Lipocine Announces FDA Acknowledgement of TLANDO™ (“LPCN 1021”) NDA Resubmission; PDUFA Goal Date, February 8, 2018
August 14 2017 - 8:00AM
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company,
today announced that the U.S. Food & Drug Administration
(“FDA”) has acknowledged receipt of the Company’s New Drug
Application (“NDA”) resubmission for TLANDO, its oral testosterone
product candidate for testosterone replacement therapy (“TRT”) in
adult males for conditions associated with a deficiency of
endogenous testosterone, also known as hypogonadism. The FDA
has deemed the resubmission a complete response to its June 2016
Complete Response Letter (“CRL”) that requested additional
information related to the dosing algorithm for the proposed label.
The FDA has assigned a new Prescription Drug User Fee Act (“PDUFA”)
goal date of February 8, 2018. The TLANDO NDA is based on the
results of the Dosing Validation (“DV”
) study. The
DV study confirmed the efficacy of TLANDO with a fixed dose regimen
without need for dose adjustment. TLANDO was well tolerated
upon 52week exposure with no reports of drug related Serious
Adverse Events (“SAEs”).
“The FDA's acceptance of the TLANDO NDA resubmission brings us
one step closer to providing an innovative oral testosterone
replacement treatment option to patients. We believe TLANDO
addresses a significant unmet medical need for men with
hypogonadism," said Dr. Mahesh Patel, Chairman, President and Chief
Executive Officer of Lipocine.
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
TLANDO, LPCN 1111 and LPCN 1107. TLANDO, a novel oral prodrug
of testosterone containing testosterone undecanoate, is designed to
help restore normal testosterone levels in hypogonadal men.
TLANDO was well tolerated and met the primary efficacy
end-points in Phase 3 testing with twice daily dosing and is
currently under FDA review. LPCN 1111, 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 and is currently in Phase 2 testing. LPCN
1107 is potentially the first oral hydroxyprogesterone caproate
product candidate indicated for the prevention of recurrent preterm
birth and has been granted orphan drug designation by the FDA. An
End of Phase 2 meeting with the FDA has been 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 regarding Lipocine’s product candidates and
related clinical trials and the FDA review process relating to its
product candidates, our belief that we have addressed the CRL
deficiency, the expected timing of the FDA review process related
to our resubmitted NDA, the path to approvability by the FDA of
Lipocine’s development programs, the potential uses and benefits of
our product candidates, and our product development efforts.
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 that the FDA will
determine there are deficiencies in our resubmitted NDA, risks
related to the possibility of an advisory committee meeting related
to TLANDO, 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, 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:
Hans Vitzhum
Phone: (646) 597-6979
hans@lifesciadviors.com
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