Tuesday, June 11, 2024

Amneal, US FTC Win Order Removing Teva Inhaler Patents from FDA List

(6/10, Blake Brittain, Reuters) ...U.S. District Judge Stanley Chesler agreed with Amneal and the FTC that Teva's patents only covered inhaler device technology, ordering it to remove the listings from the FDA's Orange Book and clearing an obstacle for Amneal's proposed generic. The decision follows the FTC's warnings to drugmakers including Teva over the misuse of Orange Book patent listings to wrongly extend patent monopolies on brand-name drugs. Chesler on Monday also rejected Teva's bid to dismiss Amneal's allegations that Teva violated state and federal antitrust law... Full

Dozens of CVS Generic Drug Recalls Expose Link to Tainted Factories

(6/10, Anna Edney and Peter Robison, Bloomberg) ...There's little incentive for large drug purchasers like pharmacies and hospitals to choose suppliers based on quality, said Kevin Schulman, a professor of medicine at Stanford University. Rather, they often choose the lowest-cost manufacturing contracts, which Schulman's research has found leads to lower-quality medicines. "The best way to make a low-price product is to skimp on quality and that's what we're seeing over and over and over again," he said... Sub. Req'd

CVS Drug Recalls Tied to Factories With History of Mold, Dirty Conditions

(6/10, Kimberly Gittleson, David Fox and David Gura, Bloomberg) ...One factory making pain and fever medications for children used contaminated water. Another made drugs for kids that were too potent. A third made nasal sprays for babies on the same machines it used to produce pesticides. A new Bloomberg investigation reveals that big pharmacy chains have used cheaper, independent factories with a history of manufacturing violations to make store-brand drugs that compete with the likes of Motrin and Tums... Sub. Req'd

Alvotech and STADA Add to Strategic Alliance Through Denosumab Partnership

(6/11, Alvotech) ...STADA assumes marketing license for Alvotech's proposed biosimilar referencing Prolia®/Xgeva® (denosumab) in Europe, including Switzerland and the UK, as well as rights in selected markets in Central Asia and the Middle East. This partnership for the osteoporosis and cancer-related molecule builds on the two company's existing strategic alliance in Europe. The first product launched through the alliance was Hukyndra®, a high-concentration biosimilar to Humira® (adalimumab). Extended alliance comes as the partners prepare to launch Uzpruvo®, a biosimilar to Stelara® (ustekinumab) in Europe following the expiry of applicable intellectual-property rights... Full

‘Keytruda? We Believe Opdivo Is The Better Choice': Xbrane's CEO Martin Åmark

(6/11, Dean Rudge, Generics Bulletin) ...The CEO of Xbrane Biopharma, a Swedish firm focused solely on biosimilar development using a partnered model to potentially take its biosimilars across the globe, speaks exclusively to Generics Bulletin about its ambitions and challenges, including the recent setback for its proposed Lucentis biosimilar in the US... Global Sub. Full

Alkem Misses Analyst Estimates In Fourth Quarter, Lowering Future Guidance

(6/10, Adam Zamecnik, Generics Bulletin) ...Alkem Laboratories has missed analyst revenue estimates in the fourth quarter of its 2024 financial year, receiving an underperform rating from the likes of Bank of America and Jefferies...According to the firm's chief executive officer Vikas Gupta, this decline was felt across the Indian pharmaceutical market, which slumped by 2.2% year-on-year. This trend is unusual and could be partly explained by the high base in the fourth quarter of the 2023 fiscal year, which saw a flu outbreak, the CEO suggests... Global Sub. Full

With 2 Planned Launches, Boehringer Ingelheim Looks to Make a Name for Itself in Oncology

(6/10, Zoey Becker, Fierce Pharma) ...With 25 launches planned through 2030, Boehringer Ingelheim is gearing up for a busy few years. As a part of that, the German drugmaker is looking forward to flexing its oncology muscles with two new cancer drug launches in 2025. While the company's overall pipeline is filled with early-stage assets acquired through recent business development deals, its oncology R&D efforts are largely centered around the late-stage prospects brigimadlin and zongertinib... Full

Citi Hikes Hikma Price Target, Cites ‘Healthy Trends' for Injectables and US Generics

(6/11, Michele Maatouk, ShareCast) ...Citi lifted its price target on Hikma Pharmaceuticals on Tuesday to 2,845p from 2,770p as it said IQVIA April data highlighted "healthy trends" for injectables and US Generics. "The strategy at US Generics (30/20% of sales/EBIT) longer-term remains reducing volatility and delivering a sustainable EBIT of $100-120m, as a result of efforts to increase contract manufacturing activities and further broadening the Specialty portfolio," it said... Full

