JATENZO is the first and only FDA-approved oral softgel for testosterone replacement therapy in adult males who have deficient testosterone due to certain medical conditions NORTHBROOK, Ill., July 28, 2022 (GLOBE NEWSWIRE) -- Clarus Therapeutics Holdings, Inc. (Clarus) (Nasdaq:CRXT), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, today announced that it has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for additional claims that cover its oral testosterone replacement product, JATENZO (testosterone undecanoate). Patent application No. 16/656,169 entitled “Oral Testosterone Ester Formulations and Methods of Treating Testosterone Deficiency Comprising Same” covers Clarus’ commercialized product, JATENZO. The U.S. patent scheduled to issue from this application will expire in 2030. “We have strategically invested in the intellectual property portfolio for JATENZO from its beginning, confident of the brand’s innovation and potential,” said Dr. Robert Dudley, President and Chief Executive Officer of Clarus. “We are very excited to add yet another patent to its growing armamentarium. Once issued, this will be the ninth patent listed in FDA’s Orange Book covering JATENZO.”
Male hypogonadism is a condition that results when the testes do not produce enough testosterone. Symptoms associated with male hypogonadism can include depression, decreased sex drive, decreased muscle mass, and decreased bone density, among others. An estimated 20 million men in the United States have hypogonadism, with approximately six million patients diagnosed. Treatments for male hypogonadism may include testosterone replacement therapy. About Clarus Therapeutics Holdings, Inc.
Clarus Therapeutics Holdings, Inc. is a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women – including potential therapies for orphan indications. Clarus’ first commercial product is JATENZO® (testosterone undecanoate). For more information, visit www.clarustherapeutics.com and www.jatenzo.com. Follow us on Twitter (@Clarus_Thera) and LinkedIn (Clarus Therapeutics). Clarus Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” for purposes of the federal securities laws. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Clarus’ forward-looking statements in this press release include, but are not limited to, statements regarding the issuance of a new patent covering JATENZO and its listing in the FDA’s Orange Book, the timing of the expiration of the new patent and the effect of the new patent on the JATENZO patent portfolio. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that Clarus has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Clarus’ control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks associated with pharmaceutical development, risks associated with Clarus’ financial position, and those factors described under the heading “Risk Factors” in Clarus’ annual report on 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (the SEC) on March 31, 2022, and those that are included in any of Clarus’ future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of Clarus’ assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the ongoing COVID-19 pandemic and there may be additional risks that Clarus considers immaterial, or which are unknown. It is not possible to predict or identify all such risks. Clarus’ forward-looking statements only speak as of the date they are made, and Clarus does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. JATENZO® is a registered trademark of Clarus Therapeutics Holdings, Inc. kstancell@clarustherapeutics.com
JATENZO® (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: Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Safety and efficacy of JATENZO in males less than 18 years old have not been established. WARNING: INCREASES IN BLOOD PRESSURE
Before initiating JATENZO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled. Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies. Check hematocrit prior to initiation and every 3 months while a patient is on JATENZO and if hematocrit becomes elevated, stop JATENZO until hematocrit decreases to an acceptable level. If hematocrit increases after JATENZO is restarted, stop permanently. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Large doses of androgens can suppress spermatogenesis by feedback inhibition of pituitary FSH. Inform patients of this risk before prescribing JATENZO. Prolonged use of high doses of methyltestosterone has been associated with serious hepatic adverse events. JATENZO is not known to cause these adverse events; however, patients should be instructed to report any signs of hepatic dysfunction and JATENZO should be discontinued while the cause is evaluated. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. Sleep apnea may occur in some patients, especially those with risk factors such as obesity or chronic lung disease. Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly after starting testosterone therapy. Androgens, including JATENZO, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. These are not all of the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. You can also obtain information regarding JATENZO at www.jatenzo.com.