TORONTO and CHICAGO and WEDEL, Germany, August 03, 2021 (GLOBE NEWSWIRE) – Medexus Pharmaceuticals Inc. (âMedexus“or the”Company(TSX: MDP) (OTCQX: MEDXF) and medac GmbH (“medac”) today announced that medac, Medexus’ licensor for treosulfan, has received a Complete Response Letter (CRL) from the Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for treosulfan.
As previously reported, the NDA was submitted for the use of treosulfan in combination with fludarabine as a preparatory regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT), and Medexus and medac were optimistic about a positive decision from FDA re a scheduled date under the Prescription Drug User Fee Act (“PDUFA”) of August 11e would allow a commercial launch of treosulfan in the United States later this year.
However, as stated in the CRL, the FDA determined that it could not approve the NDA in its current form and provided specific recommendations for additional clinical / statistical data and analyzes relating to the primary and secondary endpoints of the pivotal phase III study completed. Medexus and medac review the letter to determine the appropriate course of action. Medexus and medac will work closely with the FDA to understand and respond to their comments.
Ken d’Entremont, CEO, commented: âGiven the recent Health Canada approval, European Medicines Agency approval in 2019, as well as supporting data from over 100 publications, we we were all surprised by the response from the FDA. That being said, Medexus and medac look forward to continuing to work with the FDA to respond to their requests in a timely manner, and we remain optimistic about future approval, albeit delayed, of treosulfan in the United States, with the designation of orphan drug. The current standard of care is inappropriate for many at-risk groups, due to the high toxic effects, and treosulfan has demonstrated excellent survival data among these groups. We hope that our future communications with the FDA will be successful, and we look forward to providing further updates in due course. “
Michael Adelman, Managing Director of US Operations, said: âWe worked diligently with medac to prepare for the approval of treosulfan and its launch shortly thereafter. We are disappointed with the immediate result, but we are heartened by the incredible support from key opinion leaders and the medical community for the use of treosulfan in the United States. With the extensive launch preparations we have undertaken to date, we are well positioned to meet the expected high demand for treosulfan. As we work to meet all FDA requests, we are ready to execute our full launch plan for treosulfan upon approval.
About medac GmbH
medac GmbH is a privately held global pharmaceutical company with a growing pharmaceutical and diagnostic business. Since it was founded in Germany in 1970, medac has specialized in the treatment of diseases in the areas of indication oncology, hematology, urology and autoimmune diseases. medac is committed to perfecting existing therapeutic products and developing new therapeutic products, with a constant focus on improving the quality of life of patients. medac has become known for developing innovative products also in less common indications. This commitment has resulted in a comprehensive portfolio of pharmaceutical products that are helping to make a difference in the lives of patients. medac continually invests in the development and manufacture of its products as well as in its logistics capabilities to meet both the needs of patients and the demands of healthcare professionals.
Medexus is a leader in innovative rare disease treatment solutions with a strong North American business platform. From a proven, best-in-class product base, we are building a highly differentiated business with a portfolio of innovative and high-value products for orphans and rare diseases that will support our growth over the next decade. The company’s vision is to provide the best healthcare products to healthcare professionals and patients, through our core values ââof quality, innovation, customer service and teamwork. Medexus Pharmaceuticals focuses on the therapeutic areas of hematology, autoimmune diseases and allergies. The company’s flagship products are: Rasuvo â¢ and MetojectÂ®, a unique formulation of methotrexate (automatic pen and pre-filled syringe) designed to treat rheumatoid arthritis and other autoimmune diseases; IXINITYÂ®, a therapeutic intravenous recombinant factor IX for use in patients 12 years of age or older with hemophilia B – an inherited bleeding disorder characterized by a lack of coagulation factor IX in the blood, which is needed to control bleeding ; and RupallÂ®, an innovative prescription allergy medicine with a unique mode of action. The Company has also approved treosulfan, an allogeneic hematopoietic stem cell transplant preparation regimen for use in combination with fludarabine, from medac GmbH for Canada and the United States.
For more information please contact:
Ken d’Entremont, Chief Executive Officer
MÃ©dexus Pharma inc.
Phone. : 905-676-0003
Marcel Konrad, Chief Financial Officer
MÃ©dexus Pharma inc.
Phone. : 312-548-3139
Investor Relations (United States):
Crescendo Communications, LLC
Phone. : + 1-212-671-1020
Investor Relations (Canada):
Capital of Adelaide
Phone. : 905-330-3275
Forward-looking statements and other caveats
Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws (âforward-looking statements“). The words “anticipates”, “believes”, “expects”, “will”, “will” and similar expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these words. identification. The specific forward-looking statements contained in this press release include, but are not limited to, statements regarding the next steps in the process of applying for FDA approval of treosulfan in the United States and plans for commercial launch thereafter. These statements are based on factors or assumptions that have been applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions and expected future developments.
Because forward-looking statements relate to future events and conditions, by their very nature they require the making of assumptions and involve inherent risks and uncertainties. The Company cautions that while the assumptions are believed to be reasonable under the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set forth in the forward-looking statements. Significant risk factors include those set forth in documents of the Company filed with Canadian securities regulatory authorities from time to time, including the most recent annual information form of the Company and the MD&A. In view of these risks, one should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as specifically required by law, the Company assumes no obligation to update forward-looking statements to reflect new information, subsequent or otherwise.