delafloxacin

delafloxacin

Treatment for Gonococcal Infection -- Uncomplicated

Melinta Therapeutics Raises $70 Million to Support Delafloxacin NDA and Selection of Multi-Drug Resistant Gram-Negative Candidates from RX-04 Platform

NEW HAVEN, Conn., February 10, 2014 – Melinta Therapeutics today announced the closing of a $70 Million Series 3 equity financing. Current investor, Vatera Healthcare Partners, led the round and was joined by existing investors as well as new investors. Proceeds from this financing will be used, in part, to advance delafloxacin, a differentiated fluoroquinolone, through an ongoing Phase 3 study of a single oral dose in individuals with uncomplicated gonorrhea, to the submission of a New Drug Application (NDA) in late 2014.

In addition, the funds will support delafloxacin's two ongoing Phase 3 trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and the selection of lead candidates from Melinta's RX-04 research program. The RX-04 program is focused on the creation of novel molecular structures and selection of unique candidates that target novel binding sites on the bacterial ribosome. Melinta plans to select lead candidates and advance IND-enabling studies in 2014 for the treatment of serious and life-threatening infections caused by multi-drug resistant Gram-negative microbes.

"The continued support of Vatera, and the commitment shown by our new investors, including Falcon Flight LLC, is extremely gratifying and a testament to the strong near-term potential in delafloxacin and our deep pipeline of early-stage assets," stated Mary Szela, chief executive officer of Melinta Therapeutics. "This capital infusion will allow us to reach important clinical and regulatory milestones for delafloxacin, advance our lead Gram-negative candidates towards the clinic, and meet key corporate goals." Falcon Flight LLC is an investment vehicle for the Santo Domingo Group which has investments in a diversified global portfolio of public and private companies. Quadrant Capital Advisors, Inc., the New York-based investment advisory firm of the Santo Domingo Group, assisted Falcon Flight LLC in this transaction.

Tom Koestler, executive director at Vatera Holdings LLC and chairman of the Melinta board of directors added, "We have seen real progress in this exceptional management team's advancement of delafloxacin in terms of both its R&D and commercial strategy. We are committed to continuing to support Melinta and fostering the Company's growth into a strong and successful company with the potential near-term approval and launch of delafloxacin in 2015 as the foundation of this success."

About Delafloxacin

A Phase 3 trial of delafloxacin, a novel investigational fluoroquinolone, was initiated in January 2014 for the treatment of uncomplicated gonorrhea. The Phase 3 PROCEEDING (Prove Clinical Efficacy and Effectiveness of Delafloxacin in Neisseria Gonorrhoeae) program will assess the efficacy and safety of a single oral dose of delafloxacin compared to ceftriaxone (given in a single intramuscular injection). Delafloxacin was designated a Qualified Infectious Disease Product (QIDP) by the FDA for the treatment of uncomplicated gonorrhea.

An intravenous (I.V.) formulation of delafloxacin is also being tested in the Phase 3 PROCEED (Prove Clinical Efficacy and Effectiveness of Delafloxacin) clinical trial as an experimental treatment for ABSSSI caused by Gram-negative and Gram-positive bacteria (including MRSA). A second Phase 3 trial in this indication was initiated in January 2014 to assess administration of I.V. followed by oral delafloxacin, a regimen which would potentially enable an I.V. to oral "step-down" treatment model. Delafloxacin was also awarded QIDP status by the FDA for the treatment of ABSSSI.

About Melinta Therapeutics

Melinta Therapeutics 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) and uncomplicated gonorrhea. 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 venture firms. The company is headquartered in New Haven, CT with offices in Lincolnshire, IL.

For more information, visit www.melinta.com.

About Vatera Healthcare Partners

Vatera Healthcare Partners is a venture capital firm focused on investing in biopharmaceutical firms and products, with the goal identifying and developing best-in-class therapies to treat unmet medical needs and improve patients' lives. Vatera aims to build companies by leveraging the team's collective experience and expertise in the pharmaceutical industry and strong network of relationships within industry and academia.

Source: Melinta Therapeutics

Posted: February 2014

delafloxacin FDA Approval History

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