NORTHBROOK, Ill., May 25, 2021 /PRNewswire/ -- Today, Federal
Circuit Judge William C. Bryson, a
Senior Circuit Judge of the U.S. Court of Appeals for the Federal
Circuit, sitting by designation in the U.S. District Court for the
District of Delaware, granted
Clarus's motion for summary judgment against Lipocine, Inc.
("Lipocine"; NASDAQ: LPCN) for failure to provide adequate written
description of Lipocine's asserted patent claims. In his
decision, which gives Clarus an unequivocal win, Judge Bryson found
all of the asserted Lipocine patent claims invalid. Clarus's
defense of inequitable conduct, to be tried before Judge Bryson,
remains pending, and its disposition is expected to be addressed by
Clarus and the Court at a future date.
The action for patent infringement was brought by Lipocine
against Clarus on April 2, 2019,
arising out of Clarus's marketing of JATENZO, an oral testosterone
replacement product approved by the FDA in March of 2019, and
launched in March of 2020. Lipocine previously dismissed
infringement allegations against Clarus on two other Lipocine
patents.
"Judge Bryson's decision is extremely gratifying and completely
disposes of Lipocine's infringement claims, which Clarus viewed
from Day 1 as being without merit," said Dr. Robert Dudley, Clarus's Chairman, CEO, and
President. "We thank the Court for its carefully reasoned judgment
in favor of Clarus."
"Clarus is focused on dedicating all of our resources to the
evolution of medicines that empower people to live their best every
day," added Dr. Dudley. "With this decision, Clarus continues to
move forward with its marketing of JATENZO and broadening its
pipeline beyond men's health."
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.
Media Contact:
Russo Partners
David Schull
12 West 27th Street, 4th Floor
New York, NY 10001
(858) 717-2310
david.schull@russopartnersllc.com
Clarus Investor Relations Contact:
Ric Peterson
Clarus Therapeutics, Inc.
555 Skokie Blvd., Suite 340
Northbrook, IL 60062
(847) 562-4300
rpeterson@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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SOURCE Clarus Therapeutics