Wednesday, March 5, 2025

Spotlight On: Teva, Sanofi Bolster Best-in-Class Case for Anti-TL1A Duvakitug in IBD

(2/28, Michael Flanagan, FirstWord Pharma) ..."These are the highest numbers ever reported for this mechanism of action," noted Eric Hughes, Teva's head of global R&D and chief medical officer, who noted that the unmet need in IBD is still very high with 75% of patients with CD and 20% with UC ultimately requiring surgery. On the heels of the meeting, Hughes told FirstWord that one of the biggest highlights of the RELIEVE UCCD readout was the breadth of duvakitug's utility. "The exciting part is that the treatment-experienced patients, meaning those who had up to three advanced therapies and failed them, actually responded just as well - and actually numerically better - than the naive people," he noted... Sub. Req’d

8 Drugs Now in Shortage

(3/4, Alexandra Murphy, Becker's Hospital Review) ...Pimecrolimus 1% topical cream: Bausch Health, Glenmark and Teva reported shortages of pimecrolimus 1% topical cream in various sizes. While some presentations are available, resupply dates for the affected products are uncertain with some products expected to be back in stock by mid-March 2025... Full

Sandoz Reports Strong 2024 Results

(3/5, The Pharma Letter) ...The majority of revenues came for generics, which came in at $7,504 million (+1% YoY, +2% CER), with biosimilars sales of $2,853(+29% YoY, +30% CER). Strong sales performances in all three regions, was driven by double-digit growth in biosimilars, both in the fourth quarter and full year, benefitting from recent launches and base-business momentum...Sandoz anticipates further major biosimilar launches in 2025, including Pyzchiva and Tyruko in the USA, as well as Wyost/Jubbonti (denosumab) in Europe and the USA... Sub. Req’d

Hikma Doubles Down On R&D Investment In 2025

(3/4, Adam Zamecnik, Generics Bulletin) ...Hikma Pharmaceuticals has delivered a successful 2024 fiscal year while simultaneously doubling down on its turn to more complex drugs, with plans for a 20% increase in R&D investment in the coming year. Overall, Hikma's sales as reported were up by almost 9% to $3.13bn, while operating profit bounced back from the $367m seen in 2023 – which was significantly lowered by one-off costs – to $612m in 2024. Nevertheless, despite reporting satisfactory results for the 2024 fiscal year and hopeful 2025 guidance... Global Sub. Full

Bayer Cautions Pharma Sales Dip This Year Despite Major Upcoming Launches

(3/5, Ayisha Sharma, Endpoints News) ...The German conglomerate doesn't expect its pharma franchise to return to sales growth until 2027, with expanded margins set to follow in 2028, according to its full-year earnings release. And this year, pharma sales could slide between 1% and 4% due to continued sales erosion of the company's blood thinner Xarelto because of generic competition, a company presentation shows. Despite the tempered expectations for this year, Bayer's pharma sales grew 3.3% to €18.1 billion ($19.4 billion) in 2024 from the year prior... Full

Amgen Confirms Launch Of First US Eculizumab Rival

(3/5, Dave Wallace, Generics Bulletin) ...Confirming to Generics Bulletin that Bkemv had launched in the US, Amgen underlined that the product was "the first interchangeable biosimilar to Soliris approved by the FDA. Additionally, Bkemv is the first, and is currently the only, interchangeable biosimilar for rare diseases approved in the US."...Epysqli is set to be marketed in the US by Teva, under a partnership deal agreed at the start of this year. However, the exact launch date remains unclear: Samsung Bioepis had already agreed its own settlement with Alexion shortly after its eculizumab biosimilar was approved, but the Korean company has only indicated to Generics Bulletin that it and Teva "expect to launch Epysqli in the first half of 2025."... Global Sub. Full

US Denosumab Race Remains Busy As Amneal And mAbxience See Filing Accepted

(3/5, Dean Rudge, Generics Bulletin) ...Amneal is looking ahead to a US Food and Drug Administration target action date in the fourth quarter of 2025 for its proposed mAbxience-partnered Prolia/Xgeva (denosumab) biosimilars, after they were accepted for filing by the agency...Other contenders in the mix for denosumab biosimilars include partners Hikma and Gedeon Richter, which filed their RGB-14 version with the FDA late last year...Furthermore, Teva filed a denosumab candidate with the FDA last year, while Dr Reddy's also recently confirmed that its Alvotech-partnered AVT03 candidate had been filed with the FDA... Global Sub. Full

