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Clinical Data, Inc. Receives Notice of IND Filing by Santen, Inc. and Upcoming $2 Million Milestone Payment for A2A Agonist Development Program Focused on Glaucoma Treatments
12/22/2010 7:00:19 AM
NEWTON, Mass.--(BUSINESS WIRE)-- Clinical Data, Inc. (NASDAQ: CLDA), today announced that Santen Pharmaceutical Co., Ltd. (Osaka Stock Exchange: 4536), has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Clinical Data’s highly selective adenosine A2A agonist, ATL313, for the indication of primary open angle glaucoma and ocular hypertension. Under the terms of a license agreement for ATL313 entered into by Santen and Clinical Data in April 2010, the IND filing gives rise to a $2 million milestone payment to Clinical Data on or before January 15, 2011. Santen plans to initiate clinical trials of ATL313 in early 2011, pending FDA approval of the IND application.
In addition to this milestone payment, Clinical Data is also entitled to receive further development, regulatory and commercial milestone payments subject to the fulfillment of certain conditions, as well as royalties on product sales. Clinical Data has retained intellectual property rights for the development of ATL313 outside of the field (field is defined as any ophthalmic disease, disorder or condition treated by topical administration into the eye), as well as rights to use the data generated from the collaboration for purposes outside the field.
“Achieving this milestone with Santen, a world-leader in developing ophthalmic treatments, further validates the potential of our pipeline of products that selectively target adenosine receptors,” said Drew Fromkin, President and CEO of Clinical Data. “During the last few months, we and our collaborators have continued to announce encouraging preliminary results from studies of ATL313 in pain, multiple sclerosis, multiple myeloma and atherosclerosis. This is indicative of the opportunities that are available to us for advancing the development of our product portfolio for a variety of indications.”
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.
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, including blindness or visual loss. According to the World Health Organization, glaucoma is the second leading cause of blindness worldwide, 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 Zalicus (formerly 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’s mission is to develop first-in-class and best-in-category therapeutics. The Company is advancing its late-stage drug candidates for central nervous system disorders and cardiovascular diseases, to be followed by promising drug candidates in major therapeutic areas including oncology and inflammatory diseases. To learn more, please visit the Company's website at www.clda.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 September 30, 2010, and Current Reports on Form 8-K filed from time to time by Clinical Data.