Medexus Pharmaceuticals Provides Update on Resubmission of Treosulfan NDA

Rhea-AI Summary

Medexus Pharmaceuticals has received acknowledgment from the FDA regarding the NDA resubmission for Treosulfan, which was submitted on April 21, 2022. The FDA has requested additional data and supporting information, and medac, a strategic partner of Medexus, expects to respond within the required 12-month timeline. The review process will begin once the FDA confirms the submission is complete. Medexus is advancing its commercial launch plan for Treosulfan, which has already been approved in Canada.

Positive

• Medexus prepares for the commercial launch of Treosulfan, indicating potential revenue growth.
• Successful NDA resubmission acknowledgement from the FDA suggests progress in gaining U.S. approval.

Negative

• FDA's request for additional information may delay the review process of Treosulfan.
• Uncertainties remain regarding the outcome of the FDA approval process, impacting stock performance.

TORONTO and CHICAGO, May 24, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) has been informed by medac, a strategic partner of Medexus, that medac received acknowledgement of receipt from the U.S. Food and Drug Administration (FDA) of the New Drug Application resubmission for Treosulfan (NDA) submitted on April 21, 2022, together with a request to submit information in order to complete medac’s NDA resubmission and initiate FDA review. The FDA requested certain updates to data files submitted by medac and certain supporting information relating to data provided by medac. medac expects to respond to the FDA’s information requests within the 12-month timeline required by the FDA’s July 2021 Complete Response Letter. The review clock for the NDA resubmission will start after the response is considered complete by the FDA. Medexus continues preparing to implement the company’s commercial launch plan and will provide additional information as it becomes available.

About Medexus

Medexus is a leader in innovative rare disease treatment solutions with a strong North American commercial platform and a portfolio of proven best-in-class products. Our current focus is on the therapeutic areas of hematology, auto-immune diseases, and allergy. We continue to build a highly differentiated company with a growing portfolio of innovative and high-value orphan and rare disease products that will underpin our growth for the next decade.

Our current 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. We also hold exclusive US and Canadian rights to commercialize Gleolan (aminolevulinic acid hydrochloride or ALA HCl), an FDA-approved, orphan drug designated optical imaging agent currently indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.

We have also licensed Treosulfan, a preparative regimen for allogeneic hematopoietic stem cell transplantation to be used in combination with fludarabine, for commercialization in the United States and Canada. Treosulfan was approved by Health Canada in June 2021 and is marketed in Canada as Trecondyv®. Treosulfan is currently under review by the U.S. Food and Drug Administration.

Our mission is to provide the best healthcare products to healthcare professionals and patients. We strive to deliver on this mission by acting on our core values: Quality, Innovation, Customer Service, and Collaboration.

Contacts

For more information, please contact any of the following:

Medexus

Ken d’Entremont, Chief Executive Officer
Medexus Pharmaceuticals Inc.
Tel: 905-676-0003
Email: ken.dentremont@medexus.com 

Marcel Konrad, Chief Financial Officer
Medexus Pharmaceuticals Inc.
Tel: 312-548-3139
Email: marcel.konrad@medexus.com 

Investor Relations

Victoria Rutherford
Adelaide Capital
Tel: 1-480-625-5772
Email: victoria@adcap.ca 

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”, “potential”, and similar words or 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 press release include, but are not limited to, statements regarding the timing and expected outcome of the FDA approval process for Treosulfan, including submission of information to the FDA and the FDA’s acceptance and review of that information. 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. Medexus 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 Medexus’s materials filed with the Canadian securities regulatory authorities from time to time, including Medexus’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; Medexus’s ability to implement its business plan; Medexus’s ability to leverage its U.S. and Canadian infrastructure to promote additional growth; regulatory approval by relevant health authorities, including the FDA; product reimbursement by third party payers; litigation or expiry with respect to patents or other intellectual property rights; 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 are made only as of the date hereof. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

FAQ

What is the status of Medexus Pharmaceuticals' NDA for Treosulfan?

The FDA has acknowledged receipt of the NDA resubmission for Treosulfan and requested additional information.

When was the NDA resubmission for Treosulfan submitted by Medexus?

The NDA resubmission for Treosulfan was submitted on April 21, 2022.

What is the significance of the FDA's acknowledgment for MEDXF?

The FDA's acknowledgment is a positive step toward potential approval for Treosulfan, which could influence MEDXF's stock performance.

How long does Medexus have to respond to the FDA's requests regarding Treosulfan?

Medexus must respond within the 12-month timeline required by the FDA's previous Complete Response Letter.