Ohr Pharmaceutical, Inc. (NASDAQ:OHRP)

NEW YORK, NY--(Marketwire - May 14, 2012) - Ohr Pharmaceutical Inc. (OTCBB: OHRP) announced today that its Squalamine Eye Drops, a potent inhibitor of multiple growth factors implicated in angiogenesis, has been awarded Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of the wet form of macular degeneration (wet-AMD).

"We believe the Fast Track designation underscores the importance of developing an eye drop for the treatment of wet-AMD and its potential to address an unmet medical need for this large and growing patient population," commented Dr. Irach B. Taraporewala, CEO of Ohr. "Our eye drop could provide tremendous benefit to these patients who currently need to take chronic intravitreal injections of Roche/Genentech's Lucentis® or Regeneron's Eylea® directly into the eye. We are thrilled with the continued progress of the program and anticipate commencing a Squalamine Eye Drop phase II clinical trial in the third quarter of 2012."

The Company recently presented data from a key biodistribution and safety study at the ARVO 2012 Annual Meeting, which highlighted the potential therapeutic value of the Squalamine eye drop program in treating wet-AMD and ophthalmic neovascular disorders. The results indicated the following:

• Rapid uptake to the posterior sclera/choroid ocular tissues with slow tissue clearance
• Sustained Squalamine concentrations well above threshold anti-angiogenic levels, which persist throughout the period in between doses ("trough level")
• Safety to ocular tissues with no signs of ocular adverse clinical findings, consistent with previous longer term toxicity studies
• Negligible systemic uptake which minimizes the potential for systemic adverse events

Fast Track Designation in the United States
Under the FDA Modernization Act of 1997, the Fast Track process was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. A potential drug that receives Fast Track designation is eligible for Accelerated Approval, which provides for a potential approval by the FDA on the basis of a demonstrated effect on a surrogate endpoint deemed reasonably likely to predict clinical benefit, and Rolling Review, which facilitates the submission of individual sections of a New Drug Application (NDA) as they are completed for review by FDA. In addition, Fast Track designation for a potential drug may allow more frequent meetings between the sponsor and FDA to discuss the proposed development plan and ensure collection of appropriate data needed to support approval, as well as possibly more frequent written correspondence from FDA about such matters as the suitability of designs for proposed clinical trials. Many drugs that are eligible for Fast Track designation are also considered appropriate to receive Priority Review, an additional designation that may reduce the time required for FDA review.