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.
“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”
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.