Merck KGaA has agreed a deal with Opexa Therapeutics to develop and commercialise a new personalised treatment for multiple sclerosis (MS).
The two companies will work on Tcelna (imilecleucel-T), which was originally developed by Opexa and is currently in phase II trials investigating its use in secondary progressive MS (SPMS) – a form of MS that occurs in people who have previously experience of relapsing/remitting MS.
There are currently few treatments available for SPMS compared to other forms of MS, and the FDA has granted a fast-track designation to Tcelna to expedite its review process in this indication.
The drug is manufactured using Opexa’s ImmPath technology, and uses an individual patient’s own blood to manipulate its T-cells before being returned to the body via subcutaneous injection to trigger a therapeutic immune system response.
During the SPMS trial, patients undergo two annual courses of Tcelna treatment, consisting of five injections per year.
“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’s pharma division Merck Serono.
Merck’s current activities in MS mainly involve one of its biggest selling drugs Rebif (interferon beta-1a), which made €1.69bn during 2011.
However, the drug, which is taken as an injection, is facing stiff competition from oral MS treatments Novartis’ Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide).
Merck also announced the developmental failure of cladribine last year, and these two factors, alongside wider industry issues, led Merck to say it would cut more than 1,000 jobs by the end of 2015 in an overhaul of its business.
The deal with Opexa demonstrates the company’s belief in its MS business, however, and Opexa will receive an upfront payment of $5m granting Merck the option to exclusively license Tcelna in all MS indications.
Merck is able to exercise this option during or after the ongoing phase IIb trial into Tcelna’s use in SPMS, after which the company would pay an undisclosed upfront fee to receive worldwide development and commercial rights in all countries apart from Japan.
Opexa will also retain certain manufacturing rights and all rights for Tcelan’s use to treat any condition other than MS.