Extension of agreement with Gilead

Grupo Biotoscana announces new agreement with gilead for the Andean region

Montevideo, Uruguay, May 10, 2018. GBT-Grupo Biotoscana (B3: GBIO33), a leading biopharmaceutical company in Latin America, announces that it has entered into a new exclusive agreement with Gilead Sciences to commercialize a full portfolio of anti-infectives, hepatitis C & B, and anti-fungal in the Andean region, including Colombia, Peru, Ecuador, Paraguay and Bolivia.

Under the new agreement, GBT will be responsible for the regulatory, pharmacovigilance, market access, commercialization and distribution efforts of over 15 current products, including AMBISOME® for Peru, Paraguay and Bolivia, SOVALDI® (400 mg sofosbuvir) for Colombia, Peru, Ecuador and Bolivia, HARVONI® for Colombia, Peru, Ecuador and Bolivia and EPCLUSA® for Colombia.

The agreement also includes rights to the pipeline of breakthrough products, which will be able to provide advanced therapeutic options for patients with high unmet medical needs in those countries.

“We are excited and honored to extend our partnership with Gilead to new territories. Gilead has been a key partner of GBT for decades and this extension will become an important backbone for us in the Andean region”, said Mariano García-Valiño, CEO of GBT. “We at Gilead are thrilled to extend our partnership with GBT, a partnership that has rendered extraordinary output in Brasil and we believe will continue to be fruitful now in other areas in Latin America”, said Norton Oliveira, Gilead’s VP for the Latin American region.

The current products will result in immediate sales for GBT and Gilead, as they are already registered and commercialized in the geographies.

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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 AMBISOME®
AMBISOME® for Injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion containing 50 mg of amphotericin B, intercalated into a liposomal membrane. AMBISOME® is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions. AMBISOME® is indicated for the empirical therapy for presumed fungal infection in febrile, neutropenic patients, treatment of Cryptococcal Meningitis in HIV infected patients, treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate and treatment of visceral leishmaniasis.

About SOVALDI®
SOVALDI® (400 mg sofosbuvir). is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C genotype 1, 2, 3, or 4 infections in adults. It is not known if SOVALDI® is safe and effective in children under 18 years of age. Brazil full prescribing information for SOVALDI® is available here.

About HARVONI®
HARVONI® (90 mg ledipasvir / 400 mg sofosbuvir) is a prescription medicine used with or without ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1, 4, 5 or 6 infections. It is not known if HARVONI® is safe and effective in children under 18 years of age. HARVONI® is under review of Brazilian health authorities and it is not yet an approved drug in this territory.

SOVALDI® and HARVONI® are registered trademarks of Gilead Sciences, Inc. or its related companies.

About EPCLUSA®
EPCLUSA® is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infections without cirrhosis or with compensated cirrhosis. In case of decompensated cirrhosis, EPCLUSA® is used in combination with ribavirin.

Forward-Looking Statements (GBT)
This release includes forward-looking statements concerning a transaction between GBT-Grupo Biotoscana and Gilead, including expectations regarding the applicability of predictions to the commercialization of certain products. GBT-Grupo Biotoscana disclaims any obligation to update any forward-looking statement, except as required by applicable law.