VERTEX Pharmaceuticals - Überzahmeziel? Kursrakete? - 500 Beiträge pro Seite

[Rosenberger]

Vertex Pharmaceuticals buy
06.01.2009 - 13:37

Minneapolis (aktiencheck.de AG) - Thomas Wei, Analyst von Piper Jaffray, stuft die Aktie von Vertex Pharmaceuticals (ISIN US92532F1003/ WKN 882807) unverändert mit \"buy\" ein.

Die Aktie repräsentiere eine der Top-Empfehlungen für 2009. Das Kursziel von 43 USD habe ebenso Bestand wie das Führen des Titels in der \"Alpha List\".

Vertex sei eines von wenigen Biotech-Unternehmen, die in den kommenden Jahren einen echten Blockbuster auf den Markt bringen könnten. Eine Telaprevir-Studie der Phase III sollte im Januar abgeschlossen werden und damit eine wichtige Sicherheitshürde nehmen. Bis Mitte 2011 könnte es zu einer Zulassung kommen. Die Umsätze von Telaprevir könnten in 2013 4,2 Mrd. USD erreichen.

Vor diesem Hintergrund empfehlen die Analysten von Piper Jaffray die Aktie von Vertex Pharmaceuticals weiterhin zum Kauf. (Analyse vom 05.01.09) (05.01.2009/ac/a/a) Analyse-Datum: 05.01.2009

[Rosenberger]

Wirtschaft
05. Januar 2009, 11:57
Pfizer fasst große Übernahme ins AugeDer weltweit führende Pharmakonzern Pfizer erwägt die Übernahme eines großen Konkurrenten, um seine Wettbewerbsposition zu stärken. «Das Ziel ist letztlich, den Umsatz zu steigern.




Das wohl bekannteste Medikament des US-Unternehmens Pfizer ist die Potenzpille Viagra.

Wir sind offen für Zusammenschlüsse und sehen uns ständig potenzielle Kandidaten an - große, kleine und mittelgroße», sagte Pfizer-Chef Jeff Kindler der «Financial Times» (Montag).

Kindlers Ankündigung könnte dem Bericht zufolge eine neue Runde von Großfusionen in der Pharmaindustrie einläuten. Die heutigen Branchenschwergewichte Pfizer, AstraZeneca, GlaxoSmithKline und Sanofi-Aventis seien alle durch Zusammenschlüsse entstanden.

Seit diesen Fusionen hätten sich die meisten Wettbewerber auf kleinere Übernahmen und Partnerschaften konzentriert. Sollte Pfizer zu einer großen Übernahme ansetzen, könnte eine neue Konsolidierungsrunde beginnen.

Kindlers Wille zu einer Großübernahme ist dem Bericht zufolge auch Beleg dafür, dass Pfizer dringend etwas unternehmen muss, um einen absehbaren Umsatzeinbruch auszugleichen. Patente auf wichtige Medikamente laufen aus. Das gilt etwa für den Cholesterinsenker Lipitor, der jährlich weltweit mehr als 13 Milliarden Dollar (9,5 Mrd Euro) Umsatz bringt.

[Rosenberger]

charttechnisch eine gute Basis um bei positiven Ergebnissen zur Studie der Phase III die 35 Dollar zu durchbrechen.

[Wavrider]

Das mit dem potenziellen Blockbuster hört man schon seit 2000, nur ändert sich das Medikament mit der Zeit .

Auf eine Übernahme hoffe ich nicht. Nachdem ich die Aktien seit 2000 im Depot habe, anfänglich mit schönem Gewinn, zwischenzeitlich mit derbem Verlust hoffe ich, dass das Unternehmen selbständig bleibt. Dann heißt es Sekt oder Selters. Nach einer so langen Wartezeit und möglicherweise kurz vor dem - zum wiederholten Male - propagierten Durchbruch wäre es einfach nur ärgerlich, wenn nach Millennium auch noch Vertex verschwindet.

[trustone]

hy @all

ich kenne Vertex und mit einer Bewertung von 4,5 Milliarden Dollar sind die schon ganz schön bewertet........

aber es gibt da auch noch einen Biotech Geheimtipp für 2009

La Jolla Pharmaceutical,

an der Nasdaq gelistet wird das Unternehmen derzeit nur
mit ca. 70 Mio Dollar bewertet!

erste Wirksamkeitsstudie für eine Finale Phase 3 Studie werden schon für das erste Quartal erwartet, ist das Medikament ein Erfolg wird es Blockbuster Status erreichen

ein absolutes Schnäppchen und noch Unentdeckt wie ich meine

einfach mal ansehen:

http://www.wallstreet-online.de/diskussion/1147159-1-10/la-j…

[Rosenberger]

Antwort auf Beitrag Nr.: 36.376.861 von trustone am 14.01.09 22:19:58

mach dir nen neuen thread auf und müll hier nicht rein.

[Zunftkoelsch]

Antwort auf Beitrag Nr.: 36.376.861 von trustone am 14.01.09 22:19:58

La Jolla habe ich seit ewigen Zeiten auf meiner WL und die Entwicklung des Kurses ist alles andere als erfreulich, sogar ein 5:1 reverse split wurde bereits einmal durchgeführt, trotzdem iss der Kurs wieder auf Pennystockniveau abgesackt...Naja aber es hat sich in den letzten Tagen wohl was getan wenn man sich den Januar so anschaut

Dir aber viel Glück, vllt ziehste mit La Jolla ja das große Los

[Rosenberger]

das für januar anstehende ergebnis der studie III für einen blockbuster dürfte den kurs charttechnisch nun ausbrechen lassen. ich bin mal gespannt was passiert. die zeichen stehen gut.

[Rosenberger]

charttechnisch könnte in kürze ein ausbruch erfolgen... mein KZ liegt bei 40 dollar (keine Kaufempfehlung).

[Rosenberger]

Mark Your Calendars: The Race Is On!By Brian Orelli
January 30, 2009 | Comments (1)

Rate VRTX CAPS Rating 3/5 Stars
$33.05 $-0.67 (-1.99%)

The marathon race to bring the next hepatitis C drug to the market is coming to a close. In the last couple of weeks, both Schering-Plough (NYSE: SGP) and Vertex Pharmaceuticals (Nasdaq: VRTX) have announced that their phase 3 trials have finished enrolling patients.

That means investors can pretty much guess when data from the trials should be available. The timetable for hepatitis C trials is pretty clear, unlike cancer drugs, where the trials often conclude when enough events, like deaths or progression of the disease, have taken place, which makes the timing of their conclusion somewhat unpredictable. For instance, the results of Dendreon's (Nasdaq: DNDN) prostate cancer treatment Provenge are now expected a few months earlier than originally planned.

Almost there
Schering's Sprint-2 trial testing boceprevir and Vertex's Illuminate trial testing telaprevir have a maximum of 48 weeks of treatment and a 24-week follow up to see if the virus has been eradicated, so the subjects that just started treatment now should be done in about 17 months. Add a month or two to process the data, and investors should get results before the end of the summer next year.

Both companies are also testing the drug in patients who have failed the current treatments: Roche's Pegasys and Schering's Pegintron. Vertex is expecting final data from a phase 2 trial, confusingly called Prove 3, in the first half of this year. It's still a possibility that the company could file a marketing application with just that data given the unmet need, but the company needs to see the data and discuss it with the Food and Drug Administration first. If it can get approved with the phase 2 data, great -- Vertex would likely be first to market. But if that doesn't work out, it has a backup plan with a phase 3 trial that is expected to be fully enrolled this quarter. Schering's phase 3 trial for treatment-failure patients concluded enrollment last November.

Watch your back
Telaprevir and boceprevir are the two drugs getting the most attention, but Vertex and Schering aren't the only ones developing drugs to fight hepatitis C.

There are two drugs in development that are hoping to upstage the current treatment (Pegasys and Pegintron). Human Genome Sciences' (Nasdaq: HGSI) Albuferon has already proven itself as effective as Pegasys in treating patients infected with the easier-to-treat genotype 2 and 3 virus. Investors should find out in March whether it's effective against the harder-to-treat genotype 1 infection. Fortunately, Albuferon only has to prove that it's as effective as Pegasys to get approved since the drug is dosed half as often.

ZymoGenetics' (Nasdaq: ZGEN) PEG-interferon lambda is farther back in the clinic -- it recently completed a phase 1 trial -- but the drug is showing a lot of promise. So much promise, in fact, that Bristol-Myers Squibb (NYSE: BMY) licensed the drug for $105 million upfront and another $1 billion in milestone payments if the drug is successful in the clinic, approved by regulatory authorities for various indications, and reaches sales goals. For a phase 1 drug, that high price tag says a lot about how much potential Bristol-Myers thinks the drug has.

There are also other drugs set up to be used with the current treatment's pegylated interferons, rather than replace them. Roche, InterMune (Nasdaq: ITMN), and Pharmasset all have drugs that are further behind telaprevir and boceprevir, but hope to prove superior by the time they conclude their phase 3 trials.

A long road
Hepatitis C is clearly a large market -- Pegintron and Pegasys combined for around $1.7 billion in sales through the first nine months of last year. The first company to hit the market with a new drug will have a clear advantage, but it doesn't look like it'll last for very long. In the drug world, there's always someone on your tail.

[honigbaer]

Den Thread kann man mal offen halten.

[MartinV]

Was ist los?

[Wuscher]

Steigt wie hulle.

[honigbaer]

Besondere Ereignisse, die den anstieg erklären, gibt es wohl keine.
Anfang des Monats konnte man sich etwa eine halbe Milliarde Dollar bei einer Kapitalerhöhung zu ca. 40 Dollar beschaffen. Einerseits hat wohl das in der Pipeline befindliche Telaprevir gegen Hepatitis C Potential, andererseits liegen antivirale Medikamente im Pharmatrend.

[fab86]

steigt und steigt. gibts dafuer einen Grund?

[Retaard]

Antwort auf Beitrag Nr.: 38.633.116 von fab86 am 27.12.09 10:16:46

könnte mit der Aktionär zu tun haben. haben einen Bericht in Ihrem Heft veröffentlicht, bzw. in Ihr depot aufgenommen

[Pregasina]

Bin am Überlegen, auch hier einzusteigen. Seit einem Monat geht es jedoch ständig bergab und das, obwohl demnächst (am 4. Februar) die Q4-Zahlen veröffentlicht werden.
Wie schätzt ihr die Chancen ein, dass der Ausblick fürs Jahr 2010 und die Phase-III-Daten bzgl. Telaprevir im Besonderen, positiv ausfallen?

[zoi2002]

Die Aktie kann nicht über die 40 zulegen..ein wenig komisch bei dem Bullenmarkt - hat jemand eine Meinung?

[honigbaer]

Daytrader, oder was? z
Der Kurs kommt doch von 43 aus gerade etwas zurück.
Lies doch mal die letten News vom Unternehmen und stell hier rein, was drinsteht. Bin selbst zu faul dazu. (Frühjahrsmüdigkeit)

[Electra13]

wann es hier wohl mal wieder hoch geht?

[Electra13]

hi
ist hier sonst noch jemand???
der kurs macht in den letzten wochen wirklich keinen spass mehr...und gegenseitige erbauung findet man hier auch nicht....

[Electra13]

25.10.2010 22:18
Vertex Pharmaceuticals Reports Third Quarter 2010 Financial Results and Highlights Progress in Hepatitis C and Cystic Fibrosis Development Programs


-Hepatitis C: New Drug Application submission for telaprevir on track for fourth quarter 2010-

-Cystic Fibrosis: Phase 3 registration program ongoing for VX-770-

-Pipeline: Ongoing proof-of-concept clinical trials in hepatitis C, cystic fibrosis, epilepsy and rheumatoid arthritis-

-Financial: Company ends third quarter with a cash position of $1.2 billion-

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reviewed recent business and clinical progress and reported consolidated financial results for the quarter ended September 30, 2010.

"With the recent completion of our Phase 3 registration program for telaprevir, we remain on track to submit our New Drug Application in the coming weeks, marking what we believe will be an important milestone in our effort to bring telaprevir to people with hepatitis C," said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex Pharmaceuticals.

Mr. Emmens continued, "Later this week, clinical investigators will present Phase 3 data for telaprevir at the annual AASLD meeting in Boston. We continue to have high confidence in the potential for telaprevir to help the majority of people with hepatitis C - regardless of their treatment history - and we look forward to sharing additional telaprevir data with the medical community.

"Importantly, with a cash position of $1.2 billion at the end of the third quarter, we will enter 2011 with the financial strength needed to support the planned launch of telaprevir as well as the continued discovery and development of other new breakthrough medicines," concluded Mr. Emmens.

