Welcome to this week’s FiercePharmaAsia report. Takeda has shelled out $35 million for PvP Biologics’ celiac disease med, with an option to potentially buy the biotech. Chinese biotech Ascletis has collected $100 million in Series B as it competes against other Big Pharmas in a hepatitis C approval race in the country. Sanofi hit a bump with its dengue vaccine’s promotion efforts in the Philippines as the country’s FDA ordered the drugmaker to stop advertising for the shot. A fire at Sun Pharma’s API plant in Ahmednagar killed two people and injured two others.
Takeda has recently reprioritized its R&D focus to concentrate on cancer, GI, CNS and vaccines. After purchasing California-based Altos Therapeutics’ GI drug, the Japanese pharma is making a similar deal—paying $35 million upfront to PvP Biologics to support R&D of its celiac disease drug, KumaMax, plus the possibility to acquire the San Diego- and Seattle-based biotech if all goes as planned. A few months ago, Takeda also announced plans to delegate almost all of its drug development tasks to PRA Health and move hundreds of its staff over to the CRO. Asit Parikh, head of the gastroenterology therapeutic area for Takeda, said that neither Takeda nor the CRO is currently involved in the research of KumaMax, but said that “GI will continue to be a key driver in Takeda’s portfolio and on-market product offerings.”
The $100 million Chinese biotech Ascletis collected came quite timely. The company is competing with several pharma mega forces like Gilead, Bristol-Myers Squibb and Johnson & Johnson in a race to bring the first direct-acting antiviral HCV therapy to the Chinese market. As trial data reported last year, Ascletis' danoprevir/ravidasvir combo was able to treat all patients with genotype 1b HCV, which affects nearly two-thirds of the country's 30 million estimated HCV cases. More affluent patients in China are seeking alternative DAA therapies, which is better than the country’s standard regimen of peginteferon with ribavirin, and China’s FDA has offered fast track for DAA applications, drawing big HCV players like Gilead—which has Sovaldi and Harvoni in its arsenal—into the game.
When Sanofi launched its dengue vaccine Dengvaxia in the Philippines, a country where dengue is endemic, it expected sales in the country of the first-of-a-kind shot could contribute a large proportion to a €200 million total for 2016. But at least from figures for the first three quarters, that number just didn’t add up, and things recently ran off the rails. Citing violation of local laws, the Philippine FDA has ordered the drug company to stop advertising for the vaccine, and said that Sanofi continued with the ads two more days after the agency issued the order on Dec. 13. Now that the government has instructed TV and radio stations not to air the ads, Sanofi—though shocked by the authority’s decision—has the choice to show “why they should not be penalized for violating the law.”
Sun Pharma, which has been facing a host of FDA concerns over manufacturing, has now reported that a fire at an API plant in Ahmednagar killed two workers and injured two more. The fire occurred on Dec. 28 during excavation work. The company said it is standing with the families of the victims but assured the Bombay Stock Exchange that the event will not affect its operations.
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