Welcome to this week’s FiercePharmaAsia report. Astellas terminated an unfruitful vaccine collaboration with UMN Pharma after Flublok hit a bump in Japan. Takeda made a rare disease drug development pact with New York-based Ovid. China's Sanpower didn't just inherit the right to Provenge, but also the challenge of its expensive manufacturing. Deceptive methods were found to have been systematically used among China's phase 1 trial participants. The FDA found fake CoAs at a Chinese API company and data integrity issue at a Japanese one.
After Japanese regulators turned down Astellas and UMN Pharma’s application for a new cell-culture flu vaccine, Protein Sciences’ Flublok, Astellas decided to terminate the partnership, which dated back to 2010. In the U.S., Protein Sciences is hoping that its technology will “take over” a flu vaccine market dominated by Sanofi and GlaxoSmithKline.
Takeda’s been on a spree of making deals lately. But this time, instead of investing into a promising med from the other party, the Japanese pharma tapped New York’s private biotech Ovid to help it out on developing TAK-935, a candidate for a rare form of childhood epilepsy. The companies will equally share the costs and, if all goes well, the profits.
The bankruptcy of Dendreon in 2014 stemmed in large part from the costs of the very complex manufacturing processes required to produce and deliver its immunotherapy Provenge for prostate cancer. Now China’s Sanpower, after paying Valeant $820 million, will inherit Provenge, along with Dendron’s two remaining manufacturing sites.
China’s clinical trial data has been plagued with scandals. Following an 80% withdrawal of drug applications last year, new discoveries were made by local newspaper that even participants have used dubious ways to lie their way into clinical trials for financial compensations, moves that could potentially compromise results yielded from trials.
In a warning letter sent to a Chinese API maker in Suzhou, the U.S. FDA said a June 2016 inspection found that the company was faking certificates of analysis for products it had actually bought from another supplier that was on an FDA import alert list at the time. Another warning letter was issued to a Japanese drugmaker for data integrity issues.