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Amarex and SyneuRx Announce FDA Approval of Breakthrough Designation for Schizophrenia Treatment

Germantown, MD, USA (December 10, 2014) – Amarex and SyneuRx announced today, the FDA's first Breakthrough therapy designation for a schizophrenia treatment, an adjunctive treatment of adult schizophrenia. The designation will allow Amarex and the product's sponsor, SyneuRx, to work directly and frequently with the FDA to help this promising product move quickly towards approval for the treatment of a serious condition.

Dr. Emil Tsai, SyneuRx's CSO, stated that "this breakthrough designation is based upon a novel mechanism that will revolutionize the treatment of schizophrenia. SND-13, the therapeutic under late phase development, represents the third generation antipsychotic that not only addresses the positive symptoms like exaggerations and distortions of normal perception and thinking but, more importantly, the negative symptoms such as inexpressive faces, blank looks, monotone and monosyllabic speech, seemingly lack of interest, and inability to feel pleasure or act spontaneously, that the available antipsychotics cannot improve."

The breakthrough designation expedites the development and review of drugs for serious and lifethreatening conditions. FDA will allow for accelerated review of aspects of the development program, appoint a cross-disciplinary project lead to facilitate and serve as scientific liaison, ensure the design of clinical trials is as efficient as possible, and hold meetings and provide advice as the development program progresses.

The FDA's approval for the designation provides validation of preliminary data generated so far. Amarex CEO, Dr. Kazem Kazempour, explained that "justification for a breakthrough therapy designation requires clinical evidence that the drug may provide substantial improvement of a clinically significant endpoint over available therapies." Amarex and SyneuRx will continue to work together with the FDA to achieve a rapid approval for this very beneficial therapy.

Schizophrenia is a major mental disorder with 1% prevalence worldwide. Antipsychotics are the number one top selling class of medication for the treatment of psychotic symptoms.

About SyneuRX

SyneuRX is a global biotech company currently focused on the scientific discovery and clinical development of novel treatments for CNS illnesses, many of which face serious and disabling conditions and yet existing therapies have limited efficacies.

About Amarex Clinical Research

Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs, FDA Applications and Submissions, Applications and Submissions to international Health Authorities, GxP Compliance Audits, Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management and General Consulting. Amarex has taken clients’ products through the entire approval process from writing the initial product approval strategy to the marketing approval application with a growing list of approved products. Amarex is committed to cost effective, high quality clinical product development.

Amarex Contact:
Patrick J. Burke
Business Development
patrickb@amarexcro.com

20201 Century Blvd., Fourth Floor
Germantown, MD 20874 USA
301 528 7000
www.amarexus.com

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