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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: Linda Kaplan who wrote (2466)	2/21/1998 11:45:00 PM
From: Bruce Rosen	Read Replies (2) \| Respond to of 7041

Hi Linda. The following is excerpted from the prospectus of Zonagen's secondary offering last summer. I will post the URL at the end. I encourage you or anyone interested in Zonagen to read it. << 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 questions include inquiries regarding: the frequency with which the participant achieved (i) an erection, (ii) an erection with sufficient firmness to achieve vaginal penetration, (iii) vaginal penetration, and (iv) an erection that was maintained following penetration; the participant's difficulty in maintaining an erection to completion of intercourse; and the participant's confidence regarding his ability to achieve and maintain an erection. The answers to these questions are used to classify a participant's erectile dysfunction as severe, moderate, mild to moderate, mild or not impotent. Participants in the Company's Phase 3 clinical trials of Vasomax were considered as responding to Vasomax or placebo only if they improved at least one classification level, provided that men whose erectile function classification improved from severe only to moderate were nevertheless not considered to have responded. The Company also measured endpoints in the Phase 3 trials in addition to the primary IIEF endpoint upon which the FDA is expected to make its determination regarding the efficacy of Vasomax. These secondary endpoints included rates of successful intercourse (defined as intercourse involving the achievement of an erection, vaginal penetration and the maintenance of the erection through orgasm) 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 25 <PAGE> 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 the analysis of data from the Company's Phase 3 clinical trials and an in-process standard animal carcinogenicity study 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. The foregoing expressions of the Company's expectations regarding the completion of clinical trials and other studies, the filing of an NDA and other matters relating to the clinical development of Vasomax are forward- looking statements which are subject to certain risks and uncertainties, including those described under "Risk Factors--Uncertainties Related to Clinical Trial Results" and "Risk Factors--Government Regulation.">> sec.gov