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Notice to the Market – Approval of CRESEMBA and ZEVTERA in Peru


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