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[Wuscher]

News

Vertex Pharma Says Lexiva Combo Comparable To Pfizer Drug




07-08-04 04:57 PM EST
RESEARCH TRIANGLE PARK, N.C. -(Dow Jones)- Vertex Pharmaceuticals Inc. (VRTX) said once-a-day dose of its protease inhibitor, Lexiva, along with ritonavir provided antiviral suppression comparable with a twice-daily dose of Pfizer Inc.`s (PFE) Viracept, or nelfinavir, according to a recent study.

In a press release Thursday, the drug company said the international open- label, multi-center study evaluated 649 patients with HIV infection over 48 weeks. Both regimens were found to be well tolerated overall.

The study evaluated patients who hadn`t previously tried a protease inhibitor regimen.

Patients on the Lexiva with ritonavir regimen took four pills once a day with no food or water restrictions, while those on nelfinavir had to take five pills twice a day - or a total of 10 pills a day - with meals.

Vertex added that a once-a-day dose of Lexiva with ritonavir achieved viral suppression comparable with a twice-a-day dose of nelfinavir, or Viracept, in a comparable percentage of patients in the study.

Co-discovered by GlaxoSmithKline (GSK), Lexiva, in combination with other antiretroviral agents, received Food and Drug Administration approval in October as a treatment for HIV infection in adults.

Nelfinavir, branded Viracept, has been on the market for several years.

Protease inhibitors, work by blocking a part of HIV, called protease, and prevent the virus from infecting new cells with copies of itself.

Shares of Vertex closed Thursday at $10.04, down 70 cents, or 6.5%, undoing yesterday`s 40 cent gain for the day, on lower than average Nasdaq volume.

-Jacquie Jordan; Dow Jones Newswires; 201-938-5400; [e-mail]


Dow Jones Newswires
07-08-04 1657ET
Copyright (C) 2004 Dow Jones & Company, Inc. All Rights Reserved


Hat das Teil Zukunft ? Oder nicht ??
Meinungen
mfg

[Dausend1000]

MÜLL. FINGER WEG!!!!!
MK 700 Mio Dollar, lächerliche Umsätze, jedes Jahr höhere Verluste. NULL BLOCKBUSTER!
Aus meiner Sicht Pleitekandiat

Ich muss natürlich nicht Recht haben!

[betterthantherest]

Ich halte Vertex bereits seit einigen Jahren und habe eine Versiebenfachung mit anschließendem Absturz in die Verlustzone mitgemacht.

Die steigende Burnrate ist wirklich erschreckend, besonders wenn man den bisherigen Output sieht.

Die letzte Anleihe konnte aber ohne Probleme abgesetzt worden. Das müsste doch heißen, dass der Markt vertrauen in das Unternehmen hat.

Für mich ist Vertex eine echte Spekulation.

Kommt ein Blockbuster auf den Markt, noch bevor das ganze Geld flöten gegangen ist, oder nicht.

In der Pipeline sind einige Kandidaten zu finden. Nur leider scheint deren Entwicklung weit aus länger zu dauern als erwartet.

[betterthantherest]

Bei 96% der Patienten, welche das von Vertex und Glaxo entwickelte Medikament Lexiva verabreicht bekamen, lag der Anteil der Viren nach 2 Jahren unter der Nachweisgrenze.

Wenn man die weltweit zunehmende Ausbreitung von Aids in Betracht zieht, kann man sich gut vorstellen, welches Potenzial in diesem Medikament und damit in Vertex steckt.


Reuters
Glaxo, Vertex drug keeps HIV at bay for two years
Tuesday July 13, 3:02 am ET

BANGKOK, July 13 (Reuters) - A new HIV-fighting drug developed by GlaxoSmithKline (London:GSK.L - News) and biotechnology company Vertex Pharmaceuticals (NasdaqNM:VRTX - News) has demonstrated sustained virus suppression over two years, researchers said on Tuesday.

The drug, which is known as Lexiva in the United States and Telzir in Europe, is part of a class of AIDS medicines called protease inhibitors.

It offers an advantage over older protease inhibitors because fewer pills are needed. Patients only take two pills twice a day, or one pill twice a day plus another drug called ritonavir. Other medicines can require as many as eight pills twice a day.

New data presented at the 15th International AIDS Conference showed 96 percent of patients taking Lexiva/Telzir plus ritonavir in combination with other antiretrovirals had undetectable levels of virus in their blood after two years.

The U.S. Food and Drug Administration approved the drug last October and a final European green light is expected soon, following a positive recommendation from a panel of experts earlier this year.

Lexiva/Telzir is chemically similar to an older HIV drug from Vertex called Agenerase. The new product is expected to cannibalise much of the Agenerase market.

[Wuscher]

Die britische GlaxoSmithKline plc, Europas größter Pharmakonzern, und das US-Biotechnologieunternehmen Vertex Pharmaceuticals Inc., ein Spezialist für Wirkstoffe gegen Viruserkrankungen, erhielten von der EU-Kommission die Zulassung für ihr gemeinsam entwickeltes Arzneimittel Telzir (fosamprenavir).
Das Präparat dient in Kombination mit anderen Anti-Viruspräparaten zur Behandlung von HIV-Infektionen bei erwachsenen Patienten. Telzir, das seit Oktober 2003 in den USA unter dem Namen Lexiva zugelassen ist, gehört zur Klasse der Protease-Hemmstoffe, die den Aids verursachenden HIV-Virus unterdrücken. Dieses neue Produkt hat den Vorteil, dass Patienten eine deutlich geringere Zahl von Tabletten einnehmen müssen, als bei der Behandlung mit anderen Medikamenten erforderlich ist.

Heute fielen die Aktien von GSK in London um 1,67 Prozent und notieren aktuell bei 1.048,00 Pence.

© finanzen.net

mfg

[blb]

VRTX ist auf aktuellem Niveau sicherlich interessant, v.a. durch die letzten News. Einzig und allein die hohe Burnrate ist negativ. Könnte mir vorstellen, dass sie bald ne Anleihe oder so auflegen.

Bleib hier weiterhin dabei und werde, falls die Stabilisierung um die 10$ anhält nachlegen.

Grüße
blb

[Wuscher]

Vertex Says Hep C Drug Dosing Trial Meets Expectations




09-07-04 09:50 AM EST
CAMBRIDGE, Mass. (Dow Jones)--Vertex Pharmaceuticals Inc. (VRTX) said the dosing portion of its Phase Ia clincical trial for Hepatitis C antiviral drug VX-950 met its expectations.

In a press release Tuesday, the biotechnology company said it identified no dose-limiting toxicities in the Phase Ia trial, where 35 healthy European volunteers took doses ranging from 25 miligrams to 1250 miligrams. Based on the results, Vertex expects to begin a Phase Ib clinical study of the drug in Hepatitis C virus-infected patients in the fourth quarter.

The Phase Ia trial on investigational oral protease inhibitor VX-950 was designed to assess safety, tolerability and pharmacokinetics in escalating, single doses of VX-950. During the study, Vertex observed blood concentrations of VX-950 exceeding the concentration known to demonstrate potent antiviral activity. Preclinical data showed that VX-950, designed to treat the Hepatitis C virus, performed well on two different tests researchers use to measure antiviral activity.

Previously, Mitsubishi Pharma Corp. (4509.TO) agreed to pay Vertex precommercial fees and royalty payments as part of a development collaboration on the drug in Japan and the Far East.

Shares in Vertex closed Friday on Nasdaq at $10.25, down 9 cents, or 0.9%.

-Rob Curran; Dow Jones Newswires; 201-938-5400; [e-mail]


Dow Jones Newswires
09-07-04 0950ET
Copyright (C) 2004 Dow Jones & Company, Inc. All Rights Reserved.

mfg

[Wuscher]

14.09.2004 00:57:
Vertex Pharmaceuticals Announces Issuance of Convertible Senior Subordinated Notes ...

CAMBRIDGE, Mass., Sept. 13 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals (Nachrichten) announced today that six holders of its existing 5% Convertible Subordinated Notes due 2007 have agreed to exchange approximately $79.3 million in aggregate principal amount of such existing notes for approximately $79.3 million in aggregate principal amount of newly issued 5.75% Convertible Senior Subordinated Notes due 2011. The Senior Subordinated Notes will be issued through a private offering to qualified institutional buyers. The exchange is expected to close on September 17, 2004.

The Senior Subordinated Notes are identical in terms to the notes issued by Vertex in February 2004 and will be convertible into Vertex common stock at a price equal to $14.94 per share, subject to adjustment in certain circumstances, which represents a 41.6% premium over the average closing prices for the last four trading days of the Vertex common stock, or $10.55. The Senior Subordinated Notes will bear an interest rate of 5.75% per annum, mature on February 15, 2011 and will be redeemable by Vertex on or after February 15, 2007.

With the completion of this transaction, Vertex will have $82.6 million in aggregate principal amount of 5% Convertible Subordinated Notes due 2007 and $232.4 million in aggregate principal amount of 5.75% Convertible Senior Subordinated Notes due 2011. The $153.1 million of 5.75% Convertible Senior Subordinated Notes due 2011 issued in February 2004 and the newly issued $79.3 million of 5.75% Convertible Senior Subordinated Notes due 2011 will trade as separate series.

Vertex has agreed to file a registration statement for the resale of the new notes and the shares of common stock issuable upon conversion of the new notes within 120 days after the closing of the offering.

This announcement is neither an offer to exchange nor a solicitation of an offer to exchange any of these securities.

The new notes and the common stock issuable upon conversion of the new notes have not been registered under the Securities Act of 1933 or any state securities laws, and are being offered only to qualified institutional buyers in transactions not subject to the registration requirements of the Securities Act. Unless so registered, the new notes and the common stock issued upon conversion of the new notes may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws.

Vertex Contacts: Lynne H. Brum, VP, Corporate Communications and Financial Planning, [phone] Lora Pike, Manager, Investor Relations, [phone]

Vertex Pharmaceuticals Incorporated