Der Impotenzknüller :Vivus

Vivus Shares Surge on Impotence Study
06.23.2005, 10:32 AM

Vivus Inc., a maker of sexual dysfunction therapies, said Thursday that its experimental impotence drug helped more than half of men achieve erections within 30 minutes in a mid-stage trial, with the highest doses proving most effective.

The company's shares jumped 75 cents, or 22.5 percent, to $4.09 in morning trading on the Nasdaq.

The Avanafil drug is designed to be a fast-acting version of blood-flow boosting drugs called PDE5 inhibitors. These include Pfizer Inc.'s Viagra and Levitra, which GlaxoSmithKline PLC and Schering-Plough Corp. sell in the United States.

"The ability to initiate intercourse in 30 minutes, which is half the time as compared to the recommended initiation time of two of the currently approved PDE5 inhibitors, while maintaining a high degree of efficacy, should help differentiate Avanafil," said Dr. Joel Kaufman, one of the study researchers.

The 12-week study evaluated 284 men on varying doses of Vivus' Avanafil drug. The company said 64 percent of patients on the highest dose - 300 milligrams - achieved erections sufficient for successful intercourse, as compared with a placebo. About 84 percent of these patients had achieved erections sufficient for vaginal penetration. Somewhat fewer successful erections were recorded for patients on lower doses.

The drug was generally well-tolerated with some patients reporting headaches but no serious side effects. The company said there were no reports of visual problems, a growing concern for this class of drugs.

Vivus also noted that previous research has suggested that Avanafil can potentially be taken more than once a day.

The company's shares have traded as high as $6.37 within the past 52 weeks, but slumped as low as $2.25 in May and have been slowly edging back up.

Das ist das sensationelle Ergebnis der Studie:

VVUS - Vivus Inc (NASDAQ NM)

3:51 PM ET, 6/23/2005

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Und sie machte bereits vorbeörlsich heute einen kräftigen Satz, 17,37 heute Plus!

 

Da is tmeines Erachtens noch Luft! nach oben zum Einsteigen!

 

Associated Press
Update 1: Vivus Shares Surge on Impotence Study
06.23.2005, 02:28 PM

Vivus Inc., a maker of sexual dysfunction therapies, said Thursday that mid-stage trial data showed that its experimental impotence drug helped more than half of men achieve erections within 30 minutes - with the highest doses proving most effective.

The company's shares jumped 39 cents, or 12 percent, to $3.73 in afternoon trading on the Nasdaq.

The Avanafil drug is designed to be a fast-acting version of blood-flow boosting drugs called PDE5 inhibitors. These include Pfizer Inc.'s Viagra and Levitra, which GlaxoSmithKline PLC and Schering-Plough Corp. sell in the United States.

"The ability to initiate intercourse in 30 minutes, which is half the time as compared to the recommended initiation time of two of the currently approved PDE5 inhibitors, while maintaining a high degree of efficacy, should help differentiate Avanafil," said Dr. Joel Kaufman, one of the study researchers. Prescribing information for both Viagra and Levitra recommends taking the pills about an hour before sexual activity, though both can work more quickly.

The 12-week study evaluated 284 men on varying doses of Vivus' Avanafil drug. The company said 64 percent of patients on the highest dose - 300 milligrams - achieved erections sufficient for successful intercourse, as compared with a placebo. About 84 percent of the high-dose patients achieved erections sufficient for vaginal penetration. Somewhat fewer successful erections were recorded for patients on lower doses. All patients were instructed to attempt intercourse 30 minutes after taking the pill.

The Vivus approach contrasts with that of the newest PDE5 inhibitor, Cialis, which is marketed less for its quick action than for its ability to work for up to 36 hours after being ingested. Viagra and Levitra both last for about four hours.

Studies of Cialis, developed by Eli Lilly & Co. and Icos Corp., have also shown results within 30 minutes.

Avanafil was generally well-tolerated with some patients reporting headaches but no serious side effects. The company said there were no reports of visual problems, a growing concern for this class of drugs.

