Thursday, February 6, 2025

A $1Bn Biosimilar? Amgen Enjoying Early Monopoly On Aflibercept Competition

(2/6, Dean Rudge, Generics Bulletin) ...Amgen has swerved a suggestion that its Pavblu (aflibercept-ayyh) 2mg biosimilar to Eylea could become a $1bn product, following the firm's ‘at-risk' launch of the first and only biosimilar version of the VEGF-A agonist in October last year, which has been solidified by recent court rulings against other would-be biosimilar manufacturers... Global Sub. Full

Dr Reddy's Inks Pact with Henlius to Commercialize HLX1, A Biosimilar Candidate in US & Europe

(2/6, Pharmabiz.com) ...Dr Reddy's Laboratories SA, wholly-owned subsidiary of Dr Reddy's Laboratories along with its subsidiaries has entered into a license agreement with Shanghai Henlius Biotech, Inc related to the development and commercialization of HLX15, Henlius's investigational daratumumab biosimilar candidate to Darzalex & Darzalex Faspro... Full

Biocon Bids On Global GLP-1 Opportunities To Grow Generics Division As Q3 Sales Decline

(2/5, Urte Fultinaviciute, Generics Bulletin) ...The firm's generics division generated revenues of INR6.86bn ($78.4m), which was a decline of 2% year-on-year but a "healthy" 10% growth on a sequential basis. The quarterly increase was attributed to higher sales through Biocon's active pharmaceutical ingredient business, supported by a performance improvement of generic formulations, commented the Biocon group's CEO Peter Bains...Biocon sees GLP-1 products as the potential savior of the generics business. Bains explained that the GLP market opportunity is "clearly strategic" for Biocon, which will come in waves... Global Sub. Full

Lilly Forecasts 2025 Profit Largely Above Estimates On Weight-Loss Drug Strength

(2/6, Bhanvi Satija, Mariam Sunny and Patrick Wingrove, Reuters) ...On an adjusted basis, the U.S. drugmaker expects to earn between $22.50 and $24.00 per share in 2025. Analysts were expecting a profit of $22.86 per share, according to data compiled by LSEG. Quarterly sales of diabetes drug Mounjaro came in at $3.53 billion, compared with analysts expectations of $4.27 billion...The company has blamed physical and financial constraints at wholesalers, but some investors have expressed concerns about cooling demand for GLP-1s, the class of treatments to which both Zepbound and rival Wegovy belong... Full

Novo Nordisk CEO Says He's Confident About Wegovy Supply, Next-Generation Weight Loss Drugs

(2/5, Angelica Peebles, CNBC) ...In an interview with CNBC, Novo Chief Executive Officer Lars Fruergaard Jorgensen brushed off concerns that Novo is falling behind Lilly. "We are quite confident that as we move into the year and we'll be supplying more and more of the starter doses, we can see a nice step up in our volume and serving more and more patients," Jorgensen said...Novo's 2025 sales guidance implies a 30% increase in the number of patients taking one of the company's GLP-1 drugs, such as Ozempic, the company said on its earnings call... Full

GSK, Pfizer Sales of RSV Shots Slow as Vaccination Rates Ebb

(2/5, Delilah Alvarado, BioPharma Dive) ...Sales of both GSK's and Pfizer's vaccines for respiratory syncytial virus dropped significantly in the last three months of 2024, compared the same period one year before. In a earnings report Tuesday, Pfizer said sales of its vaccine Abrysvo fell 62% year over year in the fourth quarter. The company attributed the drop mainly to "a significant reduction in vaccination rates in the U.S." among older adults eligible for the shot after U.S. guidelines were narrowed last summer. GSK reported a similar state of affairs Wednesday. Sales of its RSV vaccine Arexvy declined 69% year over year due to lower demand "related to a more limited recommendation ... for individuals aged 60 to 74," as well "channel inventory consumption."... Full

Lundbeck Reached Record Revenue in 2024

(2/5, The Pharma Letter) ...Lundbeck's total revenue grew by +14% at constant exchange rates (CER) and 11% in kroner terms to 22,004 million kroner ($3,065 million) in 2024, with all regions contributing to growth and a record level for the company...The significant increase in R&D costs driven by the phase III investment for bexicaserin and the further maturing of Lundbeck's R&D pipeline are fully absorbed by disciplined capital reallocation initiatives. The revenue of Lundbeck's strategic brands increased by +21% CER (+20% kroner), reaching 16,462 million kroner, representing 75% of total revenue and with all four products showing double-digit growth rates both CER and reported... Sub. Req’d

