Welcome to this week’s FiercePharmaAsia report, which includes stories about the mysterious Stada deal, where several potential buyers, including two Chinese drugmakers, have emerged; Daiichi's pain drug R&D pact with Heptares, efforts by Sun Pharma to offload a regulatory burden, and more.
After Boston private equity firm Advent International put up the first legally binding bid for a snatch-up deal of Stada, CVC Capital Partners, which held talks with the generics maker last year, is ready for another try in partnership with a Chinese drugmaker. The question is who. The word is that it is talking with with Shanghai Pharma, as well as early-stage talks with Fosun Pharma, about a joint bid.
Daiichi Sankyo has shelled out $4 million upfront to strike a pain drug R&D pact with Heptares Therapeutics. Heptares will apply the G protein-coupled receptor (GPCR) and structure-based drug design skills that have landed it deals with Allergan, AstraZeneca and Pfizer to the discovery of small molecules that hit a pain target. Daiichi will also provide $8 million in research funding for Heptares, plus potential milestones.
Sun Pharma has just cleared an “official Action Initiated” ban from the FDA for its Mohali plant it got in the $4 billion buyout of Ranbaxy Laboratories in 2015. It is a small regulatory relief for the Indian pharma, whose Halol plant, which is essential to its U.S. sales, has been kept from launching new drugs for several years over by FDA concerns.
Chinese CRO Newsummit Biopharma has received a license to an antibody from MRC Technology, a medical research charity, for development of a hepatitis C vaccine. The antibody uses a antibody humanization technique that has previously been utilized in Merck’s Keytruda and helped MRCT monetize $150 million royalty. The disease is a healthcare concern in China with no vaccine available.
Badrivishal Chemicals & Pharmaceuticals, an Indian API maker, was hit with an FDA warning letter. The agency found that the company didn’t have a grasp of some basic requirements, including how to make sure the water that comes from a nearby river that runs through farmland is sanitary before using it to make its products.
For the second time in recent months, the FDA has slapped a Chinese company with a warning letter after finding that it was buying products from a banned supplier, faking Certificates of Analysis and then shipping the APIs as its own. The letter was sent to Lumis Global Pharmaceuticals after a September 2016 inspection of its site in Wuhan.