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FOR IMMEDIATE RELEASE
July 26, 2001
PHARMANETICS RECEIVES $1.5 MILLION PAYMENT FROM ASTRAZENECA
Raleigh, NC (July 26, 2001) – PharmaNetics, Inc. (Nasdaq/NM: PHAR), a leading company specializing in theranostic management of various therapeutics affecting coagulation, announced today that it had received a $1.5 million payment from AstraZeneca (AZ), payable in connection with its December 1999 AZ Interim Agreement. The payment is required under circumstances where AZ does not enter into a Collaboration and Supply Agreement with PharmaNetics by March 31, 2001. In communicating with PharmaNetics, AZ has indicated that ongoing clinical studies of its oral thrombin inhibitor, H 376/95, utilize a fixed dose without routine anticoagulation monitoring.
Under the Interim Agreement with AZ, PharmaNetics has contracted to supply AZ with test cards until December 20, 2001. By electing not to proceed at this time and paying the $1.5 million, AZ has no further legal obligation to supply PharmaNetics with access to the data generated with the test card during drug development. PharmaNetics must now establish alternate means of collecting data and initiate its own studies and trials to gain regulatory approval for the test.
Commenting on the announcement, John Funkhouser said, "PharmaNetics is in the process of setting up a scientific advisory board of medical opinion leaders to examine specific problems associated with managing therapeutic levels in patients receiving oral and injectable direct thrombin inhibitors. The issue is not whether PharmaNetics will provide a test, because the medical community will, we believe, embrace the need. The issue is just how best to facilitate getting the clinical data for FDA approval. To that end, PharmaNetics is developing a regulatory strategy to make a FDA filing for its tests used to manage thrombin inhibitors from clinical data and additional testing from other thrombin inhibitor trials. It is PharmaNetics' position that physicians will ultimately decide if testing is necessary or desirable."
PharmaNetics, Inc., a leading biotech company, conceived the term "theranostics," defining an emerging new field of medicine that enables physicians to therapeutically manage coagulation parameters of their patients in the treatment of angina, myocardial infarction (heart attack), stroke, and pulmonary and arterial emboli. PharmaNetics' proprietary diagnostic platform generates rapid feedback on blood clot formation and dissolution. PharmaNetics' technology platform is the primary driver of existing collaborations with a number of major pharmaceutical companies, including Aventis Pharmaceuticals and Knoll BASK, to develop theranostic tests for specific compounds and disease indications being developed by these corporation. If those drugs receive FDA approval, PharmaNetics' tests could become an essential component of the treatment modality of these drugs affecting coagulation.
This press release contains forward-looking statements regarding future events and the future performance of PharmaNetics that involve risks and uncertainties such as risks related to market acceptance, clinical trials and dependence on third-party distributors and collaborative partners that could cause actual results to differ materially form those projected in the forward-looking statements. Information concerning these and other of the factors that could cause results to differ materially from those in the forward-looking statements is contained in the Company's filings with the Securities and Exchange Commission, including Form 10-K, Form 10-Q and Form 8-K reports.
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