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Coyote Pharmaceuticals Initiates GMP Manufacturing Process for CNS-102 Following Successful Pre-IND Meeting
Date:2/13/2013

MENLO PARK, Calif., Feb. 13, 2013 /PRNewswire/ -- Coyote Pharmaceuticals, Inc., an emerging biopharmaceutical company focused on neurodegenerative diseases, announced today that it has initiated the GMP manufacturing process for CNS-102 following its recent pre-IND meeting with the Food and Drug Administration (FDA).  CNS-102 is being developed initially to treat amyotrophic lateral sclerosis (ALS).

In its meeting with the FDA, Coyote was advised to apply for Fast Track designation when it submits its Investigational New Drug (IND) application for CNS-102 for the treatment of ALS.  Coyote expects to file its IND in the fourth quarter of 2013 and commence a Phase 1 clinical study of CNS-102 in early 2014.

"Initiating the GMP manufacturing process for CNS-102 signals the first step in our clinical development program for ALS and follows a successful meeting with the FDA in which we were advised to seek Fast Track designation for CNS-102 in ALS," commented Hiroaki Serizawa , Ph.D., president, CEO & co-founder of Coyote Pharmaceuticals.  "Given that Fast Track designation is not typically discussed until Phase 2 data is produced, we view the FDA's position as very encouraging for our technology and strategy of targeting heat shock protein induction as a potential treatment for ALS."

According to the FDA, Fast Track designation is intended to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need.  The purpose is to get important new drugs to the patient earlier.  Most drugs eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review.  A Priority Review means that the time it takes FDA to review a new drug application is reduced.  The goal for completing a Priority Review is six months.

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