Biotechnology Industry Ends 2005 with Breakthrough Product Approvals and Steady Financing

WASHINGTON, D.C. (January 18, 2006) – The biotechnology industry ended 2005 with steady financial investments and product deliveries as companies succeeded in introducing novel therapies for patients suffering from some of the most devastating and deadly diseases. The year also marked significant advancements in agricultural and environmental biotechnology.

“The biotech industry has reached a maturity level capable of producing a steady stream of new and unique therapies. The goal is to produce even more targeted therapies that will result in more effective medicines,” said Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO).

The Food and Drug Administration (FDA) in 2005 approved seven recombinant biologics, as well as a number of first-in-class products and several “orphan drugs” – or products that treat a rare disease affecting fewer than 200,000 Americans. (See attached chart http://www.bio.org/speeches/pubs/er/approveddrugs.asp?year=2005) About 45 percent of all recombinant and monoclonal antibodies cleared for marketing have been approved since 2000, demonstrating a very recent growing trend of industry market success.

Overall, the agency approved 38 new biotech and biotech-related products as well as expanded labels and other therapies of note. Among the highlights, regulators approved three diabetes and cancer therapies including Novo Nordisk’s Levemir, for treatment of diabetes mellitus, and Onyx’s and Bayer’s Nevaxar (also an orphan), for advanced renal cell carcinoma.

“Investors have recognized the industry’s value, and in the last six years as the industry has matured, biotech and biopharmaceutical firms have raised more than $120 billion in financing, the majority of which is used for the purposes of research and development. Ongoing favorable investor response has fueled the industry’s innovative technology that has moved an idea or vision from the laboratory to the market,” Greenwood added.

Running slightly behind 2004, biotech companies last year raised about $20.1 billion in public and private financing, compared to $20.8 billion the previous year. Financings in 2004 and 2005 top all annual figures from the previous decade with the exception of the year 2000, when the industry raised a record $38 billion following completion of the draft sequence of the human genome.

Patients are the winners in 2005

Representing a step toward the promise of personalized medicine, in 2005 the FDA approved the first drug based on its performance in a specific race. NitroMed’s BiDil, approved in June, is a heart failure treatment for African Americans.

Some orphan drugs approved are: BioMarin’s Naglazyme, an enzyme replacement therapy for mucopolysaccharidosis VI; Tercica Inc.’s Increlex, long-term treatment for growth failure in children with severe primary IGF-1 deficiency; and Insmed’s IPLEX, a treatment for growth failure in children with severe primary IGF-1 deficiency or with growth hormone gene deletion.

Amylin Pharmaceuticals received FDA approval on two first-in-class drugs in 2005. Both diabetes drugs, Byetta is a first-in-class incretin mimetics while Symlin is a pramlintide acetate used in conjunction with insulin to treat Type I and II diabetes in patients who have failed to achieve desired glucose control. American Pharmaceutical Partners Inc. also received approval on first-in-class product Abraxane for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

Fortical, a nasal spray developed by Unigene Laboratories Inc., was approved to treat postmenopausal osteoporosis in women with low bone mass. For a larger population, GlaxoSmithKline Biologicals won approval of the influenza virus vaccine Fluarix for active immunization of adults 18 years of age and older against influenza disease caused by influenza virus types A and B. And Aventis Pasteur Inc. received approval for Menactra, an immunization for meningitis.

Biotechnology Crops Expand Globally

 A major milestone in agricultural biotech was reached in May when the one billionth acre of biotech crops was sown, capping a decade of plantings in 18 countries around the globe. More than 90 percent of the eight million farmers growing biotech crops are located in developing nations.

In addition to record acceptance by farmers, scientists continued to increase their understanding and knowledge of plants and animals through genome sequencing projects.  In 2005, the rice and dog genomes were mapped, and projects to sequence soybean, corn, and sheep genomes were also announced.

Researchers use these genetic maps to improve the nutrient quality of food crops and strengthen plants’ abilities to resist drought conditions, insect infestation and plant disease.  In addition, by understanding the makeup of animals at a cellular level, scientists can develop leaner and more nutritious dairy and meat products as well as help animals to live healthier lives.

Bioenergy Gets Boost from President, Capitol Hill

President Bush in August signed the Energy Policy Act, which contains almost $1 billion in funding authorizations for bioenergy projects and research and development. The act will help improve domestic energy security by setting goals for production of renewable biofuels made using industrial biotechnology to convert U.S. agricultural resources to ethanol and biodiesel.

“The act will encourage the production of domestic sources of energy and reduce America’s dependence on foreign oil,” Greenwood said.

BIO also endorsed the National Security and Bioenergy Investment Act of 2005, introduced in June by Sens. Tom Harkin (D-Iowa) and Richard Lugar (R-Ind.), members of the Senate Agriculture, Nutrition and Forestry Committee. The legislation, adopted as part of the Energy Policy Act, updated the Biomass Research and Development Act with the goal of rapidly boosting the production of biobased fuels at competitive prices, developing a broad range of biobased products that replace petroleum-based products, and expanding opportunities in the growing bioeconomy.

The bill also established incentives to increase the production of ethanol from cellulose-containing crops and crop wastes, expanded the Federal Agency Biobased Procurement Program to all federal contractors and the U.S. Capitol complex, and provided investment tax credits for the construction of biorefineries that convert cellulose to transportation fuel and biobased products.

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products.

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