Oh NOOH! Vanda's Multi-Front Battle With US FDA Extends To Insomnia Drug Hetlioz

(6/10, Bridget Silverman, Pink Sheet) ...The notice of opportunity for hearing on the US FDA's proposal not to approve an insomnia sNDA for Vanda's Hetlioz opens another front in the company's aggressive campaign against complete response letters and generic competition to the sleep disorder drug...Vanda also has launched a barrage of litigation to prevent generic competition to Hetlioz, which is approved for two orphan indications: non-24-hour sleep-wake disorder and Smith-Magenis syndrome. The US Supreme Court recent denial of a writ of certiorari exhausted the company's patent litigation options against generic tasimelteon sponsors Teva Pharmaceutical Industries Ltd. and Apotex Inc... Sub. Req'd

Sage Therapeutics Announces Phase 2 SURVEYOR Study Reinforces Cognitive Impact of Huntington's Disease

(6/11, Sage Therapeutics) ...Sage Therapeutics announced today topline results from the Phase 2 SURVEYOR Study. The study met its primary endpoint demonstrating a statistically significant difference as measured by the HD-Cognitive Assessment Battery (HD-CAB) composite score at baseline between healthy participants and participants with Huntington's Disease (HD) prior to any treatment with dalzanemdor (SAGE-718) or placebo... Full

Lilly Alzheimer's Drug Gets Unanimous Backing from FDA Advisory Panel

(6/10, Bhanvi Satija, Julie Steenhuysen, Reuters) ...Outside advisers to the U.S. Food and Drug Administration on Monday voted unanimously that the benefits of Eli Lilly's experimental Alzheimer's treatment donanemab outweighed its risks, and agreed that trial data showed it was effective in patients with an early stage of the memory-robbing disease... Full

Eli Lilly Exec Expects Obesity Pill Data in April 2025

(6/10, Michael Erman, Reuters) ...Data from Eli Lilly's late stage trial on experimental obesity pill orforglipron is expected in April 2025, a top Eli Lilly executive said on Monday...Patrik Jonsson, President of Lilly Diabetes and Obesity, speaking at a Goldman Sachs healthcare conference, said his company is not convinced that the drug will help with the disease itself, but might help with underlying conditions like obesity and stroke that lead to cognitive decline... Full

Eli Lilly Exec Says Seeing Out Of Pocket Payments for Obesity Drug in US

(6/10, Michael Erman, Reuters) ...A top Eli Lilly executive said on Monday that more patients are paying the full list price of its obesity drug Zepbound than those who had paid for its predecessor Mounjaro. Patrik Jonsson, President of Lilly Diabetes and Obesity, speaking at a Goldman Sachs healthcare conference, said a mid-single digit percentage of patients paid the full list price out of pocket for Zepbound in the first quarter of 2024 in the U.S., which compares to the low single digits for Mounjaro... Full

FDA Accepts Eisai's Monthly Dosing Application for Leqembi, Sets January 25 Decision Date

(6/10, Eric Sagonowsky, Fierce Pharma) ...Shortly after Eisai initiated a rolling FDA application for a subcutaneous form of Leqembi, another of the company's regulatory efforts on the Alzheimer's disease medicine is progressing. The FDA has accepted the company's application for a monthly intravenous maintenance dosing option, according to a Monday release. The agency is expected to decide on the filing by January 25, 2025... Full

Astellas Seeks Green Light for Eye Drug Izervay in Europe, Japan

(6/10, Akemi Terukina, Bloomberg) ...Astellas Pharma Inc. is seeking approval for eye treatment Izervay in Japan and Europe, a bid to expand sales to counter a potential revenue drop for its top cancer medicine. The drugmaker is in discussions with Japanese regulators about whether clinical trials for local patients are needed, Chief Executive Naoki Okamura told Bloomberg. If they aren't, the Tokyo-based firm plans to file for a greenlight "as soon as possible," he said... Full

TurboFil, Amneal Pharmaceuticals Partner to Fight Opioid-Related Deaths

(6/10, Contract Pharma) ...TurboFil Packaging Machines LLC, an equipment specialist dedicated solely to the design and development of liquid filling and assembly machines, is collaborating with Bridgewater, NJ-based Amneal Pharmaceuticals to develop an advanced automated assembly and vial filling machine for unidose liquid nasal devices. TurboFil's system will be utilized by Amneal to produce naloxone doses, the life-saving drug used to counteract opioid overdoses... Full

Samsung, Biogen Co-Operate Amid Italian Antitrust Investigation Into Biosimilar Lucentis

