Biotech’s Breakthrough

The biotechnology industry had a successful year in 2005 as companies succeeded in introducing novel therapies for devastating and deadly diseases.

"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.

In 2005, the US FDA approved seven recombinant biologics and several first-in-class products and l "orphan drugs" (products that treat a rare disease affecting fewer than 200,000 people in the US). About 45% of all recombinant and monoclonal antibodies have been approved since 2000, showing a growing trend in the biotech business.

The FDA approved 38 new biotech and biotech-related products and expanded labels and other therapies of note. Approvals included three diabetes and cancer therapies such as Novo Nordisk's Levemir and Onyx's and Bayer's Nevaxar (an orphan, for advanced renal cell carcinoma).

In the last six years, the biotech industry has matured, with biotech and biopharmaceutical firms raising more than $120 billion in financing to fuel R&D and innovative technology.

In 2005, biotech companies raised about $20.1 billion in financing, compared to $20.8 billion in 2004. These two years are top for the decade, with the exception of the year 2000, which saw a record of $38 billion in financing after completion of the draft sequence of the human genome.

Other approved orphan drugs included: 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 diabetes drugs: Byetta, a first-in-class incretin mimetics; and Symlin, a pramlintide acetate used with insulin to treat Type I and II diabetes in patients who can not reach desired glucose control.

American Pharmaceutical Partners Inc. received approval for a first-in-class product Abraxane, for treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

Unigene Laboratories’ Fortical, a nasal spray, was approved to treat postmenopausal osteoporosis in women with low bone mass. GSK Biologicals received approval for its flu vaccine Fluarix. Aventis Pasteur Inc. received approval for Menactra, an immunization for meningitis.

Other good news for the biotech industry is seen in the major pharma manufacturers’ lack of pipeline products, which allows room for growth for biotech. In fact, in the past five years, large pharma companies have been looking towards the biotech R&D to acquire potential products.

In fact, big biotech successes have involved deals with pharmaceutical firms. Alnylam Pharmaceuticals signed a high-profile deal with Novartis. Meanwhile, Infinity, a private company with many "druglike" molecules, deals with multiple large drug companies.

Biotech and traditional pharma companies now have a symbiotic relationship, where even smaller biotech companies can get their product to market by licensing to big pharma.

The top biotechnology companies, Genentech and Amgen, saw growth last year that pushed their market value to nearly $100 billion each, putting them firmly in the ranks of the world's biggest drug makers.

The emergence of biotech also brings on new obstacles, including: healthcare costs, coverage by insurance and Medicare, and the FDA approval process.

Sources: PR Newswire, January 18, 2006; The Boston Globe, January 16, 2006.