Financing to speed commercialization of the only FDA-approved oral treatment of its kind for testosterone deficiency1,2
NORTHBROOK, Ill., March 16, 2020 (GLOBE NEWSWIRE) -- Clarus Therapeutics, Inc., a commercial mens health specialty pharmaceutical company, announced today that it has completed a senior debt financing of up to $75M. Morgan Stanley & Co. LLC acted as sole placement agent for the transaction.
Clarus will use the proceeds from this financing to accelerate the commercialization strategy and launch for JATENZO (testosterone undecanoate) capsules, CIII, the first and only FDA-approved oral softgel testosterone replacement therapy for the treatment of men with hypogonadism due to certain medical conditions. This additional investment builds on an exceptional year for the company, which includes hiring multiple key executives and making JATENZO available for patients.
We are thrilled to have this investment as we bring JATENZO to market, said Dr. Robert Dudley, Chief Executive Officer of Clarus Therapeutics, Inc. We can now fully implement JATENZOs commercialization strategy and move Clarus closer to profitability.
About HypogonadismHypogonadism, also known as testosterone deficiency, is a condition in men in which the body does not produce enough testosterone.3 Only those men who are symptomatic and have consistently low results on a reliable testosterone assay should be offered testosterone replacement therapy, according to current treatment guidelines from both the Endocrine Society and the American Urological Association.3,4 Treatment is meant to induce and maintain secondary sex characteristics and improve clinical symptoms associated with testosterone deficiency.4About Clarus Therapeutics, Inc.Clarus is a men's specialty pharmaceutical company developing and commercializing JATENZO, a product protected by patents issued in the United States and in other major pharmaceutical markets around the world. Clarus owns the worldwide, royalty-free commercialization rights for JATENZO.For more information, please visit:www.clarustherapeutics.com.
About JATENZO JATENZO is the first and only FDA-approved oral testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).1,2
JATENZOs proprietary formulation is built around testosterone undecanoatea testosterone prodrug that the body converts to testosterone. In the JATENZO pivotal inTUne (investigational testosterone undecanoate) clinical trial, 87 percent of hypogonadal men treated with JATENZO achieved a mean total testosterone concentration in the eugonadal range at the end of treatment.1 The efficacy and safety of JATENZO was evaluated in 166 adult, hypogonadal males in a 4-month, open-label study. The primary endpoint was the percentage of patients with mean plasma total testosterone concentration (Cavg) over 24 hours within the normal eugonadal range on the final pharmacokinetic visit of the study.
INDICATIONJATENZO (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Limitation of use
Safety and efficacy of JATENZO in males less than 18 years old have not been established.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASES IN BLOOD PRESSURE
JATENZO is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, in men with a known hypersensitivity to JATENZO or its ingredients, or in men with hypogonadal conditions that are not associated with structural or genetic etiologies as JATENZO has not been established for these conditions and there is a risk of increased blood pressure with JATENZO that can increase the risk of MACE.
WARNINGS AND PRECAUTIONS
The most common adverse events of JATENZO (incidence 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).
USE IN SPECIFIC POPULATIONS
The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There is insufficient long-term safety data in geriatric patients utilizing JATENZO to assess the potentially increased risk of cardiovascular disease and prostate cancer.
Please click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure.
Media ContactAmir KhanPhone: (212) 462-8767Email: Amir.Khan@Syneoshealth.com
1JATENZO (testosterone undecanoate) [prescribing information]. Clarus Therapeutics, Inc.
2US Food & Drug Administration. FDA Approved Drug Products. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206089. Accessed October 1, 2019.
3Bhasin S, et al. J Clin Endocrinol Metab. 2018;103(5):1715-1744.
4Mulhall JP, et al. J Urol. 2018;200(2):423-432.
2020 Clarus Therapeutics, Inc. All rights reserved.
JATENZO is a registered trademark of Clarus Therapeutics, Inc.