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AT THE COMPANY:
John Funkhouser, President, CEO
Paul Storey, Director of Finance
(919) 954-9871
INVESTOR CONTACTS:
Lippert/Heilshorn & Associates, Inc.
Bruce Voss (bruce)
(310) 575-4848
Ruth Abeshaus (ruth)
(212) 838-3777
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FOR IMMEDIATE RELEASE
July 23, 1999
PHARMANETICS ANNOUNCES CESSATION OF DEVELOPMENT AGREEMENT WITH ELI LILLY
RALEIGH, N.C. (July 23, 1999) - PharmaNetics, Inc. (NASDAQ NM: PHAR), the holding company of Cardiovascular Diagnostics, Inc. ("CVDI"), today announced that it has been notified by Eli Lilly and Company ("Lilly") of their intent to terminate activities under the 1997 agreement to develop a point-of-care test for a sepsis-monitoring assay. Lilly cited the main reasons for their decision is the test's inability at this stage to provide results across a wide therapeutic range and with the precision originally specified in the marketing characteristics established at the inception of the project.
In commenting on the decision, John Funkhouser, President and CEO of PharmaNetics stated, "We are disappointed that Lilly has taken this step. However, we have developed a test to screen patients at risk of developing sepsis, which we view as an important milestone. While to date, we have not been able to meet all of the original test specifications, we believe that our test provides site-to-site precision that is equivalent to other current commercial methods with the added advantages of ease of use and the ability to standardize test results."
The Company believes that there is no known method capable of meeting all of the originally targeted specifications. Dr. Andras Gruber M.D., Vice President, Research and Development of PharmaNetics stated, "The data collected to date would indicate equivalence to the existing methods, consequently we will continue to collect data comparing the test to existing devices and submit a 510(k) to the Food and Drug Administration ("FDA") for clearance to market the product. We believe the advantages of the present test format offers health care providers an ability to rapidly screen patients and make treatment decisions."
Dr. Gruber continued, "As with other tests marketed by the Company, the tests ultimate performance may depend upon being able to optimize the reagent formulation, manufacturing and calibration. We will investigate multiple sources for the primary reagent so that we can continue to explore these parameters."
The Company feels that the impact of Lilly's decision is mitigated by PharmaNetics strategy to pursue numerous testing opportunities for multiple compounds.
We continue to receive numerous requests from physicians for a means to monitor existing FDA approved anticoagulants. Based on these inquiries, the Company will dedicate additional resources to developing rapid tests with near-term market potential.
Funkhouser added, "Having successfully completed feasibility and field trials with the Ecarin Clotting Time test for use with thrombin inhibitors, and the Low Range Fibrinogen test for use with Ancrod“, we believe we have the ability to provide the medical community with rapid diagnostics to improve disease state management and improve the standard of care and patient outcomes."
PharmaNetics, Inc. 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 for its principal target market of powerful new drug compounds, some of which may have narrow therapeutic ranges, as well as for monitoring routine anticoagulants. The Company’s therapeutic diagnostics are used to monitor the effect of antithrombotic agents in the treatment of angina, myocardial infarction (heart attack), stroke, deep venous thrombosis, and pulmonary and arterial emboli.
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.
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