Antares Pharma, Inc. (NASDAQ: ATRS) (the “Company”), a specialty
pharmaceutical company, today announced that it entered into an
exclusive license agreement with Lipocine Inc. (“Lipocine”), a
clinical-stage biopharmaceutical company, for TLANDO® (testosterone
undecanoate), an oral treatment for testosterone replacement
therapy (“TRT”) in the United States (“U.S.”).
TLANDO® was granted tentative approval from the
U.S. Food and Drug Administration (“FDA”) as a twice-daily oral
formulation of testosterone for testosterone replacement therapy
indicated for conditions associated with a deficiency or absence of
endogenous testosterone, or hypogonadism in adult males. In
granting tentative approval, the FDA concluded that TLANDO® met all
required efficacy, quality and safety standards necessary for
approval and will be eligible for final approval and marketing in
the U.S. upon expiration of the exclusivity period previously
granted to Clarus Therapeutics, Inc. for JATENZO® on March 27,
2022.
Robert F. Apple, President and Chief Executive
Officer of Antares Pharma, commented, “Testosterone replacement
therapy is a large and growing market, and we believe the expansion
of our proprietary portfolio with TLANDO enhances our growth
opportunities. Upon expiration of the JATENZO exclusivity period
and anticipated final FDA approval, we are excited to be able to
complement our current offering of XYOSTED with an oral formulation
of testosterone to physicians and patients. Leveraging strong
physician relationships, our commercial organization will continue
to expand to help build upon the success we have already achieved
with XYOSTED. Overall, TLANDO broadens our offerings in the TRT
market to those patients seeking an oral dosage option and we look
forward to the opportunity to accelerate our market share gains and
revenue growth in the testosterone market.”
“We believe physicians and patients prefer more
than one therapy option and the addition of TLANDO highlights our
commitment to the testosterone market. We expect to expand our
commercial field organization and leverage our existing
relationships with urologists, endocrinologists and primary care
physicians in tandem with a strong clinical acumen of the
testosterone market to support the anticipated U.S. launch of
TLANDO. We believe our future growth will be supported by a larger
commercial portfolio including TLANDO, XYOSTED and NOCDURNA,” added
Joseph Renda, Senior Vice President, Commercial of Antares
Pharma.
Under the terms of the agreement, Lipocine
received an upfront payment of $11.0 million and is eligible for
additional milestone payments up to $10.0 million and tiered
royalty and commercial milestones based on net sales of TLANDO® in
the U.S.
The agreement also grants Antares the option to
license and develop LPCN 1111 (TLANDO XR), an investigational
product containing testosterone tridecanoate. Upon exercise of the
option, Antares shall pay an additional $4.0 million in license
fees in two installments. Antares shall also be responsible for
additional development and commercial milestone payments as well as
tiered royalties on net sales of TLANDO XR in the U.S.
TLANDO XR is a potential once daily oral
testosterone product in development for the treatment of
hypogonadism in adult males. Results of the Phase 2b study for
TLANDO XR met its primary endpoints, including identifying the dose
expected to be tested in a Phase 3 study. TLANDO XR was well
tolerated with no drug-related severe or serious adverse events
reported and the target Phase 3 dose also met its primary and
secondary endpoints in the Phase 2b study. TLANDO XR is an
investigational drug and has not been approved by the FDA.
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.
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.
SAFE HARBOR STATEMENT UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are subject to certain risks and
uncertainties that can cause actual results to differ materially
from those described. Factors that may cause such differences
include, but are not limited to: uncertainties regarding future FDA
approval of TLANDO®, market
acceptance and future revenue from the same, whether Antares will
exercise the option for TLANDO XR
and if exercised, future timing and success of the clinical
development program for TLANDO XR
and future FDA approval, market acceptance and revenue from
the same; the Company’s ability to achieve the 2021 full-year
revenue guidance; the uncertainty regarding the ongoing COVID-19
pandemic, including new strains of the virus, and the mitigation
measures and other restrictions implemented in response to the same
and the impact on demand for our products, new patients and
prescriptions, future revenue, product supply, clinical trials, and
our overall business, operating results and financial
condition; commercial success of
XYOSTED® and future
revenue from the same; market acceptance of Teva’s
generic epinephrine auto-injector product and future revenue from
the same; future prescriptions and sales of
OTREXUP®; successful
commercialization of NOCDURNA® in
the U.S. and market acceptance and future revenue from the
same; whether the FDA will withdraw marketing
approval for AMAG Pharmaceuticals’
Makena® subcutaneous auto
injector following the FDA letter seeking withdrawal, the outcome
of the FDA hearing and whether Makena®
will be successful and future
prescriptions, market acceptance and revenue from the same; Teva’s
ability to successfully commercialize
VIBEX® Sumatriptan Injection USP
and the amount of revenue from the same; Teva’s ability to
successfully commercialize generic teriparatide in Europe, Canada
and Israel and future revenue from the same, successful development
including the timing and results of the Phase 3 trial of the drug
device combination product for selatogrel with Idorsia
Pharmaceuticals and FDA and global regulatory approvals and future
revenue from the same; the timing and results of the clinical
development program for ATRS-1902 adrenal crisis rescue
auto-injector, future NDA submission and FDA approval of the same,
and if approved, future market acceptance and revenue for the same;
FDA approval of Teva’s ANDAs for both generic
Forteo® and
Byetta® and future revenue from
the same; the timing and results of the Company’s or its partners’
research projects or clinical trials of product candidates in
development including the Company’s urology
assets in development as well as Pfizer’s
undisclosed development product; actions by the FDA or other
regulatory agencies with respect to the Company’s products or
product candidates of its partners; continued growth in product,
development, licensing and royalty revenue; the Company’s ability
to repay the debt obligation to Hercules Capital; the Company’s
ability to obtain financial and other resources for its research,
development, clinical, and commercial activities and other
statements regarding matters that are not historical facts, and
involve predictions. These statements involve known and unknown
risks, uncertainties and other factors that may cause actual
results, performance, achievements or prospects to be materially
different from any future results, performance, achievements or
prospects expressed in or implied by such forward-looking
statements. In some cases you can identify forward-looking
statements by terminology such as ''may'', ''will'', ''should'',
''would'', ''expect'', ''intend'', ''plan'', ''anticipate'',
''believe'', ''estimate'', ''predict'', ''potential'', ''seem'',
''seek'', ''future'', ''continue'', or ''appear'' or the negative
of these terms or similar expressions, although not all
forward-looking statements contain these identifying words.
Additional information concerning these and other factors that may
cause actual results to differ materially from those anticipated in
the forward-looking statements is contained in the "Risk Factors"
section of the Company's Annual Report on Form 10-K, and in the
Company's other periodic reports and filings with the Securities
and Exchange Commission. The Company cautions investors not to
place undue reliance on the forward-looking statements contained in
this press release. All forward-looking statements are based on
information currently available to the Company on the date hereof,
and the Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after
the date of this press release, except as required by
law.
Contact:Tram BuiVice President,
Corporate Communications and Investor
Relations609-359-3016tbui@antarespharma.com
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