Welcome to this week's FiercePharmaAsia report, which includes stories about Wockhardt's whole-year financials, Takeda's T-cell platform deal with an upstart and the FDA's approval for Mitsubishi Tanabe’s ALS med Radicava.
1. Wockhardt reports growing Q4 loss as FDA issues skewer its U.S. sales
Continuous regulatory issues with the FDA have put a dent in Wockhardt’s full-year financials. The Mumbai-based drugmaker reported a widened fourth-quarter loss of about $27 million. U.S. sales fell to about $112.8 million for the fiscal year, down from $149.8 million in the previous fiscal year.
2. Takeda pens GammaDelta Therapeutics $100M pact, with M&A option
Takeda’s deal spree shows no sign of slowing down. It has signed a development deal with London-based GammaDelta Therapeutics for its T-cell platform. Takeda, with investment firm Abingworth, will commit up to $100 million to boost R&D at the biotech, and the Japanese pharma holds exclusive rights to buy out the company.
3. Mitsubishi's Radicava, first ALS med in decades, beats all comers to FDA approval
The FDA greenlighted Mitsubishi Tanabe’s amyotrophic lateral sclerosis drug Radicava, the first new ALS treatment approved in 22 years. The FDA made the U.S. approval based solely on data generated in Japan. Even though the med doesn’t reverse worsening conditions, it could slow it down.
4. FDA blasts Indian drugmaker that made investigators inspect filthy plant in the dark
Drugmakers have used different methods to obstruct inspections, but none have gone to the extraordinary lengths of the Vikshara Trading & Investments plant in Gujarat, India. It lied to the FDA by claiming production stopped while its workers were on strike, then continued to manufacture products, and once inspectors got into the plant, they were left in the dark, literally.
5. GlaxoSmithKline ends Vaxem Hib production, costing Takeda a planned launch in Japan
Takeda’s plan to launch a Hib vaccine in Japan has ended in smoke as manufacturer GlaxoSmithKline has terminated production of Vaxem Hib. Takeda held a licensing deal signed with the vaccine’s previous owner Novartis until an assets swap in 2015 transferred the med to GSK, which has its own Hib shots Infanrix and Hiberix.
6. Daiichi cuts 6 medicines in last quarter, including Pieris candidate
Daiichi Sankyo axed six pipeline medications across cancer, diabetes and CV disease. This is bad news for Pieris Pharmaceuticals—although it will be buoyed by last week’s $2 billion pact with AstraZeneca—as it was partnered with Daiichi on one of the chopped meds, namely anti-PCSK9 Anticalin-Albumod DS-9001.
7. Lupin completes major expansion of U.S. manufacturing facility
Lupin has officially opened the expanded 150,000-square-foot manufacturing facility in New Jersey it picked up in its 2015 buyout of GAVIS Pharmaceuticals. The company invested about $20 million on the expansion and has added 80 workers at the site, with the intention to add 50 more.
8. FDA cites Aurobindo sterile plant for contamination concerns
India’s Aurobindo Pharma acknowledged that it had received an FDA 483 for a sterile injectables plant in Bachupally, India. Among the six observations were FDA citations for problems that could lead to microbiological contamination of sterile products. Although no direct data-integrity issue was raised, the FDA did note that the plant didn’t have enough safeguards on computers.