Merck, Opexa JV Tcelna (imilecleucel-T) development

Merck, Opexa JV for Tcelna (imilecleucel-T) development

9:18 AM, 6th February 2013
Merck, Opexa JV for Tcelna (imilecleucel-T) development

DARMSTADT, GERMANY: Merck announced the execution of an agreement with Opexa Therapeutics Inc for the development and commercialization of Tcelna (imilecleucel-T), a potential first-in-class personalized T-cell therapy for patients suffering from multiple sclerosis (MS). Tcelna is being developed by Opexa and currently is in a Phase IIb clinical trial in patients with Secondary Progressive MS.

Opexa will receive an upfront payment of $5 million for granting an option to Merck for the exclusive license of the Tcelna programme for the treatment of MS. The option may be exercised prior to or upon completion of Opexa’s ongoing Phase IIb clinical trial in patients with SPMS. Upon exercising this licensing option, Merck would pay an upfront license fee, and in return receive worldwide development and commercial rights to Tcelna in MS, excluding Japan. After exercising the option Merck would be wholly responsible for funding clinical development.

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 royalty consideration. In addition to retaining all rights outside of MS as well as retaining the ability to commercialize Tcelna (imilecleucel-T) in Japan, Opexa also retains certain manufacturing rights related to the programme.

“Opexa is pleased to retain important rights through this transaction, such as certain manufacturing rights, commercialization rights to the Japanese market and a co-funding of development option, as well as rights for all indications outside of MS, all of which are intended to enhance Opexa shareholder value,” said Neil K Warma, President and CEO, Opexa.

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