©2000-2010 Intelligent Systems
   All Rights Reserved
   Contact Webmaster here

      
  


Sharon Correia
508-497-2300 ext 224
scorreia@aderis.com

Aderis Pharmaceuticals Announces Receipt of $1 Million Milestone Payment for Binodenoson

King Pharmaceuticals begins Phase III testing of Binodenoson, an adenosine A2A agonist used as a pharmacological stress agent.

Hopkinton, MA - Jan 12, 2004 - Aderis Pharmaceuticals announced today the receipt of a $1 million milestone payment from King Pharmaceuticals, Inc. in connection with King’s commencement of the pivotal Phase III clinical trial program involving binodenoson. Binodenoson is an adenosine A2A receptor agonist that Aderis licensed to King. King is developing binodenoson for cardiac pharmacologic stress testing used in conjunction with nuclear imaging, a procedure used to diagnose the presence and severity of coronary artery disease.

Dr. William Wheeler, Chief Medical Officer of Aderis, stated, "We are very pleased with the commencement last month of King’s multi-center, double blind, controlled Phase III clinical trial program involving binodenoson. King’s Phase II clinical trial program showed that by targeting the adenosine A2A receptor subtype, binodenoson appears to detect myocardial ischemia just as well as adenosine, and produces fewer and less severe side effects such as heart block, dyspnea and chest pain than adenosine and dipyridamole. With an estimated market of approximately 3 million tests/year in the US, this program will be an important focus for King Pharmaceuticals in the coming year.”

“This payment from King Pharmaceuticals acknowledges an important accomplishment and milestone in the ongoing development of binodenoson: The initiation of pivotal Phase III clinical trials,” said Peter Savas, President, CEO and Chairman of Aderis Pharmaceuticals. “Our focus on sub-type specific receptor technologies has enabled us to create several promising new product candidates. Binodenoson is our second to reach Phase III development. We look forward to further progress on this program by King Pharmaceuticals.”

The collaboration between Aderis Pharmaceuticals and King Pharmaceuticals began in August 1997. Aderis Pharmaceuticals granted King the worldwide license to develop and commercialize some of our proprietary adenosine A2A agonists including binodenoson. Under terms of the agreement, Aderis will receive license fees and milestone payments, as well as royalties based on sales of binodenoson.

About Binodenoson

Cardiac stress testing allows physicians to identify the presence of coronary artery disease by examining the flow of blood through these vessels to the heart. Patients have traditionally achieved the coronary blood vessel dilation necessary for these tests by exercising on a treadmill. However, many patients cannot complete the required treadmill exercise due to age or infirmity. For them, blood vessel dilation is achieved through the use of pharmacological stress agents. Approximately 3 million of these pharmacological tests are performed each year in the United States alone.

The current pharmacological stress agents work through adenosine and are not able to distinguish between the four types of adenosine receptors in the heart. Binodenoson is a pharmacologic stress agent specific to only the adenosine A2A receptor, which is the receptor necessary for increased cardiac blood flow. Because the other agents stimulate all of the receptors, they can cause side effects such as low blood pressure, wheezing and a dangerously slow heart rate. In addition to being specific to the A2A receptor, binodenoson is delivered as an IV bolus dose – rather than the more complicated infusion required with current agents.

Results from King’s Phase II clinical trial program involving binodenoson were presented at the 2003 American Heart Association Scientific Sessions. These trials were multi-center, randomized, single blind, two-arm crossover dose selection studies that enrolled 240 patients. The studies looked at safety, tolerability and SPECT image concordance between binodenoson and adenosine. There was good to excellent image concordance with binodenoson and adenosine. Patients reported fewer and less severe side effects with binodenoson. And none of the patients experienced heart block with binodenoson, compared to an incidence of 3% with adenosine.

About Aderis Pharmaceuticals

Aderis Pharmaceuticals is a private, biopharmaceutical company engaged in small molecule drug development to treat central nervous system, cardiovascular and renal disorders. The Company currently has four product candidates in six clinical development programs. Aderis Pharmaceuticals has a strategic alliance with Schwarz Pharma AG, for the development of rotigotine CDS, a proprietary dopamine agonist formulated as a once-a-day, continuous delivery, transdermal patch. Rotigotine completed Phase III trials for Parkinson’s disease and is in Phase IIb for the treatment of Restless Legs Syndrome. The Company also has corporate collaborations with Fujisawa Healthcare, Inc. and King Pharmaceuticals. Aderis Pharmaceuticals’ product pipeline includes small molecule, receptor agonists and antagonists for the treatment of Parkinson’s disease, Restless Legs Syndrome, atrial fibrillation, diabetic foot ulcers, the diagnosis and prognosis of coronary artery disease, and other cardiovascular and renal indications. Founded in 1994, Aderis Pharmaceuticals is headquartered in Hopkinton, Massachusetts and has research facilities in Richmond, Virginia.

Certain statements in this news release that are not historical fact constitute "forward-looking statements." Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results of Aderis Pharmaceuticals to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Such statements include, but are not limited to, any statements relating to the Company's development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties, including but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates; unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product development or commercialization; the uncertainty of patent protection for the Company's intellectual property or trade secrets; and the Company's ability to obtain additional financing if necessary. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, some but not all of which may have been mentioned above.

# # # #