NEWTON, Mass.--(BUSINESS WIRE)--Clinical Data, Inc. (NASDAQ: CLDA), today announced a collaboration and licensing agreement with CombinatoRx, Inc. to develop an adenosine A2A agonist compound in a combination therapy for the treatment of multiple myeloma, and other B-cell cancers. Under the agreement, Clinical Data licensed its highly selective adenosine A2A agonist, ATL313, to CombinatoRx in exchange for the potential to receive up to $252 million in clinical, regulatory and commercial milestones, as well as royalties on product sales. Clinical Data also retains a co-development option, which is exercisable after review of any Phase IIa study results.
As part of the agreement, Clinical Data will contribute ATL313, a promising late-stage, preclinical compound. Under the collaboration, CombinatoRx will be responsible for the preclinical and clinical development of ATL313 to potentially treat B-cell malignancies.
Research has shown that a combination drug approach utilizing adenosine A2A agonists as a component of a combination therapy could be beneficial in the treatment of multiple myeloma. Initial results from studies utilizing this approach have been presented by CombinatoRx and demonstrated:
• broad activity in multiple myeloma cell lines
• synergy with multiple myeloma standard-of-care therapies
• potent induction of apoptosis (cancer cell death)
• selectivity and safety with broad therapeutic window over normal cells
"Adenosine A2A agonists have shown tremendous promise in the development of therapeutics to treat a variety of diseases including cancer, inflammation, and pain disorders,” said Drew Fromkin, President and CEO of Clinical Data. “We are pleased to continue to leverage the value of our highly selective adenosine pipeline by working with CombinatoRx to develop new therapies for multiple myeloma and other B-cell malignancies.”
About Multiple Myeloma
Multiple myeloma (MM) is the second most common hematologic malignancy in the US and although the disease is predominantly a cancer of the elderly (most people with MM are diagnosed after age 65), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.
About Clinical Data, Inc.
Clinical Data develops first-in-class and best-in-category targeted 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. Clinical Data plans to differentiate its therapeutics by helping to predict and enhance efficacy and tolerability by combining its drug development and biomarker expertise to improve patient health and reduce costs. To learn more, please visit the Company's website at www.clda.com.
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 CombinatoRx to develop ATL313 as a combination therapy to treat multiple myeloma and other B-cell malignancies; our ability to obtain regulatory approval for, and successfully introduce our new products; our ability to expand our long-term business opportunities; financial projections and estimates and their underlying assumptions; 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 the Company, 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, the strength of our intellectual property rights; competition from pharmaceutical, biotechnology 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 June 30, 2009, and Current Reports on Form 8-K filed from time to time by the Company.
As part of the agreement, Clinical Data will contribute ATL313, a promising late-stage, preclinical compound. Under the collaboration, CombinatoRx will be responsible for the preclinical and clinical development of ATL313 to potentially treat B-cell malignancies.
Research has shown that a combination drug approach utilizing adenosine A2A agonists as a component of a combination therapy could be beneficial in the treatment of multiple myeloma. Initial results from studies utilizing this approach have been presented by CombinatoRx and demonstrated:
• broad activity in multiple myeloma cell lines
• synergy with multiple myeloma standard-of-care therapies
• potent induction of apoptosis (cancer cell death)
• selectivity and safety with broad therapeutic window over normal cells
"Adenosine A2A agonists have shown tremendous promise in the development of therapeutics to treat a variety of diseases including cancer, inflammation, and pain disorders,” said Drew Fromkin, President and CEO of Clinical Data. “We are pleased to continue to leverage the value of our highly selective adenosine pipeline by working with CombinatoRx to develop new therapies for multiple myeloma and other B-cell malignancies.”
About Multiple Myeloma
Multiple myeloma (MM) is the second most common hematologic malignancy in the US and although the disease is predominantly a cancer of the elderly (most people with MM are diagnosed after age 65), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.
About Clinical Data, Inc.
Clinical Data develops first-in-class and best-in-category targeted 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. Clinical Data plans to differentiate its therapeutics by helping to predict and enhance efficacy and tolerability by combining its drug development and biomarker expertise to improve patient health and reduce costs. To learn more, please visit the Company's website at www.clda.com.
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 CombinatoRx to develop ATL313 as a combination therapy to treat multiple myeloma and other B-cell malignancies; our ability to obtain regulatory approval for, and successfully introduce our new products; our ability to expand our long-term business opportunities; financial projections and estimates and their underlying assumptions; 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 the Company, 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, the strength of our intellectual property rights; competition from pharmaceutical, biotechnology 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 June 30, 2009, and Current Reports on Form 8-K filed from time to time by the Company.
