Friday, January 10, 2025

Teva Leapfrogs One ANDA Sponsor But Faces Decade Wait On US Firdapse Opportunity

(1/9, Dean Rudge, Generics Bulletin) ...Teva looks set to wait until early in 2035 to launch its proposed generic version of Catalyst Pharmaceuticals' Firdapse (amifampridine) 10mg tablets in the US, after striking a settlement agreement with the originator that resolves all litigation previously pending in a district court in New Jersey... Global Sub. Full

Catalyst Settles with Teva, Staving Off Firdapse Generic Until 2035

(1/9, Fraiser Kansteiner, Fierce Pharma) ...Catalyst and its licensor SERB have inked a settlement with Teva to resolve patent litigation brought by Catalyst after Teva made its plans to seek approval for its generic known in early 2023. Under the agreement, Teva is barred from marketing its Firdapse copycat in the U.S. until Feb. 25, 2035, at the earliest, Catalyst said Wednesday. Teva's generic version of the med, amifampridine, has not yet been approved by the FDA... Full

Catalyst Staves Off Firdapse Competition from Teva for a Decade

(1/9, Zachary Brennan, Endpoints News) ...Catalyst Pharmaceuticals' controversial $375,000 rare autoimmune disease drug now won't face generic competition from Teva until Feb. 25, 2035, thanks to a patent settlement announced by the two companies... Full

Catalyst Pharmaceuticals Settles Patent Litigation Case With Teva Pharmaceutical

(1/9, Vandana Singh, Benzinga) ...On Wednesday, Catalyst Pharmaceuticals Inc. entered into a settlement agreement with Teva Pharmaceuticals Industries Ltd...The parties will terminate all ongoing patent litigation between Catalyst/SERB and Teva regarding Firdapse patents pending in the U.S. District Court for the District of New Jersey. The ongoing Firdapse patent litigation involves two defendants: Hetero, which is being challenged on all of Firdapse's Orange Book-listed patents, and Lupin, which is facing a case focused on Catalyst's Firdapse patent that expires in 2037... Full

What's in a Claim? The Federal Circuit Rules On Orange Book Patent Listings

(1/8, Sara W. Koblitz, FDA Law Blog) ...Now, the arbiter of all things patent, the Federal Circuit, has made the most definitive statement yet, holding that: To list a patent in the Orange Book, that patent must, among other things, claim the drug for which the applicant submitted the application and for which the application was approved. And to claim that drug, the patent must claim at least the active ingredient...The background of this case is pretty simple. Teva is the sponsor of ProAir® HFA, indicated for the "treatment or prevention of bronchospasm with reversible obstructive airway disease in adults and children 12 years of age or older."... Full

Transparency Is the Best Medicine: Device Parts Don't Justify Orange Book Listing

(1/9, Amit Kumar Saha, PhD, The National Law Review) ...The US Court of Appeals for the Federal Circuit affirmed a district court's delisting of patents from the Orange Book because the patent claims did not "claim the drug that was approved" or the active ingredient of the drug that was approved. Teva Branded Pharmaceutical Products R&D, Inc., et al. v. Amneal Pharmaceuticals of New York, LLC, et al., Case No. 24-1936... Full

Fueled by New Launches, US Drug Prices Poised to Continue Trending Upward: Cowen Report

(1/9, Fraiser Kansteiner, Fierce Pharma) ...Breaking down the numbers, per-unit costs for branded drugs increased by an average of 7% in 2024, Cowen said in its report, a slight increase from 5% in 2023...In sum, while the topic of drug prices is often a "source of anxiety for biopharma investors," Cowen said it sees no reason to doubt the upward trend in prices "[a]s long as biopharma delivers innovation."... Full

Biocon Dreams To Be Among The Top Three Biosimilar Firms As Stelara Rival Gets Japan Approval

(1/9, Urte Fultinaviciute, Generics Bulletin) ...In 2024, Biocon marked multiple achievements, such as surpassing the $1bn revenue milestone last March and launching over 60 products in emerging and advanced markets throughout the year. Now, it has stepped into what the firm calls "the final stage of accelerated business growth in 2025 and beyond," and has set a new goal – becoming among the top three biosimilars companies globally... Global Sub. Full

Lupin Secures Tentative U.S. FDA Approval for Ivacaftor Oral Granules

(1/10, Express Pharma) ...Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Ivacaftor Oral Granules in 25 mg, 50 mg, and 75 mg per unit dose packet. The product is a generic equivalent of Kalydeco Oral Granules by Vertex Pharmaceuticals Incorporated... Full

