Friday, August 2, 2024

Biogen Opts To Retain Biosimilars Business

(8/2, David Wallace, Generics Bullletin) ...Following a "comprehensive review" of its biosimilars business – including exploring options to sell the unit – Biogen has decided to retain it after all, and is instead planning to "optimize the business with an aim to maximize profitability."...In a August 1, note, Wolfe Research suggested that Biogen's decision to retain the biosimilars business was "bound to disappoint some," as it was "not a great business."... Global Sub. Full

Biogen CEO Sees Alzheimer's Drug On Right Path Despite Tiny Sales, Will Keep Biosimilars Business

(8/1, Andrew Dunn, Endpoints News) ...A year after unveiling its "Fit for Growth" restructuring effort, Biogen is on track to reverse multiple years of declining revenues, CEO Chris Viehbacher told reporters Thursday. The Cambridge, MA-based biotech reported its second-quarter financials, bringing in $2.5 billion in quarterly revenue. Viehbacher said that Biogen is "well on track" to realizing $1 billion in savings by the end of 2025 through its cost cuts... Full

Biogen Retains Biosimilars as Eisai-Partnered Leqembi Plows Ahead Amid Business Pivot

(8/1, Angus Liu, Fierce Pharma) ...While Biogen had originally considered divesting biosimilars from a cost perspective, it may need the additional revenues for now. The Eisai-partnered Alzheimer's drug has proven slow to ramp up, with second-quarter U.S. sales at $30 million a year into its traditional FDA approval. A recent rejection by drug reviewers at the European Medicines Agency is also delaying—if not completely throwing off track—Leqembi's expansion in the EU... Full

Last Year, Biogen's CEO Said No Risky Deals. Now, He's Ready to Be Bold

(8/1, Annalee Armstrong, Fierce Biotech) ...While Biogen's pharma peers are hunting for late-stage assets with little risk, CEO Chris Viehbacher wants to bring in more early-stage medicines, arguing that there's more shareholder value to be had the earlier a company can get in...As for what Biogen might be interested in buying or dealing with, the CEO said that the company is already "long on neuroscience," so areas like immunology or rare diseases might be more appealing. He pointed to the Reata acquisition as one he'd like to repeat... Full

India's GlaxoSmithKline Pharma Posts Higher Q1 Adjusted Profit On Strong Demand

(8/2, Kashish Tandon, Reuters) ...The Indian unit of British drugmaker GSK reported a consolidated profit before tax and exceptional items of 2.49 billion rupees ($29.7 million) for the quarter ended June 30, compared with a profit of 1.64 billion rupees year ago. The company had a one-time gain from the sale of surplus residential properties worth 173 million rupees in the year-ago period. Its revenue from operations climbed 7% to 8.15 billion rupees in the latest quarter... Full

Regeneron Touts Launch of Eylea HD—and Warns of Manufacturing Issue with Linvoseltamab

(8/1, Kevin Dunleavy, Fierce Pharma) ...With U.S. sales of $304 million during the second quarter, Regeneron's high-dose version of Eylea came up just short of analyst projections. But it was a significant increase from the $200 million the new eye medication generated in the first quarter of the year... Full

Alembic Pharma Gets US FDA Nod for Cancer Treatment Drug Nelarabine

(8/2, Business Standard) ...Alembic Pharmaceuticals said that it has received final approval from the US Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Nelarabine Injection. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Arranon Injection of Sandoz Inc...The company reported 16.78% increase in consolidated net profit to Rs 178.21 crore on 7.85% rise in revenue from operations to Rs 1,516.98 in Q4 FY24 over Q4 FY23... Full

Lilly CEO Says Weight-Loss Drug Will Be Off Shortage Soon

(8/1, Gillian Tan and Damian Garde, Bloomberg) ...Eli Lilly & Co. expects its blockbuster weight-loss drug to officially come out of shortage in the US in the coming days, the company's chief executive officer said, threatening the billion-dollar industry of copycat versions of the in-demand drugs. Lilly's drug, sold for weight loss as Zepbound, will cease to be in shortage "very soon," CEO David Ricks said in an interview in Paris on Thursday. "I think actually today or tomorrow we plan to exit that process."... Full

