Tolmar Announces Acquisition of JATENZO® (testosterone undecanoate) for the Treatment of Hypogonadism to Expand its Market Leading Urology Portfolio

-  Launched in 2020, JATENZO was the first oral softgel testosterone medicine approved in the US by the FDA in more than 60 years
-  JATENZO is an oral softgel testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired)
-  Compelling fit with Tolmar's strategy to acquire and develop therapies targeting diseases and conditions in Urology, Oncology and Orphan Diseases leveraging the company's focus and commitment in Urology community and Men's Health

BUFFALO GROVE, Ill., Oct. 28, 2022 /PRNewswire/ -- Tolmar Pharmaceuticals, Inc., a fully integrated pharmaceutical company, through its affiliate, Tolmar, Inc., today announced the acquisition of all rights to JATENZO^® from Clarus Therapeutics Holdings, Inc. (OTC: CRXTQ) and its wholly-owned subsidiary Clarus Therapeutics, Inc. (collectively, "Clarus"). Following a competitive auction process, Tolmar was selected as the winning bidder in the sale of JATENZO (and certain related assets), and the sale was approved by the U.S. Bankruptcy Court for the District of Delaware.

"The addition of JATENZO to Tolmar's robust portfolio further strengthens our position as a leader in urology and men's health," said Anil D'Souza, President and Chief Executive Officer of Tolmar Pharmaceuticals. " We have seen tremendous success in urology through our foundational therapy, ELIGARD^®, a market-leading product for advanced prostate cancer. This acquisition advances Tolmar's overall business strategy, provides substantial growth potential and helps advance our mission to advocate for patients through our therapies. In addition, we are confident that adding JATENZO to the products promoted by our successful urology field sales force will lead to fast and more profitable growth for this differentiated product."

Todd Smith, President and Chief Commercial Officer, added, "Hypogonadism affects each man differently, and JATENZO expands treatment options for patients and HCPs by offering a differentiated alternative to existing testosterone replacement therapies. The acquisition of JATENZO is another milestone that solidifies Tolmar's commitment to bringing forward therapies that improve healthcare experience as well as disease outcomes."

JATENZO's proprietary formulation is built around testosterone undecanoate—a 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 treatmentⁱ. 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 (C_avg) over 24 hours within the normal eugonadal range on the final PK visit of the study.

RBC Capital Markets is acting as financial advisor and Faegre Drinker Biddle & Reath LLP is acting as legal advisor to Tolmar in connection with the transaction.

Tolmar Pharmaceuticals is a fully integrated pharmaceutical company focused on the innovative development, manufacturing, and commercialization of specialty pharmaceuticals across multiple therapeutic areas, including Urology. Tolmar global headquarters, product development and manufacturing facilities are based in Northern Colorado, while North America commercial headquarters is based in Buffalo Grove, Illinois. For more information about the company, please visit tolmar.com.

IMPORTANT SAFETY INFORMATION

ELIGARD^®, (leuprolide acetate) for injectable suspension, is indicated for the palliative treatment of advanced prostate cancer.

ELIGARD is contraindicated in patients with hypersensitivity to GnRH, GnRH agonists, or any of the components of ELIGARD. Anaphylactic reactions to synthetic GnRH or GnRH agonists have been reported in the literature. Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression. Monitor patients at risk closely and manage as appropriate.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose level and manage according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH agonists in men. Monitor for cardiovascular disease and manage according to current clinical practice. Androgen deprivation therapy may prolong the QT/QTc interval. Consider risks and benefits. May cause fetal harm. Convulsions have been observed in patients taking leuprolide acetate with or without a history of predisposing factors. Manage convulsions according to current clinical practice.

ELIGARD may impair fertility in males of reproductive potential.

The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverse events include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia. As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported. See package insert for full Prescribing and Safety Information.

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.

Company Contact:
Tolmar Pharmaceuticals, Inc.
Julie Ferguson
[email protected]
312-385-0098

SOURCE Tolmar Pharmaceuticals, Inc.