PharmaNetics Receives Humanitarian Device Exemption for Ecarin Clotting Time Test to Monitor Refludan.

Business Editors/Health & Medical Writers

RALEIGH, N.C.--(BW HealthWire)--May 17, 2000

PharmaNetics, Inc. (NASDAQ NM: PHAR) today announced that the Company has received approval from the Food and Drug Administration (FDA) for a Humanitarian Device Exemption (HDE) for the Ecarin Clotting Time Test (ECT). The approval covers the use of the test for managing patients suffering from Heparin Induced Thrombocytopenia (HIT) who receive Refludan while undergoing cardiopulmonary bypass. Refludan, an Aventis thrombin inhibitor, is approved in 14 countries including the U.S. for use in managing patients suffering from HIT. HDE approval is an accelerated authorization process to market devices used in rare disease states where no existing solution is available.

HIT develops in patients who have an adverse reaction to heparin, and these reactions can lead to serious disability such as amputation or to death. Medical literature indicates that HIT occurs in approximately 300,000-400,000 heparin patients in the U.S. per year, and also suggests that approximately 30%-60% of cardiac surgery patients exposed to heparin will form the antibodies that cause HIT. The cardiopulmonary bypass application is a subset of this population.

John Funkhouser, President and Chief Executive Officer of PharmaNetics, stated, "We are very pleased to have received this approval from the FDA, especially since there have been only 16 other successful HDE applications. In making the HDE submission, our goal was to provide physicians with a theranostic tool to better manage Refludan and this `high risk' group of patients. The FDA approval of the ECT further supports the position that there is an unmet need in the management of new therapeutic agents affecting coagulation." Theranostic is the term used to describe the use of rapid near-patient diagnostic testing to influence patient therapy.

Recognizing that there was a need for a test specifically to monitor the effects of direct thrombin inhibitors such as Refludan, PharmaNetics and Loyola University Medical Center collaborated to develop a rapid point of care method based on the Company's dry chemistry technology. "The ECT was developed, in part, under an SBIR grant and demonstrates the value of such federal funding in fostering interactions between academia and industry. The rapid turnaround time, minimal amount of blood used and the ease of test performance make this test ideal for acute and emergency situations where test results are urgently needed. The availability of this technique to monitor these anticoagulant agents will greatly benefit the management of patients," stated Jawed Fareed, M.D., Director of Hemostasis Research Laboratories and Professor of Pathology and Pharmacology at Loyola University Medical Center in Maywood, Illinois.

"Since direct thrombin inhibitors will ultimately be used in additional indications and may be administered with other drugs, the ECT will be of major value to interventional cardiologists, cardiac surgeons and emergency room physicians to aid in the optimal management of patients. The ECT card technology will greatly facilitate the monitoring of drug levels during these procedures," commented Bruce Lewis, M.D., Chief of Cardiology for The Catholic Health Partners and Associate Professor of Medicine at Loyola University Medical Center. He added, "We are very pleased to have the ECT technology available to us as it is most helpful in maintaining drug levels at the desired range, which is crucial in patients treated with this new drug."

The Company anticipates being able to ship analyzers and test cards to facilities requesting access to the product under the HDE within 30 days. Additionally, the Company is preparing the technical file required under the European In-Vitro Diagnostic Directive to support marketing the product within the European Economic Community to monitor the use of Refludan in all indications.

PharmaNetics develops, manufactures and markets rapid turnaround diagnostics to assess blood clot formation and dissolution. The Company develops tests based on its proprietary dry chemistry Thrombolytic Assessment System. The Ecarin Clotting Time test utilizes this technology in combination with an exclusive worldwide sublicense on patents obtained from Knoll that cover the use of Ecarin for the detection of all direct thrombin inhibitors. The combination of intellectual property uniquely positions the Company as a leader in the management of thrombin inhibitors. The Company's strategy has been to develop theranostic tests for rapidly managing new drug compounds, as well as for monitoring routine anticoagulants.

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 from those projected in the forward-looking statements. Information concerning these and other of the factors that could cause actual results to materially differ from those in the forward-looking statements is contained in the Company's SEC filings, including Form 10-K, Form 10-Q and Form 8-K reports.