Agreement pairs Norgine's commercial expertise and leading
European footprint with PEDMARQSI™, the first and only
approved therapy in the European Union and U.K. for reducing the
risk of cisplatin-induced hearing loss in pediatric patients with
localized, non-metastatic solid tumors
Fennec will receive €40 million in upfront and up to €210
million in additional commercial and regulatory milestones, and
tiered royalties up to the mid-twenties
Enhances Norgine's commitment to bringing transformative
therapies to patients in Europe,
U.K., Australia, and New Zealand who currently do not have access
to a therapy to treat this life altering condition
RESEARCH
TRIANGLE PARK, N.C. and UXBRIDGE, England, March 18,
2024 /PRNewswire/ -- Fennec Pharmaceuticals Inc.
(NASDAQ: FENC; TSX: FRX), a commercial stage specialty
pharmaceutical company, and Norgine, a leading European specialist
pharmaceutical company, today announced an exclusive licensing
agreement under which Norgine will commercialize PEDMARQSI®
in Europe, Australia and New
Zealand. PEDMARQSI is the first and only approved
therapy in the EU and U.K. for the prevention of ototoxicity
(hearing loss) induced by cisplatin chemotherapy in patients 1
month to < 18 years of age with localized, non-metastatic solid
tumors.
Under the terms of the licensing agreement, Fennec will receive
€40 million in upfront consideration and up to €210
million in additional commercial and regulatory milestone payments
and double-digit tiered royalties on net sales of PEDMARQSI
in the licensed territories up to the mid-twenties. Norgine will be
responsible for all commercialization activities in the licensed
territories and will hold all marketing authorizations in the
licensed territories.
It is estimated that more than 5,000 pediatric patients annually
are eligible for platinum-based chemotherapy in Europe. PEDMARQSI was granted EU
marketing authorization by the European Commission in June 2023, and received UK approval from the MHRA
in October 2023. Approvals were based
on safety and efficacy data from two open-label, randomized Phase 3
trials, SIOPEL 6 (pivotal) and Clinical Oncology Group [COG]
Protocol ACCL0431. The studies compared PEDMARQSI plus
cisplatin-based regimens to cisplatin-based regimens alone for the
reduction of cisplatin-induced hearing loss in pediatric patients.
PEDMARQSI holds eight years plus two years of data and
market protection in Europe based
on its Pediatric Use Marketing Authorization. Approval in
Switzerland, Australia and New
Zealand will also be pursued.
The first study (SIOPEL-6) involved 114 children with
hepatoblastoma (a cancer of the liver), with an average age of
about 19 months. The results showed that 35% (20 out of 57) of
children who received Pedmarqsi 6 hours after each dose of
cisplatin developed hearing loss compared with 67% (35 out of 52)
of children who only received cisplatin. The second study involved
125 children aged 1 month to 18 years with different types of
cancer, including hepatoblastoma, neuroblastoma (a cancer of
immature nerve cells) and tumours of the central nervous system.
The study found that hearing loss was experienced by 29% (14 out of
49) of children who received Pedmarqsi after each cisplatin dose
compared with 56% (31 out of 55) of those who received only
cisplatin.
"We are delighted to partner with Norgine, who shares our belief
in the potential of PEDMARQSI to mitigate the risk of permanent and
irreversible hearing loss that can occur in pediatric patients
treated with cisplatin. Further, this partnership is an important
step in achieving our mission of expanding PEDMARQSI to patients
across the globe who are at risk of suffering from
cisplatin-induced ototoxicity," said Rosty
Raykov, Chief Executive Officer of Fennec Pharmaceuticals.
"From a deal perspective, the terms provided us many important
benefits, including an upfront payment further solidifying our
balance sheet, attractive economic terms providing meaningful
participation in the ex-US success of PEDMARQSI
and an experienced partner
to successfully launch PEDMARQSI in the licensed
territory."
Chris Bath, Chief Executive
Officer of Norgine, said "We are thrilled to announce our
partnership with Fennec, to bring this vital medicine to pediatric
patients who are being treated with cisplatin, across Europe and ANZ. We look forward to working
with the Fennec team and launching PEDMARQSI in our territories in
the coming months, establishing it as the standard of care in this
critical patient population with high unmet need. This important
milestone for our company builds on our 30 year track record of
creating partnerships of enduring value and further underscores
Norgine's position as the specialty pharma partner of choice across
Europe and ANZ."
