Approval of CRESEMBA® and ZEVTERA® in Peru

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. BIOTOSCANA INVESTMENTS S.A. (“Company” or “GBT”) (B3: GBIO33), a leading biopharmaceutical company in Latin America, announces 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 CRESEMBA® 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).

About GBT-Grupo Biotoscana
GBT-Grupo Biotoscana (GBT) is a biopharmaceutical group that operates in the fast-growing Latin American region and focuses on rapidly growing market segments such as infectious diseases, oncology and onco-hematology, special treatments, immunology and inflammation and orphan/rare diseases, among others. GBT is currently present throughout 10 Latin American countries where it operates under its companies Biotoscana, United Medical, LKM and DOSA. GBT’s strong portfolio combines world-class licenses and proprietary products. To find out more, please visit www.grupobiotoscana.com.

About ZEVTERA® (ceftobiprole)
Ceftobiprole is a cephalosporin antibiotic for intravenous administration with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp. Ceftobiprole is currently approved for sale in major European countries and several non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP). It is marketed in major European countries and Argentina. Basilea has entered into license and distribution agreements for the brand in Europe, Latin America, China, Canada, Israel, and the Middle East and North Africa (MENA) region.

About CRESEMBA® (isavuconazole)
Isavuconazole is an intravenous (i.v.) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It was approved in March 2015 by the United States Food and Drug Administration (FDA) for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.2 The European marketing authorization was granted in October 2015 to 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.1 Isavuconazole has orphan drug designation for the approved indications in Europe and the US. Basilea commercializes isavuconazole as CRESEMBA® in Germany, Italy, the UK and Austria. The drug is commercialized in the US by Basilea‘s licensee Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use.