Medexus Pharmaceuticals Inc. (the “Company” or
“Medexus”) (TSXV: MDP, OTCQB: PDDPF) today announced that
it has entered into a licensing agreement with photonamic GmbH
& Co. KG (“photonamic”) for the exclusive rights to market and
distribute Gliolan® in Canada, which assists neurosurgeons to
better visualize and more completely remove malignant brain tumors
(gliomas) by causing them to become fluorescent and glow during
surgery.
Health Canada previously granted Medexus
authorization to distribute Gliolan in Canada via the Special
Access Program (“SAP”), 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. Under the original
agreement, the Company had limited distribution rights to the
product. Under the expanded license agreement, The Company now has
the long-term exclusive rights to market and distribute Gliolan in
Canada. Medexus plans to file for registration of Gliolan
with Health Canada in 2019 and expects to receive full registration
within 12 to 18 month following application.
Every day, 27 Canadians are diagnosed with a
brain tumor, with the most common type of primary malignant brain
tumor being glioblastoma multiforme. Brain tumors are the leading
cause of solid cancer death in children under the age of 20, now
surpassing acute lymphoblastic leukemia and they are the third
leading cause of solid cancer death in young adults ages
20-391.
Gliolan is given to the patient as a drink two
to four hours before surgery. During surgery, a neurosurgical
microscope fitted with a specialized blue operating light is used,
which causes cancerous tissue to glow fluorescent pink while normal
brain tissue appears blue. This provides better visualization for
the surgeon while performing the surgery, which has shown to
provide a more complete removal of the tumor during surgery with
the use of Gliolan. Phase III studies have demonstrated
complete resection rates and a doubling of 6-month progression-free
survival in patients receiving Gliolan. (reference)
“We are very pleased with the addition of
Gliolan to our expanding product portfolio, as we aim to execute on
our vision of providing the best healthcare products to consumers
and healthcare professionals across North America. The
response from the medical community has been extremely positive, as
evidenced by strong market uptake. This expanded, long-term
exclusive agreement now provides us the opportunity to supply
Gliolan in Canada, which we believe has the potential to improve
patient survival. We expect Gliolan will be a tremendous
asset for clinicians in addressing their significant medical need
for enhanced tumor visualization during surgery,” stated Ken
d’Entremont, Chief Executive Officer of Medexus.
“We are happy to have partnered with Medexus to
make Gliolan available to patients in Canada. Through this
collaboration, photonamic is able to further expand the
accessibility of this product globally,” Ulrich Kosciessa, CEO of
photonamic explained.
The Company also announces that today, it has
re-filed its interim financial statements and interim MD&A for
the period ended December 31, 2018, as the originally filed
financial statements and MD&A, which were filed on February 25,
2019, contained incorrect figures relating to selling and
administrative expenses for the period ended December 31, 2017 as a
result of an administrative error. The correction was made to both
the financial statements and MD&A to reflect the numbers as
previous disclosed accurately in 2017. The correction in the
financial statements only impacted note 9 of the financial
statements and does not impact any of the amounts in the Condensed
Interim Consolidated Statements of Cash Flows, Condensed Interim
Consolidated Statements of Income (Loss) and Comprehensive Income
(Loss), Condensed Interim Consolidated Statements of Changes in
Shareholders' Equity, the Condensed Interim Consolidated Statements
of Financial Position, or any of the other notes to the financial
statements. No other significant changes have been made to
the financial statements or MD&A.
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 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.
About photonamic
photonamic is a German based life science
company engaged in research and development of drugs that use
5-Aminolevulinic Acid (5-ALA). As a member of the SBI group, Tokyo
Japan, photonamic’s parent company, SBI ALApharma, Hong Kong, is
focused on developing and marketing 5-ALA based products globally.
Gliolan®, as an intra-operative diagnostic drug, was launched for
the visualization of brain tumors and approved by the European
Medicines Agency (EMA) in 2007, as well as by the FDA in 2017 under
the name Gliolan. Today, Gliolan is sold in over 40 countries
worldwide.
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, 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
Neither the TSX Venture Exchange nor its
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
This press release contains “forward-looking
information” within the meaning of applicable securities
legislation. Forward-looking information includes, but is not
limited to, statements with respect to future business operation,
the timing of regulatory approvals, the success of certain drug
therapies and results. All statements, other than of historical
fact, that address activities, events or developments that the
Company believes, expects or anticipates will or may occur in the
future are forward-looking statements. Forward-looking statements
are generally identifiable by use of the words “may”, “will”,
“should”, “continue”, “expect”, “anticipate”, “estimate”,
“believe”, “intend”, “plan” or “project” or the negative of these
words or other variations on these words or comparable terminology.
Forward-looking statements are subject to a number of risks and
uncertainties, many of which are beyond the Company's ability to
control or predict, that may cause the actual results of the
Company to differ materially from those discussed in the
forward-looking statements. Factors that could cause actual results
or events to differ materially from current expectations include,
among other things, without limitation, the risk that the Company
will not receive regulatory approvals in a timely manner or at all,
the results of certain drug therapies and their impact on the
Company’s profitability, the Company's business plans, and other
risks disclosed in the Company's public disclosure record on file
with the relevant securities regulatory authorities. Although
Company believes that the expectations and assumptions on which
such forward-looking information is based are reasonable, undue
reliance should not be placed on the forward-looking information
because Company can give no assurance that they will prove to be
correct. Since forward-looking information addresses future events
and conditions, by its very nature they involve inherent risks and
uncertainties. The Company’s actual results, performance or
achievement could differ materially from those expressed in, or
implied by, the forward-looking information and, accordingly, no
assurance can be given that any of the events anticipated by the
forward-looking information will transpire or occur, or if any of
them do so, what benefits that Company will derive therefrom.
Management has included the above summary of assumptions and risks
related to forward-looking information provided in this press
release in order to provide securityholders with a more complete
perspective on the Company's future operations and such information
may not be appropriate for other purposes. Readers should not place
undue reliance on forward-looking statements. Readers are cautioned
that the foregoing lists of factors are not exhaustive. Additional
information on these and other factors that could affect the
Company's operations or financial results are included in reports
on file with applicable securities regulatory authorities and may
be accessed through the SEDAR website (www.sedar.com). The
forward-looking statements included in this news release are made
as of the date of this news release and the Company does not
undertake an obligation to publicly update such forward-looking
statements to reflect new information, subsequent events or
otherwise unless required by applicable securities legislation.
1 Source: Brain Tumor Foundation of Canada
(https://www.braintumour.ca/2494/brain-tumour-facts)
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