Clarus Therapeutics Announces Commercial Launch and Availability of JATENZO

Mar  2020

Financing to speed commercialization of the only FDA-approved oral treatment of its kind for testosterone deciency1,2

NORTHBROOK,  Ill., March  16, 2020  (GLOBE  NEWSWIRE)  -- Clarus  Therapeutics, Inc., a commercial men’s health  specialty pharmaceutical company, announced today  that  it has  completed a senior debt  nancing of up to $75M. Morgan  Stanley  & Co. LLC acted as sole placement agent for the transaction.


Clarus  will use  the  proceeds from  this  nancing to  accelerate the  commercialization strategy and  launch  for JATENZO®  (testosterone undecanoate) capsules, CIII, the  rst and only FDA-approved oral softgel testosterone replacement therapy for the treatment of   men   with   hypogonadism  due   to   certain  medical  conditions.  This   additional

 


investment  builds   on  an  exceptional  year  for  the  company,  which  includes  hiring multiple key executives and making  JATENZO available for patients.


“We are  thrilled  to  have  this  investment as we  bring  JATENZO  to  market,”  said  Dr. Robert  Dudley,  Chief Executive  Ocer  of Clarus  Therapeutics, Inc. “We can  now  fully implement   JATENZO’s   commercialization  strategy   and    move    Clarus    closer  to protability.”


About Hypogonadism

Hypogonadism, also  known  as testosterone deciency, is a condition in men  in which the   body   does  not   produce  enough  testosterone.3   Only  those  men    who   are symptomatic and have consistently low results on a reliable testosterone assay should be offered testosterone replacement therapy, according to current treatment guidelines from both the Endocrine Society and the American Urological Association.3,4 Treatment is meant to induce  and maintain secondary sex characteristics and improve  clinical symptoms associated with testosterone deciency.4


About Clarus Therapeutics,  Inc.

Clarus  is a men's specialty pharmaceutical company developing and  commercializing 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 .


About JATENZO

JATENZO is the rst and only FDA-approved oral testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deciency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).1,2


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 treatment.1 The ecacy  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 (Cavg) over 24 hours  within the normal  eugonadal range  on the nal pharmacokinetic visit of the study.


INDICATION

JATENZO®  (testosterone  undecanoate) capsules, CIII, is  an  androgen  indicated for testosterone  replacement  therapy in  adult   males for  conditions associated  with  a deciency 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) deciency 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 ecacy  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 benets 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 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 benets 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 ecacy  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-specic 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 prole may require  dose adjustment of lipid-lowering drugs  or discontinuation of testosterone therapy. Monitor the lipid prole 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.


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%).


DRUG INTERACTIONS


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 uid 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 ecacy  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  sucient numbers of geriatric  patients involved in controlled clinical studies utilizing JATENZO to determine whether ecacy  or safety in those over

65 years  of age differs  from younger  subjects. There is insucient long-term safety data in geriatric  patients utilizing JATENZO to assess the potentially  increased risk of cardiovascular disease and prostate cancer.

 


Please  click  here  for full Prescribing Information, including BOXED WARNING on increases in blood pressure.


Media Contact

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Email: Amir.Khan@Syneoshealth.com

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