Medexus Granted Authorization by Health Canada to Distribute Treosulfan in Canada
March 06 2019 - 6:50AM
Commences shipments to hospitals under the
Special Access Program
Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”)
(TSXV: MDP, OTCQB: PDDPF) today announced that Health
Canada has authorized the Company to distribute Treosulfan, a
conditioning agent used prior to stem cell transplantation.
Authorization was granted via the Special Access Program which
allows healthcare practitioners to access non-marketed drugs to
treat patients with serious or life-threatening conditions when
conventional therapies have failed, are unsuitable, or unavailable.
Medexus plans to file for registration of Treosulfan with Health
Canada in 2019 and expects to receive full registration within 12
to 18 months following the application. Medexus acquired the rights
to Treosulfan through the acquisition of Medac Pharma, Inc., in the
fall of 2018.
Treosulfan is indicated as part of conditioning
treatment prior to allogeneic haematopoietic stem cell
transplantation in adult patients with malignant and non-malignant
diseases, and in pediatric patients older than one month with
malignant diseases
(https://www.ema.europa.eu/en/medicines/human/summaries-opinion/trecondi).
Treosulfan is a significant improvement over current products used
as conditioning agents prior to bone marrow transplantation,
particularly in children, due to the increased rate of event-free
survival after 2 years.
Ken d’Entremont, Chief Executive Officer of
Medexus, commented, “We are thrilled to have been granted
authorization to distribute Treosulfan within Canada, as it
demonstrates our commitment to bringing products to market with
clear market demand that can help patients live better lives.
We have already begun shipments to hospitals across Canada and
expect to expand distribution of Treosulfan once the product has
received approval as a fully registered product.” Mr. d’Entremont
continued, “The launch of Treosulfan is further validation of the
synergies evident from our recent transformative acquisitions, and
illustrates our abilities to leverage the combined product
portfolios and North American sales force.”
While not an approved product in the US, on
December 13, 2018, The European Medicines Agency’s Committee for
Medical Products for Human Use (CHMP) adopted a positive opinion,
recommending the granting of marketing authorization for
Treosulfan, intended as a conditioning treatment prior to
allogeneic haematopoietic stem cell transplantation. In the US
Treosulfan is under clinical development and is being used in
clinical trials on patients who desire to try a new treatment
approach.
About Medexus
Medexus is a leading specialty pharmaceutical
company with a strong North American commercial platform. 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 and pediatrics. The leading products include Rasuvo and
Metoject, unique formulations of methotrexate (auto-pen and
pre-filled syringe) designed to treat rheumatoid arthritis and
other auto-immune diseases; and Rupall, an innovative 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@medexusinc.com
Roland Boivin, Chief Financial OfficerMedexus
Pharmaceuticals Inc.Tel.: 514-762-2626 ext. 202E-mail:
roland.boivin@medexusinc.com
Investor Relations (U.S.):
Crescendo Communications, LLC Tel:
+1-212-671-1020 Email: mdp@crescendo-ir.com
Investor Relations
(Canada):
Frank CandidoDirect Financial Strategies and
Communication Inc.Tel: 514-969-5530E-mail:
frank.candido@medexusinc.com
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