March 17, 2014 08:30 | Source: Clarus Therapeutics, Inc.
NORTHBROOK, Ill., March 17, 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 John P. Gargiulo has joined the Company as Chief Operating Officer.
Mr. Gargiulo was most recently North American President and CEO of Daiichi Sankyo, Inc. He will report to Robert E. Dudley, President and CEO, and will spearhead the development and, if approved, execution of Clarus' commercialization plan for REXTORO. On January 3, 2014, Clarus submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA). If approved, REXTORO will be the first U.S. commercially available oral formulation of a T prodrug for the treatment of hypogonadism.
"We are excited to have Mr. Gargiulo join Clarus at this critical stage in our company's growth as we begin building the infrastructure for the anticipated commercialization of REXTORO. John has a track record of successfully launching and commercializing several specialty and primary care products," Dudley said. "If approved by the FDA, we believe that REXTORO has the potential to be a preferred option for T-replacement therapies, and we are confident that John's expertise and relationships will enhance our ability to succeed in this effort."
Mr. Gargiulo brings to Clarus nearly 30 years of healthcare sales, marketing and commercialization experience. Most recently, he spent 18 years in senior level roles at Daiichi Sankyo, Inc., the North American subsidiary of Japan-based Daiichi Sankyo Company Limited, where he was involved in almost every aspect of business operations. Mr. Gargiulo joined Daiichi Sankyo as the first U.S. employee focused on commercialization and was promoted to North American President and CEO in 2011. By the time he left the company in 2013, its U.S. business was almost $2 billion.
Mr. Gargiulo led multiple strategic initiatives, including the formation of Sankyo Parke Davis and a co-promotion agreement with Forest Laboratories.
"I look forward to working with the Clarus team as we seek to launch REXTORO in the U.S.," Mr. Gargiulo said. "REXTORO addresses a real desire among hypogonadal men for an oral treatment option that would eliminate the risk of T transference to women and children commonly associated with topical T gels or solutions. Hypogonadal men and their physicians are looking for a new therapeutic option and I believe that REXTORO has a great opportunity to be the preferred choice for them."
Mr. Gargiulo holds a B.A. in Economics from Boston College and an M.B.A. from the Duke University Fuqua School of Business and has served on the boards of the Pharmaceutical Research and Manufacturers Association (PhRMA) and National Pharmaceutical Council Board of Directors.
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. If approved by the FDA, REXTORO will be a first-in-class, orally available T prodrug in the United States 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. 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. For more information, please visit: www.clarustherapeutics.com.
REXTORO is a proprietary softgel oral formulation of testosterone undecanoate for treating hypogonadal men. 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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