New Version of Merck's Blockbuster Cancer Drug Threatened by Patent Battle

(3/5, Jared S. Hopkins, The Wall Street Journal) ...A dispute over a microscopic enzyme is threatening Merck & Co. plans to sell a new version of Keytruda, the cancer drug that generates nearly half of the company's sales. Merck has been tweaking Keytruda to make it easier to use—and to protect billions of dollars in revenue the company could lose after U.S. patent protection runs out in 2028 and rivals can begin selling copycats. The enzyme in the new Keytruda allows it to be injected, rather than given intravenously. It is the subject of a brewing patent dispute between Merck and a biotech called Halozyme Therapeutics... Sub. Req’d

FDA Warns Indian Firm Over Cleanliness and Poor Record Keeping, US Drugmaker Over Investigation Failures

(3/4, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) recently issued two warning letters to companies in India and the US for various violations of good manufacturing practices (GMPs) related to the production of drug products. In both cases, investigators identified issues with cleanliness levels within the facilities... Full

How Are Industry Leaders Building Inclusive Supply Chains?

(3/4, Libby Hargreaves, SupplyChain Digital) ...In the pharmaceutical sector, managing supplier relationships is particularly complex. "You categorise suppliers based on priority and availability," explains Faris Hattar, Associate Director of Supply Chain for Hikma Pharmaceuticals. "In pharma, it's even more difficult because of regulatory approval processes and product testing. Ensuring transparency and timely communication with suppliers is key." Faris says this is why collaboration across the supply chain is so important: "It's all about joint value creation between trading partners. You need to look beyond the walls of your organisation to create value throughout the supply chain between suppliers and clients."... Full

US Tariffs Will Raise Drug Prices for Patients, Sandoz CEO Says

(3/5, Paula Doenecke and Ashleigh Furlong, Bloomberg) ...Most generics and biosimilars in the US contain ingredients made elsewhere or are produced entirely abroad, which will hit consumers immediately, Richard Saynor, the chief executive officer of Sandoz Group AG, said in an interview with Bloomberg TV. "In the short term I think it will drive even more patient-access instability," he said. In the medium term, pricing increases will be passed on to payers and ultimately to patients, according to Saynor, who said he doesn't believe "this is in the interest of patients or health care generally in the US." Like rivals Teva Pharmaceutical Industries Ltd. and Viatris Inc., Sandoz copies branded drugs once they lose patent protection, which leads to reduced costs. It manufactures those products largely outside of the US, with plants in Canada and Austria... Full

Generic Drugmakers Could See Negative Impact from Higher Chinese Tariffs

(3/4, Jonathan Block, Seeking Alpha) ..."US medical equipment producers and drugmakers may also be significantly affected by China's retaliation over US tariffs as China may not necessarily match the US one-for-one with retaliatory tariffs," the report says. "In fact, if China does not target all industries equally, Beijing's desire to build up its own pharmaceutical and medical equipment firms, and broader healthcare sector, means the US healthcare industry is one of those more likely to be targeted in any Chinese retaliation, hurting US companies compared to Chinese, Indian and European competitors in the Chinese market."... Full

Trump Weighs Tariff Deal With Canada, Mexico, Lutnick Says

(3/4, Josh Wingrove, Bloomberg) ..."Both the Mexicans and the Canadians were on the phone with me all day today trying to show that they'll do better, and the president's listening, because you know he's very, very fair and very reasonable," [Commerce Secretary Howard Lutnick] said Tuesday in an interview with Fox Business. "So I think he's going to work something out with them - it's not going to be a pause, none of that pause stuff, but I think he's going to figure out: you do more and I'll meet you in the middle some way and we're going to probably announcing that tomorrow."... Sub. Req’d

Trump Says Tariffs Will Stop When Opioid Deaths Fall. They've Already Fallen.

(3/4, Josh Katz and Margot Sanger-Katz, The New York Times) ..."We need to see material reduction in autopsied deaths from opioids," said Howard Lutnick, the commerce secretary, in an interview on CNBC on Tuesday, indicating that such a decline would be a precondition to lowering tariffs. "But you've seen it — it has not been a statistically relevant reduction of deaths in America." In a way, Mr. Lutnick is correct that there is no evidence that overdose deaths have fallen in the last month — since there is no such national data yet. His stated goal to measure deaths again in early April will face similar challenges. But data through September shows that fentanyl deaths had already been falling at a statistically significant rate for months, causing overall drug deaths to drop at a pace unlike any seen in more than 50 years of recorded drug overdose mortality data... Sub. Req’d

As Tariffs Begin; What Will They Do To Drug Prices And Availability?

(3/4, Steve Brozak, Forbes) ...It is a critical reality that the U.S. must return to a self-sufficient status in making critically needed drugs. But any pronouncement that the American people "may have a little short-term pain, and people understand that" must make sure that the pain also addresses the ability to fix the long-term consequences of the lack in US drug manufacturing. This resolve must focus on the impact of drug availability, accessibility, and affordability, which also has the potential to inflict severe pain, both in the short-term and the long-term, if a trade war takes place... Full

Transparency vs. Reality: Troubling Lessons from PBM Disclosure Laws

(3/5, Adam J. Fein, Ph.D., Drug Channels) ...Below, I analyze four state reports on manufacturers' rebate and fee payments to PBMs. The findings are dispiriting: mandated disclosures have yielded little actionable, reliable data. Lawmakers got to pat themselves on the back for "transparency," but the data tell a different story. Federal efforts haven't been much better... Full

Warren Asks Makary To Recuse Himself From GLP-1 Compounding, Advocates Seek FDA Nominee's Views On EOs

(3/4, Maaisha Osman, Inside Health Policy) ...Meanwhile, health advocacy groups, including Public Citizen and Doctors for America, say lawmakers should grill Makary on controversial White House calls for FDA staff terminations, removal of scientific data, new vaccine policies and more ahead of his confirmation hearing Thursday (March 6)... Sub. Req’d

US FDA May Be Shifting Its Thinking On Biosimilar Trials

(3/5, Dave Wallace, Pink Sheet) ...The US Food and Drug Administration is increasingly open to approving biosimilar filings without full Phase III clinical trial data. Two recent company disclosures revealed agency scientific advice indicating applications could be approved without the usual suite of supporting trials. Phase III trials are not a formal necessity for biosimilar approval. The FDA evaluates each proposed biosimilar individually and advises manufacturers on the scope and extent of testing necessary to show biosimilarity. Supporting data to demonstrate biosimilarity can include analytical studies as well as clinical trials, but the FDA reserves "discretion to determine that an element is unnecessary in a proposed biosimilar application."... Global Sub. Full

DOGE Terminates Lease On FDA Quality Lab in St. Louis and 29 Other Sites

(3/4, Zachary Brennan, Endpoints News) ...The Department of Government Efficiency says that it has terminated the leases of 30 FDA offices and buildings, including a 52,000 square-foot St. Louis-based lab that operates under the FDA's Office of Pharmaceutical Quality...Another scientist who works at the site said it has state of the art pharmaceutical characterization and testing equipment worth between $50 million and $100 million "that most likely won't be relocated and will be sold for a fraction of the cost." The scientist added, "The decision to terminate the St. Louis lab will cost more money than it saves." Endpoints is not naming the persons to protect them from possible retaliation... Full

Trump's FDA Staff Cuts Weigh On Agency's Drug Oversight Work

(3/5, Nyah Phengsitthy, Bloomberg Law) ...A reduced workforce could also make it challenging for the FDA to operate under the Prescription Drug User Fee Act, a law that allows the agency to collect fees from manufacturers submitting human drug applications to review and approve drugs within a certain time frame and hire more people to speed up reviews. "The reduction in force at the FDA will inevitably slow the review process, delaying the availability of potentially life-saving products to the American public," Anthony W. Lee, president of the FDA's union under the National Treasury Employees Union, said in a statement to Bloomberg Law... Sub. Req’d

Colorado Hospitals and Pharma Industry Clash Over 340b Drug Discount Program

(3/4, Marissa Ventrelli, Colorado Politics) ...Senate Bill 071, sponsored by Sens. Dafna Michaelson Jenet, D-Commerce City, and Janice Rich, R-Grand Junction, and Reps. Matthew Martinez, D-Monte Vista, and Rick Taggart, R-Grand Junction, would prohibit pharmaceutical companies from "denying, restricting, prohibiting against or otherwise limiting" the acquisition of 340b drugs by a covered pharmacy...PhRMA opposes the measure, arguing that 340b is a federal program and any adjustments to its statute should be made at the federal level... Full

