Medexus Pharmaceuticals Announces Resubmission of Treosulfan NDA

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Extra information assortment and evaluation reconfirms confidence in New Drug Utility for Treosulfan

NDA resubmission date in step with beforehand introduced timeline

FDA determination nonetheless anticipated inside six months of resubmission

TORONTO and CHICAGO, April 22, 2022 (GLOBE NEWSWIRE) —  Medexus Prescription drugs (Medexus) (TSX: MDP) (OTCQX: MEDXF) and medac, a strategic associate of Medexus, are happy to announce that medac has resubmitted its New Drug Utility for Treosulfan (NDA) with the U.S. Meals and Drug Administration (FDA). The NDA requests approval of Treosulfan together with fludarabine as a preparative routine for allogeneic hematopoietic stem cell transplantation (allo-HSCT). The resubmission contains extra medical information and statistical evaluation regarding the previously-completed part 3 medical trial of Treosulfan in addition to an replace of the built-in abstract of security, which the FDA had requested of their July 2021 Full Response Letter to medac.

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“medac’s complete information assortment and evaluation reconfirmed our confidence within the outcomes of the part 3 research, and we’re happy that the FDA can have a chance to evaluate this extra info,” commented Ken d’Entremont, Medexus’s Chief Government Officer. “Inside 30 days of resubmission, the FDA will talk the timeline for his or her evaluate. We and our companions at medac sit up for an FDA determination inside six months from resubmission. An FDA approval would then pave the way in which for a industrial launch of Treosulfan in the USA inside Medexus’s fiscal 12 months 2023.”

Michael Adelman, Medexus’s Basic Supervisor, U.S. Operations, commented additional: “Treosulfan is orphan drug designated and, if authorized, could be the primary in a brand new conditioning remedy class for allo-HSCT Diminished Toxicity Conditioning – offering sufferers and their physicians with a singular mixture of improved survival outcomes in comparison with reduced-intensity regimens and decreased toxicity in comparison with normal myeloablative regimens.”

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Mr. Adelman continued, “Throughout the prolonged registration interval, now we have continued to work diligently with our companions at medac to additional put together for the launch of Treosulfan in the USA. We stand able to execute our complete launch plan upon approval. We’re very looking forward to a positive FDA determination and imagine that, if authorized, Treosulfan will turn into the brand new normal of look after sufferers with acute myeloid leukemia and myelodysplastic syndrome present process allo-HSCT in North America.”

About Medexus

Medexus is a frontrunner in modern uncommon illness remedy options with a powerful North American industrial platform and a portfolio of confirmed best-in-class merchandise. Our present focus is on the therapeutic areas of hematology, auto-immune illnesses, and allergy. We proceed to construct a extremely differentiated firm with a rising portfolio of modern and high-value orphan and uncommon illness merchandise that may underpin our development for the following decade.

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Our present main merchandise are Rasuvo™ and Metoject®, a singular formulation of methotrexate (auto-pen and pre-filled syringe) designed to deal with rheumatoid arthritis and different auto-immune illnesses; IXINITY®, an intravenous recombinant issue IX therapeutic to be used in sufferers 12 years of age or older with Hemophilia B (a hereditary bleeding dysfunction characterised by a deficiency of clotting issue IX within the blood, which is important to manage bleeding); and Rupall®, an modern prescription allergy treatment with a singular mode of motion. We additionally maintain unique US and Canadian rights to commercialize Gleolan (aminolevulinic acid hydrochloride or ALA HCl), an FDA-approved, orphan drug designated optical imaging agent at the moment indicated in sufferers with glioma (suspected World Well being Group Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue throughout surgical procedure.

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We’ve additionally licensed Treosulfan, a preparative routine for allogeneic hematopoietic stem cell transplantation for use together with fludarabine, for commercialization in the USA and Canada. Treosulfan was authorized by Well being Canada in June 2021 and is marketed in Canada as Trecondyv®. Treosulfan is at the moment underneath evaluate by the U.S. Meals and Drug Administration.

Our mission is to supply the most effective healthcare merchandise to healthcare professionals and sufferers. We try to ship on this mission by performing on our core values: High quality, Innovation, Buyer Service, and Collaboration.

Contacts

For extra info, please contact any of the next:

Medexus

Ken d’Entremont, Chief Government Officer
Medexus Prescription drugs Inc.
Tel: 905-676-0003
Electronic mail: ken.dentremont@medexus.com

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Marcel Konrad, Chief Monetary Officer
Medexus Prescription drugs Inc.
Tel: 312-548-3139
Electronic mail: marcel.konrad@medexus.com

Investor Relations

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

Ahead-Wanting Statements

Sure statements made on this press launch comprise forward-looking info throughout the that means of relevant securities legal guidelines (forward-looking statements). The phrases “anticipates”, “believes”, “expects”, “will”, “plans”, “potential”, and comparable phrases or expressions are sometimes supposed to determine forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. Particular forward-looking statements contained on this press launch embrace, however will not be restricted to, statements concerning the timing and anticipated end result of the FDA approval course of for Treosulfan and a associated launch of the product in the USA and expectations concerning the product’s prospects if authorized by the FDA. These statements are based mostly on elements or assumptions that have been utilized in drawing a conclusion or making a forecast or projection, together with assumptions based mostly on historic tendencies, present circumstances and anticipated future developments. Since forward-looking statements relate to future occasions and circumstances, by their very nature they require making assumptions and contain inherent dangers and uncertainties. Medexus cautions that though it’s believed that the assumptions are affordable within the circumstances, these dangers and uncertainties give rise to the likelihood that precise outcomes could differ materially from the expectations set out within the forward-looking statements. Materials threat elements embrace these set out in Medexus’s supplies filed with the Canadian securities regulatory authorities on occasion, together with Medexus’s most up-to-date annual info kind and administration’s dialogue and evaluation; future capital necessities and dilution; mental property safety and infringement dangers; competitors (together with potential for generic competitors); reliance on key administration personnel; Medexus’s skill to implement its marketing strategy; Medexus’s skill to leverage its U.S. and Canadian infrastructure to advertise extra development; regulatory approval by related well being authorities, together with the FDA; product reimbursement by third get together payers; litigation or expiry with respect to patents or different mental property rights; litigation threat; inventory value volatility; authorities regulation; and potential third get together claims. Given these dangers, undue reliance shouldn’t be positioned on these forward-looking statements, that are made solely as of the date hereof. Apart from as particularly required by legislation, Medexus undertakes no obligation to replace any forward-looking statements to replicate new info, subsequent or in any other case.