Moelis & Company LLC acted as financial advisor, and LaBarge
Weinstein LLP acted as legal advisor to Fennec. Arnold & Porter
acted as legal advisor to Norgine.
About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical
company focused on the development and commercialization of
PEDMARK® and PEDMARQSI® to reduce the risk of
platinum-induced ototoxicity in pediatric patients. PEDMARK
received FDA approval in September
2022 and European Commission Marketing Authorization in
June 2023 for PEDMARQSI.
Further, PEDMARQSI received U.K. approval in October 2023. PEDMARK has received Orphan Drug
Exclusivity in the U.S. for seven years of market protection and
PEDMARQSI has received Pediatric Use Marketing Authorization
in Europe which includes eight
years plus two years of data and market protection. For more
information, please visit www.fennecpharma.com.
About Norgine
Norgine is a leading European specialist pharmaceutical company
that has been bringing transformative medicines to patients for
over a century. Commitment to transforming people's lives drives
everything Norgine does with fully integrated infrastructure and
exceptional partnership approach enabling creative solutions to
bring life-changing medicines to patients that they may not
otherwise be able to access. Norgine is proud to have helped more
than 25 million patients annually around the world and generated
over €500 million in net product sales in 2023.
Norgine has a direct presence in 18 European countries, as well
as Australia and New Zealand and has a strong global network of
partnerships in non-Norgine markets. Norgine possesses a flexible
and fully integrated pharmaceutical business, with manufacturing
(Hengoed, Wales and Dreux,
France), third party supply
networks and significant product development capabilities, in
addition to sales and marketing infrastructure.
NORGINE and the sail logo are trademarks of the Norgine group of
companies.
Forward Looking Statements
Except for historical information described in this press
release, all other statements are forward-looking. Words such as
"believe," "anticipate," "plan," "expect," "estimate," "intend,"
"may," "will," or the negative of those terms, and similar
expressions, are intended to identify forward-looking statements.
These forward-looking statements include statements about our
business strategy, timeline and other goals, plans and prospects,
including our commercialization plans respecting PEDMARK® and
PEDMARQSI®, the market opportunity for and market impact of PEDMARK
and PEDMARQSI, its potential impact on patients and anticipated
benefits associated with its use, and potential access to further
funding after the date of this release. Forward-looking statements
are subject to certain risks and uncertainties inherent in the
Company's business that could cause actual results to vary,
including the risks and uncertainties that regulatory and guideline
developments may change, scientific data and/or manufacturing
capabilities may not be sufficient to meet regulatory standards or
receipt of required regulatory clearances or approvals, clinical
results may not be replicated in actual patient settings,
unforeseen global instability, including political instability, or
instability from an outbreak of pandemic or contagious disease,
such as the novel coronavirus (COVID-19), or surrounding the
duration and severity of an outbreak, protection offered by the
Company's patents and patent applications may be challenged,
invalidated or circumvented by its competitors, the available
market for the Company's products will not be as large as expected,
the Company's products will not be able to penetrate one or more
targeted markets, revenues will not be sufficient to fund further
development and clinical studies, our ability to obtain necessary
capital when needed on acceptable terms or at all, the Company may
not meet its future capital requirements in different countries and
municipalities, and other risks detailed from time to time in the
Company's filings with the Securities and Exchange Commission
including its Annual Report on Form 10-K for the year ended
December 31, 2022. Fennec disclaims
any obligation to update these forward-looking statements except as
required by law.
For a more detailed discussion of related risk factors, please
refer to our public filings available at www.sec.gov and
www.sedar.com.
PEDMARK®, PEDMARQSI® and Fennec® are registered trademarks
of Fennec Pharmaceuticals Inc.
Fennec Contacts:
Investors:
Robert Andrade
Chief Financial Officer
Fennec Pharmaceuticals Inc.
+1 919-246-5299
Media:
Lindsay Rocco
Elixir Health Public Relations
+1 862-596-1304
Norgine Contacts:
Matilde Coruche
Chief People Officer
contact@norgine.com
Logo -
https://mma.prnewswire.com/media/597589/Norgine_Logo.jpg
View original
content:https://www.prnewswire.co.uk/news-releases/fennec-pharmaceuticals-and-norgine-enter-into-exclusive-licensing-agreement-to-commercialize-pedmarqsi-in-europe-australia-and-new-zealand-302090953.html