Basel, Switzerland, July 19, 2018 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that it has received a CHF 2 million milestone payment from its partner Grupo Biotoscana S.L. ("GBT"), based on the first regulatory approval of the antifungal Cresemba® (isavuconazole) in Latin America.
Adesh Kaul, Chief Corporate Development Officer, said: "We are very pleased with the approval of Cresemba in Peru. This is the first approval of the brand in the important Latin America region and the first approval of Cresemba outside Europe and the U.S. We are looking forward to GBT making Cresemba available to patients in Peru and other Latin American countries following further regulatory approvals."
Basilea and GBT entered into a supply, distribution and licensing agreement for Cresemba and also for Basilea's antibiotic Zevtera in September 2016. The agreement covers 19 countries in Latin America and Basilea received an upfront payment of CHF 11 million. Basilea supplies GBT with Cresemba and Zevtera at a transfer price and is eligible to receive further milestone payments.
About Cresemba (isavuconazole)
Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. Basilea has entered into license and distribution agreements for isavuconazole covering the United States, Europe, China, Japan, Latin America, Canada, Russia, Turkey, Israel and the Asia-Pacific and Middle East and North Africa regions. In the 28 European Union member states, as well as in Iceland, Liechtenstein, Norway and Peru, isavuconazole is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.1 It is also approved in the U.S. and Switzerland.2, 3 Isavuconazole has U.S. and European orphan drug designation for its approved indications.
This press release can be downloaded from www.basilea.com.
European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu
[Accessed: July 18, 2018]
In the United States, Cresemba is approved to treat patients 18 years of age and older for invasive aspergillosis and invasive mucormycosis (Cresemba US prescribing information, accessed July 18, 2018).
In Switzerland, isavuconazole is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of mucormycosis in adult patients who are resistant to or intolerant of amphotericin B and in adult patients with moderate to severe renal impairment (full indication in: Swissmedic-approved information for healthcare professionals as of August 2017).