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EMD Serono amends deal with Opexa for multiple sclerosis drug Tcelna

Merck subsidiary EMD Serono has made changes to its agreement with Opexa Therapeutics to develop and commercialize its investigational compound Tcelna (imilecleucel-T) for the treatment of multiple sclerosis.

Under the deal, EMD Serono will pay Opexa additional $3m to support the ongoing Phase IIb clinical trial (Abili-T Trial) in patients with secondary progressive MS (SPMS).

The US Food and Drug Administration (FDA) has also granted Fast Track Designation for Tcelna.

Merck member of the Executive Board and CEO Healthcare Belen Garijo said: "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.

"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."

The two firms have entered into an agreement in February 2013, at which time Opexa received a $5m upfront payment for granting an option to EMD Serono for the exclusive license of the Tcelna program for the treatment of MS.

The option may be exercised prior to or following completion of Opexa’s ongoing Abili-T Trial and top-line data is expected to be reported in the second half of 2016.

Opexa president and chief executive officer Neil Warma said: "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."