FiercePharmaAsia: Astellas' failed vax collab, Takeda's rare disease pact, Sanpower's Dendreon facilities

AsiaMap2
This week, Astellas, Takeda and Sanpower made the news.

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.

1. With Flublok at a standstill in Japan, Astellas ditches cell-culture vax collab

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.

Conference

The 13th Annual Digital Pharma East

Digital Pharma East returns to the Pennsylvania Convention Center September 17–20, bringing together over 1000 attendees from biotech and pharma, to better understand how to present business plans, justify budget and innovation, and de-risk proposals getting shut down — essentially, understand how they can return to the office and become champions for their internal digital needs. Join us and save 15% on standard rates when you register with Discount Code DPE19Fierce.

2. Takeda and NY biotech Ovid ink rare drug development pact

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.

3. China's Sanpower takes on expensive Provenge manufacturing with Dendreon deal

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.

4. Dishonest participants, another chapter of China’s clintrial fake data story

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.

5. Chinese API company found faking CoAs, selling potentially tainted products

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.

Suggested Articles

For just the second time, the DOJ indicted an opioid distributor for its role in illegally pushing pills at the height of the addiction epidemic.

Bristol-Myers Squibb is out to expand the pool of colorectal cancer patients it can treat with Opdivo—and it’s bringing in Bayer to help.

When AstraZeneca sold its Avlon, England plant in 2016, it thought its liabilities were over. Former employees said the drugmaker broke its promises.