Mithra and Searchlight Pharma sign DONESTA® licensing agreement for
Canada
Mithra and Searchlight Pharma sign
DONESTA® licensing agreement for
Canada
-
Mithra to receive EUR 1.5 million milestone payout as a result of
the signing of the agreement
-
Additional licensing payout of EUR 15.55 million in regulatory and
sales milestones, along with tiered royalties on annual net
sales
-
Searchlight anticipates filing of Canadian regulatory submission
for DONESTA® as a treatment for the symptoms of menopause in H1
2024
-
Both companies aim to provide innovative solutions to women by
partnering on MYRING®, ESTELLE®, and now DONESTA®.
Liege, Belgium, and Montreal,
Canada, 26 October 2023 – 07:00
CEST – Mithra (Euronext Brussels: MITRA), a company
dedicated to Women’s Health, and Searchlight Pharma Inc.
(“Searchlight”), a private Canadian-specialty pharmaceutical
company, have signed a License and Supply Agreement for the
Canadian rights to DONESTA®, Mithra’s
investigational, next generation medicine, containing Estetrol, for
the treatment of the symptoms of menopause. The signing of the
agreement activates a first milestone payout to Mithra of EUR 1.5
million.
The two companies signed a binding term sheet
for a licensing agreement in July 2023. Under the terms of the
agreement, Searchlight will have the exclusive sales and marketing
rights for DONESTA® in Canada. Mithra is expected
to receive an additional EUR 15.55 million in regulatory and
sales-related milestone payments, plus tiered double-digit
royalties on total Canadian annual net sales. Searchlight will be
responsible for obtaining and maintaining any regulatory approvals
required to market and sell DONESTA® in
Canada.
David Horn Solomon-- Chief Executive Officer of
Mithra said, “The finalization of the DONESTA®
licensing agreement for Canada is another important milestone as we
continue to deliver on Mithra’s strategy and unlock the value in
our business. We are delighted to strengthen our partnership with
Searchlight, which is well-positioned to launch the product and
provide patients in Canada access to this
differentiated-therapeutic candidate. We also continue to have
active discussions with multiple parties, as we consider
DONESTA® marketing partners for the U.S., China,
and other key markets.”
Searchlight has repeatedly ranked among the
top-growth companies in Canada, with one of the largest portfolios
of women’s health products and associated sales team in the
Canadian market. Mithra and Searchlight have a continuing
partnership for NEXTSTELLIS® the first Estetrol
(E4) based combined oral contraceptive product
(ESTELLE® project), and HALOETTE®
vaginal contraceptive ring in Canada (MYRING®
project). NEXTSTELLIS® was launched in Canada in
Q3 2021, while HALOETTE® was launched in Q1
2022.
“We are pleased to continue our relationship
with Mithra through the signing of the license agreement for
DONESTA®,” said Mark Nawacki, Searchlight’s
President and Chief Executive Officer. “This is the third licensing
arrangement we have completed with Mithra. Their ongoing confidence
in Searchlight confirms that we provide the optimal commercial
platform for our partners to ensure that each product gets the
support it needs to succeed. An unwavering commitment to improve
women’s health in Canada has been at the core of Searchlight’s
mission since its inception. Particularly now, when the attention
and focus on the unmet need around the menopause and its impacts on
quality of life is being so openly highlighted and discussed in our
society, we are proud to be in a position to deliver
DONESTA®, a new and truly innovative option, to
help Canadian women address their unmet needs in managing the
symptoms of menopause.”
In 2022, Mithra announced topline efficacy
results of the DONESTA® Phase 3 clinical program,
which demonstrated a meaningful reduction in the frequency and
severity of vasomotor symptoms from baseline and compared to
placebo, with all co-primary efficacy endpoints met with
statistical significance.
In March 2023, Mithra also announced promising
topline safety results from the DONESTA® Phase 3
trial in North America (C302). The results will support marketing
authorization filings scheduled in the U.S. in H2 2023 and in
Canada in 2024. Primary safety data are anticipated for Europe in
H1 2024.
For more information, please
contact:
Mithra Pharmaceuticals SAAlex Sokolowski, PhDHead
of Investor Relationsinvestorrelations@mithra.com+32 (0)4 349 28
22Searchlight Pharma Inc.Mark NawackiPresident
& CEOinfo@searchlightpharma.com |
Frédérique DepraetereCommunications Directorinfo@mithra.com +32
(0)4 349 28 22
|
About Mithra
Mithra Pharmaceuticals SA (Euronext: MITRA) is a
Belgian biopharmaceutical company dedicated to transforming Women’s
Health by offering new choices through innovation, with a
particular focus on contraception and menopause. Mithra’s goal is
to develop products offering better efficacy, safety and
convenience, meeting women’s needs throughout their life span.
Mithra explores the potential of the unique native estrogen
estetrol in a wide range of applications in women health and
beyond. After having successfully launched the first estetrol-based
product in 2021, the contraceptive pill ESTELLE®, Mithra is now
focusing on its second product DONESTA®, the next-generation
hormone therapy. Mithra also offers partners a complete spectrum of
solutions from early drug development, clinical batches and
commercial manufacturing of complex polymeric products (vaginal
ring, implants) and complex liquid injectables and biologicals
(vials, pre-filled syringes or cartridges) at its technological
platform Mithra CDMO. Active in more than 100 countries around the
world, is headquartered in Liège, Belgium. www.mithra.com
ESTELLE®, DONESTA®, MYRING®, HALOETTE®, and
NEXTSTELLIS® are registered trademarks of Mithra Pharmaceuticals or
one of its affiliates.
About Searchlight Pharma
Inc.
Searchlight Pharma Inc., headquartered in
Montreal, is a leading Canadian-based specialty healthcare company
that executes best-in-class search, acquisition, commercialization,
and focused development of innovative and unique specialty
healthcare products. Following its acquisition of Miravo Healthcare
in March 2023, Searchlight’s core promoted products now focus on
women’s health, dermatology, allergy, pain management and hospital
specialty markets, and its team is committed to improving people’s
lives by bringing the right products to market. Follow Searchlight,
learn more about what it does, and get to know its product
portfolio at www.searchlightpharma.com.
Important informationThe
contents of this announcement include statements that are, or may
be deemed to be, "forward-looking statements". These
forward-looking statements can be identified by the use of
forward-looking terminology, including the words "believes",
"estimates," "anticipates", "expects", "intends", "may", "will",
"plans", "continue", "ongoing", "potential", "predict", "project",
"target", "seek" or "should", and include statements the Company
makes concerning the intended results of its strategy. By their
nature, forward-looking statements involve risks and uncertainties,
and readers are cautioned that any such forward-looking statements
are not guarantees of future performance. The Company's actual
results may differ materially from those predicted by the
forward-looking statements. The Company undertakes no obligation to
publicly update or revise forward-looking statements, except as may
be required by law.
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- 2023-10-26_Mithra_Press release_Searchlight-Donesta_FR
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