Medexus Pharmaceuticals (
Medexus) (TSX: MDP)
(OTCQX: MEDXF) is pleased to announce that its
U.S. subsidiary, Medexus Pharma
(
Medexus US), has acquired the exclusive
right to commercialize Gleolan in the United States from NX
Development Corp. (
NXDC), the U.S. subsidiary
of photonamic GmbH & Co.
(
Photonamic). This transaction extends Medexus’s
strong relationship with Photonamic and complements Medexus’s
existing commercialization rights to Gleolan in Canada, where
Medexus recently launched the product. Using information provided
by NXDC, Medexus estimates that Gleolan generated U.S. net
sales of $3 million to $4 million in the fourth calendar
quarter of 2021. Based on Medexus’s evaluation of Gleolan’s
effectiveness, Medexus is confident in Gleolan’s prospects in both
Canada and the United States, and expects strong sales and
institutional uptake in both markets. Medexus and NXDC plan to work
together closely to ensure a seamless transition for existing
customers.
Under the terms of Medexus’s new license, supply, and
distribution agreement, Medexus will commercialize Gleolan in the
United States and will pay NXDC annual royalty payments (tiered
based on net sales relative to an annual minimum baseline and net
of supply price paid) and periodic low- to mid-single-digit-million
dollar milestone payments (including an upfront payment, two
payments triggered by passage of time, and three payments triggered
by achievement of net sales thresholds). NXDC will supply Gleolan
to Medexus and will remain the sponsor of the new drug application
for Gleolan on file with the U.S. Food and Drug Administration
(FDA). This transaction will allow NXDC, as
sponsor, to continue the company’s important research and
development activities, including pursuit of additional indications
for Gleolan. Medexus US’s exclusive commercialization rights
extend to one additional indication, meningioma, with the
opportunity to negotiate commercialization rights to future
indications. The initial term of the parties’ arrangement will
extend through and including March 31, 2028 with successive
two-year extension terms thereafter.
“We are thrilled to license Gleolan in the United States and
continue to drive our business forward,” said Ken d’Entremont,
Medexus’s chief executive officer. “We believe Gleolan has a bright
future and testing is currently underway for its use for
meningioma, which would be a new indication.” Mr d’Entremont
then continued, “This product fits extremely well into our
portfolio. We are already very familiar with Gleolan given our
successful launch of the product in Canada early last year.
Extending our Gleolan distribution rights into the United States
will allow us to continue developing our U.S. operations. We
expect this product will both grow our U.S. revenues and allow
us to put in place an infrastructure that will also support our
U.S. launch of Treosulfan planned for later this year,
assuming FDA approvals have been obtained.”
(Note: Dollar figures in this press release are expressed in
U.S. dollars unless otherwise indicated.)
About Gleolan
Gleolan (aminolevulinic acid hydrochloride or ALA HCl) is
an FDA-approved optical imaging agent indicated in patients with
glioma (suspected World Health Organization Grades III
or IV on preoperative imaging) as an adjunct for the
visualization of malignant tissue during surgery. The FDA has
granted Gleolan orphan drug designation through June 2024.
Gleolan makes high-grade gliomas (malignant, rapidly progressive
brain tumors) fluoresce under a particular form of fluorescent blue
light. Gleolan is a powder and is administered to patients as an
oral solution. After administration, when the brain is exposed to
blue light during surgery, areas within the tumor glow pink or red
in contrast to healthy brain tissue which appears blue. This
assists neurosurgeons in better visualizing these gliomas to
facilitate more complete removal.
Surgeons using fluorescence-guided surgery with Gleolan
demonstrated significant improvement in extent of resection when
compared to procedures using white light. NXDC estimates that to
date ALA HCl has been used in over 42 countries for over
100,000 patients worldwide.
The American Society of Clinical Oncology estimated that in 2021
approximately 24,500 adults in the United States would be
diagnosed with primary cancerous tumors of the brain and spinal
cord. According to the American Association of Neurological
Surgeons, glioblastoma is the most common malignant central nervous
system tumor, accounting for 47.7% of all diagnosed cases, and has
an incidence of 3.21 per 100,000 population.
