FDA approval for commencing Phase II trials in the US for the Accordion- Zaleplon for Sleep Disorders
On September 14, 2010, Intec Pharma was informed that it received the approval of the US Food and Drug Administration (the "FDA") for the commencment of Phase II trials in the USA for the Accordion Zaleplon Pill.
Accordion Zaleplon is a proprietary product, designed to enhance the Zaleplon medication, which is currently marketed as a treatment for sleep disorders (insomnia). By incorporation of Zaleplon into the Accordion Pill, and retaining it in the stomach for the majority of the night for the purpose of releasing it in a continuous manner throughout the night, the Accordion Zaleplon aims to maintain continuous sleep while not causing a "hangover" phenomenon on the following morning.
With the receipt of the aforementioned FDA approval, Intec Pharma plans to commence the Phase II clinical trials. These clinical trials are planned to be conducted at leading sleep clinics in a number of medical centers in Israel and the USA. The trials are planned to take place over the course of a few months, in which tfhe dozens of particpants suffering from insomnia shall receive the Accordion Zaleplon Pills. During these trials, serveral parameters shall be examined, including number of awakenings, duration of the awakenings, duration of sleep throughout the night, etc.
According to various publications (Datamonitor, Forecast Insight, Insomnia, Aug 2008), the Insomnia market was estimated at approximately US$4.1 billion in the year 2007 in the seven major markets (USA, Japan, UK, France, Germany, Switzerland and Italy) and it is estimated to grow to approximately US$6.8 billion in the seven main markets by the year 2017.
Developing the Accordion Zaleplon is part of the Company`s activity of improving existing drugs based on patented technology, by extending the absorption phase of these drugs through longer periods of gastric retention. Drug improvement can be manifested by enhancing effectivness, significantly reducing the side effects of such drugs, reducing freqanut daily dosing , etc.
The Company's estimates regarding future development and expected clinical trials with respect to the Company's products, are forward looking information based upon information pertaining to potential drug development and the indications received from relevant health care authorities, that the Company has in its possession today. These estimates may not be realized, in whole or in part, and/or may be realized differently than estimated, as a result of different factors, including failure to reach the objectives of the studies and/or schedules and/or necessary funding for further drug development as well as failure to obtain regulatory approvals required for further development, failure to reach agreements with international pharmaceutical companies and other factors which are not within the Company's control and the materialization of any of the risk factors as detailed in Section 6.31 of the Company`s prospectus filed on February 10, 2010.
Sincerely,
Intec Pharma
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