Monday, Jan 8, 2001
South San Francisco, Calif. and Kenilworth, N.J. -- January 8, 2001 --COR Therapeutics, Inc. (Nasdaq: CORR), Schering-Plough Corporation (NYSE: SGP), and Genentech, Inc. (NYSE: DNA) today announced a collaboration to co-promote INTEGRILIN for non-ST-segment acute coronary syndromes (ACS), as well as TNKase (Tenecteplase) and Activase® (Alteplase, recombinant) for acute ST-segment elevation myocardial infarction in hospitals across the United States.
Under the terms of the agreement, Genentech will co-promote INTEGRILIN in the more than 5,000 hospitals that its representatives currently call upon for TNKase and Activase. COR and Schering-Plough will co-promote TNKase and Activase in the more than 2,000 hospitals that they currently call upon for INTEGRILIN.
The parties have also agreed to an exclusive clinical collaboration for any future large-scale clinical trials conducted that combine a fibrinolytic with a glycoprotein (GP) IIb-IIIa inhibitor. The agreement will not affect any clinical trials already underway.
"The agreement allows us to expand our reach in community hospitals where the vast majority of patients with chest pain initially present," stated Richard Zahn, President of Schering Laboratories. "This collaboration promises to provide more patients with broader access to the therapeutic benefits afforded by INTEGRILIN," Zahn said.
"This collaboration is a particularly good fit because of the marketing synergies that exist between INTEGRILIN and TNKase, including the same customer-base," said Myrtle Potter, Executive Vice President of Commercial Operations and Chief Operating Officer of Genentech. "We look forward to offering an additional high quality product to the cardiovascular medical community in an ongoing effort to improve patient care," said Potter.
"Through this partnership, which will broadly promote the most widely-used GP IIb-IIIa inhibitor and the leading fibrinolytics franchise in the U.S., we will help ensure that patients nationwide suffering from the broad spectrum of conditions encompassing the acute coronary syndromes have access to the most advanced therapies available," added Vaughn Kailian, President and Chief Executive Officer of COR.
INTEGRILIN® (eptifibatide) Injection
INTEGRILIN, an intravenous glycoprotein (GP) IIb-IIIa inhibitor, is used to help prevent the development of blood clots that can occlude the arteries in the heart causing heart attack and death. INTEGRILIN has the broadest range of approved indications among GP IIb-IIIa inhibitors available in the United States. INTEGRILIN is indicated for the treatment of patients with acute coronary syndrome (unstable angina and non-Q-wave myocardial infarction) including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). INTEGRILIN® (eptifibatide) Injection is also indicated for the treatment of patients undergoing PCI at the time of the procedure. As of second quarter 2000, INTEGRILIN became the most used GP IIb-IIIa inhibitor in the United States.
INTEGRILIN is contraindicated in the following patient populations: those with a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days; severe hypertension (systolic blood pressure greater than 200 mm Hg or diastolic blood pressure greater than 110 mm Hg) not adequately controlled on antihypertensive therapy; major surgery within the preceding six weeks; history of stroke within 30 days or any history of hemorrhagic stroke; current or planned administration of another parenteral GP IIb-IIIa inhibitor; platelet count less than 100,000 per cubic millimeter; serum creatinine greater than or equal to 4.0 mg/dL; dependency on renal dialysis; or known hypersensitivity to any component of the product.
Bleeding is the most common complication encountered during INTEGRILIN therapy. The majority of excess major bleeding events were localized at the femoral artery access site. Oropharyngeal, genitourinary, gastrointestinal and retroperitoneal bleeding were also seen more commonly with INTEGRILIN compared to placebo.
COR Therapeutics, Inc. and Schering-Plough Corporation are worldwide development partners for INTEGRILIN. Both companies market and sell the drug in the United States. Schering-Plough markets INTEGRILIN in Europe. INTEGRILIN is a registered trademark of COR Therapeutics, Inc.
TNKase (Tenecteplase) and Activase®, (Alteplase, Recombinant)
TNKase is the first ''clot-buster'' that can be administered over five seconds in a single dose. A bio-engineered plasminogen activator, TNKase is a recombinant DNA-derived version of naturally-occurring tissue plasminogen activator (t-PA). TNKase has unique features specifically designed to prolong its half life, enabling single bolus dosing. It also has been designed to increase specificity for fibrin, a key component of intracoronary clots and results in less disturbance of the body's coagulation, or natural clotting, system. The clinical significance of fibrin-specificity on safety or efficacy has not been established.
Activase is a bio-engineered version of the naturally occurring tissue plasminogen activator (t-PA), which works to dissolve blood clots by triggering the body's own clot-dissolving mechanism. As with all thrombolytics, Activase and TNKase increase the risk of bleeding, including intracranial bleeding, and should be used only in eligible patients. In addition, thrombolytic therapy increases the risk of stroke, particularly in elderly patients. TNKase and Activase are trademarks of Genentech, Inc.
COR Therapeutics, Inc. COR Therapeutics, Inc. is dedicated to the discovery, development, and commercialization of novel pharmaceutical products for the treatment and prevention of severe cardiovascular diseases.
In addition to the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially from the anticipated results discussed in such forward-looking statements, due to factors such as results of clinical trials with INTEGRILIN and other factors discussed in the Company's SEC reports, including, but not limited to, the Company's Report on Form 10-Q for the quarter ended September 30, 2000, and Report on Form 10-K for the year ended December 31, 1999. Forward-looking statements are based on current expectations and the Company does not intend to update such information to reflect later events or developments.
Schering-Plough Corporation, of Kenilworth, NJ, is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. Schering Laboratories is the U.S. prescription pharmaceutical marketing arm of Schering-Plough.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Fourteen of the currently approved biotechnology products stem from Genentech science. Genentech markets nine biotechnology products directly in the United States. The company has headquarters in South San Francisco, CA and is traded on the New York Stock Exchange under the symbol DNA.
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