Republican Lawmakers Introduce Bill to Lower Drug Costs, Increase Transparency

(3/5, Joseph Panzer, The Daily Cardinal) ...The bill, authored by Sen. Mary Felzkowski, R-Tomahawk, and Rep. Todd Novak, R-Dodgeville, is titled Cole's Act, named after Cole Schmidtknecht, a 22-year-old from Poynette who died from an asthma attack after PBM practices led to his daily steroid inhaler jumping from $60 to $539.19. PBMs are companies that negotiate between pharmaceutical companies, insurers and pharmacies on drug prices and covered medications... Full

Why Vermont Sen. Welch is Trying Again to Let Americans Buy Canadian Prescription Drugs

(3/5, Dan D'Ambrosio, Burlington Free Press) ...Sen. Peter Welch, D-Vermont, is co-sponsoring a bill that would allow Americans to import prescription drugs from Canada. The bill would require prescriptions from U.S. physicians and limit purchases to 90-day supplies for personal use. Canadian researchers argue that allowing Americans to buy Canadian drugs would lead to shortages in Canada. They urge U.S. politicians to address the high cost of prescription drugs domestically... Full

Global Freeloading: Americans Shouldn't Bear the Brunt of Drug Development Costs

(3/5, Bobby Jindal and Charlie Katebi, STAT) ...Drug manufacturers care about market size. On average, every $2.5 billion increase in global drug sales to treat a specific disease incentivizes those manufacturers to develop an additional new drug for the same condition. When other countries systematically underpay for drugs, the global market shrinks. As a result, drug manufacturers develop fewer drugs, and chronically ill patients often languish as their conditions worsen. America can fix this... Full

Trump's Tariffs Could Hit Israeli Tech and Pharma Industries Hard

(3/5, Adrian Filut, CTech) ..."For Israel, the risk is slightly less direct because our economy is more service-oriented," said Prof. Amir Yaron, Governor of the Bank of Israel and Economic Advisor to the Government, in an interview with Calcalist last week, assessing the implications of Trump's trade war on the local economy...According to Israel's Central Bureau of Statistics, the country's pharmaceutical exports total about $2 billion annually, while electronic board exports amount to roughly $6.5 billion—together accounting for about 12% of Israel's industrial goods exports. These figures dwarf the relatively minor impact of previous metal tariffs. Meanwhile, Israel's diplomatic efforts are focused on lobbying against outgoing President Joe Biden's decision to impose restrictions on the sale of advanced AI chips... Full

To Fight U.S. Tariffs, Canada Should Suspend U.S. Patents On Medicines, One Expert Argues

(3/4, Ed Silverman, STAT+) ...Now that the Trump administration has imposed 25% tariffs on goods from Canada, the Canadian government is levying tariffs in return. But other measures are also being examined and one notion the Canadian government should consider is suspending patent rights held by U.S. companies, including pharmaceutical companies, according to Richard Gold, a professor of law and medicine at McGill University who specializes in intellectual property issues...We spoke with Gold about this idea, which he floated several weeks ago in Canada, and what it would take to happen. This is an edited version of our conversation... Sub. Req’d

Non-Compliant Pharma Firms Face European Health Data Space Exclusion and Fines

(3/4, Eliza Slawther, Pink Sheet) ...If companies fail to provide anonymized patient health data under the European Health Data Space regulation, they could be fined and banned from making such requests themselves. The new rules will not impact other data sharing obligations and frameworks in the EU, such as those related to pharmacovigilance. Clinical trial data will only need to be shared when trials are completed, in line with the EU Clinical Trials Regulation rules... Global Sub. Full

France's New Carbon Footprint Measuring Method Could Guide Purchasing Decisions

(3/4, Francesca Bruce, Pink Sheet) ...A new methodology for measuring pharmaceutical company carbon footprints could lead to a single standard for producing these calculations that is applicable to all medicines sold in France, said the industry association, Leem. However, it warned that there remains uncertainty about how the methodology will work in practice... Global Sub. Full

India-US FTA Talks: US to Push India On Trade, Patents & Data Rules Business

(3/4, Sangeetha G, Deccan Chronicle) ...As India prepares for bilateral talks on FTA with the US, the latter is expected to demand opening up government procurement, reduction of agricultural subsidies, weakening of patent protections and unrestricted data flows. The US has been raising a few demands in several multilateral fora, including WTO, and it is expected that during the FTA talks, these demands will be brought up... Full

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