How Encysive Botched the FDA Game

Texas Biotechnology complied and, after two long years, finally won the FDA over. David McWilliams, who served as CEO at the time, felt that the company's regulatory strategy had paid off in the end.

"Granted, we didn't do it in the smoothest of fashions," he confessed to BIOWORLD Today in the summer of 2000. "But no matter how you get there, getting there is the point.

"Tenacity is 99% of the biotechnology business -- I'm convinced."

Oddly enough, another company formerly run by McWilliams encountered similar regulatory setbacks. Zonagen, now known as Repros (RPRX Quote), saw the FDA change course and issue new study requirements for its own drug -- a potential competitor to Viagra -- as well.

Zonagen found itself scrambling to sell itself as a result. Yet, unlike Encysive, the company stopped short of blaming the FDA for its problems.

"I think, in many ways, the regulatory process is viewed as a scapegoat to explain our failures," Zonagen CEO Joseph Podolski told The Houston Chronicle in 2001. "But that's just the nature of the business."

WBB Securities' Brozak still sees problems with the current system.

By now, Brozak has spent more than a decade studying the drug-approval process. He has seen some companies stumble badly and others prevail without real clear reasons along the way.

"Encysive is like a microcosm of everything I've seen over the last 10 years involving biotechnology companies and government regulators," Brozak proclaims. "As difficult as this has been for Encysive, it hasn't made things any easier for other biotechnology companies looking to instill confidence in their investor bases.

"But this is just business as usual when it comes to dealing with biotech companies and the regulatory bodies that serve as the gatekeepers of their drugs."