Ohr Pharmaceutical has aggressively assembled an extremely promising portfolio of therapeutic compounds engineered specifically to fill gaps in market demand, offering hope to patients whose needs for better quality of life, or some form of easier/more effective treatment, go unsatisfied, or outrightly unmet by competitors.
In fact, OHRP’s wealth of clinical/pre-clinical data amassed to date, via superb execution of a late-stage clinical acquisition strategy, is so impressive for an operation founded in 2008, that the forward competitive outlook is astounding, even at a glance. The company stands poised to carve out a major slice of the pie currently taken up by FDA-approved market superpowers like Roche/Genentech’s Lucentis®/Avastin® and Regeneron’s Eylea®, via their lead wet-AMD therapeutic, Squalamine.
Squalamine, you see, is here formulated in an easy to self-administer eye drop, (in Phase I/II trials of 250 patients using an intravenous formulation, pre-clinical testing of eyedrop shows great results) which has demonstrated improved visual acuity response in early, as well as advanced lesions (thanks in large part to its novel intracellular mechanism of action). The competitors however are all injected directly into the eye (around $2k per injection every 4-8 weeks). The basic logistics here are pretty easy to figure out from a consumer standpoint and OHRP is well-positioned to capture significant territory of the $3B (2011 annual revenues) plus global wet-AMD market. This is a considerable space to operate in, even if we are just talking domestic market, as the affected U.S. population alone totals some 1.75M.
Squalamine’s mechanism of action has broader impact for other indications such as neovascular eye diseases; however, in the case of wet-AMD we see a clear, demonstrably validated benefit of this small molecule (aminosterol) formulation across two key anti-angiogenic factors: vascular endothelial growth and platelet derived growth (even potential basic fibroblast growth). Safe too, with further obvious development potential in solid tumor treatment via intravenous delivery, meaning the company has its hands on a real option for resistant ovarian cancer patients (previous intravenous oncology study of 200 patients with solid ovarian, lung, and prostate tumors). So we have a safe, easy to use, broad-spectrum product that shunts anomalous/aberrant growth of microvascular networks, via a very handy mechanism that also shuts down tissue growth in tumors and looks like a real winner for IV-based solid tumor treatment.
With a firm foundation of in vivo studies that validate wet-AMD efficacy (concentration in posterior sclera/choroid tissues where the problem originates were in excess of target) well beyond what is required for therapeutic effects, the (May 6-10, 2012) Association for Research in Vision and Ophthalmology 2012 Annual Meeting presentation by OHRP on the positive data out of preclinical work on Squalamine eye drops, as well as the planned Phase II clinical trialing in wet-AMD, has got investors buzzing.
Squalamine was obtained along with Trodusquemine, which has broad potential as a tyrosine phosphatase 1B inhibitor (offering a huge range of identified target applications), features great selectivity (something lacking thus far in the development of such inhibitors), and is even able to cross the blood-brain barrier, during the (Aug 2009) Genaera Corp. acquisition.
This same shrewd acquisition strategy employed by OHRP’s management also led to the securing of OHR/AVR 118, a powerful, peptide-based immunomodulating drug for severe wasting disorder, Cancer Cachexia, via Advanced Viral Research Corp., which also shows promise in helping to treat rheumatoid arthritis (previous 27-patient trial). OHR/AVR 118 has seen evaluation in some 70 AIDS Cachexia patients, where the drug offered extremely positive results, showing beneficial mitigation of multiple symptoms.
The lack of an FDA-approved competitor in the Cancer Cachexia space is a perfect example of how deftly OHRP is employing the overall strategy. Non-toxic, with no observed adverse reactions in human clinical use (save but for minor irritation at the injection site), OHR/AVR 118 shows exceptional market vectors, potentially addressing the needs of as much as 30% of cancer patients (the percentage which suffer from Cachexia). Phase II trailing for OHR/AVR 118 is fully funded to completion by a QTDP grant (Qualifying Therapeutic Discovery Project (IRS/Department of Health and Human Services program for funding potentially cost-saving therapies), making this product’s component vector quite tantalizing indeed. The broad-spectrum potential of OHR/AVR 118 and the company’s other technology, as well as the clearly defined biologic effects that underlie the potency of said technology, should not be underestimated, and markets will be keen to keep a close eye on OHRP as the product pipeline develops.
President, CEO, and Director of OHRP, Dr. Irach Taraporewala, is a 30-year industry veteran, with vast experience in the trenches of drug development, handling regulatory affairs like a master artist, and he knows from his countless hours engineering regulatory strategies for some of the world’s top pharma players. It is no wonder looking at the management roster that OHRP has been able to execute this strategy so capably, empowered by a carefully selected scientific advisory board with some of the top minds in ophthalmology/oncology.
Small/micro cap registered investment advisor and equity research gurus, Vista Partners LLC recently initiated coverage on OHRP with a 12-month price target of $2.20 (closed at $0.950 on Friday, with a 52-week range of $0.18/1.07), showing the kind of response the market is already having to the tremendous potential of the company’s assembled drug portfolio.
For more information on this constantly evolving developer of first-in-class products for underserved/unnerved markets, please visit the Ohr Pharmaceutical, Inc. website at: www.OHRPharmaceutical.com
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