06.02.2013 - Merck Serono has secured an exclusive licence option for Opexa Therapeutics’ autologous T cell-based Multiple Sclerosis therapy imilecleucel-T.
Opexa’s Tcelna (imilecleucel-T) therapy currently is tested in a Phase IIb study on patients with Secondary Progressive MS (SPMS), which is less common than relapsing forms of MS that are targeted by Merck’s blockbuster Rebif® (interferon beta-1a) In case of market entry and successful commercialisation, the US firm could gain US$225m in total from the option and license agreement.
Under the terms of the contract, Opexa will receive an upfront payment of $5 million for granting an option to Merck Serono for the exclusive license of the Tcelna (imilecleucel-T) programme as a treatment of MS. The option may be exercised prior to, or upon completion of, Opexa’s proof-of-concept trial. If Merck Serono opts for the programme, Opexa is eligible for $25m or $15m upfront depending on fulfilment of certain undisclosed conditions. The Germans, in return, would receive worldwide development and commercial rights in MS, excluding Japan. When exercising the option, Merck Serono would have to pay all clinical development, as well as the cost for regulatory authorisation and marketing of the MS programme. Milestone payments to Opexa could sum up to $195m plus a tiered royalty rate from the high single digits to the mid-teens based on net sales.
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 royalty consideration. In addition to retaining all rights outside of MS as well as retaining the ability to commercialise imilecleucel-T in Japan, Opexa also retains certain manufacturing rights related to the programme.
Tcelna (imilecleucel-T) is an autologous T cell therapy. After collection of peripheral blood mononuclear cells, myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP) are expanded, irradiated and given back to the patient subcutaneously to trigger a therapeutic immune response.
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