Medexus Pharmaceuticals Inc. (the “
Company”
or
“Medexus”) (TSXV: MDP) (OTCQX:
MEDXF)
(Frankfurt: P731) is pleased to
announce it has entered into an exclusive license agreement with
Ethypharm (“
Ethypharm”) to register and
commercialize Triamcinolone Hexacetonide Injectable Suspension 20
mg/mL (“
TH”) in the United States.
TH is indicated for intra-articular,
intrasynovial, or periarticular use in adults and adolescents for
the symptomatic treatment of subacute and chronic inflammatory
joint diseases, including: rheumatoid arthritis, juvenile
idiopathic arthritis (JIA), osteoarthritis and post-traumatic
arthritis, synovitis, tendinitis, bursitis and epicondylitis. It is
the longest-acting corticosteroid for intra articular injection,
often lasting twice as long as competitive products.
The companies have agreed to a small upfront
fee, which will be funded by Medexus with available liquidity,
along with milestone payments at the time of FDA approval, at
commercial product launch, and upon certain sales milestones.
Medexus will also pay a double-digit royalty to Ethypharm on net
sales of TH in the United States. TH has the potential to become
the standard of care by offering a longer duration of action along
with fewer injections (and by extension, fewer hospital visits and
general anesthetics), as well as a safer and more cost-effective
solution than competitive products. The Company expects to file for
FDA approval of TH within 12-24 months.
Ken d’Entremont, Chief Executive Officer of
Medexus, commented, “There has been a long-standing drug shortage
of Triamcinolone Hexacetonide in North America due to previous
manufacturing issues. Through the commercialization of Trispan, our
Canadian product for the same indication, we have witnessed the
urgency of providing patients with a solution firsthand. Our work
with Health Canada prompted the FDA to reach out to us and inquire
about the possibility of Medexus providing a similar solution in
the United States. While we are committed to pursuing FDA approval
for a commercial product launch, in the near term, we are engaged
with the FDA’s CDER Drug Shortage Staff in an effort to facilitate
the import of finished drug product to address the ongoing drug
shortage.”
Ken d’Entremont continued, “This exclusivity
agreement is a major step towards offering a critical solution for
patients suffering from debilitating forms of joint disease in the
United States. The transaction is indicative of our continued
efforts to bring in additional products and grow the Company both
organically and inorganically. We will continue to look for
additional opportunities to bring important specialty treatments to
physicians and patients across North America.”
About the Ethypharm Group
Ethypharm is a European pharmaceutical company
focused on two therapeutic areas: the Central Nervous System and
Critical Care. Ethypharm markets its drugs directly in Europe and
China, and with partners in North America and the Middle East where
its drugs are in high demand. The Group employs more than 1,500
people, mainly in Europe and China.
Ethypharm works closely with authorities and
healthcare professionals to ensure the appropriate use of and
access to its medicines, by as many people as possible.
About Medexus Pharmaceuticals
Inc.
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,
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.
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):Tina ByersAdelaide Capital Tel:
905-330-3275E-mail: tina@adcap.ca
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
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 certain payments to be made by Medexus
in connection with the license, the potential for TH to become the
standard of care, the Company’s intention to seek FDA approval, and
the Company’s plans for future growth. 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; 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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