Ohr Pharmaceutical Inc. (OHRP-OTC: BB)

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February 11, 2011 Issue

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With their OHR/AVR118 Compound for Cancer Cachexia Showing Promising Results in Phase II Efficacy Studies and their Squalamine Compound for Treating Macular Degeneration also Receiving Orphan Drug Status by the FDA for Resistant Ovarian Cancer, Ohr Pharmaceutical Inc. is Well Positioned to Make an Impact in These Areas of Unmet Medical Needs

Company Profile:

Ohr Pharmaceutical Inc. is focused on the development of two drugs: OHR/AVR 118 for the treatment of cancer cachexia and Squalamine for the treatment of the wet form of age-related macular degeneration (Wet-AMD). Cancer cachexia, the syndrome of body wasting that affects late-stage cancer patients, is a debilitating condition which adversely affects their quality of life. Wet-AMD is a leading cause of vision loss and blindness in the elderly. The promise shown by Ohr Pharmaceutical's products pipeline offers a new ray of hope to patients suffering from these devastating diseases.

Dr. Irach B. Taraporewala B.S., M.S., Ph.D.
Chief Executive Officer
Dr. Taraporewala has over 30 years in drug development and regulatory affairs experience. He was formerly the Vice President of Regulatory Affairs and Clinical Research at Austin, TX-based Mystic Pharmaceuticals Inc. where he led the regulatory strategy for the company's ophthalmic and intranasal drug products and drug delivery systems. Prior to that, Dr. Taraporewala served as Senior Consultant in the Drug Development Consulting division of Boston-based PAREXEL International Corp., a leading global pharmaceutical services provider, where he provided technical expertise and regulatory advice to small and large biotechnology and pharmaceutical company clients worldwide, and also conducted due diligence for companies and venture capital firms on technology and portfolio evaluation and product acquisitions. From 1998 to 2004, Dr. Taraporewala was Director of Chemistry and Quality Control at Yonkers, NY-based Advanced Viral Research Corporation where he helped take OHR/AVR118, an immunomodulator drug, into clinical trials for AIDS, cancer cachexia and rheumatoid arthritis. He has also served as principal investigator on four National Institute of Health and U.S. Department of Defense funded biomedical research grants on antiviral drugs, DNA-based cancer diagnostics and on antimalarial compound development. Dr. Taraporewala earned bachelors' and masters' degrees in chemistry and microbiology from the University of Bombay, India and a Ph.D. in medicinal chemistry from the Philadelphia College of Pharmacy. He conducted postdoctoral research at the University of Texas at Austin, the University of Minnesota and the Southwest Foundation for Biomedical Research. Dr. Taraporewala has multiple scientific publications and patents to his credit, and has lectured extensively.

Healthcare
Biotechnology
(OHRP-OTC: BB)

Ohr Pharmaceutical Inc.
489 Fifth Avenue, 28^th Floor
New York, NY 10017
Phone: 212-682-8452
 

Interview conducted by: Lynn Fosse, Senior Editor, CEOCFOinterviews.com, Published – February 11, 2011

CEOCFO: Dr. Taraporewala, you have a long history in the industry, what attracted you specifically to Ohr Pharmaceutical?

Dr. Taraporewala: The Ohr Pharmaceutical strategy is different from most biopharmaceutical companies in that Ohr has acquired a portfolio of late-stage compounds already in Phase-II development. These were drugs that showed particular promise in various clinical conditions, but the companies that had originally developed them and poured over one hundred million dollars into their development were forced to divest these assets due to the unprecedented collapse of the capital markets in late 2008 and early 2009. Taking advantage of the downturn in the pharmaceutical industry, Ohr Pharmaceutical did extensive due diligence and acquired compounds that showed very good clinical trial results and had already been developed to the Phase II and phase III clinical level and is proceeding with continuing the development of these compounds into the marketplace.

CEOCFO: Would you tell us about your compounds?

Dr. Taraporewala: The two primary compounds that Ohr Pharmaceutical is currently developing are those compounds code-named OHR/AVR118, which is an immuno-modulator drug and the other compound is a small molecule called Squalamine, which is an anti-angiogenesis compound. Our first compound, OHR/AVR118, is in clinical trials currently for cancer cachexia, which is a devastating wasting syndrome that occurs in late-stage cancer patients. The drug is being evaluated at the Ottawa Hospital Cancer Center in a Phase II efficacy study and the results to date have been very promising. The interim results of the first patients in the study were presented at the International Conference of Cachexia and Wasting Disorders, in Barcelona. They have recently been published in a peer reviewed journal, based on the results in the initial group of patients.

CEOCFO: What differentiates your two compounds in their respective categories?

Dr. Taraporewala: The OHR/AVR118 compound is different from other drugs that have been used in the past to mitigate cachexia, in that is addresses the root etiology of the condition. Cancer cachexia occurs mainly in late-stage cancer patients and is often exacerbated by chemotherapy or radiation that the patients undergo, which affects the immune system. Cachexia is a disorder that is characterized by what is known bio-chemically as a cytokine storm in which the tumor releases certain bio-chemicals in the body called cytokines, which have a destructive impact. Among other things, they affect appetite, cause weight-loss, muscle loss, gastrointestinal symptoms, and muscular weakness. Drugs that have been used to treat cachexia include anabolic steroids to increase the muscle mass, or drugs such as the steroid Megestrol, which causes weight-gain without increasing muscular strength. So, while other drugs that have been tried in the area target one or the other symptom of the condition, none of the current drugs available on the market today, address the entire picture of cachexia, and adequately treat all the clinical symptoms because they do not address the root etiology. Our drug, OHR/AVR118 actually controls the bio-chemical cytokine storm and therefore mitigates many of the symptoms of cachexia, not just one or two. There is currently no FDA approved therapy for cancer cachexia. Our other drug in our pipeline, the small molecule Squalamine, was acquired from Genaera Corporation, which pursued it for macular degeneration, which is a leading cause of blindness in the elderly and for its anti-cancer application. There were also some very good results obtained with squalamine in late-stage ovarian cancer patients, and Ohr Pharmaceutical intends to pursue both the macular degeneration and potentially the ovarian cancer application. The FDA has actually awarded Orphan Drug status to this compound for ovarian cancer.

CEOCFO: Are you looking for partnerships, or are you doing this on your own at this point?

Dr. Taraporewala: At this point, we are continuing development on our own. With the late stage resistant ovarian cancer indication for Squalamine, we will probably be looking for a partnership.

CEOCFO: What is the timetable moving forward?

Dr. Taraporewala: We have recently completed a reformulation of the Squalamine drug. The original formulation developed by Genaera was an injected version, which was given intravenously. We have gone ahead and reformulated it to deliver the drug in a very patient-friendly manner. The current standard of care in AMD with currently marketed drugs is an intravitreal injection directly into the eye every month or two, which is obviously quite uncomfortable for patients. We are currently carrying out studies in animals on the new formulations and we will be going to the FDA with the data on that to move ahead with another Phase II trial later this year. The cancer cachexia trial is moving ahead nicely and we expect to present full results from the trial in the coming year.

CEOCFO: What is the financial picture like for Ohr Pharmaceutical today?

Dr. Taraporewala: Ohr has just completed a round of private equity placement financing; it was publicly announced recently. We raised $1.05 million in this round and that will take care of our current needs for this year.

CEOCFO: Do you do much investor outreach?

Dr. Taraporewala: Ohr actually relocated its offices from Salt Lake City into Manhattan in New York City in the middle of last year and we have begun investor outreach in the last couple of months, so it is currently in progress. Word is getting out on our company and we will continue to push ahead in that arena.

CEOCFO: There a lot of companies to choose from, why should potential investors consider Ohr Pharmaceutical today?

Dr. Taraporewala: Ohr Pharmaceutical is probably one of the most undervalued biopharmaceutical companies today in terms of its market cap. One outstanding feature of Ohr is its small size and the fact that it has 3 clinical indications for its compounds in Phase II in very large unaddressed markets. It has acquired Phase II compounds and is moving ahead with very promising drugs already well into the FDA process. These drugs have shown good efficacy and they have shown safety, so Ohr is in a unique situation of having acquired late-stage compounds with a minimum amount of capital invested by Ohr. The R&D was all done by the predecessor companies to develop these drugs, and Ohr is moving them forward in an extremely cost efficient manner that is rarely seen in the biotech industry.

CEOCFO: Final thoughts, what should people remember most about Ohr Pharmaceutical?

Dr. Taraporewala: Ohr is a very entrepreneurial company. We operate very efficiently. As I said, we are an undervalued company that has great potential rewards. These are very promising, exciting compounds we have acquired, which address unmet medical needs. Therefore, we can become major players in the marketplace in a short amount of time; all with the promise of these compounds.

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While other drugs that have been tried in the area target one or the other symptom of the condition, none of the current drugs available on the market today, address the entire picture of cachexia, and adequately treat all the clinical symptoms because they do not address the root etiology. Our drug, OHR/AVR118 actually controls the bio-chemical cytokine storm and therefore mitigates many of the symptoms of cachexia, not just one or two. - Dr. Irach B. Taraporewala B.S., M.S., Ph.D.