Sanofi to Invest 1.3 Bln Euros in New Insulin Plant in Frankfurt

(8/1, Friederike Heine, Reuters) ...French drugmaker Sanofi will invest 1.3 billion euros ($1.40 billion) in a new insulin production facility at its existing site in Frankfurt, where it makes insulin brand Lantus, the company said on Thursday. The investment will pave the way for the construction of a 36,000-square-metre facility that will replace Sanofi's current insulin production plant in Frankfurt's Hoechst district by 2029, the company said... Full

Sun Pharma's Leqselvi Faces Legal Challenges in US Launch

(8/1, Ekta Batra, CNBC TV 18) ...Sun Pharmaceutical Industries Ltd's alopecia drug Leqselvi (Deuruxolitinib) approved by the US Food and Drug Administration earlier this month could see immediate legal hurdles when it comes to its launch. A motion seeking a preliminary injunction has been filed in a US court to prevent the product's launch. The management cannot comment on the timeline for when they will be able to launch Leqselvi in the US due to the ongoing legal proceedings... Full

Novartis Sues FDA Over Approval of Entresto Generic, Following Rejection of Petition

(8/1, Katherine Lewin, Endpoints News) ...Novartis is going after the FDA over the agency's decision to approve a generic version of the cardiovascular drug Entresto earlier this year..."Time is of the essence in this case," the company wrote. "MSN's approval permits MSN to flood the market at any moment, creating imminent and irreparable harm to Novartis." It's seeking a temporary restraining order. The FDA told Endpoints News that it doesn't comment on pending litigation. A spokesperson for Novartis said the company also asked the court to make the FDA rescind its approval of the generic application... Full

Lupin Copy of Kidney Drug Found Not to Infringe Otsuka Patents

(8/1, Christopher Yasiejko, Bloomberg Law) ...The ruling—if it withstands Otsuka's likely appeal—would clear Lupin's path to launch its copies upon approval nearly four years before the latest of the two patents would've expired...The same two patents are the focus of Otsuka's April 2022 lawsuit against Teva Pharmaceutical Industries Ltd. over its proposed Jynarque copies. A three-day bench trial in that case, also in Delaware, is set to start Oct. 15 in Wilmington... Sub. Req'd

We Asked Mark Cuban How He's Going to Disrupt Big Pharma. He Said it's Pretty Straightforward, Actually.

(8/1, Hilary Brueck , Business Insider) ..."We are completely transparent, with the same price for anyone and everyone," Cuban told Business Insider via email. "We believe that when all data is transparent, then the market becomes efficient. At that point, prices will drop significantly." Importing $15 penicillin to compete with $500 shots from Pfizer is just the beginning...Normally, Pfizer is the only American manufacturer of this specific shot, called Bicillin L-A, but it has been in short supply of that medication for over a year. For now, the US Food and Drug Administration is allowing Cost Plus to import Portuguese penicillin to the US ($15) but only until Pfizer's (about $500 or over) supply comes back out of shortage, likely in early 2025... Full

GLP-1 Drugs Driving Big Budget Impact: PwC's Medical Cost Trend 2025

(8/1, Ben Comer, Life Science Leader) ...In 2025, however, PwC anticipates an 8% increase; report authors also revised upward the real percentage increases experienced during 2023 and 2024. Those increases in medical cost, and the increases expected next year, source back to a key "inflator," according to the report: higher than expected utilization of GLP-1 inhibitors, known to just about everyone as the Novo Nordisk brands Ozempic and Wegovy, and the Eli Lilly brands Mounjaro and Zepbound... Full

Cigna CEO Promises ‘Aggressive' Defense of Pharmacy Benefit Managers

(8/1, Rebecca Pifer, Healthcare Dive) ...Cigna's chief executive is pledging to be more aggressive in defending its pharmacy benefit manager amid mounting public criticism of the drug middlemen — and as its PBM, Express Scripts, continues to drive soaring revenue for the insurance giant. That includes heavier lobbying in Washington, sponsoring more research into the value of PBMs and working more with independent pharmacists, which have been some of PBMs' loudest critics, CEO David Cordani told investors on a Thursday morning call to discuss the payer's second quarter results... Full