Stada Chairman Appointment Lays Groundwork For IPO

(1/9, Dave Wallace, Generics Bulletin) ...The firm has announced the appointment of Andreas Fibig as independent chairman of a nine-member board of directors that will be established "in the event of an IPO," with Stada characterizing the news as a sign that current owners Cinven and Bain Capital are "setting the course for the future." The board "will be established at Stada's future listed group holding company, which will be incorporated under Dutch law, but based in Germany," the firm said... Global Sub. Full

Sanofi Scores with its Subcutaneous Version of Sarclisa as it Tries to Play Catch Up with J&J's Darzalex

(1/9, Kevin Dunleavy, Fierce Pharma) ...The company has taken a major step in the development of its OBDS as a phase 3 trial has met its primary co-endpoints, showing non-inferiority to intravenous (IV) Sarclisa. The company reported the trial result in a press release Thursday. In the IRAKLIA study, 531 patients with relapsed or refractory multiple myeloma received either Sarclisa SC or Sarclisa IV. Patients in both treatment arms also received pomalidomide and dexamethasone (Pd)... Full

Samsung Biologics Expands ADC Collaboration with LigaChem

(1/9, Charlie Sternberg, Contract Pharma) ...Samsung Biologics will support a series of LigaChem Biosciences' ADC programs at Samsung Biologics' new dedicated ADC facility. The two companies have already been collaborating on ADC programs for the treatment of solid tumors. "The latest collaboration will further strengthen Samsung Biologics' capabilities across all stages of ADC development and manufacturing as part of our commitment to deliver safe and high-quality therapeutics to patients," said John Rim, CEO and President of Samsung Biologics... Full

Lilly Crafts Deal for Up to 5 New ALS Antibodies with UK Biotech Alchemab

(1/9, Darren Incorvaia, Fierce Biotech) ...It's been a rough month for several clinical amyotrophic lateral sclerosis (ALS) candidates, but that's not stopping Eli Lilly from pursuing new drugs of its own for the devastating neurological disease. The Big Pharma has inked a deal with British biotech Alchemab Therapeutics to develop new antibodies for ALS. Under the terms of the deal, Alchemab and Lilly will work together on up to five new antibodies, according to a Jan. 9 release... Full

IGM Biosciences' Autoimmune Pivot Lasts Three Months After Interim Data Disappoint

(1/9, Max Bayer, Endpoints News) ...About three months ago, IGM Biosciences announced plans to stay afloat by focusing its resources on a clinical-stage autoimmune asset. Now the company is shelving the drug, laying off most of its remaining employees and potentially shutting down or selling itself... Full

This Generic Drugmaker Is Adding Novel, Branded Antibiotics to the Mix

(1/10, Jon Asplund, Crain's Chicago Business) ...Two commercial leaders at Chicago-based Meitheal sat down with Crain's to discuss the way the company's strategy of U.S. commercialization of two branded drugs, Xenleta and Contepo, along with bringing biosimilars and generics to market matches a mission of bringing consistently available, cost effective pharmaceuticals to health care... Sub. Req’d

Dr. Reddys to Close Shreveport Site in Sale, 111 Workers to Lose Jobs

(1/8, Jonathan McCall, KTBS 3 Louisianna) ...Dr. Reddy's, a global pharmaceutical company with ties to Louisiana, will close its Shreveport manufacturing plant and terminate workers as part of a deal that will cease operations in Shreveport. Company officials met with 111 plant workers to notify them of the sale... Full

After Rejection, Vanda CEO Pens Searing Letter to FDA Commissioner About ‘Disturbing Pattern of Conduct'

(1/9, Gabrielle Masson, Fierce Biotech) ...After Vanda Pharmaceuticals' phase 3 miss and FDA rejection for its stomach disorder candidate, CEO Mihael Polymeropoulos, M.D., is calling out the regulatory agency for a "disturbing pattern of conduct" that "harms the American public." In a searing letter penned to current FDA Commissioner Robert Califf, M.D., Polymeropoulos addresses the rejection Vanda received in September 2024, deeming the agency's review process as "faulty," according to the Jan. 8 letter... Full

Kroger to Pay $110 Million to Resolve Kentucky Lawsuit Over Opioid Epidemic

(1/9, Nate Raymond, Reuters) ...Kroger has agreed to pay $110 million to resolve a lawsuit by the state of Kentucky alleging the supermarket chain's pharmacies helped fuel a deadly opioid epidemic by flooding its communities with hundreds of millions of doses of addictive painkillers... Full

With BIOSECURE in Limbo, Should BeiGene or Legend Sell Itself in 2025? Analysts Weigh In

(1/9, Angus Liu, Fierce Pharma) ...Both firms have a star, fast-growing blood cancer product: BTK inhibitor Brukinsa for BeiGene and Johnson & Johnson-partnered CAR-T therapy Carvykti for Legend. And questions have been raised regarding the value of their pipeline assets. But the prospects of the two companies being bought out appear quite different, according to analysts... Full

2025 Forecast: As Companies Rush to Radiopharmaceuticals for Oncology, What's Next?

(1/10, Kevin Dunleavy, Fierce Pharma) ...Novartis paid $1 billion for Mariana Oncology. Eli Lilly jumped in with a $1.4 billion buyout of Point Biopharma. AstraZeneca spent $2.4 billion for Fusion Pharmaceuticals. And Bristol Myers Squibb ponied up $4.1 billion for RayzeBio. Why is Big Pharma suddenly placing bets—big and small—on a medicine type that has been in the works for nearly a century, starting with radioactive iodine? It has much to do with the ability of today's technologically souped-up products—which use radioisotopes with improved stability—to deliver radiation directly to tumors and with minimal side effects... Full

Some Pharmaceutical Mergers Lower Drug Prices: Study

(1/9, Paige Twenter, Becker's Hospital Review) ...Other studies have drawn a link between pharmaceutical mergers and higher drug prices, lower innovation and decreased competition. However, as the University of Iowa researchers pointed out, "large-sample rigorous analysis of the impact of mergers on drug prices is scarce." They examined 125 pharmaceutical mergers between 2007 and 2020 and, using data on Medicaid-covered drugs, found contrasting results. Highly innovative firms with brand-name therapies, such as Eli Lilly and Novo Nordisk, increase prices by an average 6.3% after a merger... Full

After Lackluster 2024, Biopharma Industry Prays Stalled M&A Will Finally Move into Gear

(1/9, Kyle LaHucik, Endpoints News) ...Biopharma leaders will descend on San Francisco next week hopeful that the industry's biggest dealmaking event will finally yield some much sought-after M&A. The industry needs it after a slow fourth quarter, which had the lowest number of deals and total quarterly value since the first quarter of 2022, according to a JP Morgan analysis published this week. There were only 18 M&A transactions in the final three-month stretch of 2024, compared to 31 in the same period in 2023. The total deal value was about one-tenth of 2023's exuberant fourth quarter... Full

Why isn't AI Transforming Biopharma as Fast as We'd Like?

(1/10, Greg Meyers, STAT+) ...There's truly never been a more exciting time to be in the life sciences, especially as a technologist. Seismic AI transformation is inevitably coming for our industry. We just don't know when, in part because of the challenges I've outlined here. The wisest course for tech/AI and pharma right now is to partner in driving immediate, achievable, incremental advancements with the tools on hand without overestimating the velocity of change... Sub. Req’d

AAM: Tariffs Would Block Shared Goals Of Generic Drug Makers & Trump Admin

(1/9, Gabrielle Wanneh, Inside Health Policy) ...The U.S. generic drug lobby hopes to convince the incoming Trump administration that imposing tariffs on imported medical products would hurt generic drug makers and hinder their shared goal of lowering drug prices, Association for Accessible Medicines CEO John Murphy tells Inside Health Policy in an exclusive interview. The lobby's other top priorities include getting Congress to pass bills allowing so-called "skinny" labeling and automatic interchangeability of biosimilars with reference biologics, Murphy says... Sub. Req’d

US vs. Foreign Drug Pricing Debate Must Include Global R&D ‘Free Riding,' Pharma CEOs Say

(1/9, Cathy Kelly, Pink Sheet) ...Recent public comments from the CEOs of Lilly and Pfizer advocated for increasing drug prices in other developed countries instead of focusing only on lowering prices in the US. The two apparently discussed the issue with president-elect Trump at a recent meeting. Trump remains interested in international reference pricing, but his administration's approach to the issue remains unclear. Lilly CEO David Ricks suggested an announcement may be coming 'soon.'... Global Sub. Full

Trump Says World Is Free-Riding on U.S. Health Spending. He Has a Point.

