myTomorrows and Omeros Corporation Collaborate to Provide an Expanded Access Program for Narsoplimab

myTomorrows, a global health technology company, and Omeros Corporation (Nasdaq: OMER), an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics, today announced a collaboration. The collaboration broadens Omeros’ expanded access program to support availability of Omeros’ novel investigational complement inhibitor narsoplimab in several countries around the world. Narsoplimab is being developed by Omeros as a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and may be provided to eligible patients who have no other treatment options and when prescribed on a Named Patient basis.

“Through our Medical Team, we engage with physicians looking for treatment options for their patients with high unmet needs and who cannot access an existing clinical trial,” said Steve Glass, COO of myTomorrows. “Our collaboration with Omeros is an important step in growing our expanded access programs and providing physicians information on potential treatment options.”

“We are pleased to partner with myTomorrows to broaden our expanded access program,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “We are excited by the results seen with narsoplimab in patients with HSCT-TMA, and this partnership with myTomorrows advances our mission to help patients with this devastating condition by continuing to provide them access to narsoplimab.”

Narsoplimab has been granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) in patients with high-risk HSCT-TMA and has orphan drug designation in both the US and Europe. Omeros has initiated submission of a rolling biologics license application (BLA) to the FDA to be followed by a marketing authorization application for HSCT-TMA in Europe. In preparation for completing its BLA submission, Omeros recently stopped enrollment of its pivotal clinical trial of narsoplimab for the treatment of HSCT-TMA.

About Expanded Access Programs

An Expanded Access Program (sometimes called “compassionate use”) supports in a compliant and controlled way the treatment with a medicine currently not licensed in a patient’s country of residence. Such treatment can be an option for patients who have high unmet medical need and have exhausted all registered treatment options and cannot participate in a clinical trial.