The latest list of FDA observations includes three repeat observations related to air supply, air sampling and the root cause for microbial contamination. Last year, Pfizer had to halt production at its Chennai plant, which was also obtained as part of the Hospira acquisition, due to quality concerns. EMA endorses suspending 300 drugs due to clinical data integrity pitfalls Late last year, the European Medicines Agency (EMA) had raised data-integrity concerns over another contract research organization (CRO) in India — Chennai-based, Micro Therapeutics Research Labs. The concerns had regulators reviewing the data of over 300 generic medicines being sold across Europe. Last week, the EMA announced it is recommending the suspension of more than 300 approvals and applications for generic drugs for which bio-equivalence studies were conducted at Micro Therapeutic Research Labs. The review concluded that data from studies conducted at two sites between June 2012 and June 2016 was “unreliable and cannot be accepted as a basis for marketing authorization in the EU.” However, there is no evidence of harm or lack of effectiveness of these medicines. EMA’s list of drugs it is recommending for suspension covers just about every EU member state, including Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Spain, The Netherlands and the UK. Generic drugs recommended for suspension include those being marketed by Novartis’ Sandoz, Sanofi’s Zentiva, Teva, Aurobindo Pharma and others. It includes dosage forms containing the active substances bupropion, voriconazole, betahistine, amlodipine/valsartan, tadalafil and naproxen. Though not a manufacturing compliance issue, clinical data-integrity has made headlines recently as labs across India had their data invalidated due to data-integrity concerns. Clinical trial falsification issues at the labs of Quest Life Sciences, GVK Biosciences, Alkem Laboratories, Semler Research Center and now Micro Therapeutics indicate that a sustained supply of generics can no longer be taken for granted. Struggling Teva to slash jobs to improve profitability Things haven’t been going right for the Israeli generic drug giant Teva for quite sometime now. First, it’s CEO Erez Vigodman left the company. Second, its books were debt-ridden post the acquisition of Allergan Plc in July 2015. Third, its R&D has not seen a breakthrough in years. And now, Teva is said to be going in for major layoffs. The Israeli newspaper Calcalist reported that Teva is planning to cut 6,000 staffers (or 11 percent of its global workforce) after Passover. The company, however, denied this by saying it won’t layoff thousands. Instead, Teva said it is ending certain activities, consolidating operations and freezing new recruitments. “The efficiency program is an integral part of Teva’s business reality. The program includes, among other things, ending unprofitable activities and consolidating functions, in addition to freezing recruitment and natural employee turnover,” the company said. Teva is also looking for a new CEO to turn around the business after its US $ 40.5 billion acquisition of Allergan’s generic business pushed it into debt. Trump's plan to repeal and replace Obamacare suffers a major setback For seven years, the Republican Party has pursued repealing Obamacare like an obsession. But on Friday last, Speaker Paul Ryan and US President Donald Trump withdrew the bill at around 3.30 in the afternoon. Ryan could not bridge the ideological gap between the center and the far right within the Republican Party. The first presentation of Trumpcare couldn’t pass, as it was not sufficiently hard-hearted for the far-right members of the Freedom Caucus. But Trump and Ryan kept tweaking the bill to appease the hardliners. They even did away with the essential benefit guarantees that health insurance plans in American must now cover. And then the bill lost supporters at the center. The Bill fell short of around a dozen votes to get a winning vote count. The Congressional Budget Office had said the bill would deprive 24 million Americans of insurance coverage, while only saving the federal government US $ 151 billion. Meanwhile, Trump sought to spread blame for the failure of his first attempt at replacing Obamacare. He said: “Bad things are going to happen to Obamacare. There's not much you can do to help it”. On Sunday morning, Trump wrote on Twitter: “Democrats are smiling in DC that the Freedom Caucus, with the help of Club for Growth and Heritage, have saved Planned Parenthood & Obamacare.” However, latest reports signal that Trump hasn’t given up hope. On Tuesday, he spoke to a “semi-bipartisan” group of Democratic and Republican senators and their spouses in the White House, where he signaled support for another run at a new GOP health care bill. Trump hopes a second go-around will be more successful. Stada CEO finds his car bugged amid takeover talks Germany’s Manager Magazin reported last week that the chief executive of German drugmaker Stada — Matthias Wiedenfels — found a bugging device in his car. Stada has faced pressure to overhaul its strategy and has also received two takeover approaches. Wiedenfels, who became the CEO of Stada last summer, also received anonymous letters containing photographs that depict him in private or confidential business situations, the magazine said. The magazine, which did not cite sources or give information on those behind the bugging, said the incidents took place in the second half of 2016. Stada, however, did not comment on this report. Stada is the subject of takeover approaches from two private equity consortia. It has postponed the structured auction to give the bidders a chance to improve their offers which last valued the company at $3.9 billion. Over 1,100 drugs in Australia to become cheaper from next month From April 1, millions of Australians will benefit from reduced prices of more than 1,100 medicine brands. Vital drugs have been added to Australia’s Pharmaceutical Benefits Scheme (PBS). The price of drugs used in conditions like high cholesterol, Parkinson’s disease, depression, breast cancer, eczema and psoriasis will cost lesser. For instance, 467,000 Australians using rosuvastatin for high cholesterol will save 22 percent per script. According to Australia’s Health Minister Greg Hunt, “sick Australians will save $500 million (US $ 383 million) over four years and up to $200 (US $ 153 million) a year each on the cost of medicines.” The country also plans to list new drugs on its PBS. These include drugs for two rare cancers — Hodgkin’s lymphoma, and an advanced type of skin cancer — and treatments for psoriasis, arthritis, schizophrenia and iron deficiency. Hunt said the savings for patients would be "considerable".

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30 Mar 2017

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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

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#PharmaFlow by PHARMACOMPASS

13 May 2015

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Find PharmaFlow Article for MolPort-000-883-884

MolPort-000-883-884

MolPort-000-883-884

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

29 API Suppliers

2 USDMF

27 Listed Suppliers

DEVELOPMENTS

8 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

9 Suppliers

DOSSIERs // Finished Dosage Formulations

406 Dossiers

62 Europe

104 Australia

50 South Africa

190 Listed Dossiers

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

46 Finished Drug Prices

MARKET PLACE

17 APIs

13 DOSSIERS // FDF

ANALYTICAL SOLUTION(s)

2 BioAnalytical Methods

19 Other Ref. Standards

DIGITAL CONTENT

5 Data Compilations & Company Tracker #PharmaFlow

87 News

API SUPPLIERS

API REF. PRICE (USD / KG)

INTERMEDIATES

DOSSIERS // FDF

GLOBAL SALES (USD Million)

EXCIPIENTS

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

REF STANDARD

SERVICES

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

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