Right after Eisai and partner Biogen admitted their aducanumab failure, Eisai pushed another Alzheimer's candidate into phase 3. AstraZeneca is making more inroads to China, co-investing in a new life sciences hub in the city of Wuxi. Ono inked an immuno-oncology pact in the U.K., securing an option to license drugs that come out of research collaboration. And more.
Eisai started phase 3 testing of its anti-beta amyloid candidate BAN2401, seemingly undeterred by the high-profile failure of its previous candidate aducanumab. Both drugs are covered under a Biogen co-development and co-marketing deal, but unlike previous announcements, the new BAN2401 release was missing the U.S. company’s name, triggering speculation that the partnership is in jeopardy.
AstraZeneca, which already enjoys a strong presence in China, has signed on to be a founding partner for a new life sciences research hub to be housed just west of Shanghai. AZ is joined by Sweden’s BioVentureHub, The Skolkovo Foundation from Russia, and the U.K. BioIndustry Association in helping to establish the International Life Science Innovation Park in Wuxi.
Japan’s Ono Pharmaceutical has formed an immuno-oncology pact with nonprofits Cancer Research UK and Life Arc. Ono is pouring “multimillion-pound” cash to fund work to identify new targets and the discovery of drugs. After that, Ono will get the chance to license antibodies and small-molecule drugs and bring them through clinical development and commercialization.
4. China eyes more foreign innovation with second invitation for 30 drugs (Microsoft Word file)
Last August, Chinese drug agency’s Center for Drug Evaluation made a list of 48 drugs already approved abroad, hoping their makers would apply for Chinese approval based on foreign trial data. Now, the agency has come up with a second batch of 30 drugs, with about half targeting rare diseases. Other major names include Sanofi’s PCSK9 Praluent, Roche’s novel flu drug Xofluza, Gilead’s HIV therapy Biktarvy, AZ’s hyperkalemia treatment Lokelma, among others.
China’s Luye Pharma said Thursday it has completed its new drug application to the U.S. FDA for Rykindo. The drug, an extended-release microsphere independently developed by Luye, is designed to treat schizophrenia and bipolar disorder. If approved, it would become the first Chinese innovative drug to receive an FDA nod, Luye says.
Astellas and Seattle Genetics are preparing to file for FDA approval of enfortumab on the strength of phase 2 data. The trial showed the antibody-drug conjugate could reach a 44% response rate in previously treated patients with locally advanced or metastatic urothelial cancer.