Mr. Ken d'Entremont reports

FDA ACCEPTS FOR REVIEW MEDEXUS'S IXINITY SUPPLEMENTAL BIOLOGICAL LICENSE APPLICATION FOR PEDIATRIC PATIENTS

The U.S. Food and Drug Administration (FDA) recently accepted for review Medexus Pharmaceuticals Inc.'s supplemental biological licence application (sBLA) for Ixinity (coagulation factor IX (recombinant)) for the on-demand, prophylactic and perioperative treatment of pediatric patients under 12 years of age with hemophilia B -- a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood. Ixinity, an intravenous recombinant factor IX therapeutic, is currently approved for use in patients 12 years of age or older with hemophilia B.

"Approximately one-third of patients treated for hemophilia B in the United States are children 13 years of age and under," said Ken d'Entremont, chief executive officer of Medexus. "Risk of bleeding events can severely limit these children's daily activities. The FDA's commitment to review our sBLA brings us a step closer to making Ixinity a viable factor IX treatment option for this important population."

About Ixinity

Ixinity (coagulation factor IX (recombinant)) lyophilized powder for solution for intravenous injection is a coagulation factor IX (recombinant) indicated in adults and children greater than or equal to 12 years of age with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.

The most common adverse reaction observed in greater than 2 per cent of patients in clinical trials was headache. For more information about Ixinity, including important safety information, see the full prescribing information, which is available on the product's website.

Ixinity 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 Ixinity is appropriate for, or authorized for sale to or use by, persons who are not located in the United States.

About hemophilia B

Hemophilia B is a genetic bleeding disorder caused by a deficiency of coagulation factor IX, a protein needed to produce blood clots to stop bleeding. The clinical spectrum may include spontaneous or trauma-induced bleeding into joints, muscles and soft tissues, resulting in joint damage, reduction in mobility and severe arthritis, all of which negatively impact health-related quality of life. The primary aim of care is to prevent and treat bleeding by replacing the deficient clotting factor.

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 oncology, hematology, rheumatology, autoimmune diseases, allergy and dermatology.

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