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Company Prepares to Enter Clinical Studies for Vulvovaginal Atrophy (VVA)
GALES FERRY, CT --(Marketwired - March 08, 2016) - Azure Biotech, Inc. a private biotechnology company developing novel formulations of lasofoxifene announced today that David Thompson, PhD will lead the Company as its president. Azure is preparing to enter clinical studies in VVA with a proprietary formulation.
Dr. Thompson is a seasoned pharmaceutical executive with extensive research and clinical development experience. Most recently, at Alexion Pharmaceuticals, Dr. Thompson was the Vice President and Global Team Leader responsible for the worldwide regulatory approval of Strensiq (asfotase alfa), a compound to treat hypophosphatasia.
Prior to Alexion, Dr. Thompson was Executive Director, Development Team Leader for Lasofoxifene, Pfizer Global Research and Development. Dr. Thompson was initially recruited to Pfizer to build Pfizer's osteoporosis research program. His research team successfully identified numerous clinical candidates including the selective estrogen receptor modulator (SERM), lasofoxifene.
Dr. Thompson subsequently led the lasofoxifene clinical development team through regulatory filings and EU approval. This clinical development program completed 40 clinical trials, including a large, long-term Phase 3 trial in 8,556 postmenopausal women.
Earlier in Dr. Thompson's career, he was a Senior Research Fellow at Merck Research Laboratories where he conducted preclinical research with Fosamax.
"David is one of the few individuals in the drug industry who has led teams that have taken a drug from idea, through preclinical research, through Phase I, II, and III clinical trials, successful defense in US and EU regulatory agencies, and approval," commented Dr. Steven R. Goldstein, Azure's clinical advisory board chairman and a globally recognized clinical leader in women's health. "He will be a huge asset as Azure's lead product, lasofoxifene, a drug for which he possesses extensive knowledge, enters clinical studies later this year."
Dr. Thompson stated, "Lasofoxifene is an incredible drug for postmenopausal women with a proven safety and efficacy profile. This is why I founded the company along with my partners and why I am excited to lead Azure in this next stage of lasofoxifene development."
About Azure Biotech, Inc.
Azure Biotech, Inc. is a private biotechnology company that is developing novel, formulations of lasofoxifene. Azure's first product, lasofoxifene, a selective estrogen receptor modulator will be entering clinical studies in vulvovaginal atrophy (VVA), a women's health indication of high unmet medical need. The oral, 0.5 mg form of lasofoxifene tartrate was developed by Pfizer and progressed through regulatory approval in the EU for the treatment of osteoporosis in postmenopausal women. Azure plans to rapidly build upon the extensive safety and efficacy data already available from trials completed with an oral formulation in more than 15,000 women.
Safe Harbor Statement
The information posted in this release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by use of the words "may," "will," "should," "plans," "explores," "expects," "anticipates," "continue," "estimate," "project," "intend," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, lack of available funding; general economic and business conditions; competition from third parties; intellectual property rights of third parties; regulatory constraints; changes in technology and methods of marketing; delays in completing various engineering and manufacturing programs; changes in customer order patterns; changes in product mix; success in technological advances and delivering technological innovations; shortages in components; production delays due to performance quality issues with outsourced components; those events and factors described by us in Item 1.A "Risk Factors" in our most recent Form 10-K; other risks to which our Company is subject; other factors beyond the Company's control.
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