Medexus Pharmaceuticals and medac GmbH enter into Licensing Agreement for First-in-Class Conditioning Agent, Treosulfan, in C...
12 Juillet 2021 - 3:29PM
Medexus Pharmaceuticals Inc. (the “
Company”
or “
Medexus”) (TSX: MDP) (OTCQX: MEDXF) today
announced that it has entered into a licensing agreement,
formalizing its relationship with medac GmbH
(“
medac”) to commercialize treosulfan, a
bifunctional alkylating agent, in Canada.
Treosulfan will be marketed in Canada under the
brand name Trecondyv® and indicated in combination with fludarabine
as part of a conditioning treatment prior to allogeneic
hematopoietic stem cell transplantation
(“allo-HSCT”). Medexus will be responsible
for selling and marketing the product, while medac will be
responsible for the manufacturing and supply of the product.
Medexus has been distributing treosulfan in
Canada under the Special Access Program and recently received
Health Canada approval to commercialize Trecondyv® for the
treatment of adult patients with Acute Myeloid Leukemia
(“AML”) or Myelodysplastic Syndromes
(“MDS”) who are at increased risk for standard
conditioning therapies, as well as for pediatric patients older
than one year with AML or MDS.
Michael Pine, Senior Vice President of Business
Development and Strategy, commented, “We are pleased to have signed
our third licensing agreement with medac and to expand our strong
collaboration. Our approval in Canada and anticipated commercial
launch in September will provide an important new option for
patients and physicians in Canada, and this licensing deal further
solidifies our partnership with medac and reinforces our commitment
to building out our innovative product portfolio in North America.
Furthermore, the Company continues preparations for the launch of
treosulfan in the US with the Prescription Drug User Fee Act
(“PDUFA”) date approaching on August 11th, and we
expect to be in a position to launch quickly subject to anticipated
approval.”
Magnus Küster, Vice President International
Sales & Regions of medac, emphasized, “This licensing deal with
Medexus represents a further milestone in our long collaboration
history, as it offers us the opportunity of providing patients and
physicians with our very promising new treatment option in the area
of allogeneic hematopoietic stem cell transplantation, now in
Canada. The treosulfan-based conditioning regimen stands out for
its combination of being highly effective - similar to the potency
of myeloablative procedures - while simultaneously exhibiting
significantly reduced toxicity. We at medac are very proud of our
first-in-class conditioning agent as it fully meets our company’s
goals of improving patients’ lives and supporting healthcare
professionals in the best possible way."
About medac GmbH
medac GmbH is a privately held, global
pharmaceutical company with a growing pharmaceutical and
diagnostics business. Since its foundation in Germany in 1970,
medac has been specializing in the treatment of diseases within the
indication areas oncology, hematology, urology and autoimmune
disorders. medac is committed to the refinement of existing and the
development of new therapeutic products – always with the focus on
improving patients’ quality of life. medac has become known for
developing innovative products also in less common indications.
This dedication has resulted in a comprehensive portfolio of
pharmaceutical products that help make a difference in the lives of
patients. medac continually invests in its product development and
manufacturing as well as logistic capacities to meet both patients’
needs and the demands of healthcare professionals.
About Medexus
Medexus is a leader in innovative rare disease
treatment solutions with a strong North American commercial
platform. From a foundation of proven best in class products
we are building a highly differentiated company with a portfolio of
innovative and high value orphan and rare disease products that
will underpin our growth for the next decade. The Company’s vision
is to provide the best healthcare products to healthcare
professionals and patients, through our core values of Quality,
Innovation, Customer Service and Teamwork. Medexus Pharmaceuticals
is focused on the therapeutic areas of auto-immune disease,
hematology, and allergy. The Company’s 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.
For more information, please contact:
Ken d’Entremont, Chief Executive OfficerMedexus Pharmaceuticals
Inc.Tel.:
905-676-0003E-mail: ken.dentremont@medexus.com
Roland Boivin, Chief Financial OfficerMedexus Pharmaceuticals
Inc.Tel.:
514-344-8765E-mail: roland.boivin@medexus.com
Investor Relations (U.S.):Crescendo Communications, LLCTel:
+1-212-671-1020Email: mdp@crescendo-ir.com
Investor Relations (Canada):Tina ByersAdelaide CapitalTel:
905-330-3275E-mail: tina@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” and similar 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 with respect to the
timing of the commercial launch of treosulfan in both Canada and
the U.S. and the Company’s expectations regarding receipt of FDA
approval for treosulfan. 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. The
Company 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 the
Company’s materials filed with the Canadian securities regulatory
authorities from time to time, including the Company’s most recent
annual information form and management’s discussion and analysis.
Given these risks, undue reliance should not be placed on these
forward-looking statements, which apply only as of the date hereof.
Other than as specifically required by law, the Company undertakes
no obligation to update any forward-looking statements to reflect
new information, subsequent or otherwise.
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