Science vs. products

While the foundation of biotechnology is the application of cutting edge basic science, not all science is capable of making the transition into a world that is focused on clinical data, patient benefit and eventual product sales. While early on companies can only be judged by their technology, at some point investors, regulators and corporate partners will only care what a particular compound can do in the clinic.

Last week, the FDA approved Isis Pharmaceuticals Inc.'s Vitravene fomivirsen antisense agent to treat cytomegalovirus infection in AIDS. In July, when the ophthalmic drugs subcommittee of the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee reviewed the agent, the panelists considered a number of clinical, medical and social issues. But in its 5-2 recommendation to approve Vitravene , the committee wasn't at all interested in the fact that fomivirsen would be the first antisense product to gain approval (see BioCentury Extra, July 23). ...