VIVUS auf Erfolgskurs...
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VVUS: Reports Positive Phase 2 Clinical Trial Results w/Qnexa
VIVUS, Inc. (VVUS) announced positive results from a 200-patient, double-blind, placebo-controlled clinical trial of Qnexa(TM), an investigational oral treatment for obesity. In the study conducted by Duke University Medical Center, more than 50% of obese patients in the Qnexa treatment group experienced 10% or more total body weight loss during the 24-week study period. Mean weight loss on an intent-to-treat (ITT) basis in the Qnexa group was 25.1 lbs., compared to 4.8 lbs in the placebo group (p<0.0001). Importantly, the rate of weight loss for patients in the Qnexa group had not plateaued by the end of the study. Qnexa was well-tolerated with a study completion rate of 92% versus a completion rate of 62% for the placebo group.
Proceeds to Fund Clinical Advancement of the Qnexa Program for the Treatment
of Obesity
MOUNTAIN VIEW, Calif., May 10 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS), a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health, today announced that it has entered into a purchase agreement with two institutional investors for the sale of $12 million of its common stock in a registered direct offering. Under the terms of the financing, VIVUS will sell 3,669,725 shares of VIVUS common stock at a price of $3.27 per share. The transaction is expected to close on May 10, 2006, subject to customary closing conditions. All of the shares of common stock are being offered pursuant to an effective Registration Statement previously filed with the Securities and Exchange Commission.
A new investor, OrbiMed Advisors, LLC, led the financing in addition to an existing VIVUS investor. The shares were priced at market, based on a five-day average close ending on May 9, 2006. VIVUS intends to use the proceeds from the financing to fund clinical trials, including certain studies required prior to the initiation of a Phase 3 clinical trial of VIVUS' recently announced Qnexa(TM) program for the treatment of obesity, as well as for general corporate purposes.
About VIVUS
VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. VIVUS has four products that are positioned to enter Phase 3 clinical trials, and one product that has completed Phase 3 evaluation, for which an NDA is anticipated to be submitted to the U.S. Food and Drug Administration (FDA) in late 2006. The pipeline includes: Qnexa(TM), for which a Phase 2 study has been completed for the treatment of obesity; ALISTA(TM), for which a Phase 2B program is ongoing for the treatment of Female Sexual Arousal Disorder (FSAD); Testosterone MDTS(R), for which a Phase 2 program has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); Evamist(TM), for which a Phase 3 program has been completed for the treatment of menopausal symptoms; avanafil, for which a Phase 2 program has been completed for the treatment of erectile dysfunction (ED); and, MUSE(R), which is approved and currently on the market for the treatment of ED. For more information on clinical trials and products, please visit the company's web site at www.vivus.com.
Friday May 5, 8:00 am ET
Evamist, First Novel Transdermal Spray, Shows 78% Decrease in Moderate to Severe Hot Flashes
MOUNTAIN VIEW, Calif., May 5 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS - News) today announced positive results from the pivotal Phase 3 clinical trial of Evamist(TM). VIVUS' investigational estradiol metered dose transdermal spray is being developed for the treatment of vasomotor symptoms associated with menopause. The study showed a statistically significant reduction in the number and severity of moderate and severe hot flashes for all three doses tested. Evamist is a novel, once a day proprietary, first-in-class, transdermal spray that delivers estradiol, a naturally occurring estrogen, for the treatment of hot flashes in women. 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 fast drying, non-irritating and invisible after application. Studies have shown that once administered, Evamist's formulation is not affected by washing and does not transfer to partners. Evamist is easily titratable between one, two or three sprays.
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.
