Medexus Granted Priority Review Status for Gliolan® by Health Canada
November 19 2019 - 8:30AM
Medexus Pharmaceuticals Inc. (the “Company” or
“Medexus”) (TSXV: MDP, OTCQB: PDDPF) today announced that
Health Canada has granted priority review status for the New Drug
Submission (NDS) for Gliolan® (5-aminolevulinic acid
hydrochloride). Gliolan® is used for guiding maximal surgical
resection of high-grade gliomas (malignant brain tumors) in adults.
Gliolan® assists neurosurgeons to better visualize and more
completely remove gliomas by causing them to become fluorescent and
glow during surgery. Medexus anticipates filing the NDS in 2019 for
approval to market and sell Gliolan® in Canada.
Priority Review status assigns eligible
submissions a shortened review target of 180 days, in comparison to
300 days for non-priority review. Priority review status may be
granted by Health Canada to an NDS intended for the treatment of
serious, life-threatening or severely debilitating diseases or
conditions for which there is no existing drug on the Canadian
market with the same profile or where the new product represents a
significant improvement in the benefit/risk profile over existing
products.
Gliolan® is a diagnostic aid to facilitate
maximal safe resection of high-grade gliomas (WHO grade
III-IV). High-grade gliomas are malignant, rapidly
progressive cancers. Glioblastoma multiforme (WHO grade IV),
the most common glial tumor, accounting for approximately 80% of
patients with primary malignant brain tumors, has a median survival
of 12 to 15 months. There are currently no optical imaging agents
approved in Canada for the purpose of visualization of malignant
tissue during glioma surgery.
Ken d’Entremont, Chief Executive Officer of
Medexus, commented, “Priority review for Gliolan® should
significantly accelerate our path to approval and follows the
recent draft recommendation for public reimbursement by Health
Quality Ontario. Feedback from the medical community has been
extremely positive and we are experiencing strong market uptake
under the Special Access Program, even prior to full registration.
Gliolan® not only improves patient outcomes but is also a
cost-effective solution for high level glioblastoma patients. Once
Gliolan® becomes a fully registered product, we expect it to gain
much broader distribution in Canada, which represents a sizeable,
underserved market opportunity.”
Health Canada previously granted Medexus
authorization to distribute Gliolan® in Canada under the Special
Access Program, which provides healthcare practitioners with access
to non-marketed drugs to treat patients with serious or
life-threatening conditions when conventional therapies have
failed, are unsuitable, or unavailable. The Company has long-term
exclusive rights to market and distribute Gliolan® in
Canada.
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
is focused on the therapeutic areas of auto-immune disease and
pediatrics. The 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; and Rupall™, an innovative allergy medication
with a unique mode of action. For additional information,
please visit the Company’s website: www.medexus.com.
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.: 514-762-2626 ext. 202E-mail:
roland.boivin@medexus.com
Investor Relations
(U.S.):Crescendo Communications, LLCTel:
+1-212-671-1020Email: 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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Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of this release.
READER ADVISORIES
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”,
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Specific forward-looking statements contained in this news release
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including assumptions based on historical trends, current
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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 most recent MD&A; future capital
requirements and dilution; intellectual property protection and
infringement risks; competition (including potential for generic
competition); reliance on key management personnel; the Company’s
ability to implement its business plan; the Company’s ability to
leverage its United States and Canadian infrastructure to promote
additional growth, including with respect to the infrastructure of
Medexus Inc. and Medac Pharma, Inc. and the potential benefits the
Company expects to derive therefrom;, regulatory approval by the
Canadian health authorities; product reimbursement by third party
payers; patent litigation or patent expiry; 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 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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