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Zysis Receives US Patent for Long Acting Oral Aripiprazole Once Weekly
Date:11/13/2013

LONDON, November 13, 2013 /PRNewswire/ --

First-in-class antipsychotic therapy for Schizophrenia and Bipolar Disorders

Zysis, a private pharmaceutical company optimising therapies for disorders of the Central Nervous System, today announced that the United States Patent and Trademark Office has granted U.S. patent 8,575,172 covering its Phase II ready Long Acting Oral Aripiprazole Once Weekly (LAO Aripiprazole OW) product, a first-in-class antipsychotic therapy for orally dosed relapse prevention in patients suffering from Schizophrenia and Bipolar Disorders.

LAO Aripiprazole OW with medically supervised dosing is an alternative option to Long Acting Injectables (LAI) in the rapidly expanding market for prevention of psychotic relapse.  Non-adherence rates are extremely high with schizophrenia therapy; around 75% of patients are non-adherent within two years of being discharged from hospital[1], the consequences of which are medically and economically severe with 69% of patients with poor adherence suffering a relapse[2].

Peter Cozens, Chairman of Zysis said: "LAO Aripiprazole OW is a promising, cost effective option in the treatment of Schizophrenia, Schizoaffective Disorder and Bipolar Disorders for the large number of patients struggling with adherence.  We are very pleased to receive the U.S. Patent. This is an important event for Zysis. LAO Aripiprazole OW represents a breakthrough treatment providing another option to address unmet patient needs while improving their quality of life." 

Dr Robert Millet, Distinguished Fellow of the American Psychiatric Association and renowned US expert in long-acting therapies for the treatment of psychotic symptoms at Carolina Behavioral Care added: "I see adherence as a major factor in schizophrenia treatment today and this once weekly therapy has the potential to provide a very real benefit in relapse prevention for those patients struggling to comply to daily oral treatment but who are not ready for monthly injectable therapy"

Professor Allan Young, Professor of Psychiatry at Imperial College London added: "Adherence is a big issue and contributes significantly to poorer outcomes in schizophrenia and bipolar disorder. The potential market for a weekly oral antipsychotic would likely be significant, and an accompanying "compliance" package would be welcomed by the community."


The recently granted U.S. Patent covers the treatment of psychotic conditions with orally-delivered formulations of aripiprazole that provide for sustained-release, once-weekly therapy. Patents have already been granted in Europe, Israel and Australia and applications are pending in Canada, South Korea and Japan. The new patent and related applications are all solely owned by Zysis.

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1. Weiden PJ et al. Psychiatr Serv, 1995; 46: 1049-1054

2. Morken G et al. BMC Psychiatry, 2008;  8: 32-38

Notes to editors:

About Zysis

Zysis is a privately-owned specialty pharmaceutical company optimising therapies for disorders of the central nervous system (CNS).  Zysis has reformulated aripiprazole, an effective antipsychotic molecule, to provide a patent-protected, sustained-release, once-weekly maintenance phase therapy in oral tablet form to improve clinical outcomes in schizophrenia and bipolar disorder therapy. Formulation development / initial Phase I studies have been successfully completed and the Phase II clinical programme has been established.  Zysis is currently seeking funding to progress the phase II study either through licensing or by raising finance. http://www.zysis.com

About LAO Aripiprazole Once Weekly

LAO Aripiprazole Once Weekly with medically supervised dosing is intended to reduce relapse rate in the population of schizophrenic and bipolar patients who require approaches to increase adherence but who are not ready yet for the highly invasive and extremely expensive option of the LAIs.  The ability to achieve oral once weekly dosing for aripiprazole comes from a combination of sustained release technologies; long drug plasma half-life; and the very slow disassociation of drug from the D2 receptors in the brain which appears to be unique to this anti-psychotic.   LAO and LAI products are highly synergistic in the market and provide a broader range of options for use in improving adherence, dependent on severity of the condition and relapse history of the patients. 


For further information, please contact:

Zysis
Dr Peter Cozens, Chairman
Tel: +44-1798-831278

Hume Brophy
Mary Clark, Hollie Vile, Supriya Mathur
Tel: +44-20-3440-5653
Email: healthcareteam@humebrophy.com


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