DFH Pharma, Hetero Group Partner on Developing Second-Generation HIV Maturation Inhibitor Drugs

The pharmaceutical firms are looking to develop treatments that block replication of the virus.

DFH Pharma, Inc., a privately held pharmaceutical company focused on the development of HIV therapeutics, announced that it has entered into a Research and Product Development Agreement with Hetero Group ("HETERO"), a privately held research-based global pharmaceutical group with headquarters in Hyderabad, Andhra Pradesh, India, to develop the next generation of HIV maturation inhibitor drugs.

Maturation inhibitors are a new class of HIV drug that blocks virus replication by interfering with the formation of infectious HIV virus.  The clinical proof-of-concept for maturation inhibitors was established in HIV-infected patients with the first-in-class drug bevirimat. While bevirimat was shown to be safe, well-tolerated and effective in reducing virus in many patients, only limited effectiveness was observed in others.  It was determined that this variable response to bevirimat was due to small changes in the makeup of a key viral structural protein in different HIV strains.  The goal of the current effort is to identify maturation inhibitor drugs that are effective against all HIV strains, including those with the types of changes associated with reduced sensitivity to bevirimat.

The focus of the joint R&D effort is to expedite research into and the development of new maturation inhibitor drugs by combining DFH Pharma's background and experience in HIV therapeutic development with Hetero's world class expertise in product development, medicinal chemistry, manufacture of active pharmaceutical ingredients (APIs) and finished dosage forms.  "We are very excited to be working with Hetero, to develop the next generation of HIV maturation inhibitor drugs," said Dr. Carl Wild , DFH Pharma President & CEO. "The partnership will provide DFH access to Hetero's world-class chemistry and product development capabilities allowing for the rapid return of maturation inhibitor drug candidates to the clinic." DFH Pharma provided an update on progress to identify new maturation inhibitor drugs in a presentation to the 20th annual Conference on Retroviruses and Opportunistic Infections held recently in Atlanta, GA.

Dr. B.P.S. Reddy , Founder, Chairman & Managing Director of Hetero said "The collaboration with DFH will give a new paradigm to our discovery program(s). The DFH team's clinical expertise with HIV drugs will complement our drug discovery capabilities to expedite the development and enhance the success rate". He also stated that "This collaboration strengthens our commitment towards our work in the HIV therapeutic area."

About Maturation Inhibitors

Maturation inhibitors are a new class of antiretroviral drug candidates that inhibit HIV-1 replication by interfering with virus maturation. Specifically, drugs in this class block the last step in the processing of the HIV-1 Gag protein. This interference leads to the formation of noninfectious, immature virus particles, thus preventing subsequent rounds of HIV infection. As expected for a novel mechanism of action, these drugs retain inhibitory activity against HIV isolates resistant to all classes of currently approved drugs commonly used by HIV infected patients. The DFH-Hetero Team plans to develop maturation inhibitors for application in both first-line and salvage therapy.

About DFH Pharma, Inc.

DFH Pharma was founded by Carl Wild , PhD and David E. Martin , PharmD in 2011. Dr. Wild is a co-founder of Panacos Pharmaceuticals and served as Chief Science Officer. He serves as DFH's President and Chief Executive Officer as well as on the Board of Directors.  While at Duke University, Dr. Wild discovered the Fusion Inhibitor class of HIV drugs and invented the first approved member of that drug class, Fuzeon® (Enfuvirtide). Dr. Martin was Senior Vice President, Drug Development and Regulatory Affairs at Panacos.  He serves as DFH's Chief Development Officer and on the Board of Directors.  While at Panacos, Drs. Wild and Martin played critical roles in the development of bevirimat, the first-in-class maturation inhibitor drug. In addition, Dr. T.J. Nitz serves as Chief Science Officer. Dr. Nitz was Senior Director of Chemistry at Panacos and headed up the medicinal chemistry program that resulted in the discovery of the second-generation maturation inhibitors. Together, the DFH Pharma team has more than 60 years of experience in antiviral drug discovery and development.

About Hetero Group

Hetero Group, headquartered at Hyderabad, India, is a research driven vertically integrated pharmaceutical company and manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, and ANVISA Brazil. The company's robust product portfolio is spread over all therapeutic/product areas with emphasis in Anti-Retrovirals and Oncology and are supported by an outstanding R&D set-up. The company is marketing these products globally and has operations in India, USA, Europe, Latin America, Middle East, Africa and other emerging markets. Hetero has approximately 25% of the global Anti-Retroviral market segment and works with various prominent agencies such as Clinton Health Initiative, PEPFAR, MSF, UNICEF, VPP, and USAID to provide cost effective medicines to the under developed and developing countries.

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