(6/10, Dean Rudge, Generics Bulletin) ...Italy's competition authority has opened an investigation into European Lucentis (ranibizumab) biosimilar sponsors Samsung Bioepis and Biogen and originators Genentech and Novartis, alleging that the companies unlawfully coordinated their commercial strategies to postpone the launch of Samsung/Biogen's Byooviz biosimilar, and restrict a market which could have formed as early as July 2022...Responding to Generics Bulletin enquiries, Biogen says it is cooperating with the Italian competition authority's inspection and review. Meanwhile, Samsung Bioepis says it is fully cooperating with the ongoing investigation... Global Sub. Full

GSK Asks to Appeal Delaware Ruling Allowing Zantac Cases to Go Forward

(6/10, Brendan Pierson, Reuters) ...GSK and other drugmakers on Monday asked a Delaware court for permission to appeal a ruling allowing more than 70,000 lawsuits claiming that heartburn drug Zantac causes cancer to go forward. If Judge Vivian Medinilla of Delaware Superior Court grants the petition, which is also joined by Pfizer, Sanofi and Boehringer Ingelheim, the appeal will go directly to the Delaware Supreme Court. If she denies it, GSK said, the companies will ask the Supreme Court directly to hear the case... Full

Baltimore City Wins $45M Settlement with Allergan, Seeks Billions in Suits vs. Other Opioid Distributors

(6/10, Dillon Mullan, The Baltimore Sun) ...Baltimore City wins $45M settlement with Allergan, seeks billions in suits vs. other opioid distributors...An attorney representing Allergan did not respond to a request for comment Sunday. The city is still suing Johnson & Johnson, McKesson, Cardinal Health, AmerisourceBergen, Walgreens, CVS, Teva, former Insys CEO John Kapoor, members of the Sackler family and others. And those companies and executives could be forced to pay much more... Full

'A Smorgasbord of Tactics': Mallinckrodt Docs Outline 'Tricks' Used to Boost Opioid Sales, BMJ Analysis Finds

(6/10, Andrea Park, Fierce Pharma) ...A report published in The BMJ on Monday details two researchers' findings from digging through nearly 900 contracts included in that trove of documents, which "reflect concrete efforts backed up by payments." According to Sergio Sismondo, Ph.D., and Maud Bernisson, Ph.D., the docs "outline a smorgasbord of tactics to achieve greater sales." Tying those tactics together was an apparent effort to convince medical professionals that opioids like those sold by Mallinckrodt were not only effective treatments for acute and chronic pain but also safe for prolonged use... Full

Review Finds 7 Themes That Can Help Define the Value of Biosimilars

(6/10, Skylar Jeremias, The Center For Biosimilars) ..."The conceptual framework described here creates a basis for validating the elements through future research efforts…. It may be possible that new themes may emerge with a stakeholder survey and that some of the hypothetical themes may be deemed non-essential in describing biosimilar portfolio value. Additionally, it would be of interest to complete the survey across countries and regions given intrinsic differences in healthcare systems," the authors suggested... Full

IQVIA Institute: Innovative Therapies and Strong Pipeline to Combat Rise in Cancer Diagnoses

(6/10, IQVIA) ...Cancer incidence is expected to rise significantly through 2050, particularly in lower-income countries, to 32 million new cases annually – a potential increase of more than 12 million new annual cases. Global spending on cancer medicine increased to $223 billion in 2023, $25 billion more than in 2022, and is projected to reach $409 billion by 2028... Full

GSK Stands by Orange Book Patents That FTC Has Asked to Rescind

(6/10, Nicole DeFeudis, Endpoints News) ...This weekend, the deadline passed for drugmakers to pull, amend or reaffirm the patent listings. GSK told Endpoints News on Monday that "we have affirmed that all of those Orange Book listings are appropriate and in compliance with applicable law, regulations and guidance." The FTC had called into question several of GSK's patents on Ellipta, an asthma and COPD treatment. Alongside GSK, the FTC has sent challenges to AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Teva, Amphastar Pharmaceuticals, Covis Pharma and Novartis. A Novo spokesperson on Monday said the FTC's "allegation that we use this listing to keep prices artificially high is simply false."... Full

Biden Plan to Save Medicare Patients Money on Drugs Risks Empty Shelves, Pharmacists Say

(6/11, Susan Jaffe, KFF Health News) ...Months into a new Biden administration policy intended to lower drug costs for Medicare patients, independent pharmacists say they're struggling to afford to keep some prescription drugs in stock. "It would not matter if the governor himself walked in and said, 'I need to get this prescription filled,'" said Clint Hopkins, a pharmacist and co-owner of Pucci's Pharmacy in Sacramento, California. "If I'm losing money on it, it's a no."... Full

