Oct. 26 Quick Takes: COVID trips up Spectrum’s Rolontis at FDA; plus Jazz-SpringWorks, Novartis’ iptacopan, Kantaro, Eternygen
Delay for Spectrum due to COVID-19 travel restrictions
Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said FDA is deferring action on the company’s BLA for its Rolontis eflapegrastim because the agency was unable to inspect Hanmi Bioplant, the drug substance manufacturing facility in South Korea the company is using, due to COVID-19 travel restrictions. The delay for the long-acting G-CSF analog is the latest in a series of setbacks for the oncology company. Shares of Spectrum fell 11% to $3.40.
Jazz takes rights to SpringWorks’ FAAH program
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) obtained exclusive, worldwide rights to a FAAH inhibitor program including PF-04457845 from SpringWorks Therapeutics Inc. (NASDAQ:SWTX), and plans to develop the therapy for post-traumatic stress disorder. SpringWorks will receive $35 million up front and is eligible for $375 million in milestones, plus royalties. PF-04457845 has been tested clinically for several indications, including cannabis withdrawal and fear extinction. Jazz will also assume obligations owed to Pfizer Inc. (NYSE:PFE), which spun out SpringWorks in 2017...