Clarus Therapeutics Expands Executive Team in Preparation for Landmark Launch of JATENZO® (testosterone undecanoate) Capsules CIII
NORTHBROOK, Ill., Dec. 11, 2019 -- Clarus Therapeutics, Inc. today announced the appointment of five senior leaders, each of whom bring valuable industry and category experience to the team. Together they strengthen the company's commercialization capability for JATENZO® (testosterone undecanoate) capsules, the first-in-class oral testosterone replacement therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypogonadism. See indication and important risk information, including boxed warning below.
- Jay Newmark, MD, MBA, joined Clarus Therapeutics in December 2019 as Chief Medical Officer. Following 16 years as an independent urologist in private practice, Dr. Newmark established himself as a leading voice in men's health. As Senior Director of Medical Affairs at Genomic Health and OPKO Health, he championed advanced detection technologies for prostate cancer. Dr. Newmark has also worked closely with both commercial development organizations and academic researchers to design clinical trial protocols and co-author publications on topics in oncology and urology. He received his MD from the University of Michigan Medical School and completed his residency in urology at The Johns Hopkins Hospital. He holds a Master of Business Administration from the University of Chicago.
- Frank Jaeger, MA, MBA, was appointed Chief Commercial Officer effective September 2019. He is a passionate leader with diversified experience across multiple therapeutic and functional areas. Prior to joining Clarus, Mr. Jaeger served in numerous leadership positions throughout his career, including in research and development, medical affairs and business development, and oversaw licensing and contracting both locally and globally. As a Regional Sales Director at AbbVie, he was responsible for the company's sales growth for metabolic products in one of its largest regions. Most notably, Mr. Jaeger led the company's men's health franchise. During his tenure in this role, Mr. Jaeger was responsible for commercial sales and marketing strategy, franchise development, and partnership management. He was instrumental in launching AbbVie's testosterone replacement therapy, which reached blockbuster status under his leadership. With a proven track record in sales, marketing and business development, Mr. Jaeger will lead all commercial activities at Clarus. He holds a Master of Arts from the University of Illinois at Chicago and a Master of Business Administration from Lake Forest School of Management.
- Jose Luis Rodriguez, MBA, joined Clarus Therapeutics in November 2019 as Vice President, Marketing. Mr. Rodriguez has more than 25 years of experience supporting commercial and pipeline pharmaceutical product franchises through his roles at Astellas Pharmaceuticals, Johnson Matthey Pharmaceuticals, and EUSA Pharma. At Astellas Pharmaceuticals, he managed the U.S. Marketing Oncology team during a period of accelerated pre-launch and launch activities that delivered $822 million in incremental revenue. An astute brand strategist with strong analytical technical skills, Mr. Rodriguez has led more than 12 branded product launches, and has a passion for improving experiences and health outcomes for patients and caregivers. Mr. Rodriguez holds a Master of Business Administration from Carnegie Mellon University.
- LaTonya Wright has been appointed Vice President, Sales. Ms. Wright joined the organization in October 2019 from AbbVie, where she advanced through the sales organization holding several leadership positions including Regional Sales Director. Under her leadership there, Ms. Wright's team consistently exceeded sales targets and won national awards for innovative business strategies and sales performance. Previously, she was responsible for launching another testosterone replacement therapy with an innovative go-to-market model. At Clarus, she is in charge of creating and leading the sales and national accounts organization.
- James Holloway joined Clarus Therapeutics in October 2019 as Vice President, Manufacturing and Supply. Mr. Holloway brings extensive experience in pharmaceutical manufacturing from his roles of increasing responsibility at DSM Pharmaceuticals, Cardinal Health, Pfizer, and Boehringer Ingelheim. Most recently, he led the research and development project management office of the Infection Prevention franchise of CareFusion (now BD Medical) where he increased revenue by $70 million and improved on-time delivery. A chemist by training, Mr. Holloway has launched more than 55 drugs and biologic products.
Dr. Newmark, Mr. Jaeger, Mr. Rodriguez, Ms. Wright and Mr. Holloway join a management team led by Robert Dudley, Ph.D., Clarus Therapeutics' Chief Executive Officer and co-inventor of JATENZO. Dr. Dudley's legacy in men's health includes CEO leadership of the company that developed and launched AndroGel®, a product he co-invented and the last major advancement in testosterone replacement therapy delivery.
"We are proud to bring Jay, Frank, Jose, LaTonya, and James into an organization that shares their focus on innovation and excellence. They have each demonstrated an ability to connect with medical professionals who are invested in men's health," said Dudley. "Their expertise will help us make the long sought-after oral testosterone option widely available to appropriate hypogonadal men."
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
JATENZO™ (testosterone undecanoate) capsules, for oral use CIII
Initial US approval: 1953
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.
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
- JATENZO can increase blood pressure, which can increase the risk of MACE, with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease. Before initiating JATENZO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled. Monitor blood pressure approximately 3 weeks after initiating, increasing the dose, and periodically while on JATENZO, and treat any new or exacerbations of hypertension. Re-evaluate benefits and risks of continued treatment with JATENZO in patients who develop cardiovascular risk factors or disease. JATENZO is contraindicated in men with hypogonadal conditions such as "age-related hypogonadism" because the efficacy of JATENZO has not been established for these conditions and the increases in BP can increase the risk of MACE.
- Polycythemia may require a lower dose or discontinuation of JATENZO. 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.
- Some studies, but not all, have reported an increased risk of major adverse cardiovascular events (MACE) in association with use of testosterone replacement therapy in men. Long-term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use JATENZO. JATENZO can increase blood pressure, which can increase the risk of MACE.
- Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH. Patients treated with androgens may be at increased risk for prostate cancer and should be evaluated prior to initiating and during treatment with androgens. Monitor prostate-specific antigen (PSA) levels periodically.
- Postmarketing reports of 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. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. If abuse is suspected, check testosterone levels to ensure they are in therapeutic range. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
- JATENZO is not indicated for use in women.
- 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.
- Androgens, including JATENZO, may promote retention of sodium and water. 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.
- The treatment of hypogonadal men with testosterone may potentiate sleep apnea 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. Advise patients and caregivers to seek medical attention for manifestations of new-onset or worsening depression, suicidal ideation or behavior, anxiety, or other mood changes.
The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).
- JATENZO can cause changes in insulin sensitivity or glycemic control. Androgens may decrease blood glucose and may require a decrease in the dose of antidiabetic medications.
- Anticoagulant activity may be affected by androgens. More frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at initiation and termination of androgen therapy.
- Use of testosterone and corticosteroids concurrently may increase fluid retention and requires monitoring in patients with cardiac, renal, or hepatic disease.
- Some prescription and nonprescription analgesic cold medications contain drugs known to increase blood pressure and concomitant use of these medications with JATENZO may lead to additional increases in blood pressure.
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 see accompanying full Prescribing Information, including BOXED WARNING on increases in blood pressure.
JATENZO is a first-in-class proprietary oral soft gel formulation of testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
JATENZO's proprietary formulation is built around testosterone undecanoate – a testosterone prodrug that the body converts to testosterone. In the JATENZO pivotal inTUne (investigation of its oral Testosterone Undecanoate) clinical trial, 87% (n=222) of men treated with JATENZO achieved average circulating levels of testosterone in the normal range for men.
About Clarus Therapeutics, Inc.
Clarus is a men's specialty pharmaceutical company developing and preparing for the commercial launch of 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.