About VIVUS
VIVUS, Inc. is a pioneer in the research and development of proprietary products to restore sexual function for women and men. VIVUS' current product pipeline includes four investigational products in late stage clinical development. For women, VIVUS has completed a Phase 3 program for Evamist(TM) for the alleviation of menopausal symptoms, and initiated a Phase 2B program with ALISTA(TM) for female sexual arousal disorder. Additionally, the company has completed Phase 2 development of Testosterone MDTS® for the treatment of hypoactive sexual desire disorder (HSDD). The MDTS system is a patented new-generation, transdermal drug delivery technology that delivers drugs directly through the skin. For men, VIVUS has completed Phase 2 development of avanafil for erectile dysfunction. The company currently markets MUSE® (alprostadil) suppository for the treatment of erectile dysfunction in the U.S. and internationally through distributors. For more information on clinical trials and products, please visit the company's web site at www.vivus.com.
den ganzen Bericht auf www.dellarue.de
Acrux ist ein Pioneerunternehmen in der Entwicklung von Produkten für ein besseres Wohlbefinden.
Derzeit befinden sich 7 innovative Produkte in der Pipeline. Mit “Evamist (Estradiol MDTS)“ welches sich momentan in der FDA Phase III befindet, steht das Unternehmen kurz vor dem Zulassungsverfahren. Das Präparat kann die Behandlung der Wechseljahrbeschwerden revolutionieren. Die hervorragenden Aussichten wollte sich das ameri- kanische Unternehmen VIVUS nicht entgehen lassen und sicherte sich bereits im Vorfeld die Lizenzen für den amerikanischen Vertrieb. Gelingt es dem Unternehmen die Zulassung für “Evamist (Estradiol MDTS)“ in den nächsten Monaten zu bekommen, dürften sich Patienten sowie Investoren gleichermaßen freuen.
Noch lukrativer scheint derzeit die Zulassung von “Testosteron (MDTS)“ zu werden. Das Präparat könnte in Zukunft das einzig marktreife und geprüfte Präparat gegen die Störung der sexuellen Erregung der Frau werden und somit einen geschätzten Gesamtmarkt von 4 Milliarden USD abdecken. Das Potential des Testosteron-Präparates ist immens und lässt sich nur schwer schätzen. Bis andere Pharma-Riesen ein vergleichbares Präparat auf den Markt bringen, könnten sich Acrux und VIVUS einen entscheidenden Image und Know-how Vorsprung schaffen.
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.
Wednesday May 10, 8:22 am ET
Vivus Shares Rise As Study Shows Qnexa Contributes to Weight Loss
MOUNTAIN VIEW, Calif. (AP) -- Shares of Vivus Inc. surged before the bell Wednesday as the drug developer said a mid-stage clinical study showed its weight loss drug showed significant results after 24 weeks.
Vivus shares climbed 37 cents, or 11.3 percent, to $3.65 in premarket activity on the INET electronic exchange.
In the Phase II clinical study, participants given Qnexa lost an average of 25.1 pounds after 24 weeks, compared with the average 4.8 pounds in the placebo group. More than 50 percent of people in the Qnexa group lost 10 percent or more of their body weight after 24 weeks.
The study enrolled 159 women and 41 men with an average age of 40. All were considered obese by federal health guidelines. People in the Qnexa and placebo group were told to reduce their caloric intake by 500 calories per day.
Gewinne mitnehmen
Aufgrund der neuen “ONEXA“ Studie, deren Existenz VIVUS erst am 11.05.06 bekannt gab, sowie eine Kapitalerhöhung über 12 Mio. USD, stieg der Kurs von VIVUS seit unserer Analyse vom 08.05.06 auf bis zu 80% an.
Nach wie vor sind wir vom Geschäftsmodell und den Aussichten überzeugt. Langfristig sehen wir daher enormes Potential. Dennoch rechnen wir damit, dass sich in den nächsten Monaten günstigere Einstiegsmöglichkeiten bieten werden.
Wir raten daher den Kursverlauf in den nächsten Tagen genau zu verfolgen. Gewinnmitnahmen erscheinen uns aufgrund der großartigen Performance ebenfalls sinnvoll.
14.07.2006
VIVUS bietet Anlegern hervorragende Zukunftsperspektiven. Das DEL LA RUE - Investment Team sieht daher erneut eine gute Gelegenheit sich mit VIVUS Aktien einzudecken.
