JATENZO is the first FDA-approved oral softgel for testosterone replacement therapy in adult men who have testosterone deficiency due to certain medical conditions
Upon issuance, this patent will be listed in the FDA’sOrange Book, bringing to eight the total number of patents listed in the Orange Book covering JATENZO
NORTHBROOK, Ill., April 28, 2022 (GLOBE NEWSWIRE) — Clarus Therapeutics Holdings, Inc. (“Clarus”) (Nasdaq: CRXT), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing therapies Androgens and Metabolics for Men and Women, today announced that it has received Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims regarding its oral testosterone replacement product, JATENZO (testosterone undecanoate).
Patent Application No. 16/656,178 entitled “Hydrophobic Drug Delivery Systems and Compositions Comprising Them” covers Clarus’ marketed product, JATENZO. The US patent to be issued from this application will expire in 2026.
“As we continue to grow the JATENZO brand, we are extremely pleased to be able to further strengthen its strong intellectual property portfolio,” said Dr. Robert Dudley, President and CEO of Clarus. “Once granted, this new patent will be listed in the FDA’s Orange Book, bringing the total number of patents covering JATENZO in the United States to eight.
About Male Hypogonadism
Male hypogonadism is a condition that occurs when the testicles do not produce enough testosterone. Symptoms associated with male hypogonadism can include depression, decreased libido, decreased muscle mass, and decreased bone density, among others. An estimated 20 million men in the United States suffer from 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 focused on the development of 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 Therapeutic).
Clarus Forward-Looking Statements
Certain statements contained in this press release constitute “forward-looking statements” for purposes of federal securities laws. The words “anticipate”, “believe”, “contemplate”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “could”, ” plan”, “possible”, “potential”, “predict”, “project”, “should”, “shall”, “would” and similar expressions may identify forward-looking statements, but the absence of such 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 Orange Book, the timing of the expiration of the new patent and the effect of the new patent from the JATENZO patent portfolio. These forward-looking statements are based on current expectations and beliefs regarding future developments and their potential effects. There can be no assurance that future developments affecting us will be those anticipated by Clarus. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Clarus’ control) or other assumptions that could cause actual results or performance to differ materially from those expressed or implied by these forward-looking statements. . These risks and uncertainties include, but are not limited to, risks associated with pharmaceutical development, risks associated with Clarus’ financial condition and the factors described under the heading “Risk Factors” in Clarus’ annual report for the 10 -K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (the SEC) on March 31, 2022, and those included in any future Clarus 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 differ materially from those projected in such forward-looking statements. Some of these risks and uncertainties may in the future be magnified 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 of these risks. Clarus’ forward-looking statements speak only as of the date on which they are made, and Clarus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, events future or otherwise, except as may be required under applicable securities laws.
JATENZO® is a registered trademark of Clarus Therapeutics Holdings, Inc.
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JATENZO® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with deficiency or absence of endogenous testosterone:
- Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, testicular leak syndrome, orchiectomy, Klinefelter syndrome, chemotherapy or toxic damage caused by alcohol or heavy metals. These men usually have low serum levels of testosterone and gonadotropins (follicle-stimulating hormone [FSH]luteinizing hormone [LH]) above the normal range.
- Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury due to tumors, trauma, or radiation. These men have low serum testosterone levels but have gonadotropins in the normal or low range.
Limitation of use
The safety and effectiveness of JATENZO in men under 18 years of age have not been established.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASE IN BLOOD PRESSURE
- JATENZO may cause an increase in blood pressure (BP) which may increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and death from cause. cardiovascular.
- Before starting JATENZO, consider the patient’s baseline cardiovascular risk and ensure that blood pressure is adequately controlled.
- Periodically monitor and treat new-onset hypertension or exacerbations of pre-existing hypertension and reassess whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease while on treatment.
- Because of this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.
JATENZO is contraindicated in men with known or suspected breast cancer or prostate cancer. JATENZO is contraindicated in pregnant women because testosterone may harm the fetus.
WARNINGS AND PRECAUTIONS
- Check hematocrit before initiation and every 3 months while a patient is taking JATENZO and if hematocrit becomes elevated, discontinue JATENZO until hematocrit decreases to an acceptable level. If hematocrit increases after resumption of JATENZO, permanently discontinue.
- Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens for an increased risk of worsening signs and symptoms of BPH.
- Venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone replacement products such as JATENZO. Evaluate patients with signs or symptoms consistent with DVT or PE and, if VTE is suspected, discontinue JATENZO and initiate appropriate evaluation and management.
- Testosterone has been abused, usually at higher doses than recommended for the approved indication and in combination with other anabolic androgenic steroids.
- High 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 side effects; 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, can be a serious complication in patients with pre-existing heart, kidney, or liver disease. In addition to drug discontinuation, diuretic therapy may be required.
- Gynecomastia may develop and persist in patients treated for hypogonadism.
- Sleep apnea can occur in some patients, especially those with risk factors such as obesity or chronic lung disease.
- Changes in serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy. Monitor lipid profile periodically, especially after starting testosterone therapy.
- Use JATENZO with caution in cancer patients at risk of hypercalcemia. Regularly monitor serum calcium concentration during treatment with JATENZO in these patients.
- Androgens, including JATENZO, may decrease thyroxine-binding globulin concentrations resulting in decreased total serum T4 concentrations and increased T3 and T4 resin uptake. However, free thyroid hormone concentrations remain unchanged and there is no clinical evidence of thyroid dysfunction.
- Cases of depression and suicidal ideation have been reported in patients treated with JATENZO in clinical trials.
The most common adverse reactions of JATENZO (incidence ≥ 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3 %) and nausea (2%).
These are not all the risks associated with JATENZO. For more information, click here for full prescribing information, including BOXED WARNING about increases in blood pressure. You can also obtain information about JATENZO at www.jatenzo.com.
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