Medexus Announces Availability of Triamcinolone Hexacetonide in the United States
Medexus Pharmaceuticals (MEDXF) has announced the immediate availability of Triamcinolone Hexacetonide (TH) Injectable Suspension in the U.S. through the FDA’s Drug Shortage program. This drug is indicated for treating various inflammatory joint diseases. Medexus is collaborating with Ethypharm to expedite the data necessary for filing an Abbreviated New Drug Application (ANDA). The company aims to establish a solid portfolio in rare diseases, focusing on innovative healthcare products and expanding its commercial presence across North America.
- Immediate availability of Triamcinolone Hexacetonide (TH) in the U.S. addresses ongoing drug shortages.
- Collaboration with Ethypharm aims to expedite ANDA filing, potentially increasing product availability.
- Focus on rare diseases aligns with industry trends, enhancing growth prospects.
- Dependence on timely ANDA filing could pose risks if data generation faces delays.
- Potential for market competition upon entry of alternative suppliers following drug shortage resolution.
TORONTO and CHICAGO and MONTREAL, June 09, 2021 (GLOBE NEWSWIRE) -- 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 Officer
Medexus Pharmaceuticals Inc.
Tel.: 905-676-0003
E-mail: ken.dentremont@medexus.com
Roland Boivin, Chief Financial Officer
Medexus Pharmaceuticals Inc.
Tel.: 514-344-8765
E-mail: roland.boivin@medexus.com
Investor Relations (U.S.):
Crescendo Communications, LLC
Tel: +1-212-671-1020
Email: mdp@crescendo-ir.com
Investor Relations (Canada):
Tina Byers
Adelaide Capital
Tel: 905-330-3275
E-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.
FAQ
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