Cypress Bioscience Acquires Novel Intranasal Carbetocin Therapy for Autism
Therapy May Represent Novel Approach to Treating the Repetitive Behaviors and Social Deficits of Autism
SAN DIEGO, CA--(Marketwire - August 26, 2010) - Cypress Bioscience, Inc. (NASDAQ: CYPB), a pharmaceutical company engaged in the development of innovative drugs to treat central nervous system (CNS) disorders, today announced that it has acquired patent rights and technology related to a novel, intranasal formulation of carbetocin, a potential breakthrough treatment for the core symptoms of autism. The therapy, which was developed by Marina Biotech, Inc. (NASDAQ: MRNAD), is expected to further strengthen Cypress' CNS pipeline.
Under the terms of the agreement, Cypress will make an upfront payment to Marina Biotech of $750,000. Subject to certain late-stage clinical and regulatory milestones, including approval in the United States, Cypress may make up to $27 million in additional payments to Marina Biotech. Cypress will also fund all continuing development activities and pay single-digit royalties to Marina Biotech based on commercial sales, if any.
"We are enthusiastic about this acquisition, which exemplifies our strategy to build one of the highest quality CNS pipelines in the industry," said Jay D. Kranzler, MD, PhD, Chairman and Chief Executive Officer of Cypress Bioscience. "Given the number of autism cases in children, we believe that the addition of this novel therapy will enable us to address an important unmet medical need. The intranasal formulation of carbetocin is based on well-established pharmacology, and we believe that this therapy could be a breakthrough in the treatment of the core symptoms of autistic spectrum disorder. We plan to work expeditiously and expect to announce details regarding the clinical program in the coming months."
"Over the past decade, the rates of diagnosis of autistic spectrum disorders have increased by more than 50%1," said Christopher McDougle, MD, Albert E. Sterne Professor and Chairman of the Department of Psychiatry, Indiana University School of Medicine, Indianapolis. "Carbetocin represents a potential treatment that, for the first time, targets the core symptoms of autism, particularly the social impairments and repetitive behaviors associated with this devastating disease. If successful, carbetocin could revolutionize the treatment of autism, thereby improving the lives of those individuals and families affected by this condition."
Carbetocin is a synthetic version of the endogenous hormone, oxytocin, modified for greater serum half-life. This compound was originally developed by Ferring Pharmaceuticals and is sold in multiple countries outside of the U.S. solely in a parenteral form for the treatment of postpartum hemorrhage. Marina Biotech, with its expertise in intranasal peptide delivery originating from its predecessor company, Nastech Pharmaceuticals, developed an intranasal formulation of this agent with the goal of assessing its efficacy for the treatment of autism. Phase 1 studies have been completed with this novel formulation.
Autistic spectrum disorders are developmental disorders that affect one in 110 children in the U.S., per recent surveys completed by the Centers for Disease Control2. These disorders are characterized by social impairments, repetitive behaviors, and, in more severe subgroups, by language and communication deficits as well as intellectual impairments2, 3. The social impairments can take the form of abnormal eye contact and body language, a lack of age-appropriate peer relationships, and a lack of social reciprocity. The spectrum of repetitive behaviors can include restricted interests, a need for rigid routines or rituals, stereotypes, and odd preoccupations. Both of these core symptoms have profound effects upon the lives of affected individuals and their caregivers. The cost to society on the whole in the U.S. alone is estimated at over $35 billion per year4, 5.
About Marina Biotech
Marina Biotech (formerly known as MDRNA, Inc.) is a biotechnology company focused on the development and commercialization of therapeutic products based on RNA interference (RNAi). Marina Biotech's pipeline currently includes a clinical program in Familial Adenomatous Polyposis (a precancerous syndrome) and two preclinical programs -- in hepatocellular carcinoma and bladder cancer. Marina Biotech's goal is to improve human health through the development of RNAi-based compounds and drug delivery technologies that together provide superior therapeutic options for patients.
About Cypress Bioscience
Cypress Bioscience is a pharmaceutical company dedicated to the development of innovative drugs targeting large unmet medical needs for patients suffering from a variety of disorders of the central nervous system. Since 1999, Cypress has received multiple FDA approvals, including for ProsorbaTM, a medical device for rheumatoid arthritis, and Savella® (milnacipran HCl), for fibromyalgia. The Company focuses on generating stockholder value by reaching clinical development milestones as quickly and efficiently as possible. Cypress' currently marketed products include Savella and the AvisePG(SM) and AviseMCV(SM) therapeutic monitoring, diagnostic and prognostic testing services for rheumatoid arthritis. Development-stage assets include BL-1020 for cognitive impairment in schizophrenia, as well as AVISE-SLE(SM), a lupus diagnostic testing service. More information on Cypress and its products and development assets is available at http://www.cypressbio.com/.
This press release, as well as Cypress' SEC filings and website at http://www.cypressbio.com, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include statements with respect to carbetocin's mechanism of action and its potential to strengthen Cypress' CNS pipeline, treat autistic spectrum disorder and revolutionize the treatment of autism, statements regarding Cypress' ability to obtain regulatory approval for and to commercialize carbetocin and statements with respect to Cypress's business strategy. Actual results could vary materially from those described as a result of a number of factors, including risks involved with the high uncertainty that characterizes research and development activities in general, particularly those of drug development, including the risks that carbetocin may not demonstrate adequate safety and/or efficacy in subsequent clinical trials to support continued development, may not have adequate intellectual property right protection to support its continued development, may be unable to obtain FDA or similar regulatory approval as a drug candidate for any of many reasons relating to the regulatory approval process, or may address a commercial market that is smaller than currently anticipated by Cypress and that does not support its continued development, or that Cypress may otherwise fail to successfully develop and commercialize carbetocin, and other risks and uncertainties described in Cypress' most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and any subsequent SEC filings. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "potential," "expects," "plans," "anticipates," "intends," or the negative of those words or other comparable words to be uncertain and forward-looking. The statements in this press release speak only as the date hereof, and neither Cypress nor Marina Biotech undertakes any obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
1 Prevalence of Autism Spectrum Disorders -- Autism and Developmental Disabilities Monitoring Network, United States, 2006, http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5810a1.htm.
3 Levy et al. Autism. Lancet (2009) vol. 374 (9701) pp. 1627-38.
4 Shimabukuro et al. Medical expenditures for children with an autism spectrum disorder in a privately insured population. J Autism DevDisord (2008) vol. 38 (3) pp. 546-52.
5 Ganz, M.L. The costs of autism. In: Moldin SO, Rubenstein JLR. Understanding autism: from basic neuroscience to treatment (1st ed). Boca Raton (FL): CRC Press; 2006:475-502.