Israel-Medical-Healthcare

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Cypress Bioscience In-Licenses BioLineRx's Novel Antipsychotic

http://www.streetinsider.com/Press+Releases/Cypress+Bioscience+In-Licenses+BioLineRxs+Novel+Antipsychotic/5744253.html

SAN DIEGO, CA -- (MARKET WIRE) -- 06/20/10 -- Cypress Bioscience, Inc. (NASDAQ: CYPB) announced that Cypress has entered into an exclusive North American license for the development and commercialization of BioLineRx's novel antipsychotic (BL-1020, hereafter, CYP-1020), a potential breakthrough treatment for schizophrenia. Specific terms of the transaction were not disclosed, but the total upfront payment to BioLineRx was $30 million, with total potential clinical and regulatory milestones of up to $160 million through to approval in the United States (the majority of which are related to improvement in cognition), potential commercial milestones of $85 million, and a potential additional $90 million associated with approval for additional indications in the United States or for approval in other countries in North America. In addition, Cypress will fund all continuing development activities and pay BioLineRx a royalty based on applicable sales.

"This agreement reflects our renewed strategic focus on R&D, where we have successfully demonstrated leadership, creativity and a competitive advantage," said Jay D Kranzler, MD, PhD, Chairman and Chief Executive Officer of Cypress Bioscience. "This transaction represents a step down a path that we have successfully navigated before -- late stage, innovative drug development of a novel compound to address a significant unmet medical need. From fibromyalgia, and our success with Savella?, we believe Cypress has the experience and expertise required to successfully continue the development of CYP-1020, a novel antipsychotic that has the potential to address both the psychotic symptoms and cognitive deficits associated with schizophrenia. CYP-1020's data to date is compelling and we believe that it has the potential to set a new standard in the field as a first-line antipsychotic."

"This licensing agreement is a reflection of BioLineRx's proven business model, which focuses on conducting high-quality proof of concept programs with novel compounds and then partnering with companies which have the clinical and commercial expertise to help fully realize their potential. We believe that CYP-1020 is especially exciting, insofar as the cognitive impairments associated with schizophrenia reflect such a dramatic unmet medical need," said Kinneret Savitsky, PhD, Chief Executive Officer of BioLineRx.

Carol Tamminga MD, Professor of Psychiatry at the University of Texas Southwestern, a specialist in schizophrenia and translational neuroscience, and a BioLineRx consultant, said, "Patients with schizophrenia demonstrate symptoms in several functional domains, including psychosis and cognitive impairment. While antipsychotic therapies improve psychosis, there are no medications that affect cognition. CYP-1020 is a new antipsychotic drug candidate designed to reduce psychosis and augment cognition. Importantly, a recent proof of concept trial showed that CYP-1020 not only reduced psychosis compared to placebo, but it also improved cognition as compared to both placebo and an active control. This is a remarkable finding and will generate enormous enthusiasm in the field, if it can be replicated and its implications for psychosocial function demonstrated."

As a result of funds received from the Office of Chief Scientist of the Ministry of Industry, Trade and Labor of the State of Israel, or the OCS, in respect to BioLineRx's preclinical and clinical program related to CYP-1020, the effectiveness of the license agreement is subject to the consent of the OCS and OCS may condition providing its consent on the parties' agreeing to modifications in the license agreement. Cypress and BioLineRx have agreed to work together to attempt to secure OCS approval on terms that minimize financial and non-financial obligations on the parties that may be imposed as a condition to receipt of the OCS consent. Cypress is not required to agree to any modifications to the license agreement that would have, or would be likely to have, a material adverse impact on its rights and obligations under the license agreement, and whether OCS provides its consent on terms acceptable to Cypress, and the timing of any such consent, cannot be estimated at this time. BioLineRx has agreed that it will assume sole responsibility for any financial obligations imposed by the OCS. In addition, the upfront payment was placed into an escrow account pending receipt of a satisfactory OCS consent and effectiveness of the license agreement.

CYP-1020 Phase 2b Trial Design

BioLineRx designed and conducted a six week, double blind, placebo and active-comparator (risperidone) controlled multisite phase 2b clinical trial. The phase 2b EAGLE (Effective Antipsychosis via GABA Level Enhancement) study was conducted under a U.S. Food and Drug Administration Investigational New Drug Application (IND) at 40 sites in the U.S., Europe and India and included patients suffering from acute exacerbation of schizophrenia. In this six week study, 363 patients were randomized equally to treatment with low (10 mg/day) or high (20-30mg/day) dose of CYP-1020, risperidone (2-8mg/day) or placebo.

The study was designed to demonstrate statistically significant superiority of CYP-1020 to placebo on the primary efficacy measure, the change from baseline in the total score of the Positive and Negative Symptoms of Schizophrenia (PANSS). Risperidone at a dose of 2-8 mg was included as a positive control to validate the trial results.

Cognitive function in the EAGLE trial was measured by the Brief Assessment of Cognition in Schizophrenia (BACS) neuropsychological battery. The BACS test battery assesses a variety of aspects of cognition, including: verbal memory, working memory, motor speed, verbal fluency, attention and speed of information processing, and executive functioning. All of these functions are significantly impaired in patients with schizophrenia(1).

CYP-1020 Phase 2b Data

Results of the phase 2b EAGLE study demonstrated that CYP-1020 at the 20-30mg dose range exhibited clinically relevant and statistically significant improvement on the cognition endpoint assessed using the BACS neuropsychological test battery. The 20-30mg dose range of CYP-1020 was superior to both risperidone and placebo at endpoint on the BACS total score (p=0.027 for both), with positive trends in all subsets within the BACS.

CYP-1020 was also effective as a treatment for the other symptoms of acute schizophrenia exacerbation, as measured by the Positive and Negative Symptom Scale (PANSS). The CYP-1020 high dose group (20-30mg/day) experienced a statistically significant reduction in the PANSS from baseline versus placebo (LS mean -23.6 vs. -14.4; p=0.002). The superiority of CYP-1020 (20-30mg/day) over placebo was also supported by additional secondary efficacy measures such as the clinical global impression of severity (CGI-S) and change (CGI-C).

The incidence of serious adverse events was low in the CYP-1020 (20-30mg/day) group (0%) compared to risperidone (3.3%) and placebo (6.5%). Discontinuations due to adverse events (AEs) were similar in the CYP-1020 (20-30mg/day) group and in the placebo group (4.3%) but higher in the risperidone group (8.8%). There were no statistically significant or clinically relevant metabolic related AEs including body weight gain, glucose increases, or changes in lipids. The incidence of cardiovascular, sexual, psychiatric, autonomic and gastrointestinal AEs was low and did not increase compared to placebo. There were no statistically significant or clinically relevant changes in subject electrocardiography (ECG), laboratory or vital signs (blood pressure, heart rate, temperature).

Recent results from an extension trial showed that patients receiving CYP-1020 (20-30mg/day) for six additional weeks maintained the improvements on the PANSS and CGI that had been observed after the initial six weeks of treatment and, more importantly, showed continuing improvement in cognitive function as assessed by the BACS. The 12 weeks of treatment were not associated with any increased toxicities.

About CYP-1020

CYP-1020 (formerly BL-1020) is a first-in-class GABA-enhanced antipsychotic that combines dopamine antagonism with GABAergic activity. CYP-1020's dopamine antagonism reflects a well-established pathway to improve the psychotic symptoms of schizophrenia. Furthermore, both preclinical and clinical data suggest that CYP-1020's GABA enhancement may provide the basis for improved cognition

About Schizophrenia...snip