Medexus Pharmaceuticals Inc. (the “Company” or
“Medexus”) (TSXV: MDP, OTCQX: MEDXF) today announces that
on September 9, 2020, it received a Notice of Compliance from
Health Canada granting approval for the marketing of
Gleolan® in Canada. Gleolan® is a 5-aminolevulinic acid
hydrochloride (5-ALA) powder for oral solution, and is indicated as
an adjunct for the visualization of malignant tissue during surgery
in patients with Grades III or IV gliomas (suspected on
preoperative imaging) as classified by the World Health
Organization (WHO).
"Every day in Canada it is estimated that 27 new
primary brain tumours will be diagnosed. With limited
treatment options, new advancements that assist neurosurgeons in
successfully removing brain tumours bring hope to patients facing
this often devastating disease,” says Susan Marshall, CEO for Brain
Tumour Foundation of Canada, which supports the 55,000 people in
Canada affected by brain tumours.
Gleolan® is an imaging agent that makes
high-grade gliomas (malignant, rapidly progressive brain tumours)
fluoresce under blue light, assisting neurosurgeons to better
visualize these gliomas for more complete removal. After
administration, areas within the tumour glow pink or red, and
healthy brain tissue appears blue when exposed to a special blue
light during surgery. There are currently no other optical
imaging agents approved in Canada for the purpose of visualization
of malignant tissue during glioma surgery.
A pivotal Phase III study, published in The
Lancet Oncology Medical Journal, has shown that use of
Gleolan® during brain tumour surgery has nearly doubled the
rate of achieving a complete resection of the tumour, which in turn
has resulted in a doubling of the number of patients without
progression of their brain cancer six months after surgery.[1]
The study reported complete resection of malignant brain
tumour tissue in 65% of patients receiving Gleolan® compared
to 36% of patients in the study's control arm (difference between
groups 29% [95% CI 17-40], p<0·0001). Six-month progression-free
survival was achieved in 41% of patients receiving
Gleolan® compared to 21% of patients who were operated on
without the use of the drug (difference between groups 20% [95% CI
9·1–30·7], p=0·0003).[1]
Mr. Ulrich Kosciessa, Chief Executive
Officer of photonamic GmbH & Co. KG, noted, “Gleolan® is
already approved for use in more than 40 countries,
including Germany, United States, United
Kingdom, Japan, South Korea, Australia and New Zealand,
and the approval in Canada marks another milestone in the
global development of the drug.” Mr. Kosciessa continued, “We are
delighted that Medexus has been able to successfully achieve an
approval from Health Canada and that Gleolan® will now be
available for Glioblastoma multiforme patients in Canada. More
than 80,000 patients globally have already benefited from the use
of Gleolan® in brain tumour resection."
Health Canada had previously granted Medexus
authorization to distribute Gleolan® in Canada under the Special
Access Programme, 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. In March 2020, the Quality
business unit at Ontario Health, based on guidance from the Ontario
Health Technology Advisory Committee, recommended publicly funding
Gleolan® for guiding maximal surgical resection of high-grade
gliomas, which was conditional on Health Canada approval of the
technology. The Company is awaiting final funding approval from the
Ontario Ministry of Health.
Ken d’Entremont, Chief Executive Officer of
Medexus, commented, “We are very pleased to have received
regulatory approval from Health Canada allowing Gleolan® to be
commercially available in Canada for use in fluorescence-guided
brain cancer neurosurgery. Thanks to the collaboration and ongoing
support from our partners at photonamic, in obtaining the full
registration of Gleolan®, we are now able to access a much larger
group of adult patients suffering from high-grade
gliomas in Canada. The incidence of glioblastoma is 4 per
100,000 people in Canada and about 1,000 Canadians will be
diagnosed with glioblastoma every year, according to the Brain
Tumor Registry of Canada. The feedback from the medical
community has been extremely positive, and I’d like to
acknowledge the special contribution of Dr. John Sinclair
and his team from The Ottawa Hospital that have
pioneered the use of Gleolan® in Canada. We expect
Gleolan® will be a tremendous asset for clinicians in addressing
their significant medical need for enhanced tumor visualization
during surgery.”
Dr. John Sinclair, Neurosurgeon and Director of
Neurosurgical Oncology at The Ottawa Hospital, commented, “Using
Gleolan® for complicated brain tumor surgery can lead to
substantially improved outcomes for patients, while serving as a
cost-effective tool for surgical resection of glioblastoma
and other high grade tumours. Gleolan® enables neurosurgeons to
find the ill-defined tumor margin, as achieving this in surgery is
often difficult since the brain and tumor tissue appear visually
similar under the typical white light microscope. This is a
game-changer for neurosurgeons who are treating patients facing
life threatening malignant gliomas. Gleolan® helps the surgeon to
remove cancerous cells with improved accuracy and enhanced
visualization of high-grade glioma tissue. This surgery technique
has been practiced in other parts of the world for years and is
standard in Europe. I would like to see fluorescence-guided surgery
become the standard in Canada with Canadian hospitals offering
patients this breakthrough treatment technology.”
About MedexusMedexus 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, 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 allergy medication
with a unique mode of action.
References:1. Stummer W,
Pichlmeier U, Meinel T, et al., Fluorescence-guided surgery with
5-aminovulinec acid for resection of malignant glioma: a randomised
controlled multicentre phase III trial, Lancet Oncol,
2006;7:392-401
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.
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contain forward-looking information within the meaning of
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timing of regulatory applications and approvals and the efficacy
and success of certain drug therapies. These statements are based
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historical trends, current conditions and expected future
developments. Since forward-looking statements relate to future
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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 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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