Medexus Announces Availability of Triamcinolone Hexacetonide in the United States
June 09 2021 - 8:30AM
Medexus Pharmaceuticals Inc. (the “
Company”
or
“Medexus”) (TSXV: MDP) (OTCQX: MEDXF)
(Frankfurt: P731)
announced today that it is
initiating immediate availability of Triamcinolone Hexacetonide
Injectable Suspension, USP (20 mg/ml) (TH) in the United States via
the U.S. Food and Drug Administration’s (FDA) CDER Drug Shortage
program. More information about the FDA’s Drug Shortage program is
available at: FDA Drug Shortages.
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.
To address the ongoing shortage of TH in the
United States, Medexus is coordinating with Ethypharm, its
licensing partner, to generate the data needed to support an
Abbreviated New Drug Application (ANDA) filing in an expedited
timeframe.
About Medexus
Medexus is a leading innovative and rare disease
company with a strong North American commercial platform. From a
foundation of proven best in class products we are building a
highly differentiated company with a portfolio of innovative and
high value orphan and rare disease products that will underpin our
growth for the next decade. 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 prescription
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.: 514-344-8765E-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 CapitalTel:
905-330-3275E-mail: tina@adcap.ca
Forward looking and other cautionary
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 the
immediate availability of TH in the United States and the Company’s
ability to generate the data needed to support an ANDA filing in an
expedited timeframe. 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. 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.
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.
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