NEW HAVEN, Conn. and Sao Paolo, Brazil, Jan. 8, 2015 (GLOBE NEWSWIRE) -- Melinta Therapeutics and Eurofarma Laboratórios, one of the largest pharmaceutical companies in Brazil, announced that the companies have entered into commercialization and distribution agreements for delafloxacin, an investigational fluoroquinolone. Under the terms of the agreements, Eurofarma will be responsible for obtaining regulatory approval in Brazil and will then have the right to market, sell and distribute delafloxacin in that country for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Melinta will receive a combined upfront cash and equity payment of $15 million, as well as milestones and royalties on future sales of delafloxacin.
"Eurofarma is one of the top pharmaceutical companies in Brazil with a broad therapeutic focus that includes hospital therapeutics. They are growing rapidly, led by a very impressive management team and we are thrilled to build a mutually beneficial partnership with such a strong company," said Mary Szela, chief executive officer of Melinta Therapeutics. "These agreements provides Melinta with near-term capital and secures plans for an important geography."
Delafloxacin is currently in Phase 3 clinical development comparing the efficacy and safety of oral and intravenous (I.V.) delafloxacin to a control regimen of I.V. vancomycin plus aztreonam in adults with ABSSSI. Melinta recently completed one of two Phase 3 studies; enrollment continues in a second confirmatory trial. Delafloxacin was designated a Qualified Infectious Disease Product (QIDP) by the FDA for the treatment of ABSSSI, a classification that provides an additional five years of market exclusivity (for a total of ten years) following approval. Additional details on these studies may be found at www.melinta.com or on www.clinicaltrials.gov under the registry numbers NCT01984684 and NCT01811732.
"The incidence of serious infections, including ABSSSI, has increased in recent years in Brazil, as has the overall incidence of bacterial resistance," added Martha Penna, vice president of innovation at Eurofarma. "We are therefore keenly interested in products such as delafloxacin that have demonstrated favorable activity and tolerability in clinical studies. Beyond delafloxacin, the Melinta team is building a strong and sustainable company with very strong potential for growth. We look forward to working with the Melinta team to bring delafloxacin to market in Brazil and, as an investor, in advancing their corporate goals across the portfolio."
About Melinta Therapeutics
Melinta Therapeutics, Inc. is dedicated to the discovery, development and commercialization of groundbreaking antibiotics to overcome drug-resistant, life-threatening infections. The need for new therapies for drug-resistant infections is widely recognized as one of the most serious public health issues facing the world today. To meet this need, Melinta Therapeutics is rapidly progressing its late-stage investigational antibiotic, delafloxacin, which is currently in Phase 3 development for acute bacterial skin and skin structure infections (ABSSSI). Delafloxacin has been designated a Qualified Infectious Disease Product (QIDP) for both ABSSSI and community-acquired bacterial pneumonia by the U.S. Food and Drug Administration. A key initiative at Melinta is to develop, through the application of Nobel Prize-winning science, a new class of antibiotics designed to overcome the drug-resistant ESKAPE pathogens known to cause serious hospital infections. Melinta Therapeutics is privately held and backed by lead investor Vatera Healthcare Partners among other private investors. The company is headquartered in New Haven, CT with offices in Lincolnshire, IL. Visit www.melinta.com for more information.
About Eurofarma Laboratorios Ltda.
Eurofarma is a Brazilian company, with Latin America presence, founded in 1972. Currently, Eurofarma is the second largest pharmaceutical company in Brazil measured by prescription volume, with sales of over US$1 billion and 22% of EBITDA over net sales in 2013. The company has the largest sales force in the country (around 2,000 sales force employees) and in-licensed products represent more than 10% of Eurofarma's revenue.