Clinical Data, Inc. Receives Notice of IND Filing by Santen and Upcoming Milestone Payment for A2A Agonist Development Program Focused on Glaucoma Treatments
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.