About Medexus
Medexus is a leader in innovative rare disease treatment
solutions with a strong North American commercial platform and a
portfolio of proven best-in-class products. Our current focus is on
the therapeutic areas of hematology, auto-immune diseases, and
allergy. We continue to build a highly differentiated company with
a growing portfolio of innovative and high-value orphan and rare
disease products that will underpin our growth for the next
decade.
Our current leading products are Rasuvo™ and Metoject®, a unique
formulation of methotrexate (auto-pen and pre-filled syringe)
designed to treat rheumatoid arthritis and other auto-immune
diseases; IXINITY®, an intravenous recombinant factor IX
therapeutic for use in patients 12 years of age or older with
Hemophilia B (a hereditary bleeding disorder characterized by
a deficiency of clotting factor IX in the blood, which is
necessary to control bleeding); and Rupall®, an innovative
prescription allergy medication with a unique mode of action.
We have also licensed Treosulfan, a preparative regimen for
allogeneic hematopoietic stem cell transplantation to be used in
combination with fludarabine, for commercialization in the United
States and Canada. Treosulfan was approved by Health Canada in June
2021 and is marketed in Canada as Trecondyv®. Treosulfan is
currently under review by the U.S. Food and Drug
Administration.
Our mission is to provide the best healthcare products to
healthcare professionals and patients. We strive to deliver on this
mission by acting on our core values: Quality, Innovation, Customer
Service, and Collaboration.
Contacts
For more information, please contact any of the following:
Medexus
Ken d’Entremont, Chief Executive OfficerMedexus
Pharmaceuticals Inc.Tel: 905-676-0003Email:
ken.dentremont@medexus.com
Marcel Konrad, Chief Financial OfficerMedexus
Pharmaceuticals Inc.Tel: 312-548-3139Email:
marcel.konrad@medexus.com
Investor Relations
Victoria RutherfordAdelaide CapitalTel: 1-480-625-5772Email:
victoria@adcap.ca
Forward-Looking Statements
Certain statements made in this press release contain
forward-looking information within the meaning of applicable
securities laws (forward-looking statements). The
words “anticipates”, “believes”, “expects”, “will”, “plans”,
“potential”, and similar words or expressions are often intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Specific forward-looking statements contained in this news release
include, but are not limited to, statements regarding potential
future annual net sales, potential future indications for Gleolan,
and the timing of Treosulfan launch in the United States and
related FDA approval, among others. These statements are based on
factors or assumptions that were applied in drawing a conclusion or
making a forecast or projection, including assumptions based on
historical trends, current conditions and expected future
developments. Since forward-looking statements relate to future
events and conditions, by their very nature they require making
assumptions and involve inherent risks and uncertainties. Medexus
cautions that although it is believed that the assumptions are
reasonable in the circumstances, these risks and uncertainties give
rise to the possibility that actual results may differ materially
from the expectations set out in the forward-looking statements.
Material risk factors include those set out in Medexus’s materials
filed with the Canadian securities regulatory authorities from time
to time, including Medexus’s most recent annual information form
and management’s discussion and analysis; future capital
requirements and dilution; intellectual property protection and
infringement risks; competition (including potential for generic
competition); reliance on key management personnel; Medexus’s
ability to implement its business plan; Medexus’s ability to
leverage its U.S. and Canadian infrastructure to promote additional
growth; regulatory approval by relevant health authorities,
including the FDA; product reimbursement by third party payers;
litigation or expiry with respect to patents or other intellectual
property rights; litigation risk; stock price volatility;
government regulation; and potential third party claims. Given
these risks, undue reliance should not be placed on these
forward-looking statements, which are made only as of the date
hereof. Other than as specifically required by law, Medexus
undertakes no obligation to update any forward-looking statements
to reflect new information, subsequent or otherwise.
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