Vivus also noted that previous research has suggested that Avanafil can potentially be taken more than once a day, the limit for Cialis, Levitra and Viagra.

The company's shares have traded as high as $6.37 within the past 52 weeks, but slumped to $2.25 in May and have been slowly recovering since then.

Das DEL LA RUE - Investment Team hat gestern VIVUS in sein Portfolio ausgewählter Unternehmen aufgenommen. VIVUS ist eins von sechs Unternehmen, über das DEL LA RUE in Zukunft berichten wird.

Ich bin mal gespannt über die ersten Bericht!

Der Börsengang im September 2004 brachte Acrux 27 Millionen ASD an frischem Kapital. Das Vorantreiben der bisherigen Forschungen verschlang aber auch einen Großteil der Reserven. Meilensteinzahlungen brachten Acrux regelmäßige Finanzspritzen, so dass das Unternehmen am 31. Januar noch 29 Mio. ASD ausweisen konnte. Der Aufwand könnte sich aber schon 2007 rentieren. Das innovative Evamist könnte schnell zum Blockbuster aufsteigen und sich einen großen Anteil vom 1,4 Milliarden USD Markt sichern. Das Potential ist für Acrux und VIVUS enorm. Als Nachteil von Acrux sehen wir vor allem das geringe Interesse von europäischen Anlegern. Der Umsatz am    Börsenplatz Berlin-Bremen tendiert gegen null. VIVUS ist daher unser direktes Ausweichinvestment.

Acrux ist schon heute hervorragend aufgestellt. Die volle Pipeline bieten Anlegern lukrative Chancen. Anleger die den illiquide Markt fürchten, können durch VIVUS indirekt am Erfolgt von Acrux profitieren.

VIVUS' Phase 3 study assessed the safety and efficacy of Evamist for the treatment of hot flashes in menopausal women. The Phase 3 trial, which was conducted at 43 clinical sites in the United States, was a 12-week, randomized, double-blind, placebo controlled study of 457 menopausal women. Patients were randomized into three treatment arms each administering a different dose with one, two or three sprays. This study was conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA). Results showed that the most effective Evamist dose significantly decreased the number of hot flashes by 78%, from 10.7 hot flashes per day at baseline to 2.3 hot flashes after treatment. This decrease was statistically significant compared to placebo (p<0.0001). The reduction in frequency and severity of moderate to severe hot flashes was statistically significant over placebo for all three doses of Evamist evaluated. Importantly, application site irritation was less than 1% and was mild in nature.

"We believe these positive trial results along with our novel patient-preferred transdermal delivery system will establish Evamist as a superior estrogen therapy for the treatment of menopausal symptoms," stated Leland F. Wilson, president and chief executive officer for VIVUS. "We have worked diligently toward the development of this unique and easy-to-use product, and we are thrilled with the efficacy and safety demonstrated in this trial. We now look forward to filing an NDA for Evamist in the second half of 2006."

"These clinical results demonstrate Evamist's efficacy as a treatment option for the large population of women suffering from menopausal symptoms," stated Dr. John Buster, Professor, Baylor College of Medicine. "Symptoms of menopause can be devastating and debilitating. This data indicates that Evamist offers a valuable therapeutic option to this significant patient group."

About Evamist

VIVUS believes Evamist offers significant advantages over oral, gel and patch estrogen products. Evamist is a small, hand-held, simple to use spray that is designed to provide an easy and convenient means to deliver a preset dose of estradiol via the skin. Evamist is placed gently against the skin and an actuator button is pushed which releases a light spray containing a proprietary formulation of estradiol. Estradiol is released into the blood stream on a sustained basis over 24 hours. Evamist is fast drying, non- irritating and invisible after application.

About Menopause

Approximately two million American women turn 50 each year. Women naturally enter into menopause usually between the ages of 45 and 55; however, surgical menopause may happen at any age. Menopausal symptoms occur when the ovaries stop producing estrogen. Symptoms include hot flashes, discomfort or pain during sexual intercourse due to vaginal atrophy (thinning of the vagina), and changes in skin and hair.