Tikvah Therapeutics Signs Agreement with Phase 2 Discovery to Develop and Commercialize LY156735, a Second Generation Melatonin Agonist, for Circadian Rhythm and Sleep Disorders
ATLANTA, Aug. 29, 2007 -- Atlanta-based Tikvah Therapeutics, Inc., a biopharmaceutical company focused on new treatment options to better manage central nervous system diseases, announced today that it has signed a licensing agreement with Phase 2 Discovery, a drug development company affiliated with researchers at the University of Cincinnati School of Medicine, Department of Psychiatry, for worldwide rights to develop and commercialize LY156735 for the treatment of circadian rhythm, sleep disorders and depression. Tikvah Therapeutics will also explore additional indications for LY156735 through its own research and development efforts in special subpopulations, and other general conditions of sleep deprivation and/or insomnia, among others.
Phase 2 Discovery (P2D) acquired LY156735 from Eli Lilly in 2001. Under their own IND, P2D has already generated substantial Phase II clinical data demonstrating statistically significant improvement in both objective and subjective sleep measures. Pilot clinical studies, conducted by P2D in response to the unique receptor binding profile of LY156735, suggest that improved efficacy in standard measures of sleep may be possible compared to another melatonin agonist. Further, in patients with severe insomnia, LY156735 significantly decreased latency to persistent sleep compared to placebo. Efficacious results were also obtained in pilot clinical studies where jet lag was induced by a time shift in an aerospace temporal isolation clinical laboratory unit.
In receptor binding studies, LY156735 has equal or better affinity for 5-HT2c receptors as agomelatine, a molecule which acts as an antidepressant, in part, through interaction with melatonin receptors and 5-HT2 receptors. The potential antidepressant actions of LY156735 have been shown in a preclinical rodent model of antidepressant activity.
``The use of LY156735 in treating circadian rhythm disorders, in general as well as in specific subpopulations, appears to have significant clinical implications. We are also interested in exploring further its potential utility in the treatment of depression,'' said Dr. Harold H. Shlevin, President and CEO of Tikvah Therapeutics, Inc. ``The licensing of this Phase II molecule fits nicely with Tikvah Therapeutics' risk reduction and commercialization strategy.''
P2D will be transferring its open IND for LY156735 to Tikvah Therapeutics which will then assume responsibility for the further clinical development and commercialization of the compound, which will be known as TIK-301.
``We are pleased to have licensed the LY156735 technology to Tikvah Therapeutics,'' said Dr. Stephen M. Strakowski, President of P2D and interim chairman of the Department of Psychiatry of the University of Cincinnati School of Medicine and Director of the Center for Imaging Research, a core facility of the University of Cincinnati School of Medicine. ``We are excited to be working with the outstanding research and development team that Dr. Shlevin has recruited to Tikvah.''
About Tikvah Therapeutics
Tikvah Therapeutics focuses on exploring new uses for late stage development compounds in which new therapeutic uses have been confirmed in multiple, new clinical proof-of-concept studies. This strategy shortens product development timelines -- in some cases by up to seven years -- and substantially decreases the risk associated with the research and development efforts. A second prong of its strategy is to focus on specialized products with multiple stepping-stone indications and strong patent protections for the new uses, thus helping to ensure manageable commercial risk.
Tikvah's pipeline already includes Phase II compounds such as TIK-201, an agent initially targeted to treat neurodegenerative diseases; TIK-101 and other NMDA receptor agonists for treatment of a variety of anxiety disorders and chronic pain; and multiple other products under consideration.
For further information, please see http://www.tikvahtherapeutics.com.
The Tikvah Therapeutics, Inc. logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=3966.
About Phase 2 Discovery
Phase 2 Discovery (P2D) is a pharmaceutical company focused on developing innovative drugs that fulfill unmet medical needs in the treatment of central nervous system (CNS) disorders such as insomnia, anxiety, depression, attention disorders and neurodegenerative diseases.
P2D uses its understanding of the treatment of CNS disorders and neurodegenerative diseases and its experienced team and seeks to advance a product candidate through clinical proof of concept by producing powerful and compelling clinical data and then seeking partners to complete development and commercialization. P2D is directed by Stephen M. Strakowski, M.D., Professor of Psychiatry, Psychology, Neuroscience & Biomedical Engineering. Dr. Strakowski is President and CEO of P.P.S.I., Inc., a 265 employee physician group that performs clinical trials research for major pharmaceutical companies and receives research grants from various sources. He is Interim Chairman of the Department of Psychiatry at the University of Cincinnati College of Medicine and Interim Clinical Chief of Psychiatry at University Hospital. He is Director of the University of Cincinnati College of Medicine Center for Imaging Research. He serves on study sections at the NIH and VA federal grant review subcommittees and is a reviewer for most of the major psychiatric journals.
Forward-Looking Statement:
This press release contains certain forward-looking information that is intended to be covered by the safe harbor for ``forward-looking statements'' provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as ``expect(s),'' ``feel(s),'' ``believe(s),'' ``will,'' ``may,'' ``anticipate(s)'' and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, financial projections and estimates and their underlying assumptions; statements regarding plans, objectives and expectations with respect to future operations, products and services; and statements regarding future performance. Such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of Tikvah Therapeutics Inc., that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include: those generally associated with developmental stage biopharmaceutical companies; the progress or likelihood of success of our product research and development programs including, but not limited to, those related to the development of LY156735; the status of our preclinical and clinical development of potential drugs; the likelihood of success of our drug products in clinical trials and the regulatory approval process; our drug products' efficacy, abuse and tamper resistance, onset and duration of drug action, ability to provide protection from overdose, ability to reduce the development of tolerance, ability to improve symptomatology or otherwise improve patients' symptoms; the incidence of adverse events; the ability to develop, manufacture, launch and market our drug products; our projections for future revenues, profitability and ability to achieve certain sales targets; our estimates regarding our capital requirements and our needs for additional financing; the likelihood of obtaining favorable scheduling and labeling of our drug products; the likelihood of regulatory approval under Section 505(b)(2) and other applicable Sections under the Federal Food, Drug, and Cosmetic Act; our ability to develop safer and improved versions of widely-prescribed drugs using our technology; and our ability to obtain favorable patent claims. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Tikvah Therapeutics, Inc. does not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.