Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

CENTOCOR WITHDRAWING MYOSCINT AND FIBRISCINT PLAs

Executive Summary

CENTOCOR WITHDRAWING MYOSCINT AND FIBRISCINT PLAs following the discovery of "deficiencies" in the applications, the company announced May 28. The deficiencies were found by the law firm King & Spalding, which has been conducting audits of Centocor's PLAs. Centocor declined to elaborate on the nature of the deficiencies. The audits were initiated in the summer of 1992 after FDA determined that protocol changes during Centocor's first Phase III trial for Centoxin, its antisepsis monoclonal antibody, had compromised the data. In March, Centocor scrapped a second Phase III trial of Centoxin, which was stopped in January due to excess deaths in Centoxin-treated patients without gram-negative bacteremia ("The Pink Sheet" March 22, T&G-11). The firm is evaluating clinical parameters and tests for measuring endotoxemia to better identify patients who could benefit from the product. The original PLA for Myoscint, a monoclonal antibody-based cardiac imaging agent, was filed in 1988, and the PLA for Fibriscint, a MAb-based blood-clot imaging agent, was filed in December 1991. Myoscint received an approval recommendation from an FDA advisory committee in November 1991. "With the concurrence of the FDA, Centocor intends to re- analyze the already available data relating to Myoscint...and submit a revised application," Centocor said May 28. The firm hopes to resubmit a PLA for Myoscint this year. "Additional clinical testing will be necessary to support any new application for Fibriscint," the company said. Centocor said its goal is to submit a PLA for its MAb-based platelet aggregation inhibitor CentoRx (7E3) in the third quarter of this year. The PLA will be based on the results from a 56- center study showing that CentoRx reduces by 35% heart attacks and repeat angioplasty on an emergency basis in patients following balloon angioplasty. The study was presented at the American College of Cardiology annual meeting in March ("The Pink Sheet" March 22, T&G-11). Enrollment has begun for Phase III European trials of CentoRx in treating refractory unstable angina in patients scheduled for angioplasty. The enrollment target is 1,400 patients.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

MT101489

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel