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Monmouth Junction, NJ, April 28, 2006 - Transave Inc., a biopharmaceutical company developing inhaled liposomal formulated drugs for treating life threatening lung disease, today announced the appointment of Donald J. Hayden, Jr. as executive chairman of the company's Board of Directors. Hayden is a veteran of the pharmaceutical industry bringing valuable experience and perspective gained during his successful 25-year tenure at Bristol Myers Squibb, including 15 years in senior executive positions.
Hayden began his career as a business intern with Bristol-Myers Squibb in 1981. His early career experiences included serving as director of new business development and planning for the U.S. Pharmaceutical Group, as director of marketing for Mead Johnson Pharmaceuticals and as a district sales manager within the BMS oncology division. Since 1991, Hayden has held a number of senior management positions including vice president and general manager of Mead Johnson Laboratories; president of Oncology and Immunology; senior vice president for Worldwide Franchise Management and Business Development; president of Intercontinental and senior vice president, Business Development, Pharmaceuticals; president of Worldwide Medicines; executive vice president of Strategy, e-business, Investor Relations and Competitive Intelligence; and executive vice president of the Health Care Group. For the past four years, Hayden served as executive vice president and president, Americas , overseeing two major pharmaceutical units and two healthcare businesses with combined annual sales in excess of $10 billion as well as global pharmaceutical manufacturing. Hayden received his undergraduate degree from Harvard University and has an M.B.A. from Indiana University .
“Don has a proven track record of growing successful products and businesses providing innovative strategic direction, while also building strong leadership teams,” said Frank Pilkiewicz, President & Chief Executive Officer of Transave. “Transave is extremely pleased that Don has accepted the role as executive chairman and will truly benefit from his considerable industry experience in helping Transave to build its business. “
“As our innovative Phase II SLIT™ programs for treating P. aeruginosa infections in cystic fibrosis and lung cancer continue to advance to late stages, Don's leadership will be invaluable for implementing future development and commercialization strategies,” continued Pilkiewicz.
“Transave's novel approach of formulating well characterized drugs as liposomal based inhaled products holds the potential to bring improved treatments to patients suffering from life threatening lung diseases, while also providing the basis for a robust pipeline of inhaled products,” said Hayden. “I look forward to working with the Transave team and Board of Directors to help build the future success of the company.”
About Transave
Transave, Inc. (the “Company”) is a privately held biopharmaceutical company with the time-cost characteristics of late stage companies. The Company is focused on the development of multiple product lines for the site-specific treatment of lung disease. Transave’s approach is based on its proprietary Sustained-release Lipid Inhaled Targeting (“SLIT™”) technology. The initial focus is the reformulation off-patent pharmaceuticals transformed into unique SLIT™-based inhaled pharmaceuticals for the localized, site specific treatment of lung disease. SLIT™ technology allows sustained release of the drug in the lung’s microenvironment resulting in enhanced therapeutic benefits and improved dosing regimens. This approach significantly reduces risk and enhances success in drug development by: (1) avoiding the inherent uncertainties of new chemical entities (“NCEs”); (2) building upon the demonstrated efficacy of approved agents in the target diseases; (3) via localized administration and controlled release focuses on reducing or eliminating the systemic known toxicities or dosing problems associated with systemically administered drug, and; (4) creates a new, improved product profile of a known, well characterized drug. The overall result being that Transave is able to develop therapeutics in a fraction of the time and cost as compared to a new therapeutic. Typically, a new SLIT™ product takes 4 years or less from IND to NDA and costs less than $50 million in development costs.
The Company has two products in clinical development and two programs at the preclinical stage, with a focus on pulmonary infections and lung cancer. SLIT™ Amikacin, for Pseudomonas aeruginosa (“ Pa ”) infections in cystic fibrosis (“CF”) patients, and SLIT™ Cisplatin, for lung and ovarian cancer, are both in Phase II clinical trials. Amikacin and cisplatin have already been approved for the treatment of lung infections and lung cancer, respectively, in intravenous (“IV”) form. By conferring sustained release and pulmonary disease site targeting to these active compounds, Transave increases their therapeutic benefits while reducing their systemic toxicities.
SLIT™ formulations utilize lipid constituents endogenous to the lung, via the pulmonary surfactant, to make extremely safe and biocompatible inhalable lipid/drug complexes. The combination of a sustained release benefit with limited or no detectable systemic absorption dramatically improves the therapeutic index of many commonly used drugs, creating several relatively near-term revenue candidates for the Company as well as offering significant partnering opportunities.
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