To: Bill Wexler who wrote (4107 ) 1/1/1999 5:15:00 PM From: Bill Wexler Read Replies (5) | Respond to of 4634
Details of one of the many class action complaints against Zonagen...securities.stanford.edu Of particular interest are paragraphs 34 and 49: 34. Nevertheless, in 1996, Zonagen moved forward with phase III trials for Vasomax, one in Mexico and two in the U.S. The Company also announced in June 1996 that the U.S. Patent Office had approved its patent covering the melt in the mouth use of Vasomax as a treatment of erectile dysfunction. Zonagen, however, failed to disclose that the patent office had rejected the Company's more specific application for a patent to cover the use of phentolamine as a pill to be swallowed for the treatment of impotence. According to Fortune magazine's March 16, 1998 article, defendant Podolski conceded in a recent interview that "[y]ou can say today no patent specifically covers Vasomax." (Emphasis added) 49. The Fortune article raised potentially severe safety concerns regarding the swallowing of phentolamine as a treatment for impotence, How safe is it? Vasomax raises a burning issue. . . How can a drug delivered via the bloodstream dilate penile arteries without similarly affecting blood vessels throughout the body, risking severe side effects? After all, even localized injections of 'vasodilating drugs in the penis occasionally cause sudden bodywide drops in blood pressure, accompanied by dizziness and fainting... From the beginning Zonagen and its consultants -- along with the FDA -- had been concerned about the drug's safety... [and] safety concerns can slow a drug's approval and lead to label warnings that could potentially limit its use...