Hepatitis C

Telaprevir Phase 3 Program Complete; Rolling NDA Submission On Track

In the third quarter, Vertex completed its Phase 3 registration program for telaprevir. The company remains on track to complete the submission of its rolling New Drug Application (NDA) for telaprevir in combination with pegylated-interferon and ribavirin in the fourth quarter of 2010 with clinical data from its three Phase 3 trials in people who had not been previously treated for hepatitis C and in people who received prior treatment but were not cured.
Phase 3 ADVANCE and ILLUMINATE Trials to be Presented at AASLD This Week

Vertex expects that final sustained viral response (SVR or viral cure) and safety data from the Phase 3 ADVANCE and ILLUMINATE trials will be presented as part of oral presentation sessions at the upcoming annual meeting for the American Association for the Study of Liver Diseases (AASLD or The Liver Meeting), being held October 29 to November 2 in Boston. In total, eight Vertex abstracts were accepted for presentation at the AASLD meeting.
Initiation of Phase 3b Clinical Trial to Evaluate Twice-Daily (BID) Dosing of Telaprevir

Vertex today announced the initiation of a Phase 3b clinical trial to evaluate twice-daily dosing of telaprevir (1,125 mg; BID) compared to three-times-daily dosing of telaprevir (750 mg; q8h) in combination with pegylated-interferon and ribavirin for people with genotype 1 hepatitis C. Patient screening for enrollment in the study is expected to start in November 2010. Additional details on this trial were provided today in a separate press release.
Ongoing Phase 2 Trial Evaluating Combination Regimens of VX-222 and Telaprevir

Vertex announced today that it has modified its clinical trial evaluating telaprevir dosed in combination with Vertex's lead HCV polymerase inhibitor, VX-222. The company will discontinue Arm A of this study as a result of patients meeting a pre-defined stopping rule related to viral breakthrough during the first four weeks of dosing. Arm A was designed to evaluate a two-drug regimen of VX-222 (low dose; 100 mg) and telaprevir (1,125 mg) both dosed twice daily without pegylated-interferon and ribavirin. The additional three arms of the study are continuing without modification, and no viral breakthrough has been reported in these arms.
This Phase 2 proof-of-concept trial began dosing patients in August 2010 and is designed to evaluate safety and SVR rates using 12-week response-guided regimens of telaprevir/VX-222-based combination therapy in people with genotype 1 hepatitis C. The trial is continuing to evaluate treatment regimens that include four-drug regimens of telaprevir, VX-222, pegylated-interferon and ribavirin, as well as a two-drug regimen of only telaprevir (1,125 mg) and a higher dose of VX-222 (400 mg), both dosed twice daily.
Trial sites have now completed patient recruitment, which Vertex expects will enable it to reach the initial target enrollment of 100 patients for the study. Vertex expects to obtain on-treatment clinical data from this trial in the first half of 2011 and SVR data in the second half of 2011.
Enrollment Complete in Phase 2 Trial Evaluating Telaprevir in People Co-Infected with Hepatitis C Virus and Human Immunodeficiency Virus

Vertex today announced that it has completed enrollment of 60 patients in a Phase 2 clinical trial of telaprevir-based regimens in people who are infected with genotype 1 hepatitis C virus and the human immunodeficiency virus (HIV), also know as HCV-HIV co-infection. The primary endpoint of the trial is to evaluate the safety and tolerability of telaprevir-based therapy in people co-infected with HCV and HIV. A secondary endpoint is to evaluate SVR, or viral cure, rates.
The trial enrolled 13 people who had not previously received treatment for hepatitis C and who were not currently being treated for HIV infection. The trial also enrolled 47 people who had not previously received treatment for hepatitis C and who were currently being treated for HIV infection with highly active antiretroviral therapy (HAART). Of the 47 patients on HAART, 23 were receiving a Reyataz-based regimen and 24 were receiving Atripla.
Cystic Fibrosis

Phase 3 Registration Program for VX-770

Three trials of the novel cystic fibrosis transmembrane conductance regulator protein (CFTR) potentiator VX-770 are fully enrolled and ongoing as part of a global Phase 3 registration program focused on patients with the G551D mutation.
Data from the Phase 3 registration program of VX-770 are expected in the first half of 2011. Pending results from the Phase 3 registration program, Vertex expects to submit a New Drug Application for VX-770 in the second half of 2011.
Initiation of Combination Trial of VX-770 and VX-809

Vertex recently initiated a Phase 2a clinical trial that is evaluating combination regimens of VX-809 and VX-770 in people with cystic fibrosis who have two copies of the F508del mutation. Additional details on this trial can be found in a press release issued on October 18.
Pipeline

Proof-of-Concept Trials of VX-765 in Epilepsy and VX-509 in Rheumatoid Arthritis

Vertex expects to complete a Phase 2 proof-of-concept trial of the novel caspase-1 inhibitor VX-765 in epilepsy in 2010. Top-line data, including safety and seizure frequency data, are expected later this year.
Enrollment is ongoing in a Phase 2 proof-of-concept clinical trial of the novel Janus kinase 3 (JAK3) inhibitor VX-509 in rheumatoid arthritis (RA). Interim data from the trial are expected in 2011.
Third Quarter Results

For the quarter ended September 30, 2010, the company's GAAP net loss was $209.0 million, or $1.04 per share, including certain charges totaling $34.4 million, compared to a GAAP net loss for the quarter ended September 30, 2009 of $149.6 million, or $0.84 per share, including certain charges totaling $22.6 million.

The non-GAAP loss, before certain charges, for the quarter ended September 30, 2010 was $174.6 million, or $0.87 per share, compared to $126.9 million, or $0.71 per share, for the quarter ended September 30, 2009. The increase in the company's 2010 non-GAAP loss was attributable to increased costs to support advancement of telaprevir toward potential launch.

Total revenues for the quarter ended September 30, 2010 were $23.8 million, compared to $25.0 million for the third quarter of 2009.

Research and development (R&D) expenses for the quarter ended September 30, 2010 were $170.4 million, compared to $132.1 million for the third quarter of 2009. The increase reflects greater commercial supply investment for telaprevir and increases in other development activities.

Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2010 were $48.9 million, compared to $36.6 million for the third quarter of 2009. This increase reflects building of capabilities, including an increase in the number of employees and our commercial investments, to support advancement of telaprevir toward potential launch.

At September 30, 2010, Vertex had $1.2 billion in cash, cash equivalents and marketable securities. In September 2010, Vertex issued $400.0 million of 3.35% convertible senior subordinated notes due 2015, with a conversion price of approximately $48.83 per share.

Full Year 2010 Financial Guidance

This section contains forward-looking guidance about the financial outlook for Vertex Pharmaceuticals.

The company is today reiterating its guidance for 2010 non-GAAP loss of approximately $600 million, as provided on February 4, 2010, and for its 2010 GAAP net loss of approximately $750 million, as provided on July 28, 2010.

Non-GAAP Financial Measures

In this press release, Vertex's financial results are provided both in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, Vertex provides its third quarter 2010 and 2009 loss, and guidance for its projected 2010 loss, excluding stock-based compensation and executive transition expenses, restructuring expense, acquisition-related expenses, loss on exchange of convertible subordinated notes, and revenue and expenses related to certain September 2009 financial transactions. These results are provided as a complement to results provided in accordance with GAAP because management believes these non-GAAP financial measures help indicate underlying trends in the company's business, are important in comparing current results with prior period results and provide additional information regarding its financial position. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally, and to manage the company's business and to evaluate its performance. A reconciliation of the other non-GAAP financial results to GAAP financial results is included in the attached financial statements.

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer and pain. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

Lexiva is a registered trademark of the GlaxoSmithKline group of companies.

Reyataz is a registered trademark of Bristol-Myers Squibb.

Atripla is a registered trademark of Bristol-Myers Squibb and Gilead Sciences, LLC.

Special Note Regarding Forward-looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding (i) Vertex remaining on track to submit its New Drug Application for telaprevir in the fourth quarter of 2010; (ii) clinical investigators presenting Phase 3 data for telaprevir at AASLD; (iii) the potential for telaprevir to help the majority of people with hepatitis C regardless of their treatment history; (iv) the company entering 2011 with the financial strength needed to support the planned launch of telaprevir as well as the continued discovery and development of other new breakthrough medicines; (v) the expectation that patient screening for the Phase 3b clinical trial of telaprevir will start in November 2010; (vi) the telaprevir/VX-222 Phase 2 clinical trial being designed to evaluate safety and SVR rates using telaprevir/VX-222 based combination therapy and continuing to evaluate treatment regimens that include four-drug regimens and a two-drug regimen of only telaprevir and VX-222; (vii) Vertex expecting to reach its initial target enrollment of 100 patients, and to obtain on-treatment clinical data from the Phase 2 clinical trial of telaprevir and VX-222 in the first half of 2011 and SVR data in the second half of 2011; (viii) the expectation that data from the Phase 3 registration program for VX-770 will be available in the first half of 2011 and the possibility that the company will submit a New Drug Application for VX-770 in the second half of 2011; (ix) the expectation that the company will complete and receive top-line data from a clinical trial of VX-765 in 2010; (x) the expectation that interim data from a Phase 2 clinical trial of VX-509 will be received in 2011; and (xi) the company's expectations regarding its 2010 non-GAAP and GAAP net loss. While the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the outcomes for each of its planned clinical trials and studies may not be favorable, that regulatory authorities may require supplemental clinical trials in order to support registration of telaprevir and/or VX-770, that planned or potential clinical trials may be delayed or may not be conducted, that the company may not be able to successfully develop telaprevir, VX-770, VX-509, VX-765 or combination therapies involving telaprevir and VX-222 or VX-770 and VX-809, that the company's expectations regarding its 2010 GAAP and non-GAAP net loss may be incorrect, and other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through the company's website at www.vrtx.com. The company disclaims any obligation to update the information contained in this press release as new information becomes available.


Vertex Pharmaceuticals Incorporated

2010 Third Quarter and Nine Month Results

Consolidated Statements of Operations Data

(in thousands, except per share amounts)

(unaudited)

[Ahorne]

Antwort auf Beitrag Nr.: 40.387.864 von Electra13 am 25.10.10 22:32:15

Das Schicksaljahr für den Biotech Veteran

Die News und Berichte häufen sich... die Spannung steigt

http://finance.yahoo.com/q?s=VRTX&ql=0

Ende Monat wissen wir schon ein wenig mehr

cu

[Ahorne]

Antwort auf Beitrag Nr.: 40.806.717 von Ahorne am 05.01.11 20:22:15

U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C

http://investors.vrtx.com/releasedetail.cfm?ReleaseID=544657

[blb]

Antwort auf Beitrag Nr.: 40.901.594 von Ahorne am 21.01.11 11:16:21

Hat das Ding hier keiner mehr auf dem Radar? Kursziel 100 Dollar würd ich mal sagen.



Könnte ein Moderator den Thread in das Biotech-Forum verschieben? Denke, da wäre er besser aufgehoben.

[Ahorne]

Antwort auf Beitrag Nr.: 41.151.862 von blb am 05.03.11 08:35:05

Guten Morgen blb

schön einen Mitstreiter hier zu haben
Bin seit Dez10 mitdabei und bis jetzt hat Vertex freude gemacht, wie schon geschrieben, ein Schicksaljahr für Vertex: Sollte FDA das "Approvel" für Telaprevir geben... sind die Aussichten ausgezeichnet für die Firma, wenn nicht... Absturz

fast status für Telaprevir hat Vertex schon mal erhalten... eine postitive Indikation, mehr aber auch nicht

Danke für den Chart... luft nach oben hat sie ja noch

Gruss

[blb]

Antwort auf Beitrag Nr.: 41.151.941 von Ahorne am 05.03.11 09:20:53

Bin hier auch schon einige Jahre dabei, Ahorne, nahezu alle Höhen und Tiefen mitgemacht. Aber bald ist Zahltag.

Für 2012 erwarten die Analysten schon einen Gewinn von 3,85 Dollar je Aktie. Klar, sollte es bei der Zulassung Probleme geben, wirds wieder einen Rückschlag geben. Aber ohne Risiko geht es bei den Biotechs eben nicht.

Schönes Wochenende!

[Ahorne]

Antwort auf Beitrag Nr.: 41.152.239 von blb am 05.03.11 11:21:09

also ein alter Vertex Veteran hatte die Aktie schon in den 90er mal im Depot... und jetzt wieder, alte Liebe rostet nicht... und jetzt kann es Vertex endlich gelingen, Nachhaltig Gewinne zu schreiben.

und ein wirklich grosser Player zu werden... we'll see

ps... habe ein Mod angschreiben, ob er das Forum -> Biotech wechseln kann.

gute Idee von Dir, Nasdaq ist so nix sagend...

Ich wünsche Dir auch ein schönes Wochenende

[Ahorne]

Antwort auf Beitrag Nr.: 41.152.293 von Ahorne am 05.03.11 11:42:13

ps... habe ein Mod angschreiben, ob er das Forum -> Biotech wechseln kann.

das ging ja fix!!!

Herzlichen Dank für die Umstellung an w/o Mod!!!

neu: Forum Biotech.... pass besser

[Ahorne]

Antwort auf Beitrag Nr.: 41.158.711 von Ahorne am 07.03.11 15:36:53

New Data on Telaprevir and VX-222 for the Treatment of Hepatitis C Accepted For Presentation at EASL Annual Meeting
http://finance.yahoo.com/news/New-Data-on-Telaprevir-and-bw-…
(in Berlin, Germany, March 30 to April 3, 2011.)

...“This is an exciting time for the treatment of hepatitis C and for Vertex,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. “At EASL, we will present, for the first time, complete results from the Phase 3 REALIZE study and early findings of a new study evaluating both of our oral medicines in development for hepatitis C, telaprevir and VX-222 in combination with available medicines....

[blb]

Antwort auf Beitrag Nr.: 41.161.364 von Ahorne am 07.03.11 21:52:10

Technisch wirste im mittelfristige Bereich derzeit kaum eine Aktie finden, die besser aussieht.

[milanjo]

guten morgen, weiss einer warum Vertex gegen den Trend gestern so abgestürzt ist?

[clearasil]

Antwort auf Beitrag Nr.: 41.168.529 von milanjo am 09.03.11 08:45:19

kurzfristig heiss gelaufen, extrem überkauft, gewinnmitnahmen, hoch bewertet, hier darf absolut nichts schief gehen.

[milanjo]

aber ist doch grundsätzlich einer der solidesten und besten biotecs... ich halte dies nicht so sehr für riskant.

heiß gelaufen kann ich nachvollziehen. aber nach dem kurzen verschnaufen, sollte es doch hoffentlich richtung 40 eur gehen...

