Biogen and Eisai turned to subpopulation analyses and biomarker data to defend their Alzheimer's drug BAN2401, which has seen roller coaster investor responses. On the heels of positive data presented at this year's ESMO, Taiho and Servier won FDA priority review for Lonsurf in metastatic gastric cancer. Johnson & Johnson is buying the rest shares of Japan's cosmetics specialist Ci:z for $2.1 billion. And more.—Angus Liu
Biogen and Eisai’s phase 2 data on Alzheimer’s drug BAN2401 first aroused excitement when it showed a significant effect on cognitive decline in mild AD patients at month 18. But the fact that APOE4-positive patients were getting the most benefit worried investors because regulators had halted recruitment of these patients out of safety concerns. Now the two companies used new subgroup analyses and biomarker data to make their case.
Taiho and Servier’s Lonsurf showed it could cut the risk of death by 31% in patients with heavily pretreated metastatic gastric and gastroesophageal junction (GEJ) cancers compared to placebo. That translated into a survival extension of 2.1 months. The FDA has granted priority review for the pair’s application and has set a decision date for Feb. 24, 2019.
In a flurry of consumer deals by Big Pharma companies, J&J plans to pay 230 billion Japanese yen ($2.05 billion) in cash to acquire the share of Japanese skincare specialist Ci:z it doesn’t already own. J&J gets several lines of popular medical cosmetic products, a bigger footprint in Japan and “an agile innovation model” and a large skincare customer relationship management database in Japan.
Shire just nabbed FDA panel backing for prucalopride, which could challenge Allergan’s Linzess and Synergy’s Trulance in the chronic constipation market. The vote also boosts Takeda’s case in its $62 billion Shire acquisition, which just won Japanese approval.
Takeda has paid $50 million upfront to co-develop Enterome’s early-phase Crohn’s disease candidate EB8018. The drug blocks the activity of a lectin expressed by virulent bacteria that research suggests can promote the production of TNF-alpha, which is targeted by popular Crohn’s drugs such as Humira and Remicade.
China-based CANbridge Pharmaceutical and WuXi Biologics announced a partnership to develop and market rare disease therapies, with first clinical trial application slated for next year. WuXi will provide its drug R&D and manufacturing capabilities toward global commercialization.
European drug regulators recently found 20 deficiencies in a Mercury Laboratories’ plant in Jarod, India. One critical problem was tied to manufacturing record authenticity, and the Indian company has been banned from shipping products to the EU.