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Henry McCusker
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Editor and Publisher ... Henry enters his twelve (12) year at RegMed Investors which aggregates, curates and creates bottom-line content of regenerative medicine and cell therapy news providing a "vetted" selection of relevant and high-impact synthesis. He was VP - Strategic Planning... More
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Scimitar Equity-Regenerative Medicine Investors
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Scimitar Equity Blog
  • Merck Serono Granted Option For Exclusive License From Opexa (OPXA) – UP +249% 0 comments
    Feb 5, 2013 9:13 AM

    To develop and commercialize Tcelna (imilecleucel-T), an investigational T-cell therapy for patients suffering from multiple sclerosis (NYSE:MS)

    Opexa Therapeutics (NASDAQ:OPXA) executed an agreement with Merck Serono, a division of Merck, Darmstadt, Germany, for the development and commercialization of Tcelna™ (imilecleucel-T), a personalized T-cell therapy for patients suffering from multiple sclerosis (MS).

    Tcelna (imilecleucel-T) is being developed by Opexa and currently is in a P2b clinical trial in patients with Secondary Progressive MS (SPMS). Potential payments to Opexa from the option and license agreement could total $225 M based upon the successful development and commercialization of Tcelna for MS.

    Opexa will have an option right to co-fund development, under which the OPXA 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.

    The Bottom Line: OPXA will receive an upfront payment of $5 M 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 M or $15 M (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 OPXA'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 M 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 M excluding royalty payments.

    OPXA closed at $1.21 on Monday, 2/4/13 and is UP to $5.59 with a market indication of $5.02 to $5.07 which is on the low side!

    MS is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

    Tcelna (imilecleucel-T) is a potential personalized therapy that is under development to be specifically tailored to each patient's disease profile. Tcelna (imilecleucel-T) is manufactured using ImmPath^™, Opexa's proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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