[Ahorne]

Antwort auf Beitrag Nr.: 41.169.288 von clearasil am 09.03.11 10:38:39

so sehe ich das auch... top oder flop

die Schwankungen werden bis zur Zulassungen hoch bleiben.
wenn keine Zulassung... ist Vertex tot oder unbedeutend in der Branche.

[clearasil]

Antwort auf Beitrag Nr.: 41.170.896 von Ahorne am 09.03.11 14:16:20

die schwankungen werden auch nach einer Zulassung hoch bleiben, da jede menge Konkurrenz für telaprevir am anrollen ist, gerade neue topdaten von pharmaset gekommen, auch merck ist ziemlich weit mit boceprevir.

wer ruhig schlafen will oder niedrige vola erwartet, ist hier grundfalsch.

wenn alles fantastisch läuft, ist auf Sicht von 3-5 Jahren vielleicht noch eine Verdoppelung möglich, dann ist man langsam in der gild und celg ecke, und dann wird es wirklich eng.

crv diskussionswürdig.

bin investiert, aber nicht ohne Bedenken.

[milanjo]

ich sehe es nicht ganz so pessimistisch.

vorab 5 eur ins phrasenschwein... "aktien sind per se risikoreich"... sieht man auch heute beim beben wieder...

aber selbst wenn es keine zulassung bei vertex geben sollte, sind diese gut aufgestellt. ich bin aber 100% von der zulassung überzeugt.... wann ist diese geplant... im märz? kennt einer den termin?

den verdoppler sehe ich schon für 2012

[milanjo]

es dreht doch schon wieder... seht ihr.. heute waren top-kaufkurse... man möge sich nur mal den bericht im aktionär von vor einer woche ansehen---- ziel 77 USD sollten dieses jahr erreichbar sein

[blb]

Antwort auf Beitrag Nr.: 41.187.324 von milanjo am 11.03.11 17:14:34

Telaprevir-Zulassung steht im Mai an. Für das Mukoviszidose-Medikament wird der Antrag in der zweiten Jahreshälfte gestellt.

[blb]

Antwort auf Beitrag Nr.: 41.172.364 von clearasil am 09.03.11 17:21:25

Die Studienresultate der Konkurrenz waren deutlich schlechter.

[Ahorne]

Antwort auf Beitrag Nr.: 41.188.014 von blb am 11.03.11 18:46:33

U.S. FDA advisory meetings through June 29
http://www.reuters.com/article/2011/03/16/fda-advisory-diary…

ANTIVIRAL DRUGS ADVISORY COMMITTEE

DATE: April 28, 0800/1200
LOCATION: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, Silver Spring, Md.

CONTACT: Paul Tran, 301-796-9001

The committee will discuss Vertex Pharmaceuticals Inc's (VRTX.O) experimental hepatitis C virus protease inhibitor, telaprevir. The drug aims to treat chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines already approved for chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy

[blb]

Antwort auf Beitrag Nr.: 41.232.892 von Ahorne am 18.03.11 17:00:00

Die Rallye geht weiter, freu mich schon auf den Mai.

[Ahorne]

Antwort auf Beitrag Nr.: 41.282.614 von blb am 29.03.11 14:27:51

Auch News von einer anderer Front:

Vertex Says Cystic Fibrosis Pill Helped Kids’ Lungs in Study
http://www.bloomberg.com/news/2011-03-29/vertex-says-cystic-…

Vertex Pharmaceuticals Inc. (VRTX) said a trial of its cystic fibrosis pill showed improvements in lung function in 6- to 11-year-olds in a 24-week trial, and will support its application for regulatory approval this year.

The study, the third of three phases generally required for approval, found that the children had an improvement in lung function of 12.5 percent from the beginning of the trial, the Cambridge, Massachusetts-based drugmaker said in a statement today. The patients had an improvement of 17.4 percent compared with the placebo group.

Vertex’s medicine aims to repair the effects of a genetic mutation found in about 4 percent of cystic fibrosis patients. Cystic fibrosis is an inherited disorder that causes build-ups of sticky mucus in the airways, leading to lung damage and infections that can kill patients before they turn 40. Success in treating children with the disorder could limit lung damage before it accumulates, RBC Capital Markets LLC analyst Jason Kantor said in a research note today.

“The greatest impact on clinical outcome will likely come from drugs that are effective in children, before their lung function deteriorates significantly,” said Kantor, who is based in San Francisco and recommends buying Vertex shares. “From a commercial perspective, starting chronic therapy in children and continuing through adulthood increases the size of the market substantially.”

Today’s results are an interim readout from a 48-week study, the company said. Vertex is also in the earlier stages of developing another pill that may help treat a majority of cystic fibrosis patients.
Shares Rise

Vertex rose $1.56, or 3.3 percent, to $48.90 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The shares have gained 19 percent in the last 12 months.

The company plans to seek U.S. and European clearance for VX-770 in the second half of this year. Kantor said the medicine may be on the market in the first half of 2012.

In a study released last month, Vertex reported that the medicine increased breathing function in adults by more than 10 percent in a year, reduced patients’ need for antibiotics and led to an average weight gain of 7 pounds. Children with cystic fibrosis have a hard time gaining weight. In this study, the children on the medicine gained an average of 8.1 pounds.

To contact the reporters on this story: Elizabeth Lopatto in New York at [e-mail]; Meg Tirrell in New York at [e-mail].

To contact the editor responsible for this story: Reg Gale at [e-mail].

[Electra13]

26.04.2011 17:04

AFX News · Mehr Nachrichten von AFX News · Archiv
BRIEF-Vertex Pharmaceuticals shares gain 12 percent after US FDA staff comments on proposed hepatitis c drug telaprevir

WASHINGTON, April 26 (Reuters) - Vertex Pharmaceuticals Inc:

* Shares gain 12 percent after US FDA staff comments on proposed hepatitis c

drug telaprevir

(Company news desk in Washington; [phone], [e-mail]) COPYRIGHT Copyright Thomson Reuters 2011. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.

[Electra13]

News Breaks
11:01 EDT VRTX
theflyonthewall.com: FDA panel confirms Vertex's efficacy findings for telaprevir
An FDA review team said in briefing documents that its independent analyses confirmed the Vertex Pharmaceuticals' primary efficacy findings and many secondary endpoint analyses for all pivotal clinical trials. :theflyonthewall.com

[Electra13]

26.04.2011 17:18
(22 Leser)
1
2
3
4
5

(0 Bewertungen)
Schrift ändern
AFX News · Mehr Nachrichten von AFX News · Archiv
UPDATE 1-US FDA backs efficacy of Vertex hepatitis drug

WASHINGTON, April 26 (Reuters) - A proposed Vertex Pharmaceuticals Inc drug was effective for treating hepatitis C, U.S. Food and Drug Administration reviewers said in documents released on Tuesday.

Vertex shares jumped 12 percent to $54.30 on Nasdaq. The drug, telaprevir, is considered a potential blockbuster.

'Overall, the FDA review team's independent analyses confirmed the applicant's primary efficacy findings' on telaprevir, FDA staff said in a summary prepared for an advisory panel that will evaluate the drug on Thursday.

The FDA reviewers said they would ask the panel to discuss rashes and anemia seen in clinical trials of telaprevir. Those issues were known and analysts do not expect them to derail the drug's approval.

(Reporting by Lisa Richwine, editing by Gerald E. McCormick) Keywords: VERTEX HEPATITIS/ ([e-mail]; + 1 202 310-5691; Reuters Messaging: [e-mail]) COPYRIGHT Copyright Thomson Reuters 2011. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.

© 2011 AFX News

[Electra13]

VERTEX explodiert!
von Thomas May
Dienstag 26.04.2011, 17:28 Uhr
Vertex Pharma - Kürzel: VRTX - ISIN: US92532F1003

Börse: Nasdaq in USD / Kursstand: 53,52 $

Rückblick: Die Aktien von Vertex sind am heutigen Tag mit einem Plus von über 10,00 % der absolute Spitzenreiter im Nasdaq 100 und stiegen in der Spitze bereits fast bis 55,00 $ an. Ausgangspunkt für die heutige Entwicklung war der Ausbruch aus einem symmetrischen Konsolidierungsdreieck in der vergangenen Woche, dessen Tief am heutigen Tag nochmals erfolgreich getestet wurde.

Somit hat die Aktie die nach dem Verlaufshoch bei 52,12 $ Anfang März eingeschlagene Korrekturphase am heutigen Tag mit einem Pauckenschlag beendet und erwartungsgemäß die bullischen Vorgaben der Formation vollumfänglich genutzt. Weitere Kaufwellen sind demnach nur eine Frage der Zeit.

Charttechnischer Ausblick: Verbleiben die Vertex Aktien am heutigen Tag per Schlusskurs über 52,12 $, so ist mit einem direkten Kursanstieg bis 56,00 - 57,50 $ zu rechnen. Oberhalb dieses Kursbereiches stünde dann auf mittlere Sicht einer weiteren Aufwärtsbewegung bis 65,00 und anschließend auf 75,00 $ nichts mehr im Wege.

Hierfür sollte die Aktie nun in den nächsten Tagen nicht mehr deutlich unter die 50,00 $ Marke zurückfallen, da der Ausbruch ansonsten zunächst in Frage zu stellen wäre. In diesem Fall wäre eine Korrektur bis an die Kreuzunterstützung bei 45,38 $ wahrscheinlich, ehe sich der Aufwärtstrend von dort aus fortsetzen sollte. Wird die 45,38 $ - Marke jedoch nachhaltig durchbrochen, so würde sich das Chartbild deutlicher eintrüben und weitere Verkäufe bis 40,88 $ folgen.

Kursverlauf vom 12.04.2010 bis 26.04.2011 (log. Kerzendarstellung / 1 Kerze = 1 Tag)

[Electra13]

Apr 26, 11:08 AM EDT

FDA says Vertex hepatitis drug is highly effective
Business Video

Advertisement


Multimedia
When Drugs Stop Working
Lone Protestor Rallies Ohio City Against Drugs
From Drug Addict to Counselor
Documents
CDC Report on Sexual Behavior and Drug Use
Latest News
FDA says Vertex hepatitis drug is highly effective
FDA says Merck drug successfully fights hepatitis
Summary Box: FDA reviews Merck hepatitis drug
Pfizer says patient died in oral RA drug study
AP Exclusive: Millions in malaria drugs stolen
Buy AP Photo Reprints

Multimedia
Drug war interactive

WASHINGTON (AP) -- Federal health officials say a highly anticipated hepatitis C drug from Vertex Pharmaceuticals successfully treats a clear majority of patients in less time than older medicines that have been used for 20 years.

The Food and Drug Administration posted its review of Vertex's telaprevir ahead of a meeting Thursday where outside experts will vote on the benefits of the drug. On Wednesday the experts will review a similar drug from Merck.

Both new drugs work by blocking the enzyme protease, which allows the hepatitis virus to reproduce. The new approach represents a breakthrough from older medicines, which are designed to help the immune system fight hepatitis.

FDA scientists said 79 percent of patients who added telaprevir to older medicines were virus free six months after treatment.

[Ahorne]

Antwort auf Beitrag Nr.: 41.412.728 von Electra13 am 26.04.11 17:51:36

wenn das mal keine News sind

schöner Chart:

[blb]

Antwort auf Beitrag Nr.: 41.412.865 von Ahorne am 26.04.11 18:11:00

Super, alle die einen langen Atem bewiesen haben, werden belohnt.
Diese Woche tagt das Expertenpanel, die endgültige Zulassung wird im Mai erwartet.

Grüße an alle Mitinvestierten!
blb

[Electra13]

JNJ
JNJ
Johnson & Johnson NYSE

Back to Headlines | Print Version | ShareThis





UPDATE: Vertex's Hepatitis-C Drug Effective, FDA Documents Say


(Adds analyst reaction beginning in the seventh paragraph, updated stock information and adds company comment in the 13th paragraph.)

By Jennifer Corbett Dooren and Thomas Gryta

Of DOW JONES NEWSWIRES

A U.S. Food and Drug Administration staff review of Vertex Pharmaceuticals Inc.'s (VRTX) proposed hepatitis-C drug telaprevir said clinical data showed the drug was effective in treating the liver disease.

Telaprevir faces a review by the FDA's Antiviral Drugs Advisory Committee on Thursday. A similar product, boceprevir, from Merck & Co. (MRK) will be reviewed by the panel on Wednesday. Both drugs are widely expected to be recommended for approval, as they have shown strong effectiveness in improving the cure rates in patients who use standard therapy for hepatitis C.

The drugs are known as protease inhibitors and are designed to block an enzyme that helps the hepatitis C virus replicate. Vertex's telaprevir has more- impressive clinical data and fewer questions about side effects; Merck, however, has a bigger reach and more established contacts in the medical community.

Vertex owns the North American rights to the drug and would get a royalty on overseas sales from partner Johnson & Johnson (JNJ).

The approval of both drugs, which could come in May, would pit Cambridge, Mass., Vertex against one of the world's biggest drug makers in a market that could triple to $12 billion after the introduction of the latest batch of drugs, according to Goldman Sachs.

Hepatitis C is a blood-transmitted virus that causes liver inflammation and can lead to cirrhosis, cancer and liver failure. The disease affects five million people in the U.S. and more than 200 million people in the world, and is the leading cause of liver transplants in the U.S., according to the Hepatitis C Association.