Nach der Erstanalyse vom 06.05.2006 legte die Aktie von VIVUS innerhalb einer Woche um rund 60 % zu. Daraufhin waren wir am 12.05.2006 der Meinung, den schnellen Kursgewinn zu realisieren und rieten zum Verkauf der Aktie. Wie sich rausstellte lagen wir damit gold richtig. Heute notiert die Aktie erneut um EUR 2.50, wie am Tag der Erstanalyse und ist für uns erneut eine gute Kaufgelegenheit gegeben.
Der Kursanstieg seiner Zeit wurde vor allem durch die Testergebnisse von “Onexa“ angetrieben. “Onexa“ ist ein Präparat gegen Fettleibigkeit, woran nach einer Studie vom Forschungsinstituts RTI International ein Drittel der US-Bevölkerung leidet. Das Marktpotential für ein solches Präparat ist daher enorm groß. Zudem konnten die Testergebnisse überzeugen. Innerhalb von 24 Wochen erreichten die Testpatienten eine Gewichtsabnahme von bis zu 10%. Diese Ergebnisse ähneln den Testergebnissen von “Orlistat“, ein Wirkstoff gegen Fettleibigkeit entwickelt von Roche. In der zweiten hälfte 2006 plant GlaxoSmithKline “Orlistat“ unter dem Namen “Alli“ in den USA zu vermarkten. Der Marktwert wird auf bis zu 1.6 Mrd. USD geschätzt. Mit “Onexa“ könnte ein direkter Konkurrent zu “Orlistat“ herausgebracht werden und ein ähnlich hohen Marktwert erzielen.
Bisher liegen noch keine genaueren Pläne über die nächsten Studienreihen von “Onexa“ vor. Bis zur endgültigen Marktreife könnte VIVUS aber bereits eines der vier weiteren Produkte auf den Markt bringen. Ganz oben steht dabei “Evamist (Estradiol MDTS)“ welches laut Unternehmensangaben noch vor dem 01.01.2007 auf dem US-Markt erscheinen soll.
Wir halten ein Engagement in VIVUS erneut für lukrativ. Im Zusammenhang mit dem heutigen Upgrade von VIVUS empfehlen wir Ihnen auch unsere Analyse vom 06.05.2006 über Acrux Limited und VIVUS Inc. zu lesen. Kostenlos abrufbar unter www.dellarue.de
Rating: B++
Anlagehorizont: bis 2 Jahre
Monday September 11, 12:28 pm ET
MOUNTAIN VIEW, Calif., Sept. 11 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS - News), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products addressing obesity and sexual health, today announced that Leland F. Wilson, President and CEO, will present at the ThinkEquity Partners 4th Annual Growth Conference. The conference will be held at The Ritz-Carlton San Francisco from Monday, September 11th to Thursday, September 14th.
Mr. Wilson will deliver the VIVUS presentation on Thursday, September 14th at 9:30 am local time in Salon V. A breakout session will immediately follow the initial presentation at 10:00 am. A live webcast and 30-day archive of the presentation can be accessed at http://www.vivus.com .
On September 7, 2006, ThinkEquity analyst, Adnan Butt, initiated coverage of VIVUS. Copies of this report can be obtained through ThinkEquity.
Mehr informationen üver VIVUS auf www.dellarue.de
VIVUS Submits New Drug Application With U.S. Food and Drug Administration for EvaMist(TM) - An Investigational Drug for the Treatment of Menopausal Symptoms
Monday October 2, 7:30 am ET
MOUNTAIN VIEW, Calif., Oct. 2 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS - News), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products addressing obesity and sexual health, today announced that the company has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its investigational estradiol drug, EvaMist(TM), being developed for the treatment of vasomotor symptoms associated with menopause.
VIVUS announced positive results from its pivotal Phase 3 clinical trial of EvaMist earlier this year. The study showed a statistically significant reduction in the number and severity of moderate and severe hot flashes for all three doses tested.
EvaMist is a novel, once a day proprietary, first-in-class, transdermal spray that delivers estradiol, a naturally occurring estrogen, for the treatment of hot flashes in women. 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 fast drying, non- irritating and invisible after application. Studies have shown that once administered, EvaMist's formulation is not affected by washing and does not transfer to other people. EvaMist is easily administered as one, two or three sprays.
"Clinical results for EvaMist have been impressive, and we are eager to bring this highly effective, low dose, next-generation therapy to the significant population of women suffering with hot flashes," stated Leland F. Wilson, president and chief executive officer for VIVUS.
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 454 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 FDA. Results showed that EvaMist decreased the number of hot flashes by 78%, from 10.8 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 1.5% and was typically mild in nature.
Quelle: www.dellarue.de
Wenn du up-to-date sein möchtst, bietet DEL LA RUE deutsche Berichte über das Unternehmen.
http://www.dellarue.de
In deren Aktuellem Investment-Brief steht was zu deren jetzigen Situation.
http://www.dellarue.de/Ausgabe.html
Hier der Artikel:
Das von Acrux entwickelte EvaMist™ befindet sich derzeit in der entscheidenen Phase. Nach den postiven Testergebnissen der letzten FDA-Studie (Phase III) reichte VIVUS am 03.10. bei der Food and Drug Adminstration (FDA) einen Antrag auf Marktzulassung ein.
Allein vom Antrag auf Marktzulassung profitiert Acrux durch eine Lizenz-Zahlung von 1 Mio. USD. Sollte die FDA ihr OK geben, erhält Acrux weitere 3 Mio. USD und ist an den Umsatzerlösen der VIVUS Inc. beteiligt.
EvaMist™ verringert nachweislich die Beschwerden der Frau in Ihren Wechseljahren, wie Hitzewallungen, Nachtschweiß und seelische Verstimmungen. Dem handlichen Spray von Acrux wird dabei enormes Potential zugeschrieben, denn bisher gibt es nur wenige wirksame Produkte gegen Wechseljahrbeschwerden.
Die Zukunftsaussichten für Acrux und VIVUS bei einer Zulassung von EvaMist™ stehen gut. Nach dem Hoch vom Frühsommer folgte zwar ein leichter Abwärtstrend...
...momentan befindet sich der Kurs aber in einer interessanten Bewegung leicht unter der 200-Tage-Linie. Wir raten unseren Lesern daher in den nächsten Wochen wachsam zu sein und auf Unternehmensnachrichten zu achten.
Achten, daß man einen Ausbruch nach oben verpasst oder,
dass Vivus durch die dann an Acrux fällige Zahlungen in finanzielle Schwiriegkeiten gerät ?
Gruss
EvaMist(TM) is an Investigational Drug for the Treatment of Menopausal Symptoms
MOUNTAIN VIEW, Calif., Dec. 12 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products addressing obesity and sexual health, today announced that the new drug application (NDA) filed by the company for EvaMist(TM) was accepted for review by the U.S. Food and Drug Administration (FDA) as a new treatment for vasomotor symptoms associated with menopause.
VIVUS announced positive results from its pivotal Phase 3 clinical trial of EvaMist earlier this year. The study showed a statistically significant reduction in the number and severity of moderate and severe hot flashes for all three doses tested.
EvaMist is a novel, once-a-day, proprietary, first-in-class, transdermal spray that delivers estradiol, a naturally occurring estrogen, for the treatment of hot flashes in women. 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 fast-drying, non- irritating and invisible after application. Studies have shown that once administered, EvaMist's formulation is not affected by washing and does not transfer to other people. EvaMist is easily administered as one, two or three sprays.
"We are pleased to announce the FDA acceptance of our submission for EvaMist," stated Leland F. Wilson, president and chief executive officer for VIVUS. "We are already working with the agency and look forward to gaining regulatory approval of this important new treatment for women suffering with the symptoms of menopause."
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 454 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 FDA. Results showed that EvaMist decreased the number of hot flashes by 78%, from 10.8 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 1.5% and was typically mild in nature