WASHINGTON -- Two biotechnology drugs, Chiron Corp.'sBetaseron for treating multiple sclerosis and Genentech Inc.'sPulmozyme for the treatment of cystic fibrosis, shared topbilling with a new Alzheimer's pharmaceutical, Warner-Lambert Co.'s Cognex, at the Pharmaceutical Manufacturers'Association's (PMA) press briefing last week on 1993 new drugapprovals.

In all, 25 new drugs were approved last year, said John Beary,PMA's senior vice president for science and technology. Besidesthe two breakthrough drugs, biotechnology contributed a newcombination vaccine for haemophilus b and diphtheria-pertussis tetanus, Tetramune from Lederle-Praxis, andKogenate, a biotechnology-derived clotting factor VIII fromMiles Inc. Biotechnology also contributed to the development ofnew pharmaceuticals through receptor tracing and othertechniques, Beary told BioWorld.

The average review time for drugs approved in 1993 -- 26.5months -- was about three months less than for 1992. Thiscontinues a rough trend of a month reduction per year since1986. Average approval time for the four new biotechnologyproducts was 19.8 months; Betaseron and Pulmozyme werereviewed in 13.1 months and 9.1 months, respectively.

Meanwhile, the changing market has pushed drug inflationdownward, said PMA President Gerald Mossinghoff. Managedcare was one factor, while "the generic share of the marketdoubled from 15 percent to 30 percent during 1983-1989" andis expected to reach 50 percent this year, said Mossinghoff.

In addition, 18 PMA companies have taken a pledge over thepast two years to restrain price hikes to the U.S. ConsumerPrice Index.

At the same time, research and development spendingincreased only 10.2 percent in 1993, compared with an annualaverage of 16 percent during the 1980s, said Mossinghoff. R&Dspending is expected to fall to 9.2 percent for 1994, the firstsingle-digit increase since 1976. Nonetheless, the absoluteincrease for 1993 was a healthy $1.2 billion, to a total of $13.8billion.

Thus, geriatric research, for example, would be hit hard bypresidential efforts to restrain price increases throughMedicare blacklisting, Beary said. "When executives of theindustry decide what drugs to work on, clearly that will be afactor," he said.

"Let's be certain that we preserve a research environment thatwill continue to produce the new medicines that help patientsstruggling with untamed diseases," Beary said.

-- David Holzman Washington Editor

(c) 1997 American Health Consultants. All rights reserved.