Tuesday, shares of Vertex traded sharply higher on the news, rising 11.1% to $ 53.42, on heavy volume after earlier hitting their highest level in more than 10 years. Merck shares rose 2.3% to $35.11, outperforming the NYSE Arca Pharmaceutical Index's 1% rise.

"We believe the positive tone of the briefing documents helps remove an overhang on [Vertex] shares, and expect a positive panel recommendation and ultimate approval," Wells Fargo analyst Brian Abrahams said in a note to clients.

Although the documents are being met with a positive reception on Wall Street, advisory committees are notoriously unpredictable and the final vote is uncertain.

The two main studies submitted to the FDA in support of telaprevir showed more patients responded to treatment by achieving a so-called sustained virologic response--essentially a cure--and in a shorter period of time than current hepatitis-C therapy. A third study looked at extending treatment with a telaprevir-based regimen.

In one study involving previously untreated patients infected with hepatitis C, an FDA analysis of the data actually showed that the drug was more effective than previously reported.

All patients in the study received the current, standard therapy of pegylated interferon and ribavirin, while some also received telaprevir. The study originally showed 75% of patients getting telaprevir were cured compared with 44% of patients getting just standard therapy for 48 weeks.

In a newer analysis--which reflected a change in how the patient data were collected--the response rates were slightly higher in both groups, with 79% cured in the drug group, compared to 46% in the control arm, according to a briefing document posted to the FDA's website.

"The new analysis took into consideration a broader follow-up window that captured more people who achieved viral cures," Vertex spokeswoman Dawn Kalmar said.

Patients being treated with telaprevir received that drug for 12 weeks in addition to the two other drugs. They then were treated for an additional 12 to 36 weeks with pegylated interferon and ribavirin.

In an similar patient population and study structure, Merck's boceprevir showed a 63% cure rate compared to 38% in the control group.

The agency said the risks of telaprevir were associated with skin reactions, such as rash, and anemia. The agency said such side effects were "common, sometimes severe, and in some cases treatment limiting." Anemia is a decrease in the number of red-blood cells.

Vertex said rash was managed in most patients with antihistamines and topical corticosteriods. The company said the significantly higher effectiveness of telaprevir. "in all subject categories has the potential to offer many more patients the benefits of eradicating [hepatitis C] and achieving a viral cure."

As for Merck's boceprevir, analysts were positive about the briefing documents released Monday ahead of the FDA panel's meeting Wednesday. Analysts, however, noted the possibility of the therapy having restrictions because of safety and efficacy concerns. The drug has been associated with various blood-related adverse events including anemia. Some analysts think the agency may curtail its use in patients who don't respond fully to initial treatment.

"Overall we see an approval for boceprevir as more likely after this briefing document," analysts from Sanford C. Bernstein wrote in a research note. "The approval is likely to have some restrictions, and the company required to complete additional studies, but the document at least reads like a product destined for first-cycle approval."

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; [e-mail]

--Peter Loftus in Philadelphia contributed to this report;.



Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

[blb]

Antwort auf Beitrag Nr.: 41.414.087 von Electra13 am 26.04.11 22:41:56

YEAH! Das Panel hat sich mit 18:0 Stimmen für eine Zulassung von Telaprevir ausgesprochen.

[Ahorne]

Antwort auf Beitrag Nr.: 41.426.007 von blb am 28.04.11 21:23:00

das sieht doch gut aus

A final decision is expected by May 23.
http://finance.yahoo.com/news/FDA-panel-endorses-Vertex-apf-…

ich wünsche Euch einen schönen Abend

[Electra13]

UPDATE 1-Vertex hepatitis drug wins U.S. panel support

By Lisa Richwine

SILVER SPRING, Md., April 28 (Reuters) - Vertex Pharmaceuticals Inc won a U.S. advisory panel's support for a new hepatitis C drug that nearly doubles the chances of curing the liver-destroying disease.

The committee of Food and Drug Administration advisers voted 18-0 on Thursday to recommend approval of telaprevir, one of two proposed medicines expected to transform treatment of a virus that infects tens of millions of people globally.

'I really think this is a stunning success, so I wholeheartedly endorse approval,' said Dr. Lawrence Friedman, medicine department chair at Newton-Wellesley Hospital in Newton, Massachusetts.

The support for telaprevir follows the FDA committee's recommendation for a similar Merck & Co drug, boceprevir, on Wednesday. The FDA usually approves medicines that win advisory panel backing and is due to rule on both drugs in May.

Vertex shares were halted on Nasdaq as the panel met.

(Reporting by Lisa Richwine in Silver Spring, Maryland and Bill Berkrot in New York; Editing by Lisa Von Ahn and Tim Dobbyn) Keywords: VERTEX HEPATITIS/ ([e-mail] [phone]; Reuters Messaging: [e-mail]) COPYRIGHT Copyright Thomson Reuters 2011. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.

© 2011 AFX News

[Electra13]

FDA panel unanimously backs Vertex's Hep C drug telaprevir

April 29, 2011 — 6:49am ET | By Maureen Martino


In an 18-0 vote, an FDA advisory committee has voted to recommend approval of Vertex's ($VRTX) telaprevir for people with genotype 1 chronic hepatitis C. The vote comes a day after the same panel offered its unanimous support for Merck's hepatitis C treatment boceprevir. And the experts' ready embrace of these breakthrough meds left both drug developers in an ideal position to follow up with a formal agency sanction in a matter of weeks--the last hurdle that separates both companies from a megablockbuster market.
Vertex's drug faced one major safety issue--about half of the patients who received telaprevir experienced an eczema-like rash. The company argued that the rash was easily managed and disappeared when patients taking the new drug were switched to the standard of care. Panelists felt physician and patient education, along with additional materials and a toll-free hotline, would be sufficient to manage that side effect. And with that the biggest potential roadblock to telaprevir's approval was gone.
Sign up for our FREE newsletter for more news like this sent to your inbox!

The FDA's final decision on the drug is expected by May 23, 2011. The agency is not bound by the committee's recommendation, but usually follows its advice. In this case, the agency's staff review clearly supported telaprevir--something rarely seen in biotech, especially as the feds have toughened up on safety concerns. For Vertex, which retains U.S. marketing rights, the vote represents one more giant step toward its vision of creating a major biotech player, with more promising therapies in the pipeline and a blockbuster revenue stream to grow the company further.
"Hepatitis C is a curable disease with potentially devastating consequences if left untreated, so we are pleased by the Committee's unanimous recommendation to approve telaprevir for a broad group of people with hepatitis C," said CSO Peter Mueller in a statement. "We look forward to working with the FDA as it prepares to make its decision next month."
- here's Vertex's release
Related Articles:
Vertex offers a blockbuster case for telaprevir
FDA team applauds telaprevir's efficacy, raises safety concerns
Confident of success, Vertex plans gangbuster rollout of telaprevir
Two new hep C drugs garner rave reviews ahead of approval


Read more: FDA panel unanimously backs Vertex's Hep C drug telaprevir - FierceBiotech http://www.fiercebiotech.com/story/fda-panel-unanimously-bac…
Subscribe: http://www.fiercebiotech.com/signup?sourceform=Viral-Tynt-Fi…

[Ahorne]

Antwort auf Beitrag Nr.: 41.430.033 von Electra13 am 29.04.11 15:25:09

sieht gut aus... doch es ist wie beim Fussball.... Schluss ist erst nach dem Schlusspfiff des Schiedsrichter...

...wer hätte das gedacht, dass Vertex mal Fett Geld verdient... Cool

doch wie gesagt... warten wir auf den Schlusspfiff

[julszw12]

Antwort auf Beitrag Nr.: 41.430.089 von Ahorne am 29.04.11 15:33:03

April 29, 2011 8:22 AM EDT
Goldman Sachs raised their price target and estimates on Buy-rated Vertex (NASDAQ: VRTX) following FDA panel backing of TVR, and they now see the chance of FDA approval at 100% (up from 95%).

The firm now sees 2012-2015 US TVR sales to $2.1/$2.6/$2.8/$2.8bn from $2.0/$2.5/$2.4/$2.4bn, respectively. As a result, 2012-2015 EPS estimates increase to $5.36/$7.13/$6.41/$6.25 from $5.09/$6.79/$5.59/$5.33. The firm's price target moves from $52 to $59.

For more ratings news on Vertex click here and for the rating history of Vertex click here.

Shares of Vertex closed at $55.54 yesterday, with a 52 week range of $31.25-$55.79.

[Electra13]

Antwort auf Beitrag Nr.: 41.430.089 von Ahorne am 29.04.11 15:33:03

Ich hoffe nur, dass wir bis zum 23. nocheinmal eine Chance bekommen guenstiger nachzukaufen!

[Electra13]

April 29, 2011, 1:17 p.m. EDT
Vertex hepatitis drug edges Merck after FDA panels

By Thomas Gryta
NEW YORK -(MarketWatch)- After FDA panels unanimously recommended the approval of two new hepatitis C drugs, Vertex Pharmaceuticals Inc.'s VRTX -0.43% telaprevir continues to be the favored agent as its likely heads to the market along with Merck & Co.'s MRK +0.22% boceprevir.

The panels proceeded as most observers had expected, with reviews of both therapies' effectiveness and some concerns about side effects. Reviewers concluded that the safety concerns were manageable in comparison to increasing the cure rates for the liver disease. The panel went a bit better for telaprevir, which has shown stronger effectiveness than boceprevir and has more data, something that could cause a problem for Merck.

"This panel meeting just reinforced our long-held view that telaprevir...will be favored by most physicians over Merck's boceprevir in a two-drug horse race," BMO Capital Markets analyst Jason Zhang.

Hepatitis C is caused by infection with the hepatitis C virus and can lead to liver failure, liver cancer and/or the need for a transplant. About 3.2 million Americans have the disease.

Both drugs are known as protease inhibitors and are designed to block an enzyme that helps the hepatitis C virus replicate. They have demonstrated significant effectiveness in improving the cure rates in patients who use standard therapy, which is pegylated interferon and ribavirin.

FDA approval of the drugs, which could come in May, would pit the much smaller Cambridge, Mass., drug maker against Merck. Vertex developed telaprevir and owns the North American rights; it would get a royalty on overseas sales from partner Johnson & Johnson JNJ +0.61% .

The market for the drugs is large, with Goldman Sachs recently projecting it could triple to $12 billion in annual sales in coming years. Analysts at the firm expect 75% of the new market to go telaprevir, with Merck grabbing the remainder.

While the excitement for telaprevir is real, Vertex's stock is up 59% for the year and has a market value of $11.4 billion before it even has a product on the market. Shares of Vertex recently traded up a penny to $55.55, while Merck rose 7 cents to $35.84.

Needham & Co. analyst Alan Carr expressed concern Friday about the high expectations surrounding telaprevir's launch and Vertex's share price.

"While we recognize [telaprevir] represents a breakthrough in the treatment of HCV, growth prospects are probably limited because of the wave of likely superior agents expected to reach the market over the next few years," Carr said.

But if new therapies need to be tested against the latest crop of drugs--something several panel members recommended--it could be harder for those drugs to enter the market.

In its review, the FDA panel seemed more enthusiastic about telaprevir's effectiveness, simpler dosing and broader range of data. At one point, Merck was criticized for not conducting more studies of boceprevir's potential interactions with other drugs, something Vertex had done. One panel member said that physicians would require "the wisdom of a Talmudic scholar" to figure out how to best use Merck's drug, although he welcomed having it as an option.

Notably, Merck's trials included the use of an anemia drug, as needed, that isn't actually approved for use in hepatitis C patients.

Some analysts said the need for additional data would likely lead to a delay for Merck's drug, while others dismissed those concerns. Regardless, the proximity of the panel to the FDA's expected decisions could lead to delays for either drug.

Also, the specifics of the labels on the drugs could restrict their use in some populations depending their data, something that wouldn't be clear until approval.

[Ahorne]

Antwort auf Beitrag Nr.: 41.432.146 von Electra13 am 29.04.11 20:50:35

völlig unaufgeregter Thread und super Chart:
Biotech läuft super und doch sind wenig Anleger dabei... so kanns es weiter gehen

Herrlich

[Electra13]

STOCKS NEWS US-Goldman Sachs suggests buy Vertex July calls

Real-time equity news

U.S. stock market report 1153 ET 09May2011 Goldman Sachs recommends Vertex July calls

Goldman Sachs Group recommends Vertex Pharmaceuticals' July $55 calls as significant catalysts are expected to drive shares higher. Vertex options are inexpensive and 'our analyst is bullish on near term,' Goldman said in a note. GS biotech analyst Terence Flynn said the stock may become a more attractive takeover target following the approval date later this month for Telaprevir, Vertex's treatment for hepatitis C. He sees 8 percent upside to his
12
month price target of $59. Merck's competitor drug Boceprevir could be approved first by regulators and set the pricing bar. While Goldman is positive on the potential for both drugs, the firm recommends adding to Vertex positions in the event of any weakness. Goldman notes upside share potential for Vertex's emerging cystic fibrosis drug pipeline.

GS strategists suggest July $55 calls for $3.90 based on Friday's close of $54.59. 'We would buy July options instead of June given a downward sloping term structure, opportunity to capture more catalysts, potential risk of key catalysts slipping, and M&A potential,' they said. Call buyers risk losing the premium paid if shares close below $58.90 by July expiration.

