Basilea-Pfizer China application for antifungal isavuconazole accepted for review

 

• Basilea Pharmaceutica (OTC:BPMUF) and its license partner Pfizer (NYSE:PFE), down 0.2% premarket, have submitted a marketing application seeking approval for the antifungal isavuconazole (Cresemba) for the treatment of adult patients with invasive aspergillosis to the National Medical Products Administration in China.
• Isavuconazole is an intravenous and oral azole antifungal, commercialized under the trade name Cresemba for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.
• As of June 2020, total in-market sales of Cresemba amounted to $230M, 30% growth Y/Y.
• In November 2017, Basilea and Pfizer extended their existing license agreement, under the agreement with Pfizer, Basilea is eligible for regulatory and sales milestone payments of up to ~USD 630M, in addition to receiving mid-teen royalties on sales.
• Previously in August 2020, Basilea had announced that an MAA for Cresemba for the treatment of mucormycosis was accepted for review by the NMPA.
• https://seekingalpha.com/news/3639328-basilea-files-china-application-for-antifungal-isavuconazole-submitted-pfizer-accepted-for