PALO ALTO, Calif., July 8, 2015 (GLOBE NEWSWIRE) -- Carbylan Therapeutics (NASDAQ:CBYL), a specialty pharmaceutical company focused on the development of novel and proprietary combination therapies, today announced that Dr. Prem Ramiya has joined the Company as Vice President, Pharmaceutical Development & Supply Chain.
In this role, Dr. Ramiya will oversee the Company's Chemistry Manufacturing and Controls (CMC) development, as well as formulation, technology and analytical development for drug substance and product from pre-Investigational New Drug (IND) candidates to marketing approval. Dr. Ramiya will also help to create and manage clinical trial material (CTM) from design of packaging and labels to forecasts, supply plans and budgets.
David Renzi, President and CEO of Carbylan Therapeutics commented, "The addition of Dr. Ramiya further strengthens the Carbylan team as we execute our Phase 3 trials and work toward FDA approval of our lead product candidate, Hydros-TA. His significant experience in drug development and proven ability to lead therapeutic development from clinical to commercial stage will be a tremendous asset for the Company. We look forward to his contributions as we work to bring Hydros-TA to market and enhance our portfolio of combination therapies."
Dr. Ramiya joins Carbylan with over 20 years of experience in drug development, most recently serving as Vice President of Process Development and Manufacturing at Geron Corporation. Prior to Geron, Dr. Ramiya held positions at deCODE Genetics and Abbott Laboratories in which he directed the development and manufacturing processes of therapeutics from pre-clinical to Phase III. His experience includes work on seven IND filings, including presenting data to the US Food and Drug Administration (FDA), and successfully managing the supply chain management of numerous development projects. He also spent several years as a research associate in the Department of Chemistry at the University of Chicago. Dr. Ramiya holds a B.Sc. and M.Sc. in Chemistry from Madurai-Kamaraj University, India, and a Ph.D from the Indian Institute of Science.
Dr. Ramiya commented, "I am excited to be joining such an innovative company that is working to help patients suffering from osteoarthritis pain by developing novel treatments. I believe that combination therapeutics such as Hydros-TA can provide substantive benefit to patients in need who, unfortunately, continue to suffer despite other available treatment options. I look forward to being a part of the Carbylan team as we work to achieve long-term success for the Company."
About Carbylan Therapeutics
Carbylan is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel and proprietary combination therapies that address significant unmet clinical needs. The Company's lead product candidate, Hydros-TA, is a proprietary, cross-linked combination of low dose corticosteroid and novel hyaluronic acid viscosupplement, designed to provide both rapid and sustained osteoarthritis pain relief via a single intra-articular injection.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Carbylan Therapeutics, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including statements regarding Carbylan's ability to successfully complete clinical and regulatory prerequisites and to bring Hydros-TA to market. Such forward-looking statements involve substantial risks and uncertainties that could cause Carbylan's future results to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing and success of regulatory filings and other matters that could affect the availability or commercial potential of Carbylan's drug candidates. Carbylan Therapeutics undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Carbylan's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 21, 2015, and its subsequent periodic reports to be filed with the Securities and Exchange Commission.