Reuters Messaging: [e-mail]

[Electra13]

Vertex Brands Its Telaprevir As “Incivek®”; Confirms It’s “Ready To Launch”

In addition, Vertex expects that it will be approved by FDA before the end of May 2011. Vertex management also confirmed that it is now fully ready for a roll-out, and that a significant number of patients have delayed starting any therapy — until Incivek is available per the AP:

[Electra13]

Vertex elects board member
Boston Business Journal - by Julie Donnelly
Date: Thursday, May 12, 2011, 2:46pm EDT
Related: Health Care

Vertex Pharmaceuticals Inc. (Nasdaq:VRTX) shareholders have elected nominee Margaret C. McGlynn to the company’s board of directors, bringing the number of directors to eight.
McGlynn previously served as president of the global vaccines and infectious diseases division at New Jersey-based Merck & Co., Inc. (NYSE: MRK), where she worked in different roles for nearly 30 years. McGlynn holds a B.S. in Pharmacy and an M.B.A. in Marketing from the State University of New York at Buffalo.
“Ms. McGlynn will provide our Board with invaluable commercial expertise as we await the approval of INCIVEK for people with hepatitis C,” said Matthew Emmens, Vertex’s Chairman, President and Chief Executive Officer. “I welcome Margie to our Board and look forward to her contributions at this exciting time for our company.”
Vertex is expected to receive an approval decision on Incivek fronm the U.S. Food and Drug Administration on or before May 23.
CEO Matthew W. Emmens and Dr. Wayne J. Riley were also re-elected to the board. All of their terms will expire at the 2014 Annual Meeting of Shareholders.
Vertex Pharmaceuticals Inc. (Nasdaq:VRTX) shareholders have elected nominee Margaret C. McGlynn to the company’s board of directors, bringing the number of directors to eight.
McGlynn previously served as president of the global vaccines and infectious diseases division at NEW JERSEY-BASED MERCK & CO., INC. (NYSE: MRK), where she worked in different roles for nearly 30 years. McGlynn holds a B.S. in Pharmacy and an M.B.A. in Marketing from the State University of New York at Buffalo.
“Ms. McGlynn will provide our Board with invaluable commercial expertise as we await the approval of INCIVEK for people with hepatitis C,” said Matthew Emmens, Vertex’s Chairman, President and Chief Executive Officer. “I welcome Margie to our Board and look forward to her contributions at this exciting time for our company.”
Vertex is expected to receive an approval decision on Incivek fronm the U.S. Food and Drug Administration on or before May 23.
CEO Matthew W. Emmens and Dr. Wayne J. Riley were also re-elected to the board. All of their terms will expire at the 2014 Annual Meeting of Shareholders.
See Comments


Read more: Vertex elects board member | Boston Business Journal

[blb]

Antwort auf Beitrag Nr.: 41.495.697 von Electra13 am 13.05.11 04:55:52

Konkurrent Merck hat sein Produkt am Freitag zugelassen bekommen. Allerdings müssen sie wohl vermerken, dass es keine expliziten Studen gab bei Patienten, die auf andere Therapien gar nicht ansprachen beispielsweise. Denke, da hat Vertex mit dem umfangreichen Studienprogramm deutlich bessere Karten.

VG blb

[Electra13]

Antwort auf Beitrag Nr.: 41.505.833 von blb am 15.05.11 22:32:40

Merck approval bodes well for Vertex, says Piper Jaffray
Piper Jaffray views the approval and broad label for Merck's (MRK) Victrelis as positive for Vertex's (VRTX) Incivek. The firm expects approval and an equally broad label for Incivek by next Monday's PDUFA date. :theflyonthewall.com

[Electra13]

Merck Girds For Hep C Battle With Roche Deal
By Adam Feuerstein 05/17/11 - 12:40 PM EDT3 CommentsAdd Comment
Stock quotes in this article:MRK, VRTX, VRUS


inShare
WHITEHOUSE STATION, N.J. (TheStreet) -- Merck(MRK_) gained an unlikely ally in the hyper-competitive battle to market a new crop of hepatitis C drugs.

More from Adam Feuerstein
Amgen: Xgeva Delays Cancer Spread to BoneCel-Sci Settles Over South African Partner FlapMerck Strikes First in Hep C Drug Battle
Market Activity
Vertex Pharmaceuticals| VRTX
DOWN
Merck & Co Inc.| MRK
DOWN
Pharmasset Inc.| VRUS
Roche said Tuesday that it will promote in the U.S. Merck's newly approved drug Victrelis in combination with its own hepatitis C drug Pegasys under a broader marketing and research alliance signed between the two drug giants.

What makes this partnership unusual is that Roche and Merck have been long-time hepatitis C treatment competitors. The new arrangement aligns the interests of two pharmaceutical marketing powerhouses, which for Merck is especially helpful as it strikes out to compete against Vertex Pharmaceuticals(VRTX_) and its new hepatitis C drug.

Roche's Pegasys, or weekly interferon injection, has about 80% market share to Merck's own long-acting interferon injection, Peg-Intron, which has about 20% market share.

Under this new agreement, Roche will be promoting the use of Merck's Victrelis in combination with Pegasys as a new, triple-combination therapy against hepatitis C. Victrelis was approved in the U.S. last Friday, making it the first in a new class of direct-acting antiviral agents against hepatitis C.

Vertex is expecting to receive similar U.S. approval on or before May 23 for its drug, Incivek. The launch of two new and similar hepatitis C drugs promises to ignite one of the fiercest drug marketing battles in years.

The Merck-Roche deal is not exclusive, which means that Roche, at some point, could agree to a similar deal with Vertex to promote Incivek. Vertex, however, may not necessarily need Roche's direct help because Incivek is already closely tied to Pegasys. Incivek's pivotal clinical trials used Roche's Pegasys as the long-acting interferon backbone, whereas Merck tested Victrelis in combination with its own Peg-Intron.

Still, bringing Roche on board to promote Victrelis is a coup for Merck because it adds a new and experienced sales force that will be able to educate doctors about how to best use Victrelis. One of the issues weighing on Merck is the complex and often confusing dosing schedules required with Victrelis as compared to a much simpler dosing schedule for Vertex's Incivek.

Victrelis and Incivek have never been compared in a head-to-head study but the Vertex drug is also widely viewed as more effective -- able to cure upwards of 80% of newly treated patients compared to an approximate 60% cure rate for Merck's drug.
Merck and Roche did not disclose financial terms of the deal but a Merck spokesman said that Merck retains 100% of the Victrelis economics even with the Roche marketing deal in place. Presumably, that means Roche will not receive a royalty on Victrelis sales but will gain as more doctors choose to use its Pegasys with either Victrelis or Incivek. Roche may have also been worried that Merck was planning to tempt doctors with a discounted bundle of Peg-Intron with Victrelis that could have hurt Pegasys market share.

Under terms of the agreement, Merck and Roche will also cooperate on new studies that will seek to combine Victrelis with Roche's experimental hepatitis C drugs. This new research alliance can include experimental drugs that Roche licensed from other companies, including one from Pharmasset(VRUS_), according to a Roche spokeswoman.

--Written by Adam Feuerstein in Boston.

[Electra13]

Quelle: www.goodmodetrader.de

VERTEX - Bereit zum großen Sprung, wenn..
von Thomas May
Dienstag 17.05.2011, 19:55 Uhr
Vertex Pharma - Kürzel: VRTX - ISIN: US92532F1003

Börse: Nasdaq in USD / Kursstand: 56,93 $

Rückblick: Die Aktien von Vertex befinden sich seit Wochen in einer steilen Aufwärtsbewegung, die mit dem Überschreiten des markanten Widerstands bei 45,38 $ Ende Februar neue Nahrung erhalten hat. Nach einer Konsolidierung in Form eines bullischen, symmetrischen Dreiecks ist die Aktie in den vergangenen Tagen erwartungsgemäß bis an und intraday bereits über das anvisierte kurzfristige Kursziel bei 57,50 $ angestiegen.

Seither konsolidiert der Wert auf hohem Niveau ohne nennenswerte Abschläge seitwärts und ein Ausbruch über das bisherige Jahreshoch bei 58,87 $ würde entsprechend eine erneute Kaufwelle auslösen.

Charttechnischer Ausblick: Oberhalb von 55,30 $ können die Bullen in Vertex jederzeit für einen Ausbruch über 58,87 $ sorgen und so die Erfolgsgeschichte seit Jahreswechsel um ein weiteres Kapitel in Form eines kurzfristigen Anstiegs bis 65,00 $ erweitern.Wird auch diese Marke überschritten so sind auf mittlere Sicht Kurse um 75,00 $ möglich.

Ein Rückfall unter 55,30 $ würde lediglich zu einer Zwischenkorrektur bis 52,12 - 52,95 $ führen, ehe der Wert von dort aus zu einem weiteren Anstieg ansetzen dürfte. Der große, zeitlich ausgedehnte Pullback an das Level des mittelfristigen Kaufsignals bei 45,38 $ ist erst bei Tagesschlusskursen unterhalb von 52,12 $ denkbar. Hier sollten die Bullen jedoch spätestens das Ruder wieder übernehmen.

Kursverlauf vom 30.04.2010 bis 17.05.2011 (log. Kerzendarstellung / 1 Kerze = 1 Tag)

[Electra13]

17.05.2011 22:17

Business Wire · Mehr Nachrichten von Business Wire · Archiv
Vertex Appoints Terrence C. Kearney to its Board of Directors

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Terrence C. Kearney has joined its board of directors. The addition of Mr. Kearney brings the number of Vertex board members to nine. Mr. Kearney was appointed to the class of directors whose term expires in 2013.

"Mr. Kearney''s more than 30 years of financial leadership experience in the life science industry will be invaluable to our Board as Vertex advances toward becoming a cash flow and earnings positive company in 2012," said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex Pharmaceuticals. "I look forward to Terry''s insights and welcome him to our Board."

Mr. Kearney has more than three decades of global health care experience at major pharmaceutical and life sciences companies. Most recently, Mr. Kearney served on the executive management team for Hospira, Inc., where he held the role of Chief Operating Officer from 2006 through 2010 and Chief Financial Officer from 2004 to 2006. In these roles, Mr. Kearney had broad responsibility for the company''s global operations, including commercial, manufacturing and research and development activities, and financial management strategies. Prior to Hospira, Mr. Kearney spent more than 20 years at Abbott Laboratories in various financial management roles, including Vice President and Treasurer. Mr. Kearney earned a bachelor''s degree in biology from the University of Illinois and a master''s in business administration from the University of Denver.

About Vertex

Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize innovative therapies so people with serious diseases can lead better lives.

Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.

(VRTX-GEN)

[Electra13]

Spaetestens Montag ist es soweit!!

Hold your breath for Vertex's big telaprevir moment

May 20, 2011 — 9:23am ET | By Ryan McBride


Free newsletter via e-mail

RELATED STORIES
Merck wins unanimous FDA panel support for blockbuster boceprevir
Two new hep C drugs garner rave reviews ahead of approval
Merck scoots past Vertex in blockbuster race for hep C drug approval
Merck's boceprevir scores high in PhIII hep C trial
Merck and Roche join forces to sell, develop blockbuster hep C cocktails
TOOLS
Subscribe
Email
Print
Comment
Contact Author
Reprint
Vertex Pharmaceuticals ($VRTX) stands at the verge of a potential and much-anticipated FDA approval of its standout hepatitis C drug telaprevir. With a PDUFA date of May 23 for its telaprevir application, Vertex is expected to get a green light for U.S. marketing of the experimental treatment after an advisory panel gave the drug its unanimous backing last month.

Many industry watchers have already moved on to discussing the hep C showdown expected between Vertex and Merck ($MRK), which gained FDA approval earlier this month for a similar drug called Victrelis (boceprevir), which also snagged a possitive opinion announced today from an EMA committee recommending its approval for the European market. Vertex might have the edge with results from one study that showed it could wipe out the liver disease in 79 percent of patients, but Merck made things more interesting with its recent deal to join forces with fellow Big Pharma player Roche in marketing and developing cocktail treatments against hep C.

Sign up for our FREE newsletter for more news like this sent to your inbox!

Vertex, whose telaprevir shined in multiple late-stage trials, has the most at stake in the brewing hep C battle. The Cambridge, MA-based company has racked up an accumulated deficit of more than $3.6 billion, much of which has been spent on developing telaprevir. The med has the potential to greatly improve the way patients with the disease are treated. Vertex could see its coffers quickly fill up if the drug meets revenue expectations on Wall Street. Needham & Co. biotech analyst Alan Carr believes the drug can attain blockbuster status next year, with potential 2012 sales of about $1.5 billion.

An FDA approval of telaprevir would continue Vertex's incredible streak with its pipeline over the past year. In addition to a string of late-stage trial success with its hep C drug, the company has shined with impressive results from Phase III trials for its cystic fibrosis drug VX-770.

[Electra13]

FDA Approves Vertex's (VRTX) Incivek for Hepatitis C


More News related to VRTX
FDA Approves Vertex's (VRTX) Incivek for Hepatitis C
Vertex (VRTX) hepatitis C drug incivek approved by the US FDA
Pill Burden a Key Concern With New Chronic Hepatitis C Drugs
Translational Science Expert, Dr. Melissa Ashlock, Joins aTyr Pharma to Advance Physiocrine-based Therapeutics
Vertex Appoints Terrence C. Kearney to its Board of Directors
More News related to VRTX


May 23, 2011 9:24 AM EDT
The U.S. Food and Drug Administration today approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin.

The current standard of care for patients with chronic hepatitis C infection is peginterferon alfa and ribavirin taken for 48 weeks. Less than 50 percent of patients respond to this therapy.

The safety and effectiveness of Incivek was evaluated in three phase 3 clinical trials with about 2,250 adult patients who were previously untreated, or who had received prior therapy. In all studies patients also received the drug with standard of care. In previously untreated patients, 79 percent of those receiving Incivek experienced a sustained virologic response (i.e. the infection was no longer detected in the blood 24 weeks after stopping treatment) compared to standard treatment alone.

