AMSTERDAM & SEATTLE–(BUSINESS WIRE)–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.
Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a significant and often lethal complication of stem cell transplants. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, GvHD, and other factors associated with stem cell transplantation. Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of HSCT-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 25,000 to 30,000 allogeneic transplants are performed annually. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an HSCT-TMA incidence of approximately 40 percent, and high-risk features may be present in up to 80 percent of these patients. In severe cases of HSCT-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae are common. There is no approved therapy or standard of care for HSCT-TMA.
myTomorrows operates as a two-sided platform. It serves the interests of both patients and healthcare providers, as well as drug development. On one side, the company provides information on all treatment options to patients and physicians when registered treatments have been exhausted. Requests may come in to myTomorrows by phone, email, or through an online portal. After which physicians and patients will be directed to a member of our Medical Team for more information regarding treatment options. And on the other side, myTomorrows specializes in expanded access regulations and administration and real-world data collection, evolving scientific clinical development. myTomorrows has gained experience in running over 25 EAPs over the past 5 years, in more than 40 countries across 5 continents. For more information, please visit www.mytomorrows.com.
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse, as well as a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros’ proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.
For specific questions regarding the Omeros’ expanded access program, please contact myTomorrows at [email protected].
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely”, “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “prospects,” “should,” “slated,” “targeting,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements, including statements regarding Omeros’ research and development programs and the therapeutic application of Omeros’ research findings, are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, unproven preclinical and clinical development activities, availability and timing of data from preclinical or clinical studies and the results of such studies, risks associated with product commercialization and commercial operations, regulatory actions and oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2019. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations