Ohr Pharmaceutical Inc. (OHRP-OTCBB)

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February 10, 2012 Issue

The Most Powerful Name In Corporate News and Information


With Very Promising Preclinical Studies for their Squalamine Eyedrop Program Showing the Potential to Treat wet-AMD in a Much More “Patient Friendly” Manner Compared with the Current Injected Drugs on the Market, and the Anticipated Completion of their Phase II Trial in Cancer Cachexia this Year, Ohr Pharmaceutical Inc. is Well Positioned for Future Growth

Company Profile:

Ohr Pharmaceutical Inc. is a pharmaceutical company dedicated to the clinical development of new drugs for underserved therapeutic needs in large and growing markets. The company is focused on two lead compounds: Squalamine eye drops for the treatment of the wet form of age-related macular degeneration, and OHR/AVR118 for the treatment of cancer cachexia, currently being investigated in a Phase II trial.

Dr. Irach B. Taraporewala
President and CEO

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. At Advanced Viral Research he worked closely with Shalom Hirschman, M.D., Ohr's Chief Science Advisor. Prior to that, Dr. Taraporewala worked in research and development at Ciba-Geigy, which later merged with Sandoz to become Novartis. 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.


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

Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – February 10, 2012

CEOCFO: Dr. Taraporewala, it has been about a year since we have spoken; would you update us on the major changes for Ohr Pharmaceutical?

Dr. Taraporewala: We are moving our Squalamine eyedrop program ahead very well. We have successfully created an eyedrop formulation of the drug with the potential to replace the current standard of therapy, which is an intravitreal injection directly into the eye of the currently approved drugs for wet-AMD. These include Lucentis (a drug which is on a run rate of about 3.5 billion dollars of revenue this year) and Eylea, the recently approved drug from Regeneron. Our preclinical studies have shown that the drug gets to the choroid in the back of the eye using the eyedrop in concentrations that far exceed the threshold known to inhibit the abnormal growth of blood vessels behind the retina, which causes the blindness in wet-AMD (wet form of age-related macular degeneration). Our animal studies have also shown that the drug is very safe to ocular tissues. Our plan is to move ahead with initiating a Phase II clinical trial with this exciting new product in the middle of this year. Our other product, the immunomodulator drug OHR/AVR 118, that is in a Phase II clinical trial, is progressing nicely at the Ottawa Cancer Center in Canada. That trial is expected to be completed by the end of this year.

CEOCFO: On the Squalamine, would this be something the patient could administer, or would it be administered by the doctor?

Dr. Taraporewala: That is obviously another great advantage of having a topical eyedrop formulation for wet-AMD. Currently approved therapies for wet-AMD such as Lucentis or Eyelea require a shot into the eye to be given to a patient in an ophthalmologist’s office every few weeks. However, our drug could be conveniently self-administered daily by the patient or caregiver at home, much like glaucoma medication is given today. So from a patient preference and compliance perspective, this certainly adds a whole new dynamic to the AMD treatment market.

CEOCFO: Assuming it develops as you expect, how do you encourage doctors to give up the revenue they are making with the injections, to go for the eyedrops?

Dr. Taraporewala: Once it becomes known in the media that there is an available eyedrop for treating AMD, patients and their families would opt for an eyedrop as a choice. Therefore, doctors would have to essentially comply to the request made by their patients. Also, if an eyedrop could be priced competitively and could be self-administered, the health insurance industry would probably opt to pay for the eyedrop treatment. There are also additional risks involved, such as risks of infection by intravitreal injection that the patients have to undergo with the currently available therapies, and those risks will likely be removed with the use of an eyedrop. It may become standard practice where most patients would opt for an efficacious eyedrop rather than a shot in the eye.


CEOCFO: How many people are we talking about on an annual basis that might be affected?

Dr. Taraporewala: The wet-AMD incidence is in the order of 1.75 million in the US alone, and the incidence is growing exponentially as the “baby boomer” population reaches the age where they develop wet-AMD. It is a rare opportunity when you can have such an impact on a multi-billion dollar established market.

CEOCFO: This sounds like a revolutionary breakthrough!

Dr. Taraporewala: Certainly, it is what will likely change the dynamics of the marketplace in the treatment of wet-AMD.

CEOCFO: What is the timetable on getting this out to people?

Dr. Taraporewala: We expect the trial to commence mid-year this year (2012). The entire trial period would essentially take a period of around 15 months before we have the Phase II results. Obviously, then you have to do a Phase III study before final regulatory approval.

CEOCFO: Has the medical community taken notice?

Dr. Taraporewala: The medical community is increasingly taking notice. We have certain key opinion leaders who are well recognized internationally in the retinal ophthalmology treatment field, serving as advisors to our clinical program in moving this drug product forward. We are also getting word out with presentations at medical conferences and to ophthalmologists.

CEOCFO: Sounds very exciting!

Dr. Taraporewala: It is very exciting, and it is interesting that you bring that up, because we do have an additional differentiator between our drug and the currently approved therapies for wet-AMD. Lucentis and Eyelea are both large molecule biological drugs that target what is known as vascular endothelial growth factor (VEGF) which is implicated in the formation of the abnormal blood vessels at the back of the eyes that leak and cause the blindness in Wet-AMD. Squalamine, on the other hand, not only acts on VEGF, but also on additional growth factors, such as platelet derived growth factor (PDGF) and Basic Fibroblast Growth Factor (bFGF), which are increasingly being recognized as contributing to the etiology of wet-AMD as well. Our drug goes after multiple biochemical targets, and therefore has the potential to be synergistic or even more effective. It is a small molecule drug, cheap and easy to produce relative to the large molecule biological drugs that the currently approved therapies represent.

CEOCFO: You have some applications in the pipeline, what else is going on today?

Dr. Taraporewala: We have academic collaborations to do novel research on some of our other pipeline compounds. This research is being conducted in oncology, and in other therapeutic areas as well.

CEOCFO: Is there any correlation among the projects you are working on; are they the same technology with different applications, or are they different technologies?

Dr. Taraporewala: Our Squalamine drug can be used for both wet-AMD as well as in oncology applications because the anti-angiogenic and secondary mechanisms of the drug have clinical applications in both of those fields. Therefore, while at first glance they look like they are very disparate clinical applications, the scientific basis for these two different medical treatment areas with the same drug is evident. The immunomodulater drug that we are developing for cancer cachexia, OHR/AVR118 is a broad spectrum cytokine inhibiting drug that has much wider applications in areas other than cachexia, such as rheumatoid arthritis, where pro-inflammatory cytokine release is the cause of the problem. Our current clinical focus is in cachexia, but that drug may have applications in many other inflammatory disease conditions as well.

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

Dr. Taraporewala: We have recently done a raise at the end of last year that will get us to initiate the clinical trial for wet-AMD, and we will be exploring other options as well.

CEOCFO: Do the options include bringing in partnerships, or do you plan on continuing on your own?

Dr. Taraporewala: We are not actively pursuing partnerships at this stage. We intend to conduct the Phase II study in the wet-AMD with Squalamine on our own. However, we are a very entrepreneurial company and if partners do come in early in the game to start initiating the discussion process of moving the program forward on a joint basis, we would certainly entertain it. We would consider partnership discussions at this stage if what we determine is the “right fit” came along.

CEOCFO: Has the investment community been paying attention?

Dr. Taraporewala: We certainly would like to have increased visibility in the general investment community. To that end, we have retained an IR firm with whom we are working with in getting the message out. We are also going to be presenting at various medical and investor conferences in this coming year and this will also increase our visibility. Our press releases will be getting notice in the investment community, and we expect the pace of investor interest to pick up very well in what we expect to be a very eventful 2012.

CEOCFO: In closing, why should potential investors pay attention to Ohr Pharmaceutical today?

Dr. Taraporewala: Ohr is a very progressive entrepreneurial company. It has two Phase II stage clinical programs with drugs that have been previously shown safety and activity in the clinical applications, and the drugs address unmet medical needs. With all the upcoming events we anticipate in 2012, Ohr Pharmaceutical is poised to make a very large impact in the marketplace. We have exciting pipeline products that have multi-billion dollar aggregate sales potential in the US and abroad, and as we move ahead this year investors are going to sit up and take notice.


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Currently approved therapies for wet-AMD such as Lucentis or Eyelea require a shot into the eye to be given to a patient in an ophthalmologist’s office every few weeks. However, our drug could be conveniently self-administered daily by the patient or caregiver at home, much like glaucoma medication is given today. So from a patient preference and compliance perspective, this certainly adds a whole new dynamic to the AMD treatment market. - Dr. Irach B. Taraporewala



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