The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care.

The studies indicate that treatment with Incivek can be shortened from 48 weeks to 24 weeks in most patients. Sixty percent of previously untreated patients achieved an early response and received only 24 weeks of treatment (compared to the standard of care of 48 weeks). The sustained virologic response for these patients was 90 percent.

When a person achieves a sustained virologic response after completing treatment, this suggests that the hepatitis C infection has been cured.

Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocellular carcinoma), and decreased mortality.

“With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection.”

According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C infection, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.

Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.

People can get HCV in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor or toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.

Incivek is a pill taken three times a day with food. Incivek should be taken for the first 12 weeks in combination with peginterferon alfa and ribavirin. Most people with a good early response to the Incivek combination regimen can be treated for 24 weeks rather than the recommended 48 weeks of treatment with the standard of care. Incivek is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.

The most commonly reported side effects in patients receiving Incivek in combination with peginterferon alfa and ribavirin include rash, low red blood cell count (anemia), nausea, fatigue, headache, diarrhea, itching (pruritus), and anal or rectal irritation and pain. Rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.

On May 13, FDA approved Victrelis (boceprevir), another new treatment for chronic hepatitis C, marketed by Merck of Whitehouse Station, N.J.

Incivek is marketed by Cambridge, Mass.-based Vertex Pharmaceuticals (Nasdaq: VRTX).

[blb]

Antwort auf Beitrag Nr.: 41.542.758 von Electra13 am 23.05.11 15:36:50

Na also, Glückwunsch allen Patienten und auch den Mitinvestierten hier.

[Ahorne]

Antwort auf Beitrag Nr.: 41.542.758 von Electra13 am 23.05.11 15:36:50

Gratulation an das Management & Mitarbeiter von Vertex... wenn das kein Meilenstein ist

[Electra13]

Quelle: Der Aktionaer

Vertex: Grünes Licht für Incivek
Bastian Galuschka

Die US-Gesundheitsbehörde FDA hat dem neuen Hepatitis-C-Medikament Incivek die Zulassung erteilt. Für den Biotech-Konzern Vertex bedeutet dies den wichtigsten Meilenstein in der 22-jährigen Firmengeschichte.

Die jahrelange Forschungsarbeit hat sich endlich gelohnt. Wie heute bekannt wurde, hat die US-Gesundheitsbehörde dem Hepatitis-C-Medikament Incivek, zuvor bekannt unter dem Namen Telaprevir, die Marktzulassung gewährt. Für Patienten wie auch den Entwickler Vertex Pharmaceuticals eine erfreuliche Nachricht.


Besser Heilungschancen, kürzere Behandlungszeit

Hepatitis-C-Erkrankte haben nun die Chance, nach 24 statt zuvor 48 Wochen Therapie von der Infektionskrankheit, die zu schweren Leberschädigungen führen kann, geheilt zu werden. Die Heilungsrate lag hier in Studien bei 79 Prozent. Zudem zeigte Incivek bei Patienten, die vorherige Behandlungen abbrechen mussten oder gar überhaupt nicht auf diese ansprachen, gute Heilungsraten. Bessere, als das jüngst zugelassene Konkurrenzprodukt Victrelis von Merck.

Analysten rechnen damit, dass Incivek in Kürze erhältlich sein wird und Vertex im kommenden Jahr Umsätze jenseits der 2-Milliarde-Dollar-Schwelle bescheren wird. Auch der Sprung in die Gewinnzone soll dann nach vielen Jahren mit hohen dreistelligen Millionenverlusten gelingen. Die Konsensschätzung lautet hier aktuell auf 4,36 Dollar Gewinn je Aktie.



Weiterhin ein Biotech-Favorit

DER AKTIONÄR hatte die Vertex-Aktie in der Printausgabe 52/10-01/11 als seinen Biotech-Topfavoriten für das Jahr 2011 vorgestellt. Der Titel konnte sich bereits sehr erfreulich entwickeln. Aufgrund der weiterhin moderaten Bewertung mit einem 2012er-KGV von 13 wird die Kaufempfehlung nochmals bekräftigt. Mit Sicht auf zwei Jahre hat die Aktie das Potenzial neue Allzeithochs, also dreistellige Dollar-Kursregionen zu erreichen.

[Electra13]

23.05.2011 16:39

AFX News · Mehr Nachrichten von AFX News · Archiv
UPDATE 2-Vertex hepatitis C drug wins U.S. approval

NEW YORK, May 23 (Reuters) - Vertex Pharmaceuticals Inc's highly anticipated hepatitis C drug won U.S. approval, heralding a new era of treatment for the liver-destroying condition.

The approval, announced by the Food and Drug Administration said on Monday, was widely expected after an FDA advisory panel unanimously recommended the drug last month. The agency approved another hepatitis C drug, Merck & Co Inc's Victrelis, earlier this month.

Incivek, also known as telaprevir, is poised to help transform treatment of hepatitis C by nearly doubling the chances of curing the serious liver disease. Some industry analysts project telaprevir sales will top $5 billion a year.

Incivek, a pill, is expected to control more of the market because it has shown a higher cure rate than Merck's Victrelis. In clinical studies, 79 percent of patients taking Incivek experienced a sustained virologic response -- meaning the infection was no longer detected 24 weeks after stopping treatment -- compared to standard treatment alone, the FDA said.

Doctors say tens of thousands of hepatitis C patients have been delaying treatment in anticipation of the new medicines, which must be taken in combination with older hepatitis drugs. About 170 million people around the world are infected with hepatitis C.

Vertex said Incivek will arrive in pharmacies this week.

'There are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition,' said Edward Cox, director of the FDA drug center's office of antimicrobial products.

The most commonly reported side effects with Incivek include rash, anemia, nausea, fatigue, headache, diarrhea, itching and anal or rectal irritation and pain, the FDA said. The agency said the rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.

Brian Skorney, an analyst at Brean Murray, Carret & Co, said he expects Incivek and Victrelis to initially split the market fairly evenly, with Incivek gradually gaining a bigger share over the next six months to a year.

Last week Merck struck a deal with Roche Holding AG under which Roche will co-promote Victrelis in the United States. Roche and Merck dominate the market for interferons, which must be given with the new drugs.

'There's certainly some pricing strategies around interferons that Merck and Roche may be able to use,' Skorney said.

Vertex shares were off 0.4 percent at $54.80 in morning Nasdaq trading on a down day for the broader stock market.

[Electra13]

www.seekingalpha.com

Vertex Pharmaceuticals: A Multi-Billion Dollar Opportunity
May 24, 2011 | about: JNJ, MRK, VRTX


The FDA has approved Vertex Pharmaceuticals' (VRTX) Incivek hepatitis C drug, propelling Vertex into what Goldman Sachs (GS) predicts will be a $12 billion market annually.
This is an important drug which cuts the standard treatment time, offers a much-improved cure rate and treats a chronic disease accounting for a significant number of liver disease cases each year.
Previously, hepatitis C patients were treated with interferon and ribavirin alone for 48 weeks. But only 50% of them were cured. Today, Incivek will be given alongside interferon and ribavirin for 12 weeks and then discontinued. Interferon and ribavirin will continue to be given for as little as an additional 12-24 weeks. Despite the shorter treatment period, the cure rate with this combination therapy jumps to an impressive 79%.
Across the United States the Center for Disease Control estimates 3.2 million cases of hepatitis C with about two thirds having the genotype 1 version treated by Incivek. As many as 4.1 million Americans have the Hepatitis C antibody, according to the National Institutes of Health. According to the Center for Disease Control, seven of every 1 million people in the United States are infected annually, resulting in 2,100 new cases each year. At a retail price of $49,200 for the 12-week treatment, new cases alone add as much as $100 million annually to a $157 billion market.
But Vertex's opportunity isn't limited to the United States. Globally, about 3% of the world population is infected with hepatitis C, with the C. Everett Koop Institute estimating 170 million to over 200 million people infected worldwide. Vertex, which owns the North American rights, will collect a royalty from Johnson & Johnson (JNJ) on overseas sales, suggesting significant sales and profit growth over the coming years.
And, given arguably better efficacy than the recently approved Merck (MRK) competitor drug, analysts suggest Vertex may win up to 75% of the marketplace. To meet the demand, Vertex has 115 sales people ready to market the drug to healthcare providers.
Analysts recognize the upside, estimating Vertex will go from losing money this year to earning $3.83 per share in 2012. Estimates for Vertex's 2012 revenue vary widely, ranging from $1.48 billion to $3.23 billion - not bad for a company just shy of $200 million in trailing 12-month revenue.
Given the drug's success in trials and the wide range of expectations, investors who buy a sell-the-news reaction will find themselves handsomely rewarded as analysts digest future quarters sales data and boost forecasts.
Disclosure: I am long VRTX.

[Electra13]

PRINTEMAIL
Vertex vs. Merck in Hepatitis Drug Title Fight
All that's at stake is a $10 billion market
May 25, 2011, 11:01 am EDT | By Barry Cohen, Health Care Writer

Industry observers are comparing the coming battle for hepatitis C drug supremacy to the one of the greatest boxing matches of the 20th century, the “Thrilla in Manila.” In that 1975 slugfest in the Philippines, Joe Frazier and Muhammad Ali traded punishing blows before the match was stopped when Frazier was unable to answer the bell for the 15th round because both eyes had been battered shut.

The pharma battle could be just as compelling. It pits two industry heavyweights: Vertex Pharmaceuticals (Nasdaq:VRTX) and its drug Incivek against mighty Merck (NYSE:MRK) and its Victrelis product. The prize will be the lion’s share of a market that could soon explode to $10 billion, as both competitors gear up efforts to raise awareness of the disease.

SPONSORED LINKS
Buy Gold Stocks Now
Beijing Bullion OTC: GTSO - Hot Stock - Invest in Gold & ...
www.BeijingBullion.com
Top Stock for 2011 - GTSO
Desperate Search For Rare Earth Minerals Solved. Rare Opp...
www.RareEarthExporters.com
Both Incivek and Victrelis were green-lighted by the FDA within days of each other after studies showed they were far more effective than treatments that have been available up to now. They became the first new FDA-approved treatments for the disease in a decade.

Hepatitis C is one of the most important causes of chronic liver disease in the U.S. It is transmitted by intravenous drug use and blood transfusions that infect an estimated 3.2 million Americans. Most don’t even know they have the disease, which is responsible for about 10,000 deaths a year in the U.S. alone.

Vertex recently underwrote a study that argued that it may be cost-effective to screen everyone between the ages of 40 and 64 because nearly 2 million Americans in that age group have hepatitis C but don’t realize it.

Longer term, the best opportunity for both drugs may lie in China, where the infected population is thought to be 10 times that of the U.S. and four times that of developed markets.

Both Vertex and Merck have industry heavyweights in their respective corners. Johnson & Johnson (NYSE:JNJ) has Incivek rights in Europe and hopes to have the drug on the market there by the end of the year. Merck, meanwhile, enlisted the aid of long-standing rival Roche, gaining access to the latter’s large sales force.

So far, oddsmakers differ on the company likely to emerge victorious. Some expect Merck to earn the edge because of the muscle and experience of its large marketing team. Others like it because of Merck’s win-at-all-costs approach that would vindicate a management group that has been under fire and offset its meager record of FDA approvals in the past few years.

Merck also would like to get a nice headstart on a Bristol-Myers Squibb (NYSE:BMY) hepatitis C treatment that should hit the market soon.

Others say Incivek is going to be the big winner. They point to the fact that in testing as many as 79% of previously untreated patients on the drug achieved undetectable viral levels, compared to 49% on the standard regimen. And Vertex ran a trial in sicker patients than Merck, showing that 65% of treatment experience patients could be helped compared to 17% on the standard of care.

In fact, one analyst has already gone out on a limb, making Vertex a prohibitive favorite and predicting that Incivek will capture a dominating 75% of the market.

Our advice to investors? Enjoy this one, folks. It’s going to be a doozy

[Electra13]

www.seekingalpha.com

Vertex: With New Drug Approval Shares May Still Have Room to Run

Vertex Pharmaceuticals Incorporated (VRTX) announced that the U.S. Food and Drug Administration (FDA) approved its Incivek (telaprevir) tablets for some patients with genotype 1 chronic hepatitis C with compensated liver disease and/or cirrhosis (liver scarring). Incivek (pronounced in-SEE-veck) was approved for people who are new to treatment and those treated previously without being cured. On May 13, the FDA also approved Victrelis (boceprevir) by Merck (MRK). These two are the first hepatitis C drugs in almost a decade to win FDA approval.

Vertex stated that Incivek should be available in pharmacies now. The company also introduced a comprehensive financial assistance and patient support program to help people who might not otherwise be able to afford the treatment get it and said that more information is available on its Website.

Vertex ran three Phase 3 studies on INCIVEK, indicating people who received it in combination treatment achieved significantly higher rates of sustained viral response (SVR) or cure compared with those who received pegylated-interferon and ribavirin alone, regardless of prior treatment experience. The Phase 3 comparison information from Vertex’s release shows a striking improvement in SVR/Cure rates:
People new to treatment:
79 percent vs. 46 percent
People who were treated previously but did not achieve a viral cure:
-- Relapsers:
86 percent vs. 22 percent
-- Partial responders:
59 percent vs. 15 percent
-- Null responders:
32 percent vs. 5 percent

Merck, through Schering-Plough, and Roche (RHHBY.PK), previously sold competing versions of interferon. After Victrelis was approved for use with either of those medications, the two entered an agreement to combat the anticipated Incivek approval. Incivek's therapy will also require interferon. Additionally, Victrelis therapy will cost less than Incivek ($26,000 to $44,000 versus $49,200). The market for these therapies will be significant. Approximately 170 million people suffer chronic hepatitis C worldwide, 3.2 million in the U.S. alone, with no vaccine in sight. Many have stated that the growth may reach epidemic levels.
While it is true that this should all result in VRTX achieving significant improvements to revenue earnings, these results are at least to some extent already included in the company's market value. The company is now valued at approximately $11 billion, with about $200 million in annual revenue before Incivek.

