Lipocine Wins Dismissal of Patent Infringement Lawsuit Related to LPCN 1021
October 07 2016 - 2:32PM
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company,
today announced that U.S. District Court in Delaware granted our
motion to dismiss a lawsuit filed by Clarus Therapeutics, Inc.
(“Clarus”). Clarus claimed that LPCN 1021 infringed Clarus’
patent (U.S. Patent No. 8,828,428). LPCN 1021 is Lipocine’s
oral testosterone product candidate for testosterone replacement
therapy ("TRT") in adult males for conditions associated with a
deficiency or absence of endogenous testosterone, also known as
hypogonadism.
“We are pleased that the court has dismissed this lawsuit.
Going forward, we will continue to aggressively defend our
intellectual property," said Dr. Mahesh Patel, President and CEO of
Lipocine Inc. "We believe that LPCN 1021 has the potential to
improve the ease of use compared to the available formulations,
including topical gels and injections, and to overcome inadvertent
testosterone transference risk to children and partners that exist
with topical gels."
About Lipocine
Lipocine Inc. is a specialty pharmaceutical company developing
innovative pharmaceutical products for use in men's and women's
health using its proprietary drug delivery technologies. Lipocine’s
clinical development pipeline includes three development programs
LPCN 1021, LPCN 1111 and LPCN 1107. LPCN 1021, a twice-daily oral
testosterone replacement therapy product candidate, was well
tolerated and met primary efficacy end point in Phase 3 testing
which utilized 24-hour pharmacokinetic data for dose adjustments.
LPCN 1111, a novel prodrug of testosterone, originated with
and is being developed by Lipocine as a next-generation oral
testosterone product with potential for once-daily dosing and is
currently in Phase 2 testing. LPCN 1107, the potentially
first oral hydroxyprogesterone caproate product candidate indicated
for the prevention of recurrent preterm birth, has been granted
orphan drug designation by the FDA. An End of Phase 2 meeting with
the FDA was recently completed. For more information, please visit
www.lipocine.com.
Forward-Looking Statements
This release contains “forward looking statements” that are made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995 and include statements that are not
historical facts relating to our intention to defend our
intellectual property, the potential uses and benefits of LPCN 1021
and the potential uses and benefits of our other product
candidates. Investors are cautioned that all such forward-looking
statements involve risks and uncertainties, including, without
limitation, our available resources, the risks related to our
products, expected product benefits, clinical and regulatory
expectations and plans, regulatory developments and
requirements, the receipt of regulatory approvals, the
results of clinical trials, patient acceptance of Lipocine’s
products, the manufacturing and commercialization of Lipocine’s
products, and other risks detailed in Lipocine’s filings with the
SEC, including, without limitation, its Form 10-K and other reports
on Forms 8-K and 10-Q, all of which can be obtained on the SEC
website at www.sec.gov. Lipocine assumes no obligation to update or
revise publicly any forward-looking statements contained in this
release, except as required by law.
CONTACT:
Morgan Brown
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
mb@lipocine.com
Investors:
John Woolford
Phone: (443) 213-0500
john.woolford@westwicke.com
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