Pictured: Cancer cell surrounded by cytokines/iStock, Marcin Klapczynski Alkermes on Wednesday announced that it has completed the spinoff of its oncology business to become a pure-play neuroscience company. Mural Oncology will begin trading on the Nasdaq starting Thursday, with Alkermes shareholders receiving a share of Mural for every 10 shares of Alkermes. Mural is launching with $275 million, which is expected to fund it through the fourth quarter of 2025, and an interleukin-2 cytokine as its most advanced asset. Nemvaleukin alfa is being studied as a monotherapy for advanced mucosal or cutaneous melanoma in Phase II and is in a Phase III study in combination with Keytruda for platinum-resistant epithelial ovarian cancer. The therapeutic is designed to avoid the hallmark toxicities of IL-2 immunotherapies. The studies are potentially registrational with readouts expected in early 2025. Additional assets include therapies targeting IL-18 and IL-12. Mural will nominate a development candidate for each program in ...
By Tristan Manalac Pictured: Novartis’ head office in Canada/iStock, JHVEPhoto Novartis on Monday inked a technology export contract with Korean biotech company Chong Kun Dang Pharmaceutical for an early-stage HDAC6 Inhibitor, according to Korea Biomedical Review. Under the agreement, Novartis will make an upfront payment of $80 million and pledge up to nearly $1.23 billion more in development and regulatory milestones. The Korean biotech will also remain eligible to future sales-based royalties, as well as an ongoing technology fee depending on net sales. In return, Novartis will gain the exclusive global rights—except in Korea—to develop and commercialize the investigational small-molecule HDAC inhibitor CKD-510. The candidate in 2021 cleared a Phase I first-in-human study in 87 healthy volunteers and the Korean company appears to be positioning the drug candidate as a potential treatment for Charcot-Marie-Tooth disease, a rare and heritable disease that afflicts the nerves in the limbs. However, a Chong ...
Only two months after the Federal Trade Commission (FTC) said it was eyeing a crackdown on “improper” patents listed at the FDA, the agency has filed a challenge against more than 100 patents in the agency’s Orange Book. The patents cover drugs marketed by the likes of AbbVie, AstraZeneca, Boehringer Ingelheim, GSK and Teva, among other companies, the FTC said in a Tuesday release. In all, the commission has sent letters to 10 companies notifying them of the patent disputes. The FTC argues “improper” listings in the FDA’s Orange Book—the registry of patents on approved medicines—can throw up hurdles to competition in the drug industry. Specifically, improper patents can trigger regulatory delays for would-be generics challengers and throw up legal hurdles for generics players, the commission says. Some of the medicines targeted in this crackdown include AbbVie’s Restasis and Viatris’ EpiPen autoinjectors. As the antitrust agency points out, FDA regulations ...
In a letter to Senate leadership, several organizations asked for the passing of legislation that would reform the patent system and improve competition in the prescription drug space. By MARISSA PLESCIA More than 60 organizations sent a letter Wednesday to Senate Majority Leader Chuck Schumer (D-New York) and Senate Minority Leader Mitch McConnell (R-Kentucky). The letter calls for the passing of legislation that the organizations say would lower drug prices through patent reform and increased competition. The organizations include Patients for Affordable Drugs Now, a nonprofit fighting to lower prescription drug prices, and AARP, a nonprofit focused on Americans aged 50 and older. They call for the Senate leadership to advance the following bills: • S. 142, which would tamp down on pay-for-delay deals. This refers to when brand name drug makers pay potential generic and biosimilar competitors to prevent them from bringing their product to market. • S. 150, ...
Ira Studin, PhD President Stellar Managed Care Consulting The old axiom, “The truth is somewhere in between” may be a useful lens to gauge how a new generation of obesity drugs will perform in the payer market. On one side is the school of thought suggesting that annual revenues will be in the multi-billions, with investment analysts’ tacitly assuming insurance will support demand. On the other side is the “PCSK9” school, referring to extreme barriers payers created to restrict Repatha and Praluent coverage as an alternative to statins. The discussion below will draw on conversations with payers and describe the likely payer market between these two sides. HEAVY DISCOUNT OR ELSE There is a through line from the cholesterol lowering drugs that put their stamp on the market starting in the 1990s and weight loss drugs today. Assuming Mounjaro follows Wegovy’s recently announced outcomes data, the parallel with statins centers ...
Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief medicine.The lawsuit, which dates to 2020 and was brought in federal court in Kansas, was filed by direct purchaser plaintiffs who claimed Pfizer and its EpiPen marketing and distribution partner Mylan conspired with Teva to delay the entry of a generic version of EpiPen. The settlement was revealed in a court filing this week. The suit claimed Mylan agreed to delay entry of its generic version of Teva’s branded blockbuster drug Nuvigil in exchange for Teva delaying entry of its EpiPen generic. The direct purchasers claimed they paid more for EpiPen than they would have if Teva’s generic was on the market. Under a prior partnership with Mylan, a Pfizer subsidiary was responsible for manufacturing EpiPen ...
Separate entity allows company to concentrate on status as focused medicines company. Image Credit: Adobe Stock Images/Livinskiy Novartis has officially completed the spinoff process for Sandoz, its generics and biosimilars division, with each shareholder receiving one Sandoz share for every five Novartis shares or one Sandoz American Depositary Receipt (ADR) for every five Novartis ADRs. In the future, Novartis intends to become solely a focused medicines company. “This is a truly historic moment for Novartis and Sandoz, as we begin new chapters as independent companies. With several consecutive quarters of sales growth, Sandoz starts out from a position of strength as a global leader in Generics and Biosimilars, and I am confident they are poised to deepen their impact on patients and society,” said Vas Narasimhan, MD, CEO, Novartis. “Today, after more than USD 100bn in transactions over the last few years, Novartis emerges as a fully focused innovative medicines ...
Danish biotech Acesion Pharma has raised €45m in an oversubscribed Series B financing round. The money will go towards funding the clinical development of the company’s atrial fibrillation therapy, AP31969. The investors that took part in the Series B financing round include Canaan, Alpha Wave, Global BioAccess Fund and Novo Holdings. AP31969 is an oral SK ion channel inhibitor that is being developed as a maintenance treatment to prevent the recurrence of atrial fibrillation. In March, Acesion announced that more than 50% of the participants in the Phase II AP31969 trial (NCT04571385) reported atrial fibrillation conversion to normal sinus rhythm within 90 minutes of infusion start, compared to zero participants in the placebo group. Atrial fibrillation is the most common form of arrhythmia or abnormal heart rhythm in which the top chambers of the heart (the atria) quiver or twitch, which is known as fibrillation. The US Centers for Disease ...
By Connor Lynch Pictured: Novartis office in Germany/iStock, TBE Sandoz is finally nearing the end of its path towards independence. Over a year after Novartis finalized its plans to spin off its generics and biosimilars division, the Swiss pharma’s shareholders on Friday approved the move, which is expected to take effect on or around Oct. 4. The Novartis board of directors also approved the move back in July, paving the way for it to go ahead once the shareholders had signed off. The deal will see Novartis shareholders receive one Sandoz share for every five Novartis shares they hold, and the same ratio of American Depository Receipts (ADRs). Board of Directors Chair Joerg Reinhardt said in a statement that with “this step, both Sandoz and Novartis will be able to optimize management focus, allocate capital on business priorities, and be in a better position to create sustainable shareholder value in ...
By Tristan Manalac Pictured: BMS office in California/iStock, hapabapaBlue Cross and Blue Shield of Louisiana on Tuesday filed a class action lawsuit against Bristol Myers Squibb, accusing the pharma giant of unlawfully extending the market exclusivity for its multiple myeloma drug Pomalyst (pomalidomide), according to Reuters. The Baton Rouge-based health maintenance organization is being joined by HMO Louisiana, a subsidiary of Blue Cross and Blue Shield of Louisiana. The plaintiffs are representing a proposed class of entities in the U.S. and its territories that paid for or reimbursed Pomalyst from October 2020. In the 151-page complaint, the not-for-profit health insurance company alleged that BMS and its subsidiary Celgene committed patent fraud by misrepresenting and concealing data regarding Pomalyst’s properties, formulations and uses that had already been publicly available. The pharma companies also “abused the federal judicial system” by launching a barrage of “sham lawsuits” against generics companies that were trying ...
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