NORTHBROOK, Ill., May 21, 2014 (GLOBE NEWSWIRE) -- Clarus Therapeutics, Inc., a men's health specialty pharmaceutical company focused on the development and commercialization of REXTORO, an oral testosterone (T) replacement product, today announced that Patrick Shea has joined the Company as Chief Commercial Officer.
In his role with Clarus, Mr. Shea will report directly to the Company's President and CEO, Dr. Robert E. Dudley. He will be in charge of developing and implementing the commercialization strategy for REXTORO. The Company filed a new drug application (NDA) for REXTORO with the U.S. Food and Drug Administration (FDA) in January 2014 and received a PDUFA date of November 3, 2014.
"Pat brings a wealth of knowledge and nearly three decades of pharmaceutical sales and marketing experience to the Clarus team. He has been deeply involved in the management of successful product launches both in specialty and primary care markets and has a strong background in pharmaceutical sales and marketing, which will be a valuable asset should REXTORO be approved for commercialization in the U.S.," commented Dr. Dudley. "Low testosterone impacts millions of men in the U.S. There is a substantial need in the market for an oral treatment that mitigates risks associated with the currently approved options, and we believe REXTORO is the product to address these risks and patient concerns."
Most recently, Mr. Shea served as Vice President of Sales and Marketing for the U.S. commercial operations of CSL Behring, where he oversaw strategic efforts for sales, marketing and managed care of a $1.9 billion business. Previously, he was Senior Vice President of Sales and Marketing for the U.S. pharmaceutical operations of Astellas Pharmaceuticals, where he led sales and marketing initiatives in connection with several product launches during his tenure. In addition, Mr. Shea has held senior sales and marketing roles at Ligand Pharmaceuticals and Boehringer Ingelheim and led teams developing commercial pre-launch and launch plans for urologic products such as Flowmax®. He received his Bachelor of Arts in Psychology from Alfred University.
Mr. Shea commented, "This is a great opportunity to join a talented management team that has unique expertise in T-replacement therapy and is poised to commercialize a product that addresses an unmet need in the treatment of hypogonadal men. If approved, there is significant opportunity for REXTORO to capture market share given the severity of potential side effects from transference and the inconvenience of administration associated with the currently approved treatment options. I look forward to working with the team as Clarus enters this exciting and important phase of its development."
About Clarus Therapeutics
Clarus is an emerging men's specialty pharmaceutical company preparing for the commercial launch of REXTORO, an oral testosterone, or T, replacement therapy. On January 3, 2014 the Company submitted a New Drug Application, or NDA, for REXTORO to the U.S. Food and Drug Administration, or FDA. REXTORO is an oral T prodrug that, if approved by the FDA, will be used to treat men diagnosed with testosterone deficiency together with an associated medical condition, also known as hypogonadism. Clarus owns the worldwide, royalty-free commercialization rights for REXTORO. For more information, please visit: www.clarustherapeutics.com.
REXTORO is a proprietary softgel oral formulation of testosterone undecanoate for treating hypogonadal men. According to the International Journal of Clinical Practice, T deficiency affects approximately 39% of men over the age of 45. Common symptoms identified in the Endocrine Society's clinical guidelines that suggest testing for T deficiency include reduced sexual activity and desire, decreased energy, increased body fat and reduced muscle mass, depressed mood and other emotional and physiological issues. Clarus completed two Phase 3 trials of REXTORO and achieved the FDA guidance for efficacious T-replacement therapy, which is at least 75% of evaluable subjects with a serum T level in the normal range of 300 to 1,000 ng/dL, in each of the Phase 3 trials. The observed safety profile for REXTORO with the final dose titration algorithm was closely aligned with, but did not precisely meet, the FDA's targets. The most common side effects were mild GI disturbances in some subjects, a modest decrease in HDL cholesterol and modest increases in hematocrit and prostate specific antigen (PSA).
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Source:Clarus Therapeutics, Inc.