Portage Biotech, Inc. together with privately-held Biohaven Pharmaceutical Holding Company Ltd. has just acquired global intellectual property rights to an extensive 300-product portfolio by ALS Biopharma, LLC. These prodrugs included in the line up, most of which are classified as New Molecular Entities (NMEs), were originally designed and prepared by Fox Chase Chemical Diversity Center, Inc. as a result of a research program sponsored by the National Institutes of Health, and a pair of Small Business Innovation Research (SBIR) grants. The acquired rights will also cover any future therapeutic indications.
Prodrugs against ALS work by modulating glutamate, which in recent reports has been linked to a number of conditions involving the central nervous system. These studies suggest agents that aid in glutamate neurotransmission may address multiple treatment-resistant disorders, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, Rett syndrome, dementia, dystonia, tinnitus, anxiety disorders, affective disorders and a variety of cancers.
Declan Doogan, M.D., Portage CEO and Biohaven Executive Chairman, commented, “Advancing Biohaven and expanding our platform of glutamate modulating agents through creative business transactions is central to our mission. We are continuously seeking opportunities to collaborate with those who share our commitment to bring novel therapies to patients suffering from treatment resistant neuropsychiatric disorders.” Chief Medical Officer of Biohaven, Robert Berman, M.D., commented “These newly acquired compounds provide an exciting addition to our pipeline and we are eager to test their value in multiple indications where aberrations in glutamate function have been implicated in the pathophysiology of the underlying illness.”
The two companies are also pleased to announce the US Food and Drug Administration has completed its review of Biohaven’s Investigational New Drug Application (IND) for BHV-0223, one of the drugs covered by the agreement and a glutamate modulating agent formulated using the Zydis® ODT fast-dissolve technology under an exclusive worldwide agreement with Catalent. Biohaven plans to proceed to a Phase I study as soon as possible, designed to evaluate the drug’s safety, tolerability, and pharmacokinetics of single and multiple doses of BHV-0223 in healthy volunteers. Data from this trial will serve as a basis for Phase 3 studies in patients who suffer from treatment-resistant anxiety disorders, planned to begin in early 2016. However, because this agent has the potential to modulate glutamate neurotransmission, it may hold therapeutic potential for treatment approaches in ALS.
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