NEWTON, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Clinical Data, Inc. (NASDAQ: CLDA), and Santen Pharmaceutical Co., Ltd. (Osaka Stock Exchange: 4536), today announced that Santen has exercised its option to license Clinical Data’s highly selective adenosine A2A agonist compound, ATL313, for the development of topical treatments for certain ophthalmic diseases, including glaucoma. ATL313, a promising late-stage preclinical compound, has shown significant pharmacological effects in vivo and has been nominated as a clinical candidate.
Under the license agreement, Clinical Data will receive an upfront payment of $2 million, followed by development, regulatory and commercial milestone payments subject to the fulfillment of certain conditions, as well as royalties on product sales. In exchange, Santen will obtain a worldwide license to adenosine agonist ATL313 and an option for an additional compound for the development and commercialization of treatments for certain ophthalmic diseases, including glaucoma. Clinical Data will retain intellectual property rights for the development of ATL313 outside of the field of any ophthalmic disease, disorder or condition by topical administration into the eye, as well as rights to use the data generated for purposes outside the field. Clinical Data has licensed certain of these rights to CombinatoRx, Inc. for developing B-cell cancer therapies, retaining a co-development option after review of initial Phase IIa study results.
“The agreement with Santen, one of the world’s leading pharmaceutical companies specializing in ophthalmic diseases, results from a growing body of data supporting the use of our highly selective adenosine A2A agonists for treating certain eye disorders,” said Drew Fromkin, President and CEO of Clinical Data. “We continue to seek new opportunities that will advance the development of our adenosine compounds for other indications, including inflammatory and pain disorders.”
In May 2007, Santen entered into an option agreement to evaluate Clinical Data’s library of adenosine A2A agonists in an effort to identify and confirm activity in one or more lead compounds. Encouraging results from advanced preclinical studies led to the selection of ATL313 for further development of topical ophthalmic treatments by Santen. Santen also retains an option to an additional compound, to be exercised within a year from signing the license agreement.
“We are encouraged by the results of our work with Clinical Data’s adenosine compounds to date and based on continued positive findings from further studies, plan to file an IND for ATL313 in the shortest possible time or hopefully in a year,” said Akira Kurokawa, President and CEO of Santen.
Glaucoma is caused by a build-up of fluid in the eye that creates pressure and damages the optic nerve, resulting in major visual defects, such as blindness or visual loss. According to the World Health Organization, glaucoma is the second leading cause of blindness, affecting 1 in 200 people aged 50 and younger, and 1 in 10 people over the age of 80. There are over 2 million people in the U.S. with glaucoma,1 and the incidence is expected to rise to over 3 million over the next 10 years.2 Total worldwide sales of products used to diagnose and treat glaucoma amounted to over $4 billion in 2008, with pharmaceuticals accounting for the majority of these revenues.
About Clinical Data’s Adenosine Compounds
The promise of agents targeting adenosine receptors is well established, however, their therapeutic potential has been limited by a lack of receptor selectivity and unwanted side effects. Clinical Data’s adenosine compounds are developed to optimize receptor selectivity and pharmacokinetics to improve tolerability and enhance overall therapeutic potential. Clinical Data’s most advanced adenosine receptor targeted product candidate is Stedivaze, a highly selective A2A agonist, which is in Phase III clinical development for use as a pharmacologic stress agent during myocardial perfusion imaging (MPI). Clinical Data also has an A2B receptor antagonist in preclinical development as an oral treatment for Type II diabetes and asthma, with Novartis holding an option to license these programs. In addition to existing license agreements with Santen and CombinatoRx, Inc. for the development of Clinical Data’s adenosine agonists in the fields of ophthalmology and B-cell cancers, respectively, Clinical Data continues to evaluate other adenosine compounds for a variety of indications, including pain and inflammatory conditions.
About Clinical Data, Inc.
Clinical Data develops first-in-class and best-in-category therapeutics. Clinical Data is advancing its late-stage drug candidates for central nervous system disorders and cardiovascular diseases, to be followed by promising drug candidates in other major therapeutic areas. Clinical Data combines its drug development and biomarker expertise in an effort to develop products with enhanced efficacy and tolerability to improve patient health and reduce costs. To learn more, please visit the Company's website at www.clda.com.
About Santen Pharmaceutical Co., Ltd.
Founded in 1890, Santen is a $1 billion global company headquartered in Osaka, Japan. Santen researches, develops and markets ophthalmic products for physicians worldwide. Among prescription ophthalmic pharmaceuticals, Santen holds the top share within the Japanese market and is one of the leading ophthalmic companies worldwide. Santen has subsidiaries in the U.S., Europe, and Asia, including its Napa, California based Santen Inc., its Tampere, Finland based Santen OY and its Suzhou, China based Santen Pharmaceutical (China) Co., Ltd. For more information, visit www.santen.com.
CLINICAL DATA’s SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains certain forward-looking information and statements that are 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, statements about the potential for Santen to develop ATL313 as a treatment for any ophthalmic disease; our ability to obtain regulatory approval for, and successfully introduce our new products; our ability to expand our long-term business opportunities; and statements regarding future performance. All of such information and statements are subject to certain risks and uncertainties, the effects of which are difficult to predict and generally beyond the control of Clinical Data, 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, but are not limited to, whether any treatment developed by Santen under our license agreement will begin, and thereafter advance further in, the clinical trials process and whether and when, if at all, any such treatment will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any treatment developed by Santen under our license agreement will be successfully marketed if approved; the strength and enforceability of our intellectual property rights; competition from pharmaceutical, biotechnology and diagnostics companies; whether Clinical Data will be able to develop or acquire additional products and attract new business and strategic partners; and those risks identified and discussed by Clinical Data in its filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward looking statements that speak only as of the date hereof. Clinical Data 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. Readers are also urged to carefully review and consider the various disclosures in Clinical Data's SEC periodic and interim reports, including but not limited to its Annual Report on Form 10-K for the fiscal year ended March 31, 2009, Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2009, and Current Reports on Form 8-K filed from time to time by Clinical Data.
SANTEN’s FORWARD LOOKING STATEMENTS
Information provided in this press release contains so-called “Forward-looking Statements”. The realizations of these forecasts are subject to risk and uncertainty from various sources. Therefore, please note that the actual results may differ significantly from the forecasts. Business performance and financial condition are subject to the effects of change in regulations made by the governments of Japan and other nations concerning medical insurance, drug pricing and other systems, and to fluctuations in market variables such as interest rates and foreign exchange rates.
1Statistics and data. National Eye Institute. http://www.nei.nih.gov/eyedata/pbd_tables.asp. Updated October 2008. Accessed March 9, 2009
2Friedman DS, Wolfs RC, O’Colmain BJ, et al. Prevalence of open-angle glaucoma among adults in the United States.
Clinical Data, Inc.
Theresa McNeely, 617-527-9933 x3373
Santen Pharmaceutical, Co., Ltd.
Takashi Hibi, +81-6-6321-9957
Corporate Communication Group
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