Mr. Ken d'Entremont reports

MEDEXUS ANNOUNCES COMMERCIAL AVAILABILITY OF GRAFAPEX (TREOSULFAN) FOR INJECTION

Medexus Pharmaceuticals Inc.'s Grafapex (treosulfan) for injection is commercially available in the United States.

"We are pleased to report this positive development, which marks a strategically important step forward for our business and, importantly, will now benefit eligible patients across the United States," commented Ken d'Entremont, Medexus's chief executive officer. "Not only will Grafapex make a substantial contribution to alloHSCT in the United States, but it also solidifies Medexus's leadership position in this therapeutic field."

"We have achieved a commercial launch even earlier in calendar year 2025 than previously anticipated, around one month after FDA approval, with orders already received now that product is commercially available," added Richard Labelle, Medexus's chief operating officer. "Given our recent experience in Canada, we are very optimistic about the potential of Grafapex in the U.S. market. We anticipate that Grafapex will have a meaningful impact on Medexus's total revenue and believe that annual product-level revenue in the United States has the potential to exceed $100-million (U.S.) within five years after commercial launch."

"We were encouraged by the level of positive feedback we heard at the 2025 tandem meetings (transplantation and cellular therapy meetings of ASTCT and CIBMTR) earlier this month," concluded Virginie Bernier, PhD, vice-president, hemato-oncology, at Medexus. "We are already aware of requests for Grafapex in connection with urgent patient needs, and we have begun engaging with several key U.S. institutions interested in learning about Grafapex, so we are glad that this product is now FDA approved and available to benefit eligible patients."

Medexus has established a wholesale acquisition cost for Grafapex in the United States of $3,050 (U.S.) per five-gram vial and $610 (U.S.) per one-gram vial. The dosage form for Grafapex is treosulfan as a lyophilized powder in a single-dose vial for injection.

About Grafapex (treosulfan) for injection

Grafapex (treosulfan) for injection, an alkylating agent, is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients one year of age and older with acute myeloid leukemia or myelodysplastic syndrome. Grafapex holds orphan drug designation under the Orphan Drug Act, meaning that the product will benefit from a seven-year period of regulatory exclusivity in the Food and Drug Administration-approved indication.

Efficacy was evaluated in MC-FludT.14/L trial 2 (NCT00822393), a randomized active-controlled trial comparing treosulfan to busulfan with fludarabine as a preparative regimen for allogeneic transplantation. Eligible patients included adults 18 to 70 years old with AML or MDS, Karnofsky performance status greater than or equal to 60 per cent and age 50 years or older, or hematopoietic cell transplantation comorbidity index score greater than two. There were 570 patients randomized to treosulfan (n equals 280) or busulfan (n equals 290).

The major efficacy outcome measure was overall survival, defined as the time from randomization until death from any cause. The hazard ratio for OS (stratified by donor type and risk group) compared with busulfan was 0.67 (95-per-cent CI: 0.51, 0.90) in the randomized population, 0.73 (95-per-cent CI: 0.51, 1.06) in patients with AML and 0.64 (95-per-cent CI: 0.40, 1.02) in patients with MDS.

The most common adverse reactions (greater than or equal to 20 per cent) were musculoskeletal pain, stomatitis, pyrexia, nausea, edema, infection and vomiting. Selected Grade 3 or 4 nonhematological laboratory abnormalities were increased GGT (gamma-glutamyl transferase), increased bilirubin, increased ALT (alanine aminotransferase), increased AST (aspartate aminotransferase),and increased creatinine.

The recommended treosulfan dose is 10 grams per square metre daily on days minus 4, minus 3 and minus 2 in combination with fludarabine 30 milligrams per square metre daily on days minus 6, minus 5, minus 4, minus 3 and minus 2, and allogeneic hematopoietic stem cell infusion on day 0.

For more information about Grafapex, including important safety information, see the full prescribing information, which is available on the Drugs@FDA drug database. For more information about the pivotal phase 3 clinical trial of treosulfan conducted by medac GmbH, including its methods, results and conclusions, and about the publication of the study in the American Journal of Hematology, see Medexus's June 6, 2022, press release, including the section entitled "About the study," available on the investors-news and events section of Medexus's corporate website.

Grafapex (treosulfan) for injection is approved by the FDA for sale and use in the United States only, and is not intended for export outside the United States. Medexus makes no representation that Grafapex (treosulfan) for injection is appropriate for, or authorized for sale to or use by, persons who are not located in the United States.

Medexus holds exclusive commercial rights in the United States under a February, 2021, exclusive licence agreement with medac.

About Medexus Pharmaceuticals Inc.

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology-oncology and allergy, dermatology and rheumatology.

We seek Safe Harbor.