As all of you know, the NDA for Pfizer's Viagra (sildenafil) was submitted for filing with the FDA and was met with indifference by the market (PFE fell with the rest of the major pharm companies). This wasn't completely unexpected, but what was a surprise was the 2 1/2 point rise in Vivus which has further provoked the shameless hyping and promotion on multiple boards (here and Motley Fool/AOL) by several individuals. Further, these individuals are trashing both Viagra and Vasomax with blatant misinformation and distortion of the facts. This is most likely being done by short-term traders, not investors, who seek to squeeze the Vivus shorts and run up the stock price in the short term for their own personal and selfish gains.
This shouldn't be a reason to despair. It's easy for the Vivus longs to take pot-shots at products in Phase III trials since there's still very little hard data to debate at this time. This will hopefully change soon so that a more balanced discussion of the merits of all ED therapies can be initiated. Until that time, the following reminder will have to suffice:
THE VASOMAX SOLUTION
Vasomax
Vasomax is a fast-acting oral treatment for male erectile dysfunction that systemically delivers phentolamine mesylate ("phentolamine"). Zonagen has recently completed two pivotal Phase 3 clinical trials of Vasomax. Vasomax produces an alpha-adrenergic block of relatively short duration, leading to vasodilative effects on vascular smooth muscles to help restore normal penile function. Phentolamine has been approved by the FDA for the treatment of hypertension and for use in the diagnosis of certain tumors of the adrenal gland, and has been used "off-label" by urologists, either alone or in combination with other drugs, in penile needle injection therapies for the treatment of erectile dysfunction. The Company believes that due to its mode of action, Vasomax will provide the greatest benefit to men who suffer from mild to moderate erectile dysfunction, a significant percentage of men with
the condition.
Based on the Company's clinical trial results, Vasomax's expected benefits and advantages include the following:
. Oral Administration. Vasomax is a tablet which is taken orally, and
therefore is painless, non-invasive, convenient and discreet for the user.
. Speed of Efficacy. Vasomax's fast-dissolving formulation enables an erectile response within 15 to 30 minutes of administration.
. Normal Penile Response. Vasomax more closely duplicates normal sexual function by enabling and maintaining an erection only in the presence of actual sexual stimulation.
. Reduced Side Effects. Vasomax may produce fewer side effects than many of the currently available treatments.
Clinical Trials
The Company completed two pivotal Phase 3 clinical trials of Vasomax in May 1997. These Phase 3 trials were designed to evaluate Vasomax's effectiveness in treating men suffering from erectile dysfunction, using the Erectile Function Domain of the International Index of Erectile Function ("IIEF"). The IIEF is a validated statistical analysis of erectile dysfunction, based upon 15 questions answered by each participant. The Company also measured secondary endpoints in the Phase 3 trials which included successful intercourse rates and other measures of overall sexual experience. The trials included men with a broad variety of medical conditions, including cardiovascular conditions, diabetes and prostate conditions, and men who took other medications during the trials. Because the Company believes that an intact nervous system is required for Vasomax to be effective, men with erectile dysfunction caused by spinal cord injury or radical prostectomy were intentionally excluded from the trials.
The first of these clinical trials to have been completed was a double-
blinded, placebo-controlled study involving 435 men at 20 centers across the United States testing 40mg and 80mg doses of Vasomax against a placebo. Physician diagnoses indicated that substantially all of the patients enrolled in the trial suffered from erectile dysfunction with physiological causes, a majority of which involved vasculogenic conditions; the erectile dysfunction of only 2% of enrolled patients was classified as having purely psychogenic causes by the attending physician. Vasomax yielded a statistically significant (p<0.001) improvement over placebo using the primary IIEF endpoint, with 40%
of the men in the study responding to the 40mg dose of Vasomax and 48% responding to the 80mg dose of Vasomax, as compared to 17% responding to placebo. Vasomax also yielded a statistically significant (p<0.001) improvement over placebo using successful intercourse as a secondary endpoint, with 42% of the men in the study responding to the 40mg dose of Vasomax and 39% responding to the 80mg dose of Vasomax, as compared to 22% responding to placebo. The study included an in-office test dose of 80mg on all of the men considered for participation in the study to assess side effects before exposing men to at-home use of Vasomax. Although one patient exhibited both an increase in heart rate and a decrease in blood pressure of greater than 30% and another patient experienced chest pain, both in the in-office 80mg study, no other serious adverse events related to drug were observed in either the in-office or at-home portions of the trial. The Company and PPD Pharmaco are continuing to evaluate the safety data from the clinical trial.
The second trial was a double-blinded, placebo-controlled study involving 293 men at 14 centers across the United States, testing 40mg doses of Vasomax against a placebo. Vasomax yielded a statistically significant (p<0.01) improvement over placebo using the primary IIEF endpoint, with 34% of the men in the study responding to the 40mg dose of Vasomax as compared to 21% responding to placebo. The trial included an in-office test dose of 40mg on all of the men considered for participation in the study to assess side effects before exposing men to at-home use of Vasomax. No serious adverse
events were observed in either the in-office or at-home portions of the trial. The Company and PPD Pharmaco are continuing to evaluate the safety data from the clinical trial.
Zonagen intends to submit an NDA to the FDA for Vasomax promptly following the completion of certain in-progress studies and data analysis that are expected to be completed in late 1997. There can be no assurance that the NDA will be filed on a timely basis or that it will ultimately be approved by the FDA.
The Company is also currently conducting an open-label clinical trial of
Vasomax involving approximately 300 patients, and is preparing to commence a second open-label clinical trial involving approximately 1,000 patients. The pivotal clinical trials necessary for the submission of an NDA for Vasomax have been completed. The Company intends to use the additional data generated by the open-label trials for marketing purposes.
Go Zonagen and Viagra. The market is big enough for everyone.
Bradpalm1
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