SALT LAKE CITY, Oct. 18, 2021 /PRNewswire/ --
Under the terms of Agreement Lipocine to receive:
- Up to $21.0 million in licensing
fees, including $11.0 million payable
immediately and $10.0 million to be
paid in the future subject to certain conditions
- Commercial sales milestone payments of up to $160.0 million
- Tiered royalties on net sales of TLANDO from mid-teens up to
20%
- Antares Pharma to undertake all commercialization,
post-marketing study obligations, and sourcing of TLANDO in the
U.S.
- Lipocine grants Antares Pharma an option to license TLANDO XR
for development and commercialization in the U.S. Upon exercise of
the option, Lipocine to receive:
-
- An additional $4.0 million in
license fees, clinical and regulatory milestone payments of up to
$35.0 million, and tiered royalties
on net sales from mid-teens up to 20%
- Antares Pharma to be responsible for all clinical development
costs, regulatory filings, commercialization, and post-marketing
commitments
- Lipocine retains all rights for ex-U.S. territories, and non
TRT indications for TLANDO and TLANDO XR
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical
company focused on metabolic and endocrine disorders, today
announced it has entered into an exclusive licensing agreement with
Antares Pharma, Inc. to commercialize TLANDO in the United
States. TLANDO is an oral testosterone product for
testosterone replacement therapy ("TRT") in adult males indicated
for conditions associated with a deficiency or absence of
endogenous testosterone: primary hypogonadism (congenital or
acquired) and hypogonadotropic hypogonadism (congenital or
acquired).
As previously announced, the U.S. Food and Drug Administration
("FDA") granted tentative approval to TLANDO. Upon the
expiration of the exclusivity period granted to Clarus
Therapeutics, Inc., with respect to its drug, JATENZO®,
under the Hatch-Waxman Act, which expires on March 27, 2022, TLANDO will be eligible for final
approval. The FDA has affirmed the NDA resubmission for final
approval will be a Class 1 resubmission which includes a two-month
FDA review goal period.
Under the terms of the agreement, Lipocine will receive an
immediate upfront cash payment of $11.0
million and, subject to certain conditions, an additional
$5.0 million licensing payment in
January 2025 and another $5.0 million licensing payment in January
2026. Lipocine will also be entitled to receive sales-based
commercial milestone payments totaling up to $160.0 million based on TLANDO net sales and, if
Antares Pharma exercises its option, TLANDO XR sales, in addition
to tiered royalty payments at rates ranging from the mid-teens to
up to 20% on net sales of TLANDO. Lipocine retains all rights for
ex-US territories, and non TRT indications for TLANDO. Under the
agreement, Antares Pharma will undertake all commercialization,
post-marketing obligations, and sourcing of TLANDO in the U.S.
In addition, Lipocine has granted Antares Pharma an option to
license, on or before March 31, 2022,
TLANDO XR, a next-generation, potential once-daily oral product
candidate for TRT, in the U.S. TLANDO XR met primary and
secondary regulatory end points for TRT in an earlier Phase 2
clinical study. Upon exercise of the TLANDO XR option, Lipocine is
entitled to receive an additional $4.0
million in license fees, clinical and regulatory milestone
payments of up to an aggregate of $35.0
million, and tiered royalties on net sales at rates ranging
from the mid-teens to up to 20%. Antares Pharma will be responsible
for development costs, regulatory filings, commercialization, and
post-marketing commitments for TLANDO XR.
"We are very pleased to be partnering with Antares Pharma, a
strong market leader with one of the largest sales forces in the
TRT space," said Dr. Mahesh Patel,
Chairman, President and Chief Executive Officer of Lipocine. Dr.
Patel further stated, "Our agreement with Antares Pharma
demonstrates our commitment to ensure efficient and effective
patient access to TLANDO in the U.S. We are confident in Antares
Pharma's capabilities, given its established marketing experience
and demonstrated success in the TRT space. Consistent with our
current core competency, this agreement allows us to focus
diligently on progressing our innovative pipeline candidates with
the goal of serving patients with serious unmet needs."
About Lipocine Inc.
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, LPCN
1154, and LPCN 1107. TLANDO, a novel oral prodrug of testosterone
containing testosterone undecanoate, has received tentative
approval from the FDA for conditions associated with a deficiency
of endogenous testosterone, also known as hypogonadism, in adult
males. LPCN 1144, an oral prodrug of bioidentical
testosterone, recently completed a Phase 2 clinical study
demonstrating the potential utility in the treatment of
non-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 cirrhosis.
LPCN 1154 is an oral neuro-steroid targeted for the treatment of
post-partum depression. 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. For more information,
please visit www.lipocine.com.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company
focused primarily on the development and commercialization of
self-administered injectable pharmaceutical products using advanced
drug delivery auto injector technology. The Company has a portfolio
of proprietary and partnered commercial products with several
product candidates in various stages of development, as well as
significant strategic alliances with industry leading
pharmaceutical companies including Teva Pharmaceutical Industries,
Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and
Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma's
FDA-approved products include XYOSTED® (testosterone enanthate)
injection, OTREXUP® (methotrexate) injection for subcutaneous use
and Sumatriptan Injection USP, which is distributed by Teva. The
Company also markets NOCDURNA® (desmopressin acetate) in the U.S.,
which was licensed from Ferring Pharmaceuticals.
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 the receipt of final FDA
approval of TLANDO, the timing and amount of sales and development
milestone payments and royalties under the License Agreement, the
exercise of Antares' option with respect to TLANDO XR, the costs
and timing of any post-marketing studies of TLANDO and clinical
studies relating to TLANDO XR, our ability to compete in the TRT
market, the degree to which TLANDO will gain market share in the
TRT market, if at all, Antares Pharma's ability to successfully
commercialize TLANDO, the benefits to Lipocine and Antares Pharma
under the License Agreement, the potential benefits of TLANDO to
patients, Lipocine's product candidates and related clinical
trials, 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 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.
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SOURCE Lipocine Inc.