EMD Serono and Opexa Amend Agreement to Support Ongoing Development of Tcelna (imilecleucel-T) for Multiple Sclerosis

- Personalized immunotherapy Tcelna (imilecleucel-T), an investigational compound currently in a Phase IIb clinical study in patients with secondary progressive multiple sclerosis (SPMS), an area of high unmet medical need

- EMD Serono pays Opexa additional $3 million to support clinical study in patients with SPMS

ROCKLAND, Mass., March 9, 2015 /PRNewswire/ -- EMD Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, announced today the execution of an amendment to its agreement with Opexa Therapeutics, Inc. for the development and commercialization of its investigational compound Tcelna® (imilecleucel-T).

"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 Belen Garijo, Member of the Executive Board of Merck KGaA, Darmstadt, Germany 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."

A $3 million payment to Opexa will support the ongoing Phase IIb clinical study (Abili-T Trial) in patients with secondary progressive MS (SPMS). Tcelna (imilecleucel-T) has received Fast Track Designation from the United States Food and Drug Administration.

EMD Serono and Opexa entered into an agreement in February 2013, at which time Opexa received a $5 million upfront payment for granting an option to EMD Serono for the exclusive license of the Tcelna (imilecleucel-T) program for the treatment of MS. The option may be exercised prior to or upon completion of Opexa's ongoing Abili-T Trial. Top-line data is expected in the second half of 2016.

"We are very pleased with this show of support by EMD Serono towards Opexa's potential personalized immunotherapy," said Neil K. Warma, Opexa's President and Chief Executive Officer. "Our relationship with EMD 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 EMD Serono."

About EMD Serono
EMD Serono, a subsidiary of Merck KGaA, Darmstadt, Germany, is a leading U.S. biopharmaceutical company focused exclusively on specialty care. For more than 40 years, EMD Serono has integrated cutting-edge science, innovative products and devices, and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in neurology, oncology, immunology and immuno-oncology. Today, EMD Serono has more than 1,100 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.

For more information, please visit www.emdserono.com

About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – EMD Serono, Consumer Health, Allergopharma, Biosimilars, EMD Millipore and Performance Materials – and generated sales of € 11.3 billion in 2014. Around 39,000 Merck KGaA, Darmstadt, Germany employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges. Merck KGaA, Darmstadt, Germany is the world's oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. The company operates as EMD Serono, EMD Millipore and EMD Performance Materials in Canada and the United States.

Erin-Marie Beals
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