After a dismal year of product blow-ups and failed companies, thebiotech industry got a boost Thursday when Centocor Inc. said theFDA and European regulatory authorities approved its anti-bloodclotting drug, ReoPro, for use in high risk angioplasty patients.
The ReoPro approval was described by market analyst DavidCrossen, of UBS Securities in New York, as one of the mostsignificant biotechnology achievements in "a long time," proving theindustry can produce new products.
In addition, Crossen observed that ReoPro was approved by the FDAone year after Malvern, Pa.-based Centocor submitted its new drugapplication, indicating the regulatory agency is becoming moreproactive and more willing to get biotech drugs on the market.
Centocor's stock (NASDAQ:CNTO) was up $1.75 to close Thursdayat $18.25, an 11 percent jump. ReoPro is the company's first drug toreach the market.
Dave Holveck, Centocor's president and CEO, told BioWorld, "Theindustry should be heartened by the fact the FDA is sensitive toinnovative products. From an innovative and biotechnology side, Iwould think this [approval] should warm somebody's heart."
ReoPro will be the second monoclonal antibody on the market in theU.S. and the 20th biotechnology product approved by the FDA sincethe industry's inception more than 10 years ago. ReoPro is designedto inhibit platelet aggregation and prevent blood clots from formingfollowing angioplasty.
The only other monoclonal antibody to pass FDA regulators isOrthoclone OKT 3, which is marketed by Johnson & Johnsonsubsidiary Ortho Biotech Inc., of Raritan, N.J. The antibody is usedto reverse kidney transplant rejection.
With the FDA and European approvals of ReoPro, Holveck said,Centocor's partner, Eli Lilly and Co., of Indianapolis, expects tolaunch sales of the drug in February in the U.S. and in 11 of 12European Union countries. Although the EU's Committee ForProprietary Medicinal Products recommended approval, Belgiumsaid it wanted to see additional clinical trials before approving theproduct.
Lilly's stock (NASDQ:LLY) Thursday closed at $63.50, down$1.75.
ReoPro represents a victory not only for biotechnology, but acomeback for Centocor, which experienced a major product blow-upin January 1993 when Centoxin failed in Phase III trials for sepsis.The company subsequently was restructured.
"Science won't carry the day," Holveck told BioWorld. "You haveto have the regulatory ability and understanding, the clinical controland the manufacturing to get a product to market."
What biotechnology companies have had to learn, he suggested, isthat just because a drug looks good in the laboratory and in Phase IIstudies, doesn't mean it's destined for quick approval.
Following the Centoxin failure, Holveck said he realized Centocorhad to match the pharmaceutical industry's standards in confrontingthe regulatory process. To that end, he said, Centocor brought inpeople from Merck & Co., of New York, and Schering-PloughCorp., of Madison, N.J.
In addition to the science, Holveck told BioWorld, "What allowedus to get here [with ReoPro] was paying attention to the form of theregulatory submission."
Despite getting ReoPro approved, some analysts have speculatedsales might be limited because its current labeling restricts use to arelatively small market - angioplasty patients at high risk of abruptartery closure. There also are concerns about bleeding side effectscaused by the combination of ReoPro and heparin, which is useduniversally to prevent blood clotting during coronary surgery.
However, Crossen estimated the labeling makes ReoPro available for30 percent to 50 percent of all angioplasty patients, who numberabout 750,000 in the U.S. and Europe.
In addition, he observed, another Centocor study is under way and asecond is scheduled to begin next month to expand the drug's use.
As for the side effects, because ReoPro performs some of the sametasks as heparin, Centocor is testing ReoPro in combination withlower doses of heparin to alleviate excess bleeding problems.
Patients receive a dose of ReoPro during angioplasty and a 12-hourinfusion of the drug following the procedure. In clinical trials, theendpoints were prevention of artery blood clots at 30 days afterangioplasty and at six months.
According to market analysts, the clinical studies indicate that 13 outof every 100 high risk angioplasty patients who receive ReoPro willbenefit from the treatment.
With approval of ReoPro, Holveck said, Centocor is moving towardits goal of achieving the company's first profitable year in 1995. Hedeclined to discuss pricing of the drug, saying Lilly will release thosefigures when the product is launched onto the market. In itsagreement with Lilly, Centocor will receive royalties from the sales.
Two other parts to Centocor's profitability equation, Holveck addedare completing a corporate partnering deal for development ofCenTNF, a monoclonal antibody targeting tumor necrosis factor, andregulatory approval of Panorex, a treatment for colorectal cancer. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.