Pfizer get China approval for antifungal Cresemba

Basilea Pharmaceutica’s license partner, Pfizer, has received a Drug Approval License from the National Medical Products Administration (NMPA) in China, for the oral formulation of its antifungal Cresemba (isavuconazole).

With this authorization, oral Cresemba is now approved in China for the treatment of adult patients with invasive mucormycosis, Basilea said in a press release. The granting of the Drug Approval License triggered a milestone payment of USD 10 million from Pfizer to Basilea. The intravenous formulation for the treatment of invasive mucormycosis is currently being reviewed under a separate marketing authorization application.

In October 2020, Pfizer also submitted marketing authorization applications for oral and intravenous Cresemba for the treatment of invasive aspergillosis. These applications are under regulatory review by the Center for Drug Evaluation at the NMPA, Basilea said in the press release.

David Veitch, Basilea’s CEO said: “We congratulate our partner Pfizer on the approval of Cresemba for the treatment of adult patients with invasive mucormycosis in China. Invasive fungal infections, such as mucormycosis, can pose a serious threat to patients if left untreated. With this approval, patients in China who are suffering from mucormycosis will now have access to a treatment that can help to address their unmet needs. China is a very important commercial market for Cresemba, accounting for approximately 20 percent of global sales for newer antifungals.”

The license agreement between Basilea and Pfizer covers Europe (excluding the Nordic countries), Russia, Turkey and Israel, as well as China (including Hong Kong and Macao) and sixteen countries in the Asia Pacific region. In addition to receiving mid-teen royalties on sales, Basilea remains eligible for further milestone payments of up to approximately USD 600 million under the agreement with Pfizer.

Cresemba has been approved in more than 60 countries to date and is currently marketed in 55 countries, including the United States, most EU member states and additional countries inside and outside of Europe. In the twelve-month period between July 2020 and June 2021, total “in-market” sales of Cresemba amounted to USD 285 million, a 24 percent growth year-on-year.