Biotechnology Industry Posts 37 FDA Approvals, $16.4 Billion in Financing in 2003

WASHINGTON, D.C. (January 5, 2004) — The biotechnology industry enters 2004 stronger than ever after earning 37 FDA approvals, raising $16.4 billion in new financing and winning significant battles on Capitol Hill in 2003.

"Biotechnology is a performance-driven industry," said BIO President Carl B. Feldbaum. "In 2003, the biotechnology's results at the FDA were terrific, driving an industry recovery on Wall Street and further boosting the industry’s political credibility."

The FDA approved 25 new biotechnology drugs and biologics in 2003, up 25 percent from 2002. The new approvals include first-in-class medicines for genetic disorders, HIV/AIDS, Alzheimer's disease, psoriasis, asthma and cancer. The agency also cleared 12 new indications for previously approved biotech products.

"The results that matter most in this industry are the ones that benefit patients, and the biotech products approved this past year will help many whose needs would otherwise be unmet," said Feldbaum. "The upswing in approvals in part reflects new energy at the FDA under the leadership of Commissioner Mark McClellan, who brought a deep commitment to innovation and sensible risk-benefit analysis to the agency in 2003."

FDA approvals, combined with stellar earnings performances at companies with marketed products, drove the Nasdaq biotech index up 46 percent in 2003 and helped biotech companies to raise $16.4 billion in new financing, up 56 percent from 2002.

"It's not just the industry's established companies that have done well," noted Feldbaum. "Small-cap stock gains outpaced those of the industry's top tier, and venture capitalists poured $3.3 billion into privately held biotechs. In fact, the life sciences eclipsed software in the third quarter to become the number one destination for venture capital funding."

Industry Advances Political Agenda:

BIO's pro-innovation principles were incorporated into the Medicare drug coverage law, which also reversed deep cuts in biotech products that were already covered under the program.

Bills to allow biotechnology companies to take advantage of net operating losses were introduced in both the House and Senate.

The comprehensive energy legislation that passed the House and is now pending in the Senate includes more than $800 million in bioenergy incentives and sets mandatory requirements for usage of biofuels.

Efforts to ban therapeutic applications of cloning technology were defeated in Congress, at the United Nations, and in several states.

The international food safety organization Codex Alimentarius approved science-based risk-assessment rules for foods derived from biotechnology.

In 2004, BIO's legislative priorities include passage of tax reform and energy legislation, as well as Project BioShield, the Patent and Trademark Office fee bill and small business legislation that would ensure venture-backed biotech firms qualify for Small Business Innovation Research grants.

BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.

Note: A list of biotech drug approvals can be found at www.bio.org/features/20040105.asp.