Peptidream Inc. and Genentech Inc, a Roche Holding company, signed a deal worth up to $1 billion to discover and develop macrocyclic peptide-radioisotope (peptide-RI) drug conjugates. Peptidream of Kawasaki, Japan, will use its peptide discovery platform system technology to discover, optimize and develop macrocyclic peptide candidates for use as peptide-RI drug conjugates against targets of interest to Genentech. Genentech will pay Peptidream an up-front payment of $40 million and up to $1 billion in potential development, regulatory, and commercial-based milestones. In addition, Peptidream is eligible to receive tiered royalties on net sales (ex-Japan) of any products arising from the collaboration.
Merck cuts big AI deals with Benevolentai and Exscientia
Merck KGaA has entered deals that could bring artificial intelligence companies Benevolentai Ltd. and Exscientia plc more than $1 billion. Exscientia and Merck will collaborate to find small-molecule candidates in oncology, neuroinflammation and immunology. Exscientia is getting $20 million up front and could bring in $674 million in milestones payments. Benevolentai and Merck plan to find and develop small molecules up to preclinical work. Benevolentai is eligible for up to $594 million, which includes a low, double-digit, million dollar up-front payment and discovery, development and commercial milestones. Benevolentai dropped development of several assets in May after a phase II study stumble in treating atopic dermatitis and then reduced its roster by 180 employees to save about $55 million.
Chinabio 2023: As tide turns to China, what will keep biotechs afloat in rocky capital, political seas?
“Why do the top 10 pharmaceutical companies remain in the top 10?” asked Li Chen, founder and CEO of Hua Medicine, to audience members at the Chinabio Partnering Forum in Shanghai on Sept. 20. “[It comes down to] their ability to innovate themselves, but also the capability to acquire technology from partnerships, [to] manufacture and sell in countries like the U.S. … Chinese companies need to be able to do that – whether it be players like Beigene Inc., Innovent Biologics Inc., or others – we need this type of firm,” Chen said.
ARS shares dive on CRL for allergy spray neffy
Shares of ARS Pharmaceuticals Inc. (NASDAQ:SPRY) plummeted 74% Sept. 20 on word that the U.S. FDA issued a complete response letter (CRL) for neffy, despite receiving a recommendation for approval in May from the agency’s advisory committee and following a three month delay in action. Neffy is the San Diego-based company’s epinephrine nasal spray for type I allergic reactions, including anaphylaxis for adults and children that are 30 kg or greater. The CRL requested completion of a pharmacokinetic/pharmacodynamic study comparing repeat doses of neffy with that of an epinephrine injection product under allergen-induced allergic rhinitis conditions.
Newco news: Not just another cytokine? Simcha looks to rejuvenate IL-18 field with decoy-resistance
Although preclinical studies of genetically engineered interleukin-18 (IL-18) historically indicated its potential in cancer treatment, interest in the cytokine languished after Glaxosmithkline plc shelved its IL-18 therapeutic on lack of response in a phase II melanoma trial. But in 2020, Yale University-based professor of immunology Aaron Ring set about reviving IL-18 as a cancer therapeutic and went on to engineer a decoy-resistant form of IL-18. Ring then founded Simcha Therapeutics to develop the drug – named ST-067, raising a little over $25 million in a series A round from companies such as Wuxi, Pfizer Ventures and Sequoia China.
US FDA advises sponsors on conducting trials in the face of disasters, PHEs
The U.S. FDA is going straight to final guidance with its “Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies [PHEs].” The agency justified the immediate implementation of the guidance without a comment period in a notice to be published in tomorrow’s Federal Register, saying, “Prior public participation is not feasible or appropriate … because disasters and PHEs may occur without notice and, as we have learned from experience during the COVID-19 PHE, may rapidly cause major disruptions to clinical trial conduct.”
Bipartisan momentum gathering for reforms of US Medicare program
The U.S. Centers for Medicare & Medicaid Services (CMS) is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation. Many of these bills enjoy bipartisan support in the House Energy and Commerce Committee, enhancing the odds that novel medical devices will receive more timely Medicare coverage even as CMS considers an administrative overhaul of its related coverage mechanisms.
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