Nonetheless, Incivek appears to have the potential to be a true blockbuster drug therapy. At its current cost, approximately every 20,000 patients that pay full price would represent $1 billion in revenue. It is lilely, though, that the cost of such therapies will come down over time, especially where any other competitors are approved.

If Vertex ends up dominating market share versus Merck's Victrelis and any coming therapies, Incivek will truly be a blockbuster drug. The well known efficacy results for Incivek indicate that many hepatitis C patients will ask for it by name, especially if they have insurance that will cover the considerable cost. It probably will not be long before Vertex is the one making agreements with Roche, Merck and others.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

Disclaimer: Each investment should be considered relative to the total portfolio and its objectives.

[Stoxtrayder]

heute ca. 10% im Minus! klinische Tests waren nicht so gut wie erwartet...

Vertex Pharma falls on cystic fibrosis study data
Vertex Pharma slides as trial of cystic fibrosis combination therapy disappoints Wall Street

s. hier: http://finance.yahoo.com/news/Vertex-Pharma-falls-on-cystic-…

(Nach-)Kaufegelegenheit? was meint Ihr?

[Electra13]

Vertex Pharma Reports Final Results From Phase 3 STRIVE Study Of VX-770

CAMBRIDGE (MASSACHUSETTS) (dpa-AFX) - Vertex Pharmaceuticals Inc. (VRTX) announced final results from its pivotal Phase 3 STRIVE study that evaluated VX-770, a medicine in development that targets the defective protein that causes cystic fibrosis.

According to the company, data from the study showed rapid improvements in lung function that were sustained through 48 weeks among those who received VX-770, compared to those treated with a placebo. Significant improvements in all key secondary endpoints were observed among people who received VX-770 compared to placebo.

STRIVE was designed to evaluate VX-770 among 161 people 12 years or older with a mutation known as G551D in the CF gene. VX-770 is Vertex's lead medicine in development for the treatment of people with cystic fibrosis.

[Electra13]

Vertex Pharma (VRTX) Reports Improvements in Lung Function from Recent VX-770 Phase 3 STRIVE


More News related to VRTX
Vertex Pharma (VRTX) Reports Improvements in Lung Function from Recent VX-770 Phase 3 STRIVE
Phase 3 STRIVE Study of VX-770 Showed Durable Improvements in Lung Function (FEV1) and Other Measures of Disease Among People With a Specific Type of Cystic Fibrosis
Unusual 11 Mid-Day Movers 06/09: (JVA) (NEP) (AXK) Higher; (FFN) (CGA) (SEH) Lower
Wells Fargo Downgrades Vertex (VRTX) to Market Perform, Shares Look Range Bound For Sometime
Morning Movers 06/09: (JVA) (NEP) (CBAK) (FOR) Higher; (YUII) (SEH) (FVE) Lower
More News related to VRTX

More News related to Corporate News
Gulf Resources (GFRE) Unit Terminates Cooperation Agreement with East China University
JetBlue (JBLU) Load Factor Increases 1.3 Points in May
Hill International (HIL) Awarded Two Contracts in Romania Valued at $6.1 Million
Vertex Pharma (VRTX) Reports Improvements in Lung Function from Recent VX-770 Phase 3 STRIVE
Atrinsic, Inc. (ATRN) Begins Trading on The NASDAQ Capital Market Today
More News related to Corporate News

June 10, 2011 11:02 AM EDT
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reports results from its pivotal Phase 3 STRIVE study that evaluated VX-770, a medicine in development that targets the defective protein that causes cystic fibrosis (CF). S

From the release: "Data from the study showed rapid improvements in lung function (FEV1) that were sustained through 48 weeks among those who received VX-770, compared to those treated with a placebo. Significant improvements in all key secondary endpoints were observed among people who received VX-770 compared to placebo. Adverse events that occurred more frequently among those treated with VX-770 compared to placebo were headache, upper respiratory tract infections, nasal congestion, rash, dizziness and bacteria in the sputum. These data were presented today at the 34th European Cystic Fibrosis Society (ECFS) Conference in Hamburg, Germany.

The results of STRIVE showed a mean absolute improvement in lung function of 10.6 percent through week 24 (primary study endpoint) and 10.5 percent through week 48 (secondary study endpoint) among those treated with VX-770 (n=83). The mean relative improvement from baseline in lung function among people treated with VX-770 compared to placebo (n=78) was 16.9 percent through week 48. Absolute and relative changes in lung function are being reported in today’s announcement. Phase 3 results and product labeling for currently available CF medicines generally describe relative improvements in lung function."

[Electra13]

http://www.dailyfinance.com/rtn/pr/phase-3-strive-study-of-v…


Phase 3 STRIVE Study of VX-770 Showed Durable Improvements in Lung Function (FEV1) and Other Measures of Disease Among People With a Specific Type of Cystic Fibrosis

Business Wire
Posted 11:00 AM 06/10/11
Text Size A A A
Print this page|EmailShare on FacebookShare on TwitterShare on DiggShare on Lifestream
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the final results from its pivotal Phase 3 STRIVE study that evaluated VX-770, a medicine in development that targets the defective protein that causes cystic fibrosis (CF). STRIVE was designed to evaluate VX-770 among 161 people 12 years or older with a mutation known as G551D in the CF gene. Approximately 4 percent of people with CF have at least one copy of the G551D mutation.

Data from the study showed rapid improvements in lung function (FEV1) that were sustained through 48 weeks among those who received VX-770, compared to those treated with a placebo. Significant improvements in all key secondary endpoints were observed among people who received VX-770 compared to placebo. Adverse events that occurred more frequently among those treated with VX-770 compared to placebo were headache, upper respiratory tract infections, nasal congestion, rash, dizziness and bacteria in the sputum. These data were presented today at the 34th European Cystic Fibrosis Society (ECFS) Conference in Hamburg, Germany.

The results of STRIVE showed a mean absolute improvement in lung function of 10.6 percent through week 24 (primary study endpoint) and 10.5 percent through week 48 (secondary study endpoint) among those treated with VX-770 (n=83). The mean relative improvement from baseline in lung function among people treated with VX-770 compared to placebo (n=78) was 16.9 percent through week 48. Absolute and relative changes in lung function are being reported in today’s announcement. Phase 3 results and product labeling for currently available CF medicines generally describe relative improvements in lung function.

“Improving lung function is vitally important in the treatment of cystic fibrosis, but the disease affects many organs in a person's body,” said Stuart Elborn, M.D., Belfast City Hospital, Ireland, UK, and one of the study’s lead investigators. “These data are significant because they are the first to show that treating the underlying cause of cystic fibrosis may have profound effects on the disease, even among people who have been living with it for decades. The remarkable reductions in sweat chloride observed in this study support the idea that VX-770 improves CFTR function thereby addressing the fundamental defect that leads to CF.”

“In this study, people treated with VX-770 experienced significant improvements in lung function and reductions in sweat chloride within the first two weeks of treatment, and these benefits were sustained through the nearly year-long study,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. “Given the significance of these findings, we are moving quickly to submit regulatory applications for approval in the United States and Europe in the second half of 2011.”

Adverse events that were 5 percent or greater among those treated with VX-770 compared to placebo were headache, upper respiratory tract infections, nasal congestion, rash, dizziness and bacteria in the sputum. The most commonly reported serious adverse events included pulmonary exacerbation (13 percent in the VX-770 group compared to 33 percent in the placebo group), hemoptysis (or bloody cough; 1 percent in the VX-770 group and 5 percent in the placebo group) and hypoglycemia (2 percent in the VX-770 group and zero in the placebo group). Discontinuations through 48 weeks due to adverse events were less frequent in the VX-770 treatment group compared to placebo (1 percent compared to 5 percent).

[Electra13]

http://www.finanznachrichten.de/nachrichten-2011-06/20498137…

AFX News · Mehr Nachrichten von AFX News · Archiv
Vertex's VX-770 In Cystic Fibrosis Patients Achieve Primary Endpoints

CAMBRIDGE (MASSACHUSETTS) (dpa-AFX) - Vertex Pharmaceuticals Inc. (VRTX), Friday said its phase III STRIVE study in patients with a specific type of Cystic Fibrosis recorded improvement in lung function, compared to placebo and met both primary and secondary endpoints. The company plans to submit regulatory applications for VX-770 in the second half of 2011.

Cystic Fibrosis or CF is a life-threatening genetic disease caused by a genetic defect that results in defective or missing Cystic Fibrosis Transmembrane Conductance Regulator or CFTR proteins. The defect or lack of CFTR would result in poor ion flow across cell membranes and accumulation of thick, sticky mucous that would lead to infections and lung damage.

The outcome of the study showed a 16.9 percent relative improvement from baseline in lung function in patients treated with VX-770 compared to placebo, through week 48. The primary end point of the study was a mean absolute improvement in lung function of 10.6 percent through week 24, while the secondary endpoint was improvement of 10.5 percent through week 48. The study also showed a reduction in sweat chloride concentration, reflecting improvement in functioning of Cystic Fibrosis Transmembrane Conductance Regulator Protein.

STRIVE was designed to evaluate VX-770 among 161 people 12 years or older with the G551D mutation in the CF gene.

Robert Kauffman, chief medical officer for Vertex, said,' Given the significance of these findings, we are moving quickly to submit regulatory applications for approval in the United States and Europe in the second half of 2011.'

Vertex plans to make VX-770 available to the G551D mutation subpopulation prior to potential FDA approval, as early as July, pending FDA review and approval.

Another phase III study Envision is evaluating VX-770 in children with CF between the ages of 6 years and 11 years old who have at least one copy of the G551D mutation. Today, Vertex said no new safety concerns were identified with VX-770 through 48 weeks. In March, Vertex reported positive preliminary 24-week results from the study.

On Wednesday, Vertex reported results of a phase II study whose primary goal was to evaluate the safety and tolerability and the effect on CFTR function of the combination of VX-770 and VX-809 as measured by sweat chloride. In this study, 62 people aged 18 years or older with two copies of the most common mutation in the CF gene, known as the F508del mutation, were enrolled.

The study found a statistically significant reduction in sweat chloride. Further, the company said that no serious adverse events were reported during the study.

Vertex plans to begin the second part of the phase 2 study in the fourth quarter after the completion of further analyses of data from part 1.

VRTX is currently trading at $48.30, up $0.23 or 0.48%, on the Nasdaq.

Copyright RTT News/dpa-AFX

© 2011 AFX News

[Electra13]

http://www.finanznachrichten.de/nachrichten-2011-06/20505826…

Vertex and Alios BioPharma Announce Exclusive Worldwide Licensing Agreement for Two Nucleotide Drug Candidates, Broadening Vertex's Efforts to Develop New Combinations of Medicines for Hepatitis C
-Vertex gains worldwide rights to two distinct nucleotide analogues, ALS-2200 and ALS-2158, that act on hepatitis C polymerase-

-Collaboration provides multiple opportunities to develop new "all-oral" combination regimens-

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Alios BioPharma, Inc. today announced an exclusive worldwide licensing agreement that will add two distinct nucleotide analogues to Vertex''s hepatitis C portfolio. The compounds, which were discovered by Alios and are known as ALS-2200 and ALS-2158, have shown in in vitro studies to be potent inhibitors of the hepatitis C virus (HCV) polymerase, an enzyme essential for replication of the virus. The addition of these compounds provides Vertex with multiple opportunities to develop potential, new, all-oral combination regimens for chronic hepatitis C. Vertex expects ALS-2200 and ALS-2158 to enter clinical development later this year.

"We are excited to begin working with Vertex, as we believe that the Alios nucleotide analogues provide an important opportunity to improve patient care in hepatitis C," said Lawrence M. Blatt, Ph.D., Founder and Chief Executive Officer of Alios BioPharma. "For more than a decade, Vertex has been a leader in the development of new approaches for treating hepatitis C, and together we have the potential to create an all-oral, interferon-free, combination therapy that could improve the safety, efficacy and ease of administration for patients. We look forward to initiating clinical development later this year."

"The recent approval of INCIVEK was a milestone in hepatitis C care, and today''s announcement underscores our long-term commitment to further improving the treatment of this disease with new combinations of medicines," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "Alios has discovered anti-HCV nucleotides that have the potential to be leading agents in hepatitis C. Based on impressive in vitro data, we look forward to evaluating ALS-2200 and ALS-2158 together and in combination with our approved and investigational hepatitis C medicines with the goal of creating a highly potent all-oral regimen in the years ahead."

About ALS-2200 and ALS-2158

ALS-2200 and ALS-2158, currently in preclinical development, are highly potent nucleotide analogues that appear in in vitro and non-clinical studies to have a high barrier to drug resistance and the potential to be dosed once-daily. Both compounds are designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase. Each compound has its own unique mechanism of action, which supports the potential for developing these compounds together as a dual nucleotide regimen and as part of combination therapy regimens with Vertex''s other approved and investigational medicines for chronic hepatitis C, including INCIVEKTM (telaprevir), an FDA-approved hepatitis C protease inhibitor, and VX-222, an investigational hepatitis C non-nucleoside polymerase inhibitor. Data from in vitro studies showed that both ALS-2200 and ALS-2158 had a synergistic effect when combined together and with INCIVEK and VX-222. Additionally, in those in vitro studies, both compounds showed antiviral activity across all genotypes, or forms, of the hepatitis C virus, including genotypes more prevalent outside of the U.S. Pan-genotypic compounds for hepatitis C have the potential to be used across a broad range of people with hepatitis C worldwide.

