Biotech Firms See New-drug Upswing

BIOPHARMACEUTICALS

BIO 2005 rolled into Philadelphia last week with an estimated 18,000 attendees and 1,500 exhibitors. The Biotechnology Industry Organization, the event's sponsor, claims both figures are records.

If participation in BIO continues to grow, so does pressure on the biotechnology industry to deliver on its promise of new therapies for diseases such as cancer, HIV, and central nervous system disorders. The need to expedite biotech drug discovery and development--a topic encompassing regulation, technology, and financing--dominated discussion in Philadelphia.

Anxiety was offset by enthusiasm, however, as speakers pointed to FDA programs to fast- track drug candidates, advances in information technology for research, and a new wave of monoclonal antibody drugs. Partnerships between small biotech companies and large drug firms, several of which exhibited at BIO, are a continuing trend.

Speakers and attendees agreed that the next three years should see a significant increase in the number of new biotech drugs, a figure that has averaged a disappointing 20 per year in recent years. Given the development cycle of 12 years for most new drugs, attendees said it is likely that technologies such as genomics and proteomics that emerged in the 1990s will begin to bear fruit.

Typical of biotech firms attending BIO was PTC Therapeutics, which this year is moving its first compound, the small molecule PTC124, into Phase II clinical trials for Duchenne muscular dystrophy and cystic fibrosis. Chief Executive Officer Stuart Peltz said the firm has begun a second program, an antiangiogenesis therapy that inhibits the formation of blood vessels in tumors.

Dyax, which has developed a phage display platform for drug discovery, is advancing DX88, a therapy for hereditary angioedema developed in partnership with Genzyme, into Phase III trials. And Vical, which has a plasmid DNA technology platform for vaccines, has 14 programs in clinical trials, including a melanoma therapy in Phase III.

Wyeth announced a four-year biopharmaceutical research agreement with Ireland's Dublin City University at BIO. In a presentation, Wyeth Research President Robert R. Ruffolo predicted that patients will see a significant number of important new drugs from the biotech industry by the end of the decade. He said partnerships with major drug firms will be a crucial means of getting them to market.

Several threats and obstacles to the sector were also noted by speakers at BIO; perhaps most significant are cuts in NIH and other government funding for biotechnology. BIO Executive Director James C. Greenwood said in a luncheon address that regulatory delays, inadequate protection of intellectual property, and public opposition are among the forces that could stop biotech in its tracks. Greenwood, a former Pennsylvania congressman, said the organization plans to step up advocacy efforts with the government and the public.