Neurotrope, Inc. (Nasdaq: NTRP) today announced its entry into a strategic agreement with BryoLogyx Inc., www.BryoLogyx.com, for the supply of synthetic, GMP-certified Bryostatin-1, manufactured by Albany Molecular Research, Inc., a leading global CDMO provider of advanced drug development and manufacturing solutions. Neurotrope expects to use the synthetic Bryostatin-1 in its clinical development initiatives aimed at advancing its lead product candidate for the treatment of Alzheimer's disease and other neurodegenerative diseases and, ultimately, as a source for potential commercial drug supply if regulatory approval is received.
"This strategic partnership with BryoLogyx brings to Neurotrope the first fully synthetic, scalable source of Bryostatin-1, providing a clinical supply for the Company's planned Phase 3 study and a manufacturing alternative that delivers a dramatically superior cost of goods," stated Dr. Daniel Alkon, President and Chief Scientific Officer of Neurotrope. "Having better ongoing access to Bryostatin-1 drug supply is expected to have a positive impact on our future development efforts and, ultimately, our potential commercialization efforts if regulatory approval is received. Neurotrope has an exclusive license agreement with Stanford University for the use of this synthetic Bryostatin-1 in the treatment of all neurological disorders. In addition, BryoLogyx's innovation-driven work utilizing bryostatins for use in cancer immunotherapy make them an ideal partner to continue advancement of the CD22+ B-cell acute lymphoblastic leukemia ("ALL") development program, where they have the expertise and resources to realize its full potential."
Under the terms of the agreement, BryoLogyx will supply Neurotrope with specified amounts of synthetic, GMP-grade Bryostatin-1., manufactured by AMRI Group. BryoLogyx will pay a fee on gross revenues generated by the commercial sale of Bryostatin-1 product sold by BryoLogyx for the treatment of ALL. In exchange, Neurotrope will transfer to BryoLogyx the program right to develop Bryostatin-1 with CAR-T therapy for the potential treatment of CD22+ B-cell ALL with the National Cancer Institute. Relapsed ALL in CD22 CAR-T treated patients has been associated with reduced CD22 antigen density. Bryostatin-1 has been shown to increase CD22 expression levels, resulting in improved durability of chimeric antigen receptor ("CAR") response. Neurotrope will also transfer to BryoLogyx the Investigational New Drug ("IND") application that is in development, as well as its Cooperative Research and Development Agreement ("CRADA") with the NCI under which Bryostatin-1's ability to modulate CD22 in patients with relapsed/refractory CD22+ disease has been evaluated to date. BryoLogyx will be responsible for the IND and CRADA going forward.
As recently announced, Neurotrope has entered into a definitive merger agreement pursuant to which Metuchen Pharmaceuticals, L.L.C. and Neurotrope have agreed to merge in an all-stock transaction resulting in a newly formed holding company focused on men's health conditions, which will be named Petros Pharmaceuticals, Inc. ("Petros"). Upon closing of the transaction, Bryostatin-1 and substantially all of Neurotrope's existing assets, operations and liabilities, except for cash retained by Petros in accordance with the terms of the merger agreement, will be spun-out into a new, separately traded company which will retain the name Neurotrope Bioscience, Inc. ("NBI").
Dr. Charles S. Ryan, Neurotrope's Chief Executive Officer, added: "As we continue to work toward completing our agreement with Metuchen Pharmaceuticals and offer Neurotrope stakeholders pro-rata ownership in two distinct investment opportunities, we are pleased to have access to synthetic bryostatin. This agreement further underscores the long-term potential of both NBI and Petros as distinct, standalone, publicly-traded companies in two areas of high unmet medical need in the life sciences."
About Neurotrope, Inc.
Neurotrope is a clinical-stage biopharmaceutical company working to develop novel therapies for neurodegenerative diseases. Neurotrope has conducted clinical and preclinical studies of its lead therapeutic candidate, Bryostatin-1, in Alzheimer's disease, and preclinical studies for rare diseases and brain injury, including Fragile X syndrome, multiple sclerosis, stroke, Niemann-Pick Type C disease, Rett syndrome, and traumatic brain injury. The FDA has granted Orphan Drug Designation to Neurotrope for Bryostatin-1 as a treatment for Fragile X syndrome. Bryostatin-1 has already undergone testing in more than 1,500 people in cancer studies, thus creating a large safety data base that will further inform clinical trial designs.
Neurotrope has entered into a definitive merger agreement pursuant to which Metuchen Pharmaceuticals, L.L.C. and Neurotrope have agreed to merge in an all-stock transaction resulting in a newly formed holding company focused on men's health conditions, which will be named Petros Pharmaceuticals, Inc. ("Petros"). Upon closing of the transaction, Bryostatin-1 and substantially all of NBI's existing assets, operations and liabilities, except for cash retained by Petros in accordance with the terms of the merger agreement, will be spun-out into a new, separately traded company named Neurotrope Bioscience, Inc.
Additional information about Neurotrope may be found on its website: www.neurotrope.com.
