Opexa Therapeutics, Inc. OPXA today announced the execution of an
agreement with Merck Serono, a division of Merck, Darmstadt, Germany, 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 (imilecleucel-T) is being developed by Opexa
and currently is in a Phase IIb clinical trial in patients with Secondary
Progressive MS (SPMS). Potential payments to Opexa from the option and license
agreement could total $225 million based upon the successful development and
commercialization of Tcelna for MS.
Tcelna (imilecleucel-T) is being developed as a personalized therapy
specifically tailored to each patient's individual disease profile and has
been evaluated in Phase I and II clinical studies in MS that included SPMS
patients. Tcelna (imilecleucel-T) has received Fast Track Designation from the
United States Food and Drug Administration as a potential treatment for SPMS.
Under the terms of the agreement, 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) program 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
Serono would pay an upfront license fee of either $25 million or $15 million
(depending upon whether certain conditions are met), and in return receive
worldwide development and commercial rights to Tcelna (imilecleucel-T) in MS,
excluding Japan. After exercising the option Merck Serono would be wholly
responsible for funding clinical development, subject to Opexa's co-funding
option, as well as regulatory and commercialization activities for the MS
program. Additional financial considerations of the agreement include
development and commercial milestone payments to Opexa of up to $195 million
and a tiered royalty rate from the high single digits to the mid-teens based
on net sales payable to Opexa. The potential payments to Opexa could,
therefore, total $225 million excluding royalty payments.
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 program 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 program. Further
details of the transaction are included in a Form 8-K that was filed this
morning by Opexa with the United States Securities and Exchange Commission.
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