Takeda Pharmaceutical Co. Ltd. is paying $4 billion up front and pledging as much as $2 billion more in potential milestone rewards to take over privately held Nimbus Therapeutics LLC’s wholly owned subsidiary, Nimbus Lakshmi Inc., to bring aboard tyrosine kinase 2 (TYK2) inhibitor NDI-034858 for autoimmune diseases. Osaka, Japan-based Takeda has agreed to two payments of $1 billion each upon achieving annual net sales for the compound of $4 billion and $5 billion. In September, Bristol Myers Squibb Co. won U.S. FDA clearance for first-in-class TYK2 drug Sotyktu (deucravacitinib) in psoriasis.

Wave Life Sciences could bring in up to $3.3B in new GSK deal

Wave Life Sciences Ltd. is getting $170 million up front – $120 million in cash and a $50 million equity investment – in its new partnership with GSK plc to advance oligonucleotides in unnamed targets. The agreement, which has a four-year research term, allows for GSK to advance up to eight programs using Wave’s platform and for Wave to advance three of its own programs. Should the GSK programs be successful, Wave could bring in up $3.3 billion in milestone payments, plus tiered royalties on net sales. GSK is getting the exclusive global license to Wave’s preclinical RNA editing program, WVE-006, to treat alpha-1 antitrypsin deficiency, a genetic disease that affects the liver and lungs. Wave said it expects to submit clinical trial applications for the program in 2023. Wave’s stock (NASDAQ:WVE) had surged 30% at midday to about $4.70 per share.

Cytokinetics faces uncertainty, real-word concerns at adcom

The U.S. FDA has no issue with the design or conduct of Cytokinetics Inc.’s massive global phase III Galactic-HF trial, which evaluated omecamtiv mecarbil in heart failure patients, but it is concerned about what it describes as a “small treatment effect.” The agency review team is not certain the benefits of the novel drug outweigh the risks, which could vary depending on whether and how well a pharmacokinetic-guided dosing regimen would be followed in the real world, the FDA’s Tzu-Yun McDowell told the Cardiovascular and Renal Drugs Advisory Committee today. The committee will be asked to vote on that question later in the day.

Shionogi scores emergency approval for Japan’s first domestic COVID-19 oral antiviral 

Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), scored emergency regulatory approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for SARS-CoV-2 infection, and the Japanese government has agreed to purchase 1 million courses of Xocova for domestic supply of the antiviral. An expert panel of Japan’s MHLW pushed back in July 2022 on recommending conditional approval for a second time for Xocova, saying it wanted more efficacy data from ongoing trials. An MHLW panel earlier postponed a decision in June 2022 on approving what is now Japan’s first domestic COVID-19 antiviral drug.

Biopharma deal activity slipping, M&As remain low

While biopharma deal values were down year-over-year in November by 7.6%, that gap has now doubled, showing a 15.5% decline in values in 2022. There has been a significant slowdown in activity in the second half of the year. Values were up by 7% in early August 2022. All told, 1,422 deals, including licensings, joint ventures and collaborations, have brought the industry a potential $169.2 billion through the first week of December. This compares with 1,873 deals worth $200.1 billion by this point last year. In 2020, there were 1,943 deals worth $180.3 billion within the same timeframe.

Also in the news

Abbvie, Acousia, Actinium, Adicet, Affimed, Agios, Allovir, Alphamab, Altrubio, Amphera, Amphista, Angiocrine, Aptose, Arcutis, Argenx, Ascentage, Asieris, Astrazeneca, Bellicum, Biontech, Biosion, Bluebird, Blueprint, Brainstorm Cell, Bristol Myers Squibb, Calidi, Calliditas, Cardiol, Carsgen, Cellcentric, Centessa, Cogent, Contrafect, CSL, CTI, Ellipses, Enterome, Evergreen Theragnostics, Excellthera, Fate, Galera, Genentech, Genmab, Glycotope, Ideaya, Idorsia, Imbrium, Immixbio, Janssen, Lantern, Medivir, Peroxitech, Pfizer, Poolbeg, Recce, Sobi, Sosei Heptares, Tellus, Therabest, Vertex, Zyversa