Merck Serono and Opexa enter licensing agreement

Published: 6-Feb-2013

For the development of MS treatment Tcelna


Opexa Therapeutics has granted an exclusive licence to Merck Serono for the development and commercialisation of Tcelna (imilecleucel-T), its leading product candidate for multiple sclerosis (MS).

Tcelna is currently in a Phase IIb clinical trial in patients with Secondary Progressive MS (SPMS) and has received Fast Track Designation from the US Food and Drug Administration.

Under the agreement, Opexa will receive an upfront payment of US$5m, a licensing fee of either $25m or $15m after the licensing option is exercised, and potential milestone payments of as much as $195m.

After exercising the option Merck would be wholly responsible for funding clinical development, subject to Opexa’s co-funding option, as well as regulatory and commercialisation activities for the MS programme.

Under the agreement, Opexa will have an option right to co-fund development, under which the company would participate in economic support for future clinical development of the programme in exchange for additional royalties. In addition to retaining all rights outside of MS as well the ability to commercialise Tcelna (imilecleucel-T) in Japan, Opexa also retains certain manufacturing rights.

‘This agreement illustrates Merck Serono’s commitment to employ creative ways of accessing external innovation to develop potential next-generation multiple sclerosis treatments, especially in secondary progressive multiple sclerosis, an area of high unmet need,’ said Susan Herbert, Head of Global Business Development and Strategy at Merck Serono.

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