BIOGEN IDEC INC. - RESEARCH & CORPORATE CAMPUS

At the heart of Biogen Idec's mission is the development and delivery of new therapies to help patients with serious unmet medical needs. The process is long, complex and expensive. Discoveries that seem promising in the lab may never make it to market. In fact, for every 10, 000 compounds initially identified, only one on average will ultimately be approved for use in the United States.

Before testing of a potential therapeutic begins in humans, laboratory and animal studies are carried out to determine safety and biological efficacy. These studies provide information on potential toxicities and side effects, the amount of the product that is taken up by the target tissue, the amount of time the product stays in the body and the product's therapeutic effect.

After the preclinical studies are complete, the company approaches the FDA with a request to test the new product candidate in people. The company files an Investigational New Drug application (IND), which among other information contains the data from preclinical studies. Accompanying this is a proposal to study the safety and dosage in people.

When the company finishes collecting and analyzing the data from the clinical trials, it submits an application to the FDA for marketing approval. Biopharmaceuticals derived from biotechnology are now reviewed by the Center for Drug Evaluation and Research (CDER) in the form of a Biologics License Application (BLA). The BLA must contain all the data the company has collected on the drug. In accordance with FDA regulation, the FDA has at least six months to review a "priority" application (drugs for a life-threatening need) and 10 months for a standard application. Ultimate approval can take up to two years.

After the FDA has approved the BLA, physicians can prescribe the new biopharmaceutical or drug. Companies must continue to monitor for any adverse reactions and report these to the FDA. In certain instances, companies may conduct post-marketing studies, known as Phase 4 studies, to evaluate long-term or combination therapies' effects.

Under the regulations governing biopharmaceuticals and drugs, companies must keep manufacturing records for every lot of product produced, and in certain cases, submit samples of the production lots to the FDA for validation prior to marketing. Manufacturing facilities are also inspected annually by the FDA.