SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced that it hired two new senior management team members – Daniel Kirby as vice president and head of commercial and Justin McCue, Ph.D. as vice president of chemistry, manufacturing and controls (CMC). Their respective responsibilities cover all of Omeros’ programs, with the current primary areas of focus for both being the continued expansion of market success for OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% and preparations for the commercialization of OMS721. OMIDRIA is the company’s marketed drug and the only product of its kind for cataract and lens replacement surgery. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the complement system’s lectin pathway. OMS721 is in Phase 3 clinical programs for hematopoietic stem cell-associated thrombotic microangiopathy (HSCT-TMA), for immunoglobulin A (IgA) nephropathy and for atypical hemolytic uremic syndrome. OMS721 has been granted breakthrough therapy designations by FDA for both HSCT-TMA and IgA nephropathy.
“I’m excited to be joining Omeros,” said Daniel Kirby. “The breadth and depth of the company’s assets are truly impressive. With our marketed drug OMIDRIA increasingly funding the pipeline, one of my primary objectives is the rapid and successful commercialization of OMS721. With multiple Phase 3 programs for OMS721 and strong clinical data across all of the drug’s current targeted indications, my team is focused on expanding disease awareness and building market access, making OMS721 readily available for the benefit of patients and their treating physicians.”
“Omeros has strong and experienced leadership together with an impressive and deep pipeline of both small-molecule and protein therapeutic programs that holds multiple opportunities to develop new and effective therapies,” stated Justin McCue. “Using cutting-edge science, development and manufacturing processes, the company is advancing several candidate molecules with novel mechanisms of action, all of which would likely be first-in-class. I look forward to helping Omeros achieve its near-term goals of commercializing OMS721 and successfully developing our diverse pipeline.”
Mr. Kirby assumes the role of vice president and head of commercial at Omeros, having joined the company from Celgene. At Celgene, he was the U.S. commercial lead for its chimeric antigen receptor (CAR) T-cell franchise. Before its acquisition by Celgene, Mr. Kirby built and led the commercial marketing and market access functions in his role as vice president and head of marketing/market access at Juno Therapeutics. Prior to Juno, he was the head of marketing at Medivation where he oversaw all of the marketing efforts for the blockbuster Xtandi®. Mr. Kirby previously spent nearly 15 years in both marketing and sales leadership roles at Amgen, including oversight of all U.S. customer-facing marketing efforts for its multi-billion-dollar granulocyte colony-stimulating factor (G-CSF) franchise NEULASTA® and NEUPOGEN®. Before joining Amgen, he advanced through commercial positions of increasing responsibility at GlaxoSmithKline.
As vice president of CMC, Dr. McCue oversees for Omeros all development, manufacturing, and supply of both biological and small-molecule drugs. Dr. McCue joins Omeros from Celgene where he headed the development of CAR T-cell and T-cell receptor (TCR) therapy manufacturing processes. Prior to Celgene, he led Biogen’s CMC activities for the multi-billion-dollar drugs AVONEX® and PLEGRIDY®, approved for the treatment of multiple sclerosis in more than 90 countries. He began his career in the biopharmaceutical division at Millipore. Dr. McCue earned his Ph.D. and completed a post-doctoral fellowship in chemical engineering at Massachusetts Institute of Technology (M.I.T.) after receiving a degree in chemical engineering at University of California at Berkeley.
“Both Dan and Justin are strong and timely additions to our senior leadership team, and we’re pleased to have them on board,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “Their successful track records in drug development and commercialization speak for themselves. With OMIDRIA sales currently tracking to challenge record quarterly revenues and OMS721 moving toward commercialization, Dan and Justin’s collective experience and expertise are an excellent fit for our marketed, Phase 3 and pipeline programs. Both have hit the ground running and, I look forward to each of them contributing significantly to our success in bringing important new drugs to patients worldwide.”
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system. The company’s drug product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
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,” “future”, “goal,” “intend,” “likely”, “look forward to,” “may,” “on track”, “plan,” “potential,” “predict,” “project,” “prospects,” “should,” “slated,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements 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, risks associated with product commercialization and commercial operations, unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 8, 2018. 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.