Astellas Takes $760M Charge, Reveals Slowdown for Eye Drug Izervay After Regulatory Stumbles

(2/5, Zoey Becker, Fierce Pharma) ...Izervay pulled down $107 million in sales in the last three months of 2024, up merely 4% on a quarter-over-quarter basis. It marked a significant slowdown for the drug considering it remains in its early launch phase, delivering 26% sequential growth in the prior quarter. The rollout suffered a "temporary impact" from the FDA's "unexpected" decision to reject a label update for Izervay in GA secondary to age-related macular degeneration (AMD) as well as changes in inventory levels, Astellas Chief Financial Officer Atsushi Kitamura said on a conference call Tuesday... Full

Krka: ‘Quantities, Capacities No Problem' As Firm Looks To €2Bn Milestone

(2/5, Dean Rudge, Generics Bulletin) ...Krka has looked to brush aside any concerns that it will run into capacity constraint issues in the near term, as it continues to eye revenue growth of around 6% or more in 2025 to reach its group sales target of surpassing the €2bn ($2.08bn) mark for the first time in the company's history... Global Sub. Full

With Mid-Stage AML Win, Kura Details Dual-Track Phase III Programme for Ziftomenib

(2/5, Anna Bratulic, FirstWord Pharma) ...Kura Oncology is gearing up to stake a claim in the heated battleground for menin inhibitors to treat acute myeloid leukaemia (AML), announcing Wednesday that its drug ziftomenib — partnered with Kyowa Kirin — met the primary endpoint in a key trial, while unveiling plans for a Phase III programme in newly diagnosed patients... Full

A.forall Launches Generic Tromethamine With 180-Day US Exclusivity

(2/5 Adam Zamecnik, Generics Bulletin) ...A.forall and its US subsidiary Milla Pharmaceuticals have announced the approval and launch of their generic tromethamine injection while also securing the coveted Competitive Generic Therapy 180-day exclusivity in process...The injectable is a generic to Hospira's THAM solution, which is used in the prevention of metabolic acidosis, as well as its potential treatment. Hospira is a subsidiary of Pfizer... Global Sub. Full

Bristol Myers Launches Fresh Round of Major Cost Cuts in Bid to Get Ahead of Patent Cliff

(2/6, Drew Armstrong, Endpoints News) ...On Thursday, the company said it plans to find $2 billion in additional savings over the next three years, on top of the $1.5 billion in cuts it announced in April 2024. The new reductions will come in two major categories, Bristol Myers said in an interview with Endpoints News. The first includes cuts to the workforce, including contract positions, open roles and attrition. The second set is made up of operating costs such as marketing spending on older drugs, clinical trial operations and supply chain items like manufacturing facilities and outside contractors... Full

Danaher Unit Fights Amgen Subpoena in Fresenius Biosimilars Case

(2/5, Christopher Yasiejko, Bloomberg Law) ...HyClone Laboratories, a Utah-based subsidiary of Danaher's Cytiva, said Amgen hasn't shown why its off-the-shelf Cell Boost 7a supplement or any of the 22 "overbroad categories of requested information, particularly those pertaining to the formulation and manufacturing of CB7A, are actually relevant to its dispute with Fresenius," according to the redacted motion to quash filed Tuesday in the US District Court for the District of Utah... Sub. Req’d

Daewon Pharmaceutical to Distribute AstraZeneca Korea's Asthma Treatments

(2/5, Lee Han-soo, Korea Biomedical Review) ...Under the agreement, Daewon will take charge of distributing and marketing AstraZeneca's asthma medications, Symbicort and Pulmicort Respules, in Korea. Symbicort is an inhaled respiratory treatment used for asthma and chronic obstructive pulmonary disease (COPD). It is available in two formulations—Symbicort Turbuhaler and Symbicort Rapihaler—depending on the inhalation device and delivery method... Full

Wisconsin Couple Sues Walgreens and Optum Rx, Saying Son Died After $500 Price Rise for Asthma Meds

