Opexa Therapeutics said today it granted Merck Serono an option for exclusive license to develop and commercialize Tcelna (imilecleucel-T), an investigational personalized T-cell therapy for patients with multiple sclerosis (MS), in a deal that could be worth as much as $225 million.
The potential first-in-class therapy has received FDA’s Fast Track designation, and is now in an ongoing Phase IIb clinical trial in patients with secondary progressive MS.
Merck Serono agreed to pay Opexa $5 million up-front for the option, which the pharma giant can exercise before or after Opexa completes the Phase IIb trial. If it exercises the option, Merck Serono would pay an up-front license fee of either $25 million or $15 million, based on meeting a series of undisclosed conditions, and in return receive development and commercial rights to Tcelna worldwide except Japan.
Opexa would keep Japanese commercialization rights to Tcelna, as well as rights for all indications outside of MS, manufacturing rights, and a co-funding of development option.
Subject to that co-funding option, Merck Serono would oversee funding clinical development, subject to Opexa’s co-funding option, as well as regulatory and commercialization activities for the MS program. Merck Serono would also pay Opexa up to $195 million tied to undisclosed development and commercial milestones, as well as tiered royalty payments from the high single-digit to mid-teen percentage range.
“We could not ask for a more experienced partner to carry Tcelna … through development and hopefully to the market and to patients,” Neil K. Warma, Opexa’s president and CEO, said in a statement.
With the Opexa deal, Merck Serono jumps back into the increasingly crowded field of biopharma giants stepping up their activity in MS drugs. Back in 2011, parent Merck KGaA ended development of the MS drug candidate cladribine after it failed to win FDA approval. The agency sought more analysis or additional studies to better assess the drug’s potential safety risks. Merck had hoped to roll out a new product given increasing competition for its injectable MS drug Rebif.
Last month, however, Biogen Idec and Elan last month submitted applications to FDA and European Medicines Agency to add a first-line treatment indication to their MS drug Tysabri (natalizumab), now approved via injection in patients for whom other treatments have failed.
The applications come about a year after Biogen Idec developed a diagnostic for antibodies to the virus that causes progressive multifocal leukoencephalopathy. The new applications would widen Tysabri use to the approximately half of MS patients who test negative for the antibodies. Biogen Idec’s MS portfolio includes the oral drug BG-12, now in development.
Novartis’ MS drug Gilenya, the only oral MS drug now approved, survived regulatory challenges in Europe and the U.S. last year by agreeing to change the wording of its warning label to discourage its use in patients with cardiovascular and cerebrovascular disease, and require an electrocardiogram and blood pressure measurement of all patients using the drug.
Sanofi’s Genzyme subsidiary said January 30 it expects word from FDA on its application to market its MS drug Lemtrada during the second half of this year. In Europe, the European Medicines Agency’s Committee for Medicinal Products for Human Use is expected in the second quarter to recommend a decision on Lemtrada to the European Commission, which has final say.