Clarus and Lipocine (NASDAQ: LPCN) agreed to settle all outstanding
claims in the patent infringement lawsuit brought against Clarus by
Lipocine and to further resolve a patent interference between the
parties. The action for patent infringement was brought by Lipocine
against Clarus arising out of Clarus’s marketing of JATENZO®, an
oral testosterone replacement product. The interference action
involves a Clarus patent application that was pending issuance by
the USPTO.
On May 25, 2021, Clarus’s request for summary judgement of
invalidity with respect to all of Lipocine’s asserted patent claims
in the lawsuit was granted. Under terms of the settlement
announced today, Lipocine and Clarus have agreed to dismiss the
Lipocine Inc. v. Clarus Therapeutics, Inc., Civil Action No.
19-cv-622 (WCB) litigation presently pending in the U.S. District
Court for the District of Delaware. Additionally, both parties have
reached an agreement on the interference, captioned Clarus
Therapeutics, Inc. v. Lipocine Inc., Interference No. 106,128 and
presently pending in the USPTO. The terms of the settlement remain
confidential but do not involve any payment by Clarus to
Lipocine.
About Clarus Therapeutics, Inc.
Clarus is a pharmaceutical company with expertise and interest
in developing androgen and metabolic therapies for men and women –
including potential therapies for orphan indications. Clarus’s
first commercial product, JATENZO, was launched in early 2020. For
more information, visit www.clarustherapeutics.com and
www.jatenzo.com
Forward-Looking Statements
Certain statements made in this press release are
"forward-looking statements" within the meaning of the federal
securities laws, including statements about the parties' ability to
close the proposed business combination and related transactions,
the anticipated benefits of the proposed business combination, and
the financial condition, results of operations, earnings outlook
and prospects of Blue Water and/or the proposed business
combination and related transactions and may include statements for
the period following the consummation of the proposed business
combination and related transactions. In addition, any statements
that refer to projections (financial or otherwise), forecasts or
other characterizations of future events or circumstances,
including any underlying assumptions, are forward-looking
statements. Forward-looking statements are typically identified by
words such as "plan," "believe," "expect," "anticipate," "intend,"
"outlook," "estimate," "forecast," "project," "continue," "could,"
"may," "might," "possible," "potential," "predict," "should,"
"would" and other similar words and expressions, but the absence of
these words does not mean that a statement is not
forward-looking.
The forward-looking statements are based on the current
expectations of the management of Blue Water and Clarus
Therapeutics, as applicable, and are inherently subject to
uncertainties and changes in circumstances and their potential
effects and speak only as of the date of such statement. There can
be no assurance that future developments will be those that have
been anticipated. These forward-looking statements involve a number
of risks, uncertainties or other assumptions that may cause actual
results or performance to be materially different from those
expressed or implied by these forward-looking statements including:
risks related to Clarus Therapeutics' ability to increase sales of
JATENZO, secure favorable reimbursement coverage for such sales and
expand its product offerings to include a pipeline of androgen and
metabolic therapies for men and women, including orphan
indications; the ability to complete the proposed business
combination and to obtain approval from Blue Water's stockholders
or satisfy other closing conditions in the definitive merger
agreement; the outcome of any legal proceedings that may be
instituted against Blue Water or Clarus related to the merger
agreement or the proposed transaction; the ability to maintain the
listing of Blue Water's securities on a national securities
exchange; the amount of any redemptions by existing holders of Blue
Water's common stock; the ability to recognize the anticipated
benefits of the business combination; other risks and uncertainties
included under the header "Risk Factors" in the registration
statement on Form S-4 to be filed by Blue Water, in the final
prospectus of Blue Water for its initial public offering dated
December 16, 2020 and in Blue Water's other filings with the
SEC.
Clarus Investor Relations Contact:
Kara StancellClarus Therapeutics, Inc.555 Skokie Blvd., Suite
340Northbrook, IL 60062(847) 562-4300
X206kstancell@clarustherapeutics.com
###
About JATENZO
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. You can
also obtain information regarding JATENZO at
www.jatenzo.com.
© 2021 Clarus Therapeutics, Inc. All rights reserved.
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