(2/5, Todd Richmond, Associated Press) ...According to the lawsuit, Cole Schmidtknecht suffered from asthma all his life. He managed it with daily inhaler doses of the medication Advair Diskus and its generic equivalents...The Schmidtknechts allege that pharmacy benefits management company OptumRX violated Wisconsin law by raising the cost of the medication without a valid medical reason and failing to provide 30 days' advance notice of drug price increases... Full

Policy Experts Forecast Potential Trump Admin Sympathy For Generics

(2/5, Jessica Karins, Inside Health Policy) ...Alex Brill, a senior fellow at the American Enterprise Institute who previously served as chief economist of the House Ways & Means Committee, said Trump administration officials could be sympathetic to the generic industry's argument that FDA regulations are preventing safe, low-cost alternatives from quickly reaching consumers. "What you all do is a market that's generally working, that is providing greater access and greater affordability without the government having to come in," Brill told the generic industry crowd... Sub. Req’d

Novo Nordisk Is Prepared for Trump's Tariff Threat, CEO Says

(2/5, Naomi Kresge, Sanne Wass and Francine Lacqua, Bloomberg) ...Novo has more than 10,000 employees in the US and a large part of its supply chain there that would be sufficient for the country's needs "to a large degree," CEO Lars Fruergaard Jorgensen said Wednesday in a Bloomberg TV interview. "The base case is that this is something we can handle."...Novo's "investments in the US align well with the government's wishes," the CEO said later at a press conference at the company's headquarters outside Copenhagen... Sub. Req’d

Hospitals Ask Trump to Exempt Medical, Pharma Products from Tariffs

(2/5, Dave Muoio, Fierce Healthcare) ...Jason Hollar, CEO of healthcare product manufacturer and distributor Cardinal Health, told investors during a Jan. 30 earnings call to "make no mistake. If there are widespread tariffs, anywhere from the 10% to 25% range, I anticipate there will be corresponding price increases."... Full

Health Experts Alarmed By DOGE Infiltration In CMS; Dems Call For Hearings

(2/5, Amy Lotven, Inside Health Policy) ...CMS claims that experienced agency officials are collaborating with so-called DOGE officials who, according to the New York Times, gained access to several of the agency's payment systems Wednesday, and says officials are taking a "thoughtful approach" to finding more efficient use of resources, but health experts and Democratic lawmakers are raising alarms about potential privacy breaches, security threats and harassment that may stem from Elon Musk and DOGE employees gaining influence over CMS and other agencies... Sub. Req’d

Novo Nordisk 'Comfortable' with Impact of Medicare Price Negotiations for GLP-1s: CEO

(2/5, Anjalee Khemlani, Yahoo! Finance) ...Novo Nordisk CEO Lars Jørgensen isn't too worried about the upcoming Medicare price negotiations over blockbuster GLP-1 drugs, even though the company still stands with the industry against the new practice because he says the prices are comparable to those in Europe...But the biggest reason Novo isn't overly concerned is because Medicare is not its largest market in the US. Until the start of 2025, only Ozempic and Rybelsus for diabetes were covered by Medicare Part D. The government is not allowed to cover the drugs for weight loss, which kept the cost to Medicare down... Full

Medicare Part D Redesign: More Firms See New Discounts Offsetting Spending Cap Benefit

(2/5, Cathy Kelly, Pink Sheet) ...In recent earnings calls, AbbVie, J&J and Merck echoed earlier comments by Pfizer about the expected net impact of two key aspects of the Medicare Part D redesign. The companies' projections about revenue declines caused by the redesign in 2025 range from $400m to $2bn. But all the companies expect the 'unfavorable' impact of a new mandatory price discount in the catastrophic phase of the benefit will more than offset any increased volume from the $2,000 cap on out-of-pocket spending... Global Sub. Full

Your All ACCESS! Pass

(2/5, AAM) ...The opening day of Access! 2025 set the stage for an urgent and forward-looking discussion on the state of the generics and biosimilars industry. Against the backdrop of major news events—including the Trump administration's proposed and paused tariffs, and Robert F. Kennedy Jr.'s nomination as HHS Secretary passing out of Senate committee—the conference tackled the challenges and opportunities ahead for manufacturers, policymakers, and patients alike... Full

