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, and McGill University (“McGill”), Canada’s top ranked
medical doctoral university, today announced a licensing agreement
whereby Clarus will develop and commercialize McGill’s proprietary
technology designed to treat conditions associated with CoQ10
deficiencies in humans.
CoQ10 is synthesized in the inner membrane of mitochondria, a
cellular organelle whose primary function is to produce the body’s
chemical energy. Deficiencies of CoQ10 can lead to severe multiple
organ dysfunctions that involve the brain, nerves, kidneys, heart,
GI tract and muscle. Oral CoQ10 is largely ineffective because it
does not result in intracellular uptake of CoQ10. McGill has
identified a method to substantially increase such uptake, thereby
forming the basis for a new, and potentially profound, method of
addressing deficiencies of CoQ10.
“This collaboration with world-renowned McGill University
expands our focus beyond androgen-based medicines to a metabolic
therapy for CoQ10 deficiencies that have very limited treatment
options,” said Dr. Robert Dudley, Clarus’s Founder, President and
Chief Executive Officer. “Knowing the role McGill’s discovery may
have to address this important, unmet medical need is a terrific
opportunity, and we are excited to get started.”
McGill’s discovery, a combination of CoQ10 plus caspofungin (an
FDA-approved antifungal drug for adults and children), was made by
Dr. Siegfried Hekimi and his colleague, Dr. Ying Wang. Dr. Hekimi
is a Professor of Biology and holds the Robert Archibald &
Catherine Louise Campbell Chair in Developmental Biology. He is an
expert in aging research and a Fellow of the Royal Society of
Canada, which awarded him the Flavelle Medal for his outstanding
contribution to biological science.
“Deficiencies of CoQ10 are a major medical challenge, and I am
delighted that a discovery from my laboratory has been licensed by
Clarus,” said Dr. Hekimi. “We look forward to working with the
excellent team at Clarus to bring forward a treatment that could be
potentially game changing for individuals afflicted with a severe
lack of CoQ10 as well as individuals with other mitochondrial
disease.”
Terms of the AgreementUnder the terms of the
licensing agreement, Clarus will pay McGill a one-time upfront
payment of $350,000 and up to $10.5 million in potential
development and regulatory milestone payments. Additionally, McGill
would be eligible for up to $30 million in potential commercial
milestone payments. The success-based milestones denote important
steps associated with building value for these
programs.
About Mitochondrial DiseasesMitochondrial
diseases are chronic, genetic diseases that occur when the
mitochondria, structures in our body cells that produce energy from
oxygen and food, fail to function properly. Mitochondrial diseases
can affect almost any area of the body and can occur at any age,
making them often misdiagnosed. It is estimated that approximately
one in 5,000 adults worldwide has a mitochondrial disease.
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 Therapeutics’ first commercial product is JATENZO®. For more
information, visit www.clarustherapeutics.com and www.jatenzo.com.
Follow us on Twitter (@Clarus_Thera) and LinkedIn (Clarus
Therapeutics).
About McGill UniversityFounded in Montreal,
Quebec, in 1821, McGill University is Canada’s top ranked medical
doctoral university. McGill is consistently ranked as one of the
top universities, both nationally and internationally. It is a
world-renowned institution of higher learning with research
activities spanning two campuses, 11 faculties, 13 professional
schools, 300 programs of study and over 40,000 students, including
more than 10,200 graduate students. McGill attracts students from
over 150 countries around the world, its 12,800 international
students making up 31% of the student body. Over half of McGill
students claim a first language other than English, including
approximately 19% of our students who say French is their mother
tongue.
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 its or its management team’s expectations,
hopes, beliefs, intentions or strategies regarding the future,
including those relating to the potential benefits and outcomes of
the collaboration with McGill, and the ability to develop products
for conditions associated with CoQ10 deficiencies, whether or not
the success-based milestones will become payable. 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 proxy/prospectus filed with the
Securities and Exchange Commission (the “SEC”) on July 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 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.
Clarus Investor Relations Contact:Kara
Stancellkstancell@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.
© 2021 Clarus Therapeutics, Inc. All rights
reserved.
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