Centocor's Myoscint returnswith positive FDA panel review

Centocor withdrew Myoscint's PLA in 1993

A Food and Drug Administration panel in January recommended approvalfor Centocor's Myoscint, a monoclonal antibody-based imaging agentthat was pulled from FDA consideration two years ago after themanufacturer was alerted to irregularities in its clinical research.

The FDA's Cardiovascular and Renal Drugs Advisory Committeerecommended approval of Myoscint as a nuclear imaging agent todetermine the existence and location of myocardial necrosis. Thepanel voted against its use in determining the extent of heartmuscle damage.

If the FDA follows the panel's findings, Myoscint will becomethe second MoAb-based imaging agent to gain U.S. regulatory clearance,after Cytogen's OncoScint, which received FDA certification inDecember 1992 (SCAN 1/27/93).

The panel recommendation for Myoscint was greeted enthusiasticallyby Centocor officials, who experienced several long delays intheir quest to commercialize the product.

"We are very pleased with the panel's recommendation,and we hope for final approval for marketing sometime soon,"said Bruce Carroll, manager of government relations.

In June 1993, Centocor voluntarily withdrew FDA product licenseapplications for Myoscint and Fibriscint, a monoclonal agent thattargets blood clots, after an independent auditor uncovered deficienciesin the applications. (SCAN 6/16/93).

Centocor reanalyzed clinical trial data for Myoscint and resubmittedits FDA application in June 1995, Carroll said.

The company envisions a synergy between Myoscint and its othercardiovascular biopharmaceutical products. In particular, Centocorofficials see a match with the company's ReoPro product, a drugtherapy prescribed for high-risk angioplasty cases. ReoPro receivedFDA clearance in December 1994 and was officially launched abouta year ago, Carroll said.

Carroll declined to comment on the commercial potential ofMyoscint, citing Securities and Exchange Commission restrictionsin place pending an upcoming 3.5-million-share stock offering.

Centocor generates less than $1 million a year from sales ofMyoscint in Europe, where the agent has been available since 1989,according to Carroll. The company is negotiating the reimbursementprice of Myoscint in Japan, the final step to receiving approvalto market the agent in that country, he said.

In the U.S., Centocor is looking for a marketing partner topromote Myoscint and Fibriscint, when that product emerges fromclinical trials, Carroll said.

The company is continuing other monoclonal antibody research,but no MoAbs designed for radiopharmaceutical applications arein serious development, he said.