Uprima-Der Viagra Konkurent mit schnellerer Wirkung!!!! - 500 Beiträge pro Seite

[waldt]

http://www.abbott.com/news/2000news/pr20000410.htm
Weitere Infos unter:
www.uprima.org
www.trinitymenshealth.com


FDA ADVISORY COMMITTEE RECOMMENDS APPROVAL OF
UPRIMA® (APOMORPHINE HCl TABLETS) SUBLINGUAL
FOR TREATMENMT OF ERECTILE DYSFUNCTION

— New class of Erectile Dysfunction (ED) therapy may benefit millions of men with ED —

Lake Forest, Illinois, April 10, 2000 – TAP Pharmaceutical Products Inc. announced today that the U.S. Food and Drug Administration’s Urology Subcommittee of the Advisory Committee for Reproductive Health Drugs recommended approval for UPRIMA® (apomorphine HCl tablets) sublingual for the treatment of erectile dysfunction (ED). The committee’s favorable recommendation will be considered by the FDA in its final review of the New Drug Application (NDA) for UPRIMA.

The committee suggested some cautionary recommendations for labeling. In addition, the committee advised that education materials be provided to patients at the point of care.

If approved, UPRIMA will be the first centrally acting oral ED treatment available to patients. "UPRIMA could offer several benefits for patients suffering from ED," says John Mulhall, MD, director of the Center for Male Sexual Health at Loyola University Chicago and an investigator in the UPRIMA clinical trials. "In clinical trials, it worked quickly, in as fast as 10 minutes, with a median response time of 16-19 minutes. With its sublingual route of administration, it is not expected that UPRIMA will interact with food. Finally, data suggest that UPRIMA is safe and effective in men with varying severities of ED."

TAP submitted an NDA for UPRIMA on July 1, 1999, for 2 mg, 3 mg and 4 mg doses. The NDA was based on data from 27 clinical studies in 3,035 men.

"We are extremely encouraged by the recommendation, as we feel that UPRIMA would greatly enhance the therapeutic options of millions of men with ED. Further, UPRIMA will be a significant addition to our product portfolio, allowing us to further build on our experience in urology and primary care," says Thomas Watkins, president of TAP Pharmaceutical Products Inc.

Erectile dysfunction is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual intercourse. Approximately 30 million American men suffer from some form of erectile dysfunction.

In clinical studies, UPRIMA was administered to men with organic, psychogenic, or mixed etiology erectile dysfunction, and was evaluated for its ability to produce an erection firm enough for intercourse. Initial studies with UPRIMA included patients with controlled hypertension and diabetes (type I and type II). TAP has also evaluated UPRIMA following nerve-sparing radical prostatectomy. In addition, a unique aspect of TAP’s clinical studies was the assessment of patients’ partners for satisfaction. This assessment showed corroboration of findings from the patient.

The most commonly reported side effect was nausea. Of the nausea reported in the NDA clinical studies, most incidences were mild to moderate in severity.

Apomorphine HCl tablets sublingual for male erectile dysfunction was licensed from Pentech Pharmaceuticals, Inc. of Buffalo Grove, Illinois.

TAP Pharmaceutical Products Inc. is a joint venture between Abbott Laboratories, headquartered in Abbott Park, Illinois, and Takeda Chemical Industries, Ltd. of Osaka, Japan. Abbott and Takeda will jointly develop and co-market apomorphine in countries outside of the United States and Canada. TAP also markets Lupron Depot® (leuprolide acetate for depot suspension) for the palliative treatment of advanced prostate cancer, management of endometriosis, anemia caused by uterine fibroids in combination with iron, and central precocious puberty, and PREVACID® (lansoprazole) for the treatment of various acid-related disorders including gastroesophageal reflux disease (GERD) and ulcers. TAP has also submitted a NDA to the FDA for the cephalosporin antibiotic SPECTRACEF™ (cefditoren pivoxil).

[Dagoberta]

Focus online hats auch schon bemerkt (siehe thread: neue Pfizer).

http://www.takeda.com/index-e.html

[HRDUERR]

Uprima, ein neues Potenzmittel, läßt Abbot-Kurs abheben !

Die beratende Komission der US-Arzneimittelbehörde hat am Montag ihre Zustimmung für ein neues Potenzmittel erteilt. Die Pille mit dem Namen Uprima sei sowohl wirksam als auch sicher, urteilte die Kommision nach Informationen der Herstellerfirma TAP Pharmaceutical Products. Das Mittel erziele denselben Effekt wie das Potenzmedikament Viagra. den Angaben zufolge wurde Uprima bisher in 27 Studien an mehr als 3.000 Männern getestet. Die endgültige Entscheidung über die Zulassung liegt bei der Arzneimittelbehörde, die sich in der Regel jedoch an die Vorgaben der beratenden Kommission hält. (HANDELSBLATT 12.04.00, S. 20)

TAP Pharmaceutical Products ist ein Joint Venture zwischen Takeda Chemical
Industries (Japan) und Abbott Laboratories (U.S.). Die Aktie von Takeda wurde prompt auch von Focus Online empfohlen (Siehe auch den Takeda-Threat), die scheinen jedoch vergessen zu haben daß nach wie vor der amerikanische Markt und damit Abbot das Zugpferd bleibt. Das zeigt sich im aktuellen Kursverlauf. Entgegen den Trend legte Abbot hier gestern um über 4 % zu. Den aktuellen Kursverlauf hier in D bitte ich selbst zu entnehmen, leider habe ich keine Ahnung wie man den Chart hier einbindet.

Viagra war übrigens bei Markteinführung das am besten verkaufte Medikament der Geschichte.

Zu Uprima selbst können übers Internet beliebige Mengen an Information nachgefragt werden.

Ich denke daß unabhängig vom aktuellen Pharma-Boom, der die aus den Biotech Aktien freiwerdenden Gelder in bekannte Blue Chips der Branche umzuschichten scheint und Abbot zusätzlich bevorzugt, die Aktie den Besitzern überproportionale Kursgewinne in den nächsten Wochen bringen wird.