moksha8 files for regulatory approval of Viibryd® and Colobreathe in Brazil and amends alliance with Forest Laboratories

Jan 06, 2014, 08:00 ET from moksha8

SAO PAULO, Jan. 6, 2014 /PRNewswire/ -- moksha8, a leader in the commercialization of CNS medicines in Latin America, today announced that it has filed applications with the Brazilian regulatory authority, ANVISA, for approval of Viibryd® (vilazodone) for major depressive disorders and Colobreathe (colistimethate sodium) to treat lung infections in patients with cystic fibrosis. 

moksha8 and Forest Laboratories have also amended the strategic alliance they signed in 2012.  Forest will no longer have ongoing financial obligations under the alliance and will no longer have the option to acquire moksha8 in a merger transaction.  moksha8 will retain the exclusive license to commercialize Viibryd, and moksha8 is working to expand its relationship with Forest to include other products for Latin America in the future.  Other financial terms were not disclosed.

Elaine Hochberg, Forest's Executive Vice President, International, Strategic Planning and Government Affairs, said, "We are pleased to continue our strategic alliance with moksha8 in Latin America.  moksha8 is uniquely positioned with strong regulatory and commercial capabilities." 

Simba Gill, Chief Executive of moksha8, said, "We are pleased to have filed Viibryd® and Colobreathe for approval by ANIVSA and we look forward to launching these products in the near future.  We expect to continue to expand our product portfolio through our corporate development activities, including our alliance with Forest."

Today, the Latin America pharmaceutical market is USD $67 billion and is projected to grow to USD $110 billion by 2017.  Brazil and Mexico account for two thirds of the Latin America market value.  The CNS market in Latin America is estimated to be approximately USD $6 billion.

About Viibryd®
Viibryd® is a novel antidepressant for the treatment of major depressive disorder (MDD). The efficacy of Viibryd® was established in two 8-week, multi-center, randomized, double-blind, placebo-controlled studies in adult (18-80 years of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD. The mechanism of action of Viibryd® is not fully understood but is thought to be related to enhancement of serotonergic activity in the central nervous system through selective inhibition of serotonin reuptake. Viibryd® is also a partial agonist of serotonergic 5-HT1a receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd® antidepressant effect are unknown.  Viibryd® is not yet approved in Brazil.

Forest will manufacture and supply Viibryd® to moksha8, under its license from Merck-Serono, and moksha8 will have exclusive rights to market, sell and distribute Viibryd® in Latin America.

About moksha8
moksha8 is a leading Latin American pharmaceutical company, with a core focus on commercializing the highest quality medicines with best in class operations and strong FCPA compliance.  The company launched its commercial operations in 2008.  moksha8 has a broad alliance with Forest Laboratories throughout Latin America and a partnerships with GSK, Aurobindo and Accord.  The company was founded by Simba Gill and TPG Biotech.  Major investors include TPG Biotech and Montreux Equity Partners.  For additional information on moksha8, please visit the company's web site at www.moksha8.com.

SOURCE moksha8



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