(1/10, David Wainer, Jon Sindreu, The Wall Street Journal) ...Trump's policy of linking U.S. prices to other countries could theoretically pressure other nations to pay more, but it risks unintended consequences. For instance, pharma companies could pull their drugs out of some European countries, says Dana Goldman, a health economist at USC. Still, he says some countries might be forced to go along if the Trump administration were to deploy a combination of the most-favored-nation rule alongside tariffs... Sub. Req’d

Trump's Return Likely Means Incremental Healthcare Changes

(1/10, Andrea Ruth, Washington Examiner) ...Supporters of the Trump rules say the benefits of short-term plans are that people can purchase them whenever they want, as opposed to Obamacare plans with a specific enrollment period. They also offer significantly lower premiums than Obamacare premiums and more choices, such as opting out of prescription coverage, out-of-pocket maximum limits, and deductibles. Those changes could come early on, but they will face plenty of resistance from House and Senate Democrats, now both relegated to the minority at the same time for the first time since early 2019... Full

Earlier Patent Litigation Could Accelerate US Biosimilar Market Entry

(1/9, Cameron Santoro, The Center for Biosimilars) ...The biosimilar market could be accelerated through patent litigation reforms that expedite biosimilar market availability throughout the US, according to a study published in Journal of Law and the Biosciences. Between 2015 and 2021, the US only had 11 biosimilars marketed compared with the European Union, which had 55 biosimilars marketed between 2008 and 2021. Despite biosimilar approval growth in the US, delayed entry into the market due to patent litigation continues to be an issue... Full

CDER Approved 50 Novel Drugs in 2024, Record Number of Biosimilars

(1/9, Jeff Craven, Regulatory Focus) ...A report released by the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) notes that the Center approved 50 novel drugs in 2024, as well as a record number of biosimilars and a significant number of therapies with orphan drug designation... Full

BIO Veteran Cartier Esham To Head Alliance For A Stronger FDA

(1/9, Jessica Karins, Inside Health Policy) ...Wide-ranging stakeholder organization the Alliance for a Stronger FDA announced Thursday (Jan. 9) that its new executive director will be Cartier Esham, a veteran of the Biotechnology Innovation Organization (BIO). Esham, the CEO of consulting firm Esham Strategies, will lead the organization as it enters what is likely to be a difficult period for FDA funding advocates, with the administration of President-elect Donald Trump set to focus on cutting costs across the federal government... Sub. Req’d

Clearing the Path for New Uses for Generic Drugs

(1/9, Laura Kleiman, Devon Crittenden, Raquel Gallagher, Federation of American Scientists) ...To encourage greater adoption of generic drugs in clinical practice – that is, to encourage the repurposing of these drugs – the FDA should implement a dedicated regulatory pathway for non-manufacturers to seek approval of new indications for repurposed generic drugs...Creating a regulatory pathway for non-manufacturers would unlock access to innovative therapies and enable the public to benefit from the enormous potential of low-cost generic drugs... Full

DIGITAL LEAP: Industry Proposes Phased Rollout of ePI for Patient Safety and Environmental Sustainability

(1/8, Medicines for Europe) ...In a significant stride towards further modernizing patient care, regulatory efficiency, and environmental sustainability, Pharmaceutical Industry Associations (AESGP, EFPIA, and Medicines for Europe) have launched a new series of position papers advocating for the implementation of electronic Product Information (ePI) and improvement of the patient leaflet content. By transitioning to ePI, patients, healthcare professionals (HCPs), and civil society will benefit from the most up-to-date, accessible medicinal information, ensuring safer use of medicinal products... Full

EU Pharma Reform: Industry Pushes For Early Roll-Out Of Electronic Product Information

(1/9, Vibha Sharma, Pink Sheet) ...EU pharmaceutical industry associations representing the R&D-based, generics and self-care product sectors, have issued a series of position papers advocating the implementation of electronic Product Information (ePI) and improvements to patient leaflets, in line with the EU pharma legislation reform. The groups argue that early and harmonized transition from paper-based product information to ePI is critical for advancing patient care, enhancing regulatory operations, and addressing environmental challenges... Global Sub. Full

African Regulators Reach Big WHO Milestones

(1/9, Francesca Bruce, Pink Sheet) ...Regulators in Africa are building momentum after authorities in Egypt, Rwanda and Senegal attained a maturity level 3 (ML3) in the World Health Organization's formal process for global benchmarking of national regulatory bodies. "Maturity level 3 reflects a stable, well-functioning, and integrated regulatory system," said the WHO. However, ML4 is the highest level, and represents an advanced regulatory system committed to continuous improvement... Global Sub. Full

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