The FDA's Cardiovascular and Renal Drugs Advisory Committee willreview Centocor Inc.'s drug ReoPro (formerly CentoRx) when thecommittee meets June 9-10 in Bethesda, Md. Centocor submitted aproduct license application (PLA) for the drug in December 1993.Evaluation of data from the multi-center Phase III trial in 2,100 patientsdemonstrated that ReoPro was effective in reducing the number ofmajor ischemic events such as death, myocardial infarction orrevascularization after high-risk angioplasty. In the short term (30days) ReoPro reduced by 36 percent the number of ischemic events. Atthe six-month follow up, ischemic events were reduced by 23 percent.Everything seemed to be set for a smooth approval process.However, in April Centocor was hit unexpectedly with a patentinfringement complaint filed by Genentech Inc. The suit alleged thatMalvern, Pa.-based Centocor had infringed South San Francisco-basedGenentech's "Cabilly patent." The Cabilly patent covers basicscientific methods used to produce chimeric antibodies.Centocor denied the charge, saying the patent had been extensivelyreviewed by lawyers from inside and outside the company and that thetechnology used to develop ReoPro (also known as c7E3) was notcovered under the patent.Centocor's spokesman, Timothy Cost, told BioWorld he did not expectGenentech's claim to enter into the FDA committee's deliberations."We don't believe that any litigation or discussion of royalties is goingto affect the FDA's thinking on whether ReoPro is safe and effective,"Cost said."Historically, we have had a good relationship with Genentech andconversations are going on with them," Cost said. "The discussions areabout what their position is and what our position is. The companiesare not discussing royalties in specific terms."Cost said the conversations were about "anything you can imagine inthe early stages of a discussion." He said it is still too early todetermine the outcome of the negotiations.Centocor is planning to come to the FDA committee meeting with anentourage of experts in tow, according to Cost."We will bring in outside experts, key clinical investigators involved inthe trial and senior management of our company," Cost said.
-- Philippa Maister
(c) 1997 American Health Consultants. All rights reserved.