Full Press Release Details
Lipocine Announces US Court of Appeals
for the Federal Circuit Affirms Decision of USPTO
SALT LAKE CITY, UT, April 9, 2020 - Lipocine
Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced today that
the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the Patent Trial and Appeal Board ("PTAB")
of the United States Patent and Trademark Office ("USPTO") under Rule 36. Previously the PTAB granted Lipocine's
Priority Motion in the interference case, Patent Interference No. 106,045, between Clarus Therapeutics, Inc. ("Clarus")
U.S. Patent No. 8,828,428 (the "Clarus 428 Patent") and Lipocine Inc. ("Lipocine"), U.S. Patent
Application No. 14/713,692 (the "Lipocine 692 Application"), and entered adverse judgment against Clarus.
"We are extremely pleased with the Federal Circuits's
affirmation of the judgement of the PTAB canceling all the claims of the Clarus 428 Patent. This decision further validates
the strength of Lipocine's patent portfolio," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine.
Lipocine Inc. is a clinical-stage
biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's
clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone
containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted
its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product of bioidentical testosterone,
recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of pre-cirrhotic NASH.
TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone
product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO
XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the
treatment of NASH cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, with end of
phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation
by the FDA. 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 regarding Lipocine's product candidates. Investors are
cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that
the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical
and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA
approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of
Lipocine's products, the manufacturing and commercialization of Lipocine's products, risk related to on-going litigation 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.
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
Phone: (617) 535-7743