JATENZO is the first and only FDA-approved oral softgel capsule for testosterone replacement therapy in adult males who have deficient testosterone due to certain medical conditions
New offerings underscore Clarus’ continued commitment to providing solutions for patients
Partnership with Vault Health enables clinical care from the comfort of patients’ homes
Partnership with AssistRx, the intelligent therapy initiation and patient support solutions provider, streamlines process for JATENZO prescription fulfillment and distribution to patients
NORTHBROOK, Ill., Feb. 24, 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 partnered with Vault Health, an innovative healthcare company bringing clinical care to people’s homes. Clarus also announced the launch of its new technology-enabled patient access platform for JATENZO (testosterone undecanoate) oral softgel capsules, supported by AssistRx’s access and fulfillment solution, CoAssist, which streamlines the prescription process for healthcare providers and home delivery of JATENZO for patients.
“These two new offerings underscore our continued commitment to providing convenient and innovative solutions for patients who are prescribed JATENZO,” said Dr. Robert Dudley, President and Chief Executive Officer of Clarus. “Millions of men struggle with hypogonadism, but only a relatively small fraction of them actually seek treatment due to everything from the inconvenience of doctor visits to social stigmas — including potentially uncomfortable conversations about signs and symptoms associated with low testosterone. We believe our new programs will ease some of these concerns by engaging with the patient at each step of the way.”
“At Vault Health, we ensure that patients are in control and are seen on their terms, whether in-person or using telehealth, to maximize access to care while providing a very high quality service,” said Dr. Alex Pastuszak, President of Clinical Care and Chief Clinical Officer at Vault Health. “Too many people forego the healthcare they need because of the many barriers involved in going to see a provider. Through these innovative partnerships, Vault brings its national healthcare practice to patients, resulting in a tailored, confidential process led by our team of healthcare experts.”
“Our technology-driven access and fulfillment solution, CoAssist, identifies patients’ comprehensive benefit information, delivers real-time e-prior authorizations and provides immediate copay screening and enrollment,” said AssistRx Co-founder and Chief Commercial Officer Edward Hensley. “CoAssist speeds the time to JATENZO fulfillment by automating all the support services needed to get a patient started on therapy at the point of prescription. This proactive, digital approach accelerates access and supports improved treatment outcomes.”
“We are very excited by our partnerships with two committed teams of experts whose focus is on our patient demographic,” said Frank Jaeger, Chief Commercial Officer of Clarus. “Our strategic partnerships with Vault Health and AssistRx are synergistic and strengthen our commitment to enhance the patient journey not only by providing an end-to-end solution from diagnosis to product fulfillment, but to eliminate barriers through a streamlined, single-portal experience. Through Vault Health and AssistRx, we can help patients determine if they are hypogonadal, ship JATENZO directly to their homes and, importantly, refill prescriptions automatically at a cost savings. We believe these customized patient support offerings will result in better adherence to therapy.”
About Male Hypogonadism
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 Vault Health
Vault Health is the first and only health tech company providing clinical care using telehealth and at-home interactions, while also supporting clinical research at scale. Vault's clinical care and research platform enables drug manufacturers and clinical trial sponsors to bring new therapies to market faster. Vault's national clinical practice facilitates patient care through telehealth and at-home sample collection and diagnostics. Vault applied its platform and emerged as a trusted leader in the fight against COVID-19, bringing the first FDA-authorized at-home saliva PCR test to market. Since the start of the pandemic, Vault has delivered more than 12 million COVID-19 tests to consumers, employers, public health agencies, and school systems.
About AssistRx
AssistRx has engineered the perfect blend of technology and talent to provide manufacturers with an intelligent therapy initiation and patient support solution to improve patient uptake, visibility, and outcomes. AssistRx’s solution integrates technology and therapy expertise to advance patient therapy in a more efficient and effective manner — delivering informed touchpoints that simplify a complex system to enable better results for today’s patients. For more information, visit www.assistrx.com.
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 anticipated benefits of the partnership with Vault Health, the benefits of the new patient hub for JATENZO through AssistRx, the impact of these new programs on patient access to treatment, as well as results in improved patient compliance to therapy. 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 the prospectus filed with the Securities and Exchange Commission (the SEC) under Rule 424(b)(3) on December 23, 2021, 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.
Clarus Contact:
Kara Stancell
Vice President, Investor Relations & Corporate Communications
kstancell@clarustherapeutics.com
(847) 562-4300 x 206
About JATENZO
Indication
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:
- Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations 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 from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
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 can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
- Before initiating JATENZO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
- Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
- Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.
CONTRAINDICATIONS
JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm.
WARNINGS AND PRECAUTIONS
- 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.
- Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for 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 like JATENZO. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue JATENZO and initiate appropriate workup and management.
- 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.
- Gynecomastia may develop and persist in patients being treated for hypogonadism.
- 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.
- Use JATENZO with caution in cancer patients at risk of hypercalcemia. Monitor serum calcium concentration regularly during treatment with JATENZO in these patients.
- 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.
- Depression and suicidal ideation have been reported in patients treated with JATENZO in clinical trials.
ADVERSE EVENTS
The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).
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.
© 2022 Clarus Therapeutics, Inc. All rights reserved.
