Notice to the Market – Approval of CRESEMBA and ZEVTERA in Peru
NOTICE TO THE MARKET
Grupo Biotoscana announces first approval of antifungal CRESEMBA in Latam and approval of antibiotic ZEVTERA in Peru
Montevideo, Uruguay, June 29, 2018. GBT-Grupo Biotoscana (B3: GBIO33), a leading biopharmaceutical company in Latin America, announces to its shareholders and the market in general that it has approved Basilea’s antifungal CRESEMBA® (isavuconazole) and broad spectrum hospital antibiotic ZEVTERA® (ceftobiprole) in Peru.
In 2016, GBT and Basilea Pharmaceutica International Ltd. (SIX:BSLN) had entered into an exclusive agreement to commercialize these two novel Basilea’s anti-infective agents: CRESEMBA® and ZEVTERA® in Latin America. Under that agreement, GBT is responsible for marketing authorization, market access, promotion, selling and distribution in 19 countries in the region. The approval of CRESEMBA® in Peru, represents the first market introduction of the drug under that agreement and the second one for ZEVTERA®.
Julieta Serna, EVP Latam, said: “We are excited of approving CERESEMBA® in the first Latam country and we continue working intensively to introduce both ZEVTERA® and CRESEMBA® into other countries within the region, upon regulatory approval”.
CRESEMBA® (isavuconazole) is approved in Peru for the isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.
ZEVTERA® is approved in Peru for the treatment of community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).
GBT – Grupo Biotoscana.
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Updated on 01/02/2019 at 04:31 pm