NEW ISSUE BRIEF: Biosimilar Competition Lowers Patient Drug Costs, New Competition Will Bring Even More Savings

(6/11, Wayne Winegarden, PRI) ...From 2019-2023, patients saved $15 billion from biosimilar competition. Had there been competition during the same period for two other biologics, Humira and Enbrel, patients would have saved another $13 billion, for a total of $28 billion. "The growing market share for biosimilars since 2019 shows that promoting more competition lowers prices and brings significant savings to patients and taxpayers," said Dr. Wayne Winegarden, director of PRI's Center for Medical Economics and Innovation and the brief's author. The CMEI brief found that, for the entire biosimilars market (including Humira and Enbrel, which currently do not have biosimilars competition)... Full

Is Congress Misleading or Ignorant? Their War On Drug Prices Provides No Answers

(6/10, Charles Sauer, RealClearHealth) ...There was a Congressional hearing last week regarding drug prices, patents, and the pharmaceutical industry. These are all things that are important for Congress to discuss, but the hearing was disappointing in both its level of understanding of these complex issues, as well as its failure to identify the problems that need to be fixed... Full

Congress Targets Medicare Solvency, CMMI; Stakeholders Rally For Site-Neutral, PBM Reforms

(6/10, Amy Lotven, Jessica Karins and Dorothy Mills Gregg, InsideHealthPolicy) ...Congress returns to a busy post-break schedule that includes a critical look by House committees at CMS' Innovation Center, and Medicare solvency, while the Senate plans vote on protecting in vitro fertilization later in the week. House Energy & Commerce is also planning a full committee markup that could include telehealth bills if lawmakers are able to secure a Congressional Budget Office score by Wednesday... Sub. Req'd

Dynamic Pricing: What Pharma Needs?

(6/10, Blake Powers, Pharmaceutical Commerce) ...The recent US Department of Health and Human Services white paper, "Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States," published in April, suggests it's time to reevaluate, noting that "Incentives throughout the supply chain must be reimagined to ensure the resilience and supplier redundancy required to prevent drug shortages from occurring."... Full

Federal Safety Net Drug Pricing Program Leaves Rural Patients and Seniors Behind

(6/10, Mark Gibbons, RealClearHealth) ...The intentions of the 340B program are honorable, but the program has clearly veered far off course. The 340B program's lax rules incentivize urban hospitals to attain RRC designations to profit from drug discounts without fulfilling their obligation to support rural Americans. Congress has a responsibility to increase accountability within the safety net program so that rural patients are not left behind... Full

Maryland Health Care Advocacy Group Wants Drug Cost Pledges From Candidates

(6/10, WFMD) ...The Maryland Citizens Health Initiative sent a letter asking Senate and Congressional primary election winners to sign a pledge supporting the health care and prescription drug affordability provisions of the Inflation Reduction Act. President Vincent DeMarco said "We're going to really let the people of Maryland know who signed on and who hasn't."... Full

Press Release: Reformed Incentives System Promises Better Patient Access in Europe

(6/11, Medicines for Europe) ...Speaking at Medicines for Europe's Legal Affairs Conference, General Counsel Sergio Napolitano said "Medicines for Europe was created 30 years ago in reaction to the Supplementary Protection Certificate (SPC) in Europe which undermined the competitiveness of the medicine manufacturing industry in Europe. The SPC Manufacturing Waiver, which took 25 years to introduce, needs to be implemented in the spirit of the legislation to exploit all its potential for manufacturing in Europe. In parallel, the EU pharmaceutical legislation reform should ensure the timely launch of generic and biosimilar medicines and introduce a European SPC granting system with the highest quality standards, a clamp down on IP abuses and a supportive industrial policy for off-patent medicines."... Full

Two New Advice Pilots to Improve Clinical Trials in Europe

(6/10, European Medicines Agency) ...Starting today, developers of medicinal products who wish to receive advice on the requirements for a MAA or a CTA may apply to these pilots. The duration of both pilots will be evaluated over time based on data and feedback collected from applicants. All this information will inform a possible change of scope and a final decision from the ACT EU steering group on how to optimise clinical trial support in the future. By strengthening the coordination of the European medicines regulatory network, these advice pilots offer applicants additional support to enhance the quality of their applications for marketing and/or clinical trial authorisation... Full

ABPI Asks UK Political Parties How They Will Unlock Pharma

(6/10, The Pharma Letter) ...The Association of the British Pharmaceutical Industry (ABPI) has issued a challenge to the UK's political parties ahead of next month's election...Richard Torbett, ABPI chief executive said: "We urge the next government to commit to being a partner with industry in unlocking economic growth and ensuring fair and timely access to treatments and vaccines in the NHS... Sub. Req'd

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