Pfizer's established drugs declined sharply in China in the second quarter, but one analyst contends the threat from bulk procurement might not be as serious for other foreign pharmas. FibroGen and its partners AstraZeneca and Astellas, and rival GlaxoSmithKline, are moving their HIF-PHI anemia drugs to Asia first. Biotech leaders are worried that the U.S. government's recent crackdown on IP theft is creating "an atmosphere of intimidation" that could discourage collaboration. And more.
During the second quarter, Pfizer’s Upjohn established medicines business—now destined to merge with Mylan—plummeted 20% in China and dragged down the drugmaker’s overall China sales growth to a mere 2%. The decline is mainly the work of a volume-based procurement program under testing in 11 major Chinese cities, and to make it worse, an expansion of the pilot to other cities is underway. But mature products aren’t all created equally, one analyst pointed out, so the program won't affect all multinationals in the same way.
Drugmakers are racing to Asia with their HIF-PHI anemia drugs, which could be serious challengers to Johnson & Johnson and Amgen’s Epogen/Procrit. This week, FibroGen and partner AstraZeneca racked up their second nod in China for roxadustat, now allowed to treat all chronic kidney disease patients regardless of whether they need dialysis. GlaxoSmithKline has picked Japan to be the first country where it seeks approval for its rival drug daprodustat, as Astellas awaits a Japanese decision for roxadustat and Mitsubishi Tanabi for Akebia Therapeutics’ vadadustat.
Jeremy Levin, Ovid Therapeutics CEO and chairman of BIO, and former BIO chair and Alnylam CEO John Maraganore joined more than 150 industry leaders voicing their concerns that the U.S. government’s crackdown on IP theft has created “a climate of fear and uncertainty in our biomedical communities.” Their open letter comes amid an NIH campaign to enforce disclosure rules on scientists’ foreign ties that led to dismissals of Chinese scientists.
The FDA has granted priority review to Pfizer and Astellas’ bid to expand Xtandi to metastatic, hormone-sensitive prostate cancer. The drug has shown it can pare down the risk of death by 33% compared with non-steroidal androgen-fighting drugs alone. Johnson & Johnson’s Erleada is also under FDA review for the same patient population.
Sun Pharma’s key Halol plant has finally won a thumbs-up from the FDA, even after the agency in June issued a Form 483 with four observations. The news came the same day that Sun disclosed a new deal with China Medical System to work on seven generic products in China.
Dr. Reddy’s Laboratories wasn’t so lucky: The Indian drugmaker has suffered its fifth Form 483 from the FDA this year. This time, it covered a generic oncology formulation facility in Duvvada, India, where inspectors found eight observations, the company said. The plant was in 2015 hit with a warning letter.
Glenmark plans to sell drugs worth up to Rs. 800 crore ($110 million) this year outside of its focus areas of dermatology, respiratory and oncology, chief executive Glenn Saldanha said. The firm is also in talks to bring in a minority shareholder in its recently spun-off API business. Its U.S.-based innovation R&D spinoff will “initiate the process to raise capital” early next year to fund its own operation, he said.
WuXi Biologics reported first-half revenues of 1.6 billion yuan ($228 million). As other Asian biologics CDMOs are expanding their capacities, WuXi expects to have a plant in Europe complete in 2021. Details of a 20-year vaccine partnership that WuXi said could generate $3 billion in revenue could also be settled by yearend with a dedicated plant to follow, the company said.
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