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PHARMANETICS CONTACTS:
John P. Funkhouser, President, CEO
or
James A. McGowan
Chief Financial Officer
(919) 582-2600
www.unispheremag.com
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FOR IMMEDIATE RELEASE
October 9, 2001
PHARMANETICS AND AVENTIS PHARMACEUTICALS ANNOUNCE FILING OF 510K APPLICATION FOR ENOXAPARIN TEST
Companies Initiate Planning Process for Joint Launch
RALEIGH, N.C. (October 9, 2000) - PharmaNetics, Inc. (NASDAQ /NM: PHAR) , a leader in theranostic management, and Aventis Pharmaceuticals, the U.S. pharmaceutical company of Aventis Pharma AG (NYSE: AVE), today jointly announced that a 510K application had been filed for the Rapidpoint ENOX Test, a new diagnostic test designed to analyze therapeutic levels of Aventis Pharmaceuticals' enoxaparin sodium (Lovenox®), the number-one selling low-molecular weight heparin (LMWH) in the world.
"We are extremely pleased with the data obtained from our clinical trials," said John Funkhouser, president and chief executive officer of PharmaNetics. "We believe the test demonstrates good correlation to the existing laboratory method and may be able to provide physicians with a rapid and convenient method to measure the effect of enoxaparin in unstable angina patients. We anticipate that the physician community will recognize the advantages of this test and will embrace it accordingly."
Under the terms of an agreement signed last year, PharmaNetics will work exclusively with Aventis Pharmaceuticals for a five-year period on an enoxaparin test card. The ENOX test has been calibrated for optimal response to enoxaparin and will be unsuitable for use with other LMWHs. Carrying the trade names and corporate logos of both companies, the card will be labeled and indicated for use as an enoxaparin test.
"We are pleased that our collaboration with PharmaNetics, which makes this technology available to physicians, puts Aventis at the forefront of addressing customer needs and helping to improve patient outcomes," said John Leone, senior vice president and chief operating officer, US Commercial Operations, Aventis Pharmaceuticals. "The application of the Rapidpoint ENOX Test in certain treatment settings will facilitate the appropriate and effective use of Lovenox and strengthen our position in the management of unstable angina."
The next stage of clinical development will be the initiation of a 650-patient study, EvaLuating Enoxaparin Clotting Time (ELECT), to establish the enoxaparin test ranges in which physicians may perform clinical procedures. The study is in its final stages of development.
"Despite a large body of clinical evidence demonstrating that patient outcomes are significantly improved by using Lovenox, many cardiologists remain reluctant to use it in certain treatment settings," said Dr. David Moliterno, lead investigator and associate professor, Cardiovascular Medicine, The Cleveland Clinic. "More than one million people each year are diagnosed with unstable angina, a serious condition that can lead to heart attack and death. The results of this study should help guide physicians in their use of Lovenox and may represent an advance in the treatment of patients with unstable angina."
Enoxaparin was approved in the U.S. and Canada in 1993 and is indicated for the prevention and treatment of deep-vein thrombosis, unstable angina and non-Q wave myocardial infarction. Enoxaparin is marketed under the trade name Lovenox® in the United States and the brand names Lovenox, Clexane® and Klexane® in other parts of the world.
PharmaNetics' technology is uniquely capable of evaluating drugs that influence both clot formation and dissolution and, as such, the Company's strategy is to further expand its menu by developing theranostic tests to assess multiple therapeutic agents. The Company intends to provide physicians with a single platform capable of monitoring numerous antithrombotic therapies, both those on the market as well as those being investigated in the treatment of diseases such as sepsis, stroke, unstable angina, deep vein thrombosis, and pulmonary and arterial emboli.
Aventis Pharmaceuticals conducts the U.S. business of Aventis Pharma AG. With headquarters in Bridgewater, N.J., Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, allergy and respiratory, diabetes, and the central nervous system.
Aventis Pharma AG is the pharmaceutical company of Aventis S.A. (NYSE:AVE). Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at fulfilling unmet medical needs. The corporate headquarters of Aventis Pharma is in Frankfurt, Germany. Aventis Pharma is comprised of Aventis Pharmaceuticals; Aventis Pasteur, a world leader in vaccines, headquartered in Lyon, France; and Aventis Behring, a world leader in therapeutic proteins, headquartered in King of Prussia, Pa.
Aventis S.A., a world leader in pharmaceuticals and agriculture, is headquartered in Strasbourg, France. The company employs approximately 92,500 people in more than 120 countries. Aventis was launched in December 1999 through the merger of Hoechst AG and Rhône-Poulenc S.A.
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. The Company's proprietary diagnostic platform generates rapid feedback on blood clot formation and dissolution. The Company's technology platform is the primary driver of existing collaborations with a number of major pharmaceutical companies, including Aventis Pharmaceuticals and Knoll BASF, to develop theranostic tests for specific compounds and disease indications being targeted by these corporations.
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.
Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.
To obtain a copy of the approved prescribing information for Lovenox, please visit Aventis Pharmaceuticals' website at www.aventispharma-us.com or call Aventis Pharmaceuticals Medical Information at 1-800-207-8049.
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