Centocor Inc. announced late Friday that it has formed apartnership with the British pharmaceutical giant Wellcome plcto develop and bring to market Centocor's oncology products.The agreement covers primarily Panorex, Centocor'smonoclonal antibody-based therapeutic for treating colorectalcancer, as well as other monoclonal-based products theMalvern, Pa., company has in earlier stages of development.
Wellcome will take an equity stake in Centocor of less than fivepercent by purchasing two million newly issued shares "at apremium over the market price," said David Holveck, Centocor'spresident and chief executive officer. In addition, Wellcomewill make milestone payments in the future. The structure ofthe alliance -- which has yet to be finalized -- "looks a lot likethe arrangement that Centocor has with Eli Lilly," Holveck toldBioWorld.
The alliance is centered on Centocor's cancer therapeuticPanorex, which Centocor (NASDAQ:CNTO) itself shepherded upto and through Phase III clinical trials in Germany. Panorex, amonoclonal antibody also known as 17-1A, is directed againstan antigen that is found on the surface of colorectal cancer cellsand a number of other tumor types, including breast and lungcancer. The Phase III clinical trial enrolled 189 colorectalcancer patients whose disease had spread to lymph nodes. Thetrial tested the effect of Panorex on minimal residual disease,and as such, required a five-year follow-up. All the data --including the five-year survival rates -- were "locked down" inthe first quarter of 1993, Holveck told BioWorld, and have beensubmitted for publication in a medical journal.
And Centocor plans to file for regulatory approval in Germanyby the end of this year or the very beginning or next, Holvecksaid.
"Centocor will work with Wellcome to develop a regulatorystrategy and additional studies necessary to secure broaderapprovals (for Panorex), but at this point we're targeting onlyGermany," he added.
Centocor has six other monoclonal antibody-based oncologytherapeutics -- for cancers of the head, neck, kidney, ovary andgastrointestinal area -- which Wellcome has the option to pickup and develop further. These potential products are in thevery early stages of preclinical development, Holveck toldBioWorld, but there's enough accumulated data on them to"make them interesting."
Holveck said the difficulty with developing therapeutics in theoncology arena is that it takes such a long time to complete theclinical studies. "We kept the Panorex study going, primarilyout of our European facility, but it was on the back burner," hesaid. He explained that it takes patience and a willingness tosee product development through to its completion to enter theoncology market. And Wellcome has that patience and theunderstanding of immunology to "see the opportunity in thisproduct," he added.
Even though Centocor made its announcement after the marketclosed on Friday, there was a flurry of trading activity that day,with more than 2.1 million shares trading hands. The stockgained 50 cents to close at $9.25.
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.