Healthcare Industry News: testosterone deficiency
News Release - June 12, 2014
Clarus Therapeutics Secures $31.5 Million in FinancingAnnounces New Appointment to Board of Directors
NORTHBROOK, Ill., June 12, 2014 -- (Healthcare Sales & Marketing Network) -- 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 it has issued $31.5 million of 8% convertible promissory notes which, unless earlier converted according to their terms, are scheduled to mature on July 31, 2015. C-Bridge Capital led the financing, and BioVeda Capital and Pavilion Capital also participated. Proceeds from the financing will be used to help support the new drug application ("NDA") approval process and commercialization of the Company's lead product candidate, REXTORO.
Dr. Robert Dudley, president and CEO of Clarus, commented, "This is an exciting time for Clarus Therapeutics as we continue to prepare for the potential marketing approval of REXTORO later this year by further strengthening the company's financial position. We welcome C-Bridge and its co-investors to Clarus and look forward to working with each of them in the continued development of our product and business strategy. The capital raised through the issuance of these convertible notes will enable us to fully prepare for our upcoming FDA advisory committee meeting and will provide funding for potential commercialization activities for REXTORO."
In connection with C-Bridge's investment, Mengjiao Jiang, partner at C-Bridge, was appointed to the Company's board of directors.
About C-Bridge Capital
C-Bridge Capital is a China-based healthcare fund with an investment strategy focused on global growth opportunities. A primary investor in C-Bridge is Tasly Group, the majority shareholder of Tasly Pharmaceutical Co., a leading pharmaceutical company in China.
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 regimen 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).
Source: Clarus Therapeutics
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