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Opexa Amends Agreement with Merck Serono and Receives Additional $3 Million Payment to Support Ongoing Development of Tcelna® for Multiple Sclerosis
03/09/2015
THE WOODLANDS, Texas--(BUSINESS WIRE)-- Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing personalized immunotherapies for autoimmune disorders, including multiple sclerosis (MS) and neuromyelitis optica (NMO), today announced that it has amended its option and license agreement with Merck Serono (a division of Merck, Darmstadt, Germany) and will receive a $3 million payment. The payment provides support for the ongoing Phase 2b clinical study of Tcelna® (imilecleucel-T), Opexa’s personalized immunotherapy in development for patients with Secondary Progressive MS (SPMS), as well as the preparation and planning of potential Phase 3 studies.
“Tremendous progress has been achieved in the treatment of multiple sclerosis over the past two decades but there remains a high unmet medical need for certain areas of the disease,” said Belén Garijo, Member of the Executive Board of Merck and CEO Healthcare. “Building on our strong heritage in multiple sclerosis, we will continue to focus our innovation efforts on areas where we can make a difference, such as secondary progressive multiple sclerosis where there are currently very limited therapeutic options. The additional support to Opexa to further develop Tcelna (imilecleucel-T) is another sign of our long-standing and continuing commitment to improving the lives of people living with multiple sclerosis.”
Opexa and Merck Serono entered into the original option and license agreement for the development and commercialization of Tcelna in MS in February of 2013, at which time Opexa received a $5 million upfront payment. Pursuant to the original agreement, Merck Serono has an option to acquire an exclusive, worldwide (excluding Japan) license of Opexa’s Tcelna program for the treatment of MS. The option may be exercised by Merck Serono prior to or upon completion of Opexa’s ongoing Phase 2b Abili-T trial of Tcelna in patients with SPMS. Top-line data from the Abili-T trial is expected in the second half of 2016. Tcelna has received Fast Track Designation from the U.S. Food and Drug Administration for SPMS.
“We are pleased with this show of support by Merck Serono towards Opexa’s novel and personalized immunotherapy,” commented Neil K. Warma, Opexa’s President and Chief Executive Officer. “Our relationship with Merck Serono over the last two years has been productive and we are pleased to strengthen this relationship and expand our development efforts with them in the critical work we are doing in the field of multiple sclerosis. We continue to focus on the careful execution of our ongoing Abili-T trial in SPMS patients and look forward to our continued collaboration with Merck Serono.”
Further details of the transaction are included in a Form 8-K filed by Opexa with the U.S. Securities and Exchange Commission.