NORTHBROOK, Ill., July 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 the expansion of its Board of Directors from six to eight with the appointments of Ms. Elizabeth (Liz) A. Cermak and Mr. Mark A. Prygocki, Sr., effective July 10, 2014.
"Clarus is fortunate to strengthen its Board of Directors with the additions of these two seasoned pharmaceutical industry executives. Elizabeth is a proven commercialization leader with more than 30 years of experience in pharmaceuticals, healthcare management services and consumer healthcare products. During her career, she led the growth and transformation of a number of brands and businesses ranging from specialty to large scale pharmaceutical portfolios," said Dr. Robert E. Dudley, Clarus President, CEO and Chairman of the Board of Directors.
Dr. Dudley continued, "Mark is an accomplished senior pharmaceutical executive with more than 21 years' experience in the specialty pharmaceutical market specializing in the development of corporate strategy and operational efficiency. Notably, his work with Medicis Pharmaceutical Corporation was instrumental in the Company's evolution from a start-up company to a $2.6 billion entity at the time of its acquisition by Valeant Pharmaceuticals in 2012."
Most recently, Ms. Cermak was Executive Vice President, Chief Commercial Officer and member of the Executive Committee of POZEN, Inc. Previously, she served as the Worldwide Vice President of Global Marketing for Personal Products, a segment of the Johnson & Johnson Consumer Health Care business, and also served as the Vice President of the Women's Healthcare RX Franchise for Ortho-McNeil Pharmaceutical. Ms. Cermak currently serves as a Board Member for ORCA (Ocean Ridge Charity Association) and is on the Advisory Board for Physicians Interactive, Inc. She received her undergraduate degree from Franklin & Marshall College and an MBA from Drexel University.
Mr. Prygocki most recently served as President of Medicis Pharmaceutical Corporation. Before being promoted to President, he held several senior executive roles within the company from 1991 until its acquisition in 2012. Prior to Medicis, Mr. Prygocki worked at Citigroup and Ernst & Young, LLP. He has also served on the Board of Whispering Hope Ranch Foundation, a non-profit organization, for more than 10 years.
Dr. Dudley added, "The collective healthcare industry leadership, management and business development experience Elizabeth and Mark possess will serve our company well as we seek FDA approval of REXTORO and prepare to shift our focus from clinical development to commercial growth. We are excited to have them join our Board and look forward to their contributions as we advance our strategic objectives."
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 a study published in the International Journal of Clinical Practice in 2006, 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 target of 2,500 ng/dL for peak T concentrations. The most common treatment-related side effects were occasional mild GI disturbances in some subjects, a modest decrease in HDL cholesterol and side effects associated with increases in hematocrit, enlargement of the prostate or increases in prostate specific antigen (PSA).
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