Employers, Insurers Press Trump and Congress to Revive PBM Bills

(2/5, Michael McAuliff, Modern Healthcare) ...Blue Shield of California, employers represented by the ERISA Industry Committee, pharmacies represented by the National Association of Chain Drug Stores and the National Community Pharmacists Association, and an umbrella group called America's Agenda that includes the insurers Elevance Health, Centene and Kaiser Permanente along with unions and drugmakers, made their plea in letters sent to President Donald Trump and congressional leaders Wednesday... Sub. Req’d

State Government Could Be Banned from Buying Narcan from Opioid Crisis Antagonists

(2/5, Clayton Murphy, KTVQ) ...Sen. Mike Yakawich, R-Billings, compares the state's purchase of overdose reversal drugs like Narcan from companies that have contributed to the opioid crisis to "paying the arsonist to put out his own fire." Yakawich is carrying Senate Bill 112, which would ban government purchase of opioid overdose reversal drugs from companies like Purdue Pharma and Hikma Pharmaceuticals. The bill passed the Senate Tuesday on a 49-1 vote... Full

Oregon Defends Drug Pricing Transparency Law Before Ninth Circuit

(2/5, Monique Merrill, Courthouse News Service) ...Whether an Oregon law requiring prescription drug companies to disclose information about how they set drug prices forces those companies to disclose trade secrets is before the Ninth Circuit, as the state vehemently denied the law asks for protected information during oral argument Wednesday morning... Full

Pharmacists Ask for Lawmakers to Pass Bill Regulating Pharmacy Benefit Managers

(2/5, Robin Opsahl, Iowa Capital Dispatch) ...Subcommittees were held in both the House and Senate to consider House Study Bill 99 and Senate Study Bill 1074 respectively, companion bills that take multiple steps advocates said would assist local pharmacies. The bills would require PBMs to reimburse pharmacies for the national or Iowa average acquisition cost for the drug — to use the wholesale acquisition cost as needed. The proposals also would restrict PBMs' ability to set limits on which pharmacies or pharmacists can fill a person's prescription if the provider has agreed to participate in that individual's health benefit plan... Full

Argentina Says It, Too, Plans to Pull Out of World Health Organization

(2/5, Stephanie Soucheray, MA, CIDRAP) ...Two weeks after US President Donald Trump took office and said the United States would be withdrawing for the World Health Organization (WHO), Argentina President Javier Milei said today his country, too, would be pulling out of the international organization...A spokesman for Milei cited "deep differences" between Milei and the WHO, especially during the COVID-19 pandemic. In a statement posted on X, Milei said the WHO promoted "endless quarantines" without scientific support during the pandemic... Full

Feedback Sought To Shape Highly Awaited EU Law On Cutting Dependency On Asian Imports

(2/5, Neena Brizmohun, Pink Sheet) ...The European Commission is intensifying efforts to fulfil its promise of proposing a Critical Medicines Act in March to tackle drug shortages and reduce the EU's overreliance on imports from Asia. It has given stakeholders until 27 February to respond to a call for evidence on the initiative, which aims to create "a more favourable framework for establishing or expanding manufacturing facilities of critical medicines in the EU."... Global Sub. Full

Supply Chains and AI Take Precedence at European Clinical Trial Meeting

(2/5, Frankie Fattorini, Pharmaceutical Technology) ...The conference will begin with opening remarks from chairperson Arnaud Dourlens, head of clinical supply operations at Sanofi. This will be followed by talks on implementing the EMA Medicines Shortage Steering Group (MSSG) solidarity mechanism to address medical shortages by Thomas Thoma from Teva Pharmaceuticals and on maximising clinical trial success by Christopher Mogg from Medidata... Full

Belgium's New Government Unveils Wide-Ranging Health Reform Agenda, Including Key Pharma Measures

(2/5, Nicole Verbeeck, Euractiv) ...The coalition agreement prioritises a more efficient, accessible, and patient-centred healthcare system by reforming hospital financing, strengthening primary care, expanding mental health services, and enhancing prevention, digitalisation, and workforce conditions. Key disease-focused initiatives include a new National Cancer Plan, strategies for neurodegenerative and rare diseases, and measures against antimicrobial resistance... Full

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