The competitive picture in drug development can change overnight. Last week's setback to Regeneron Pharmaceuticals Inc. in its drive to be first to market with a drug for amyotrophic lateral sclerosis, and the implied gains by competitors Synergen Inc. and Cephalon Inc., are only the latest example of how quickly the landscape can shift.

Companies must weigh the extent to which the competitive situation should drive their development strategies. Not surprisingly, companies insist they never take short cuts to keep ahead of or catch their rivals. They do, however, choose indications with an eye to finding unsecured niches or getting to market first, a theme that is reinforced by limited capital resources.

Not bashful

The REGN example takes competition to the limit, since both the Tarrytown, N.Y., company and SYGN are developing the same molecule, ciliary neurotrophic factor (CNTF). CEPH is developing a different growth factor, Myotrophin insulin-like growth factor-1 (IGF-1).

REGN, which moved into its pivotal trial despite equivocal data from a small 57-patient Phase II study, isn't bashful about the fact that getting to market first has been one of its goals.

"I want to be the first in, to create relationships with physicians, third-party payors and other practitioners - anyone involved in the decision-making process" said CFO Fredric Price. "I've always believed that creating a category establishes your relations with key decision makers, so the second one in has to play to a higher standard."

Orphan drug designation is a "critical" factor in the drive to get to market first, according to Price, especially in situations such as the SYGN rivalry. But even when companies aren't developing the same compound, orphan designation "can create a psychological and actual barrier for another company because orphan designation will allow you to cut corners on regulatory time," he said, making it easier to get on the market first.