Clarus Therapeutics Announces Notice of Allowance for Additional Patent Claims Covering JATENZO® (testosterone undecanoate)
July 28 2022 - 9:05AM
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 received a notice of
allowance from the United States Patent and Trademark Office
(USPTO) for additional claims that cover its oral testosterone
replacement product, JATENZO (testosterone undecanoate).
Patent application No. 16/656,169 entitled “Oral Testosterone
Ester Formulations and Methods of Treating Testosterone Deficiency
Comprising Same” covers Clarus’ commercialized product, JATENZO.
The U.S. patent scheduled to issue from this application will
expire in 2030.
“We have strategically invested in the intellectual property
portfolio for JATENZO from its beginning, confident of the brand’s
innovation and potential,” said Dr. Robert Dudley, President and
Chief Executive Officer of Clarus. “We are very excited to add yet
another patent to its growing armamentarium. Once issued, this will
be the ninth patent listed in FDA’s Orange Book covering
JATENZO.”
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 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 StatementsCertain
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 the issuance of a new patent covering JATENZO
and its listing in the FDA’s Orange Book, the timing of the
expiration of the new patent and the effect of the new patent on
the JATENZO patent portfolio. 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 Clarus’
annual report on 10-K for the year ended December 31, 2021 filed
with the Securities and Exchange Commission (the SEC) on
March 31, 2022, 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 StancellVice President,
Investor Relations & Corporate
Communicationskstancell@clarustherapeutics.com (847) 562-4300
x 206
About JATENZO
IndicationJATENZO®
(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 useSafety 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.
CONTRAINDICATIONSJATENZO 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 EVENTSThe 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.
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