Welcome to this week's FiercePharmaAsia report, which includes the latest about Takeda's petition to delay approval of Velcade copycats, drama during Sinovac's delisting process, Samsung and Biogen's EU nod for a Humira biosimilar and more.
Takeda’s multiple myeloma blockbuster Velcade is running out of patent protection soon, but the Japanese Pharma is asking the FDA to hold off on approving copies until February 2018, arguing that changes to the medication’s label should extend its exclusivity at least into next year. Some copycat candidates include different ingredients that Takeda says “raises significant safety and efficacy issues.”
To say that Sinovac Biotech’s take-private process is a mess might be an understatement. In a twist, a group of buyers is challenging a definitive agreement the biotech reached on Monday with its chairman and CEO Weidong Yin, accusing the board of secretive operations. It was complicated by a Yin-involved bribery case that implicated the former vice director of China FDA’s Center for Drug Evaluation.
The European Medicines Agency has recommended approval of Imraldi, a Humira biosimilar by Samsung Bioepis and Biogen. If greenlighted, it will be the second approved biosimilar in Europe of the world’s best-selling drug, following Amgen’s Amjevita, even though Amgen, facing legal fightback from AbbVie, is holding off on its version’s launch. Imraldi’s recommendation also covers all available indications.
INC Research has been growing its presence in Asia, and its Tokyo office can no longer sustain that growth as headcount more than quadrupled. Therefore, the CRO is moving that office to a new location. This comes around two months from its large and unexpected deal to merge with InVentiv.
After eyeing India’s vaccine market for years, Takeda finally saw that ambition come to fruition. It has signed two licensing deals with Biological E, transferring its low-cost combination vaccine bulk production technology for its measles and pertussis vaccines. Takeda said it chose licensing agreements instead of an M&A because it is currently focused on its pipeline that includes a late-phase dengue candidate.
Vivace Therapeutics has secured a combined $40 million from a series A and B. The two rounds—$25 million in series B and $15 million series A—were led by investors from the U.S. and China. The biotech, founded by Kun-liang Guan with the University of California, San Diego, is working on inhibitors of the Hippo-YAP pathway.
Takeda is positioning itself to take over stem cell production in Europe from its partner TiGenix by 2021 after Swissmedic said last week it had accepted for review the file for an investigational drug called Cx601 to treat complex perianal fistulas in Crohn’s patients. It is yet unclear whether Takeda will produce the drug in Madrid, where it’s now being manufactured, or at another European facility.