As Drug Makers Downplay Negotiated Prices, Advocates Use Grassroots Campaign To Press CEOs On Lawsuits

(8/1, Maaisha Osman, InsideHealthPolicy) ..."Patients fought hard to achieve the reforms in the Inflation Reduction Act, and they are fighting harder to defend Medicare negotiation against Big Pharma's multi-million-dollar assault," Merith Basey, executive director at P4AD told Inside Health Policy. "The tens of thousands of signatories on this petition reflect the immense support for Medicare negotiation, which is supported by over 80% of voters, and the outrage people feel as pharma tries to block relief for millions struggling with skyrocketing drug costs."... Sub. Req'd

Another IRA Lawsuit Bites the Dust with Ruling On Novo Nordisk Case; Company Pledges to Appeal

(8/1, Zoey Becker, Fierce Pharma) ..."We are disappointed that the New Jersey federal district court denied our motion for summary judgment," a Novo spokesperson said in an emailed statement. "We believe the decision fails to appreciate the serious constitutional problems raised by the Inflation Reduction Act's unprecedented drug price control provisions. We intend to pursue an immediate appeal."...Despite their complaints, each of the drugmakers with products affected by the negotiations agreed to participate in the process back in October... Full

Mylan Must Be Sanctioned in Ozempic Row, Novo Tells Patent Board

(8/1, Annelise Gilbert, Bloomberg Law) ...Mylan violated its promise against pursuing invalidity arguments it made at the Patent Trial and Appeal Board in parallel district court litigation, according to Novo's motion for sanctions filed Wednesday. Instead, it "educated and armed" co-defendants Dr. Reddy's Laboratories Inc. and Sun Pharmaceutical Industries Inc. to pursue forbidden claims... Sub. Req'd

FDA Unveils FY 2025 User Fee Rates

(8/1, Ferdous Al-Faruque, Regulatory Focus) ...The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2025 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter monograph drug programs... Full

Minnesota PDAB Discusses Process for Conducting Prescription Drug Cost Reviews

(8/1, Hannah Saunders, State Of Reform) ...Matthew Martin, project coordinator at PORTAL and a national expert on PDABs, said Minnesota's PDAB should look at three perspectives when it relates to prescription drug affordability: the cost relative to therapeutic alternatives, the out-of-pocket cost for patients, and the budgetary impact on the state's healthcare system... Full

EMA To Revamp Pre-Submission Dialog For Smoother Drug Reviews

(8/1, Vibha Sharma, Pink Sheet) ...The European Medicines Agency is working on a "pre-submission interaction revamp project" to better engage with marketing applicants...The EMA told the Pink Sheet that details on the pre-submission interaction project are sparse as it is in "very early stages," but that the plan is to "look at the way the agency manages pre-submission interactions with companies"... Sub. Req'd

EMA Proposes New Guideline Establishing Therapeutic Equivalence for Nasal Products

(8/1, Joanne S. Eglovitch, Regulatory Focus) ...The European Medicines Agency (EMA) has proposed developing a new guideline addressing the data generic drug manufacturers should submit to demonstrate therapeutic equivalence (TE) for nasal products compared to the reference product, a topic that is "insufficiently covered" in existing guidelines... Full

Sweden Favours Compulsory Application for Medicines Reimbursement in Any Member State Requesting It

(8/1, Monica Kleja, Euractiv) ...Sweden favours creating a compulsory rule for companies to apply for medicines pricing and reimbursement in any member state requesting it. A minority of EU countries currently support the approach, though pharma package negotiations continue... Full

Deepening Reform: China Further Expands Pharma Sector, Eases Market Access

(8/2, CGTN) ...China has outlined its ambitions to expand its pharmaceutical industry further and ease market access for the sector. This was contained in a policy document released after the Third Plenary Session of the 20th Communist Party of China Central Committee. Reporting from Qingdao in eastern Shandong Province, CGTN reporter He Jingyi explores how China has opened up its medical sector, even repositioning this traditionally manufacturing-focused city as a new pharmaceutical powerhouse... Full

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