H.I.G. Capital News
Clarus Therapeutics Bolsters Executive Team with Addition of Chief Medical and Chief Scientific Officers
NORTHBROOK, Ill – July 1, 2013 – Clarus Therapeutics, Inc., today announced the hiring of Theodore M. Danoff, M.D., Ph.D. and Wael A. Salameh, M.D., FACP to fill the newly created posts of VP clinical development & chief medical officer and VP medical affairs & chief scientific officer, respectively.
Dr. Danoff has been board certified in internal medicine and nephrology and has extensive pharmaceutical industry R&D experience at SmithKline Beecham, GlaxoSmithKline and, most recently, Endo Pharmaceuticals where he was vice president, clinical development and medical affairs. In this capacity, Dr. Danoff played a pivotal role in the preparation of the New Drug Applications (NDAs) for Fortesta® (a topical testosterone (T) gel) and Aveed® (a long-acting injectable T product currently under review by FDA).
“Dr. Danoff’s proven track record in clinical development, NDA preparation and FDA advisory panel presentations for T-replacement products will be of enormous benefit to Clarus as we commence work on our NDA for CLR-610. We are fortunate to have his skill set at Clarus,” said Dr. Robert Dudley, president & CEO of Clarus.
Dr. Salameh is board certified in internal medicine and endocrinology and has specialized training in andrology/men’s health. Prior to joining Clarus, Dr. Salameh was on the medical faculties of Temple University and UCLA. He left UCLA to become medical director, endocrinology, metabolism and cardiovascular laboratories at Quest Diagnostics Nichols Institute. He has also served as vice president of clinical development and CLIA validation at Telome Health and senior medical director and team leader for early clinical stage biomarker development at Genentech.
“Dr. Salameh’s clinical expertise in T-replacement therapy coupled with his clinical trial and laboratory experience will be particularly important as we analyze data from our ongoing clinical trials of our oral T replacement product, CLR-610,” Dr. Dudley added.
About Clarus Therapeutics
Clarus is a privately held biopharmaceutical company focused on the development and commercialization of our oral T-replacement product, CLR-610. The ongoing Phase 3 trials for CLR-610 are expected to be completed in mid-2013, after which the Company expects to file a New Drug Application with the FDA by the end of 2013. According to the American Urological Association, 10% of men 40-to-60 years of age, and 20% over the age of 60 have low T levels. Common symptoms associated with low T may include mild depression, reduced sex drive and erectile function, increased body fat, and decreased energy, lean body mass, muscle strength and bone mineral density. For more information, please visit: www.clarustherapeutics.com.