Biohaven has acquired the world-wide intellectual property rights to a
portfolio of over 300 prodrugs owned by ALS Biopharma, LLC ("ALSBio"). The
prodrugs covered by the agreement were designed and prepared by Fox Chase
Chemical Diversity Center, Inc. ("FCCDC") through a research program funded,
in part, by the U.S. National Institutes of Health, through two peer-reviewed
Small Business Innovation Research (SBIR) grants awarded to FCCDC. Most of
the ALSBio prodrugs would be classified as New Molecular Entities (NMEs), and
the intellectual property rights acquired by Biohaven include all future
TORONTO, Aug. 24, 2015 /PRNewswire/ - Portage Biotech Inc. ("Portage") (OTC
Market: PTGEF, Canadian Securities Exchange: PBT.U) and Biohaven
Pharmaceutical Holding Company Limited ("Biohaven") are pleased to announce
that the United States Food and Drug Administration has completed its review
of Biohaven's Investigational New Drug Application (IND) for BHV-0223 and
initial clinical studies in humans may begin. Portage holds 54% equity
interest in Biohaven.
Biohaven intends to immediately proceed with a Phase 1 study designed to
assess the safety, tolerability, and pharmacokinetics of single and multiple
doses of BHV-0223 in healthy volunteers. Data from this trial will be used to
design Phase 3 studies in subjects who suffer from treatment-resistant anxiety
disorders and planned to begin in early 2016.
BHV-0223 is a glutamate modulating agent formulated using the Zydis® ODT
fast-dissolve technology under an exclusive worldwide agreement with Catalent.
The Zydis®orally disintegrating tablet (ODT) fast-dissolve is a unique,
freeze-dried oral solid dosage form that disperses instantly in the mouth - no
water is required. With more than 20 products launched in 50 countries,
Zydis®is the World's best-in-class, ODT technology.Catalent is the industry
leader for drug development technology. BHV-0223 is also protected by methods
of use intellectual property licensed from Yale University School of Medicine.
BHV-0223 is being developed for eventual commercialization in
treatment-resistant anxiety disorders, focusing initially on Generalized
Anxiety Disorder (GAD). The mechanism of action of BHV-0223 involves the
modulation of glutamate. Recent scientific findings have linked a variety of
central nervous system and other diseases with altered glutamate function.
These findings suggest that agents that modulate glutamate neurotransmission
may have therapeutic potential for treating multiple treatment-resistant
disorders. Potential target indications thought to involve glutam
Good Lord Above. I'm about to call it quits over here. Is it fairly valued here? I guess so. Jim? are you still involved in this start up? I participated in the last two raises mate. Seems real but is it?
TORONTO, Aug. 27, 2015 /PRNewswire/ - Portage Biotech Inc. ("Portage") (OTC Market: PTGEF, Canadian Securities Exchange: PBT.U), and Biohaven Pharmaceutical Holding Company Limited (Biohaven), announced today that dosing has commenced in a Phase I study of BHV-0223, a glutamate modulating agent
i like this bold quote: Dr. Bruce H. Littman, C.E.O. of PPL, said "with these results PPL has high confidence in the properties of PPL-003 as a topical treatment for dry eye and other inflammatory eye diseases. To our knowledge, PPL-003 is the only NFkB inhibitor for these indications and we believe that it will differentiate favourably from existing drugs such as Allergan's Restasis (topical cyclosporine 0.05%), the market leader for dry eye, as well as newer agents close to approval or in trials that target only one inflammation mechanism. There is a high medical need as well as significant market potential for safer and more effective treatments."
I won't be surprised if a Major (Pfizer type) comes to the table and partners. At that time I would add to my position. Until then a 50 Mil mkt cap - for the pipeline and team- is quite sufficient perhaps overvalued Jim may have said over a pint. If all goes well later this month with phase 1 I'd change my valuation. However beware of another massive dilution potential (for phase 2) and the dreaded possibility of an up to1 for 50 stock consolidation.
TORONTO, Sept. 21, 2015 /PRNewswire/ - Portage Biotech Inc. ("Portage") (OTC Market: PTGEF, Canadian Securities Exchange: PBT.U), and Biohaven Pharmaceutical Holding Company Limited (Biohaven), announced today that Biohaven has completed the single dose portion of its Phase I study of BHV-0223, a glutamate modulating agent. This summer, Biohaven filed an investigational drug application (IND) regarding BHV-0223 and obtained clearance from the U.S. Food and Drug Administration (FDA) to proceed with human testing. Portage holds 54% equity interest in Biohaven, a private company.
The Phase I trial was designed to demonstrate the safety and unique pharmacokinetic characteristics of BHV-0223 in humans. In the first phase of the study, approximately 10 participants were treated with varying doses of BHV-0223 on four separate occasions. In the second phase of the trial, participants will receive multiple daily doses of BHV-0223.
Robert Berman, M.D., Chief Medical Officer of Biohaven comments, "The single dose phase of our first human study with BHV-0223 has been completed. There were no serious adverse events reported and pharmacokinetic data is being analysed. We will proceed to the multiple dose phase of this trial with approximately ten patients receiving multiple daily doses of BHV-0223 and expect top-line data by year end."
working with Harvard and Yale on anxiety....using an ALS drug
TORONTO, Oct. 1, 2015 /PRNewswire/ - Portage Biotech Inc. ("Portage") (OTC Market: PTGEF, Canadian Securities Exchange: PBT.U), and Biohaven Pharmaceutical Holding Company Limited (Biohaven), are pleased to announce a strategic alliance with ALS Biopharma LLC ("ALS") and Fox Chase Chemical Diversity Center, Inc. (FCCDC) to develop Biohaven's family of over 300 prodrugs of glutamate modulating agents as well as other innovative technologies. Under this agreement, Biohaven will provide $1.5M in research funding to FCCDC to advance a lead prodrug candidate to IND filing.
FCCDC is a Pennsylvania based drug discovery company with exceptional medicinal chemistry, target validation, pharmacology and chemical biology capabilities. FCCDC is located within the 112,000 square foot Pennsylvania Biotechnology Center (PBC), and is affiliated with the Pennsylvania Drug Discovery Institute. FCCDC has approximately 20 staff members and over 300 years of cumulative drug discovery experience ranging from big pharma (Johnson & Johnson, Merck) to numerous biotech companies. FCCDC has received over $18.9 M in research funding since its inception. FCCDC is fully equipped to meet chemistry synthesis and analytic needs.
FCCDC is led by CEO Dr. Allen Reitz who has over 33 years of demonstrated accomplishment as a medicinal chemist in the pharmaceutical industry, including nearly 26 years with Johnson & Johnson. Dr. Reitz led the medicinal chemistry research effort at the Spring House Pennsyvlania site of Johnson & Johnson in the area of central nervous system therapeutics for both psychiatry and neurology. Dr. Reitz has over 140 scientific publications and 60 issued U.S. patents, and is the Editor-in-Chief of the journal Current Topics in Medicinal Chemistry. He has extensive experience in project and portfolio management, target validation, hit triage, hit to lead and lead optimization medicinal chemistry, eADME profiling, and preclinical c