As part of this agreement, Vertex gains worldwide rights to both compounds, further enabling the company to potentially expand development and commercialization efforts in hepatitis C to areas outside North America over the coming years. The agreement also includes a research program that will focus on the discovery of additional nucleotide analogues that act on the hepatitis C polymerase. Vertex will have the option to select compounds for development emerging from the research program.

Future Development Plans: Alios and Vertex plan to initiate clinical development of each compound in the fourth quarter of 2011, which is expected to include studies of the compounds in healthy volunteers followed by short-duration safety and viral kinetic studies in people with hepatitis C. The goal of the first clinical studies of these compounds is to generate data to enable the initiation of Phase 2 studies as early as the end of 2012. These Phase 2 studies are expected to evaluate multiple combination regimens of ALS-2200, ALS-2158, INCIVEK and VX-222. The combination studies would be designed to generate sustained viral response (SVR or viral cure) data. Additional details on the clinical development program for ALS-2200 and ALS-2158 will be provided later in 2011 upon initiation of the first clinical study.

Terms of the Transaction

As part of the agreement, Alios will receive a $60 million up-front payment from Vertex for the worldwide rights to ALS-2200 and ALS-2158. Vertex is responsible for development costs related to ALS-2200 and ALS-2158 and will also provide research funding to Alios. In addition, Alios would be eligible to receive research and development milestone payments up to $715 million if both compounds are approved. Vertex expects to pay approximately $35 million in development milestones in 2011. Alios is also eligible to receive up to $750 million in sales milestones on sales of all approved medicines under the collaboration. The agreement also includes tiered royalties on product sales.

Important Information About INCIVEKTM (telaprevir) tablets

Indication

INCIVEKTM (telaprevir) is a preion medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.

It is not known if INCIVEK is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, you should not take INCIVEK combination treatment if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.

INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines you cannot take with INCIVEK combination treatment. Tell your healthcare provider about all the medicines you take, including preion and non-preion medicines, vitamins and herbal supplements.

INCIVEK can cause serious side effects including rash and anemia. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Tell your healthcare provider about any side effect that bothers you or doesn''t go away.

You are encouraged to report negative side effects of preion drugs to the FDA at 1-800-FDA-1088 OR 1-800-332-1088 or www.fda.gov/medwatch. You may also report side effects to Vertex at 1-877-824-4281.

Please see full Prescribing Information for INCIVEK including the Medication Guide, available at www.INCIVEK.com.

About Hepatitis C

Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1

Unlike HIV and hepatitis B virus, chronic hepatitis C is curable.2 However, approximately 60 percent of people with genotype 1 chronic hepatitis C do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8

More than 170 million people worldwide are chronically infected with hepatitis C.6 In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.9 Hepatitis C is four times more prevalent in the United States compared to HIV.9 Genotype 1 is the most common form of HCV in the United States, accounting for around 70 percent of cases.13 However, different forms are more common in other parts of the world. The majority of people with hepatitis C in the United States were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.10 Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.11,12 By 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.9

About Vertex

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.

For more information and to view Vertex''s press releases, please visit www.vrtx.com.

About Alios BioPharma

Alios BioPharma is a biotechnology company located in South San Francisco, California, that is developing novel medicines aimed at the treatment of viral diseases. Alios has an innovative team of highly experienced scientists and clinical researchers who are developing direct acting antiviral agents against several human viral pathogens of public health importance including, Hepatotropic viruses, Respiratory viruses and other chronic, acute and emerging viral diseases. Additionally, Alios is developing molecular activators of an interferon induced, broad spectrum antiviral innate immune pathway called RNase-L. The overall goal for the Alios therapeutic platform is to maximize patient benefits in areas of high unmet medical need through optimization of potency, safety and tolerability.

INCIVEK™ is a trademark of Vertex Pharmaceuticals Incorporated.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding (i) Vertex broadening its efforts to develop new combinations of medicines for hepatitis C; (ii) multiple opportunities to develop new "all-oral" combination regimens; (iii) the expectation that clinical development of ALS-2200 and ALS-2158 will begin in 2011; (iv) the potential to create an all-oral, interferon-free, combination therapy that could improve the safety, efficacy and ease of administration for patients; (v) Vertex''s long-term commitment to further improving the treatment of Hep C with new combinations of medicines; (vi) the anti-HCV nucleotides having the potential to be leading agents in hepatitis C; (vii) the goal of creating a highly potent all-oral regimen in the years ahead; (viii) the potential for development of these compounds together as a dual nucleotide regimen and as part of combination therapy regimens with INCIVEK (telaprevir) and VX-222; (ix) the potential to expand development and commercialization efforts in hepatitis C to areas outside North America over the coming years; (x) Alios'' future research program and Vertex''s option to select compounds that may emerge from the research program; (xi) all of the statements under the caption "Future Development Plans;" (xii) Vertex''s responsibility for development and research funding; and (xiii) potential development and commercialization milestones and royalty payments. While the Company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the outcomes for our planned clinical trials and studies may not be favorable, that there may be varying interpretations of data produced by one or more of our clinical trials, that the Company may not obtain the benefits it expects to obtain from this transaction for a variety of reasons including the possibilities that the Company may not be able to successfully develop combination therapies involving INCIVEK and/or VX-222 and the drug candidates that the Company is acquiring in this transaction; and that in vitro data regarding ALS-2200 and ALS-2158 may not be predictive of results that may be obtained from clinical trials, and the other risks listed under Risk Factors in Vertex''s annual report and quarterly reports filed with the Securities and Exchange Commission and available through the Company''s website at www.vrtx.com. The Company disclaims any obligation to update the information contained in this press release as new information becomes available.

[Stoxtrayder]

was ist Eure Einschätzung?

Rücksetzer zum Kauf nutzen?

charttechnisch ist ja (noch) alles im grünen Bereich.

[Electra13]

Antwort auf Beitrag Nr.: 41.663.818 von Stoxtrayder am 17.06.11 18:34:56

Vertex Tops Merck in Early Hep C Drug Launch

CAMBRIDGE, Mass. (TheStreet) -- Vertex Pharmaceuticals'(VRTX_) new hepatitis C drug Incivek is outselling Victrelis, a rival drug from Merck(MRK_), in the early weeks of their respective commercial launches.


U.S. regulators approved Incivek and Victrelis in May just 10 days apart, which means Vertex and Merck began marketing the competing hepatitis C drugs essentially at the same time. Investors rarely get to watch companies launch two similar drugs simultaneously -- particular two drugs tapping into a multi-billion dollar market like hepatitis C -- so investors are paying close attention to the early prescriptions written for Incivek and Victrelis.

So far, Vertex is beating Merck, which means the marketing battle between Incivek and Victrelis is playing out largely as expected.

For the week ended June 17 (the most current data available), doctors wrote 460 prescriptions for Vertex's Incivek compared to 160 prescriptions written for Merck's Victrelis, according to weekly prescription data compiled by IMS Health. Weekly IMS drug prescription data tracks retail pharmacy, mail order and long-term care distribution channels.

That puts Incivek's market share at 75% compared to Victrelis' 25% with about five weeks of prescription data available. Even before the two drugs launched, investors were expecting Incivek to garner more prescriptions, with some analysts forecasting a 75% market share split for Incivek at peak.

The current consensus 2011 sales forecast for Incivek is $490 million, according to the sell-side analysts who cover Vertex. Buyside investors are expecting more. A survey of 188 investors in early June yielded a 2011 consensus sales estimate of $568 million, including $43 million in the second quarter that ends June 30, according to ISI Group biotech analyst Mark Schoenebaum, who conducted the survey.

Bank of America Merrill Lynch, through IMS, is tracking daily prescriptions of Incivek for those investor clients who are totally obsessed with the launch of the new hepatitis C drugs. Those daily IMS reports, culled from prescriptions reported by retail pharmacies only, also show Incivek topping Victrelis to date.

Doctors are showing a preference for Incivek over Victrelis so far, but that advantage isn't yet translating into a higher Vertex stock price. At Monday's close of $48.73, Vertex is down 15% from May 23, the day Incivek was approved, and down 21% from the stock's 52-week high reached on May 12.

www.thestreet.com

[blb]

Die Quartalszahlen heute waren erste Sahne. Incivek kommt gut an.

[Electra13]

Thursday Oct 20
Vertex CEO sees "historic launch" for Hep-C drug
Full story: Reuters
The chief executive of Vertex Pharmaceuticals Inc , Matthew Emmens, said on Thursday that adoption of its recently-launched hepatitis C drug, Incivek, has been "very very fast." The first full quarter of U.S. sales of Incivek will emerge when the biotechnology company reports its quarterly earnings later this month.



10/21/2011
Vertex Pharmaceuticals Incorporated Presents at BioNetwork West 2011, Oct-25-2011 09:00 AM.
Venue: Ritz Carlton Laguna Niguel, One Ritz Carlton Drive, Dana Point, CA 92629, California, United States. Speakers: Phil Tinmouth, Vice President, Business Development & Alliance Management.


Vertex CEO trying not ‘to screw it up’
By Brendan Lynch
Thursday, October 20, 2011 -

Vertex Pharmaceuticals CEO Matthew Emmens said this morning the company would be -- “very proud,” of third quarter sales of its hepatitis C drug Incivek, which will be detailed in its earnings report next week--.

Emmens told a Greater Boston Chamber of Commerce audience at the Four Seasons that things are going well for Vertex. The company broke ground on a new headquarters in Fan Pier earlier this year. Incivek won Food and Drug Administration approval in May and did $75 million in second-quarter sales. This week, it submitted its cystic fibrosis drug Kalydeco to the FDA.

“I wake up every morning and say, ‘Don’t screw it up,’ ” he said


Vertex has about 6,000 employees worldwide, and 1,350 in Massachusetts. It has 130 job openings, and plans to add 500 employees by 2015.

Emmens also said drug companies have themselves to blame for the low opinion of them.

“We’re right down there with the tobacco industry and tort lawyers,” he said. “We’re not loved. I think we dug our own hole here, and we need to dig out of it.”

Companies cashing in on copy-cat drugs for frivolous ailments, and incessant, inane advertising reversed the industry’s former stature, he said.

“Particularly at night, when I come home and I’m tired, I don’t want to hear, ‘Omnaris, to the nose!’ ” he said. “What are we thinking? Stop that, it’s annoying. And I’m not sure what the two people in the bathtubs are going to do, but I don’t want to make a drug that causes anything weird like that to happen.”

As 22-year-old Vertex grows, and, according to Emmens, nears profitability, he said he thinks a lot about preserving innovation at a large company.

“The bigger you get, the less risk you take inside companies,” he said. “The reason is, career paths become important. We all want to be successful. We want to try things that work. And on top of that, there’s usually 14 to 17 layers of people who can say no, versus a small company, where there’s one or two layers who can say no.”

[Electra13]

Diese Woche werden die Q3 Zahlen kommuniziert. Laut CEO werden sie sehr gut ausfallen (siehe oben).
Habe meine Stueckzahl aufgestockt.
Ich denke Incivek wird die Erwartungen nicht enttaeuschen.

[Stoxtrayder]

hm, heute die 35er Marke kurz angetestet und aber vorerst erfolgreich verteidigt. ich glaube, hier werde ich die Tage über mal mit CK41JH auf eine Gegenreaktion nach oben spekulieren. Fundamental gabs die letzte Zeit ja eigentlich auch nur postives von Vertex (s.oben)..

[againstfotsch]

hat jemand news warum der kurs so schwach ist?
ich habe nichts gefunden...

af

[bre128]

Servus zusammen,

ich habe mal einen Link zu den letzten veröffentlichten Pressemitteilungen eingefügt:

http://investors.vrtx.com/releases.cfm?hdr02=press

VG
bre128

[bre128]

FDA Grants Priority Review for KALYDECO™ (ivacaftor), the First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis

-- Six-month review date of April 18, 2012 set by FDA --

-- European Medicines Agency accepts KALYDECO regulatory submission for accelerated assessment --

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for KALYDECOTM (ivacaftor) and granted the company's request for six-month Priority Review. KALYDECO targets the defective protein that causes cystic fibrosis (CF) in a subset of people with the disease. If approved, KALYDECO will be the first treatment to target the underlying cause of CF.

The FDA grants Priority Review to medicines that offer major advances in treatment or provide a treatment where no adequate therapy exists. A target review date of April 18, 2012 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision, which is four months earlier than the standard review time of 10 months.

In addition, Vertex announced today that its marketing authorization application (MAA) for KALYDECO has been validated by the European Medicines Agency (EMA). Validation indicates that the application is complete and starts the regulatory review process by the Committee for Medicinal Products for Human Use (CHMP). Earlier this year, the EMA accepted Vertex's request for accelerated assessment, which is granted to new medicines of major public health interest and shortens the EMA's review time.

"If approved, KALYDECO will be the first treatment to target the underlying cause of CF," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "The commitments by the FDA and the EMA to expedite their reviews of our applications underscore the significant potential of KALYDECO to help people living with cystic fibrosis."

CF is caused by defective or missing cystic fibrosis transmembrane conductance regulator (CFTR) proteins resulting from mutations in the CFTR gene. The absence of functional CFTR proteins results in poor flow of salt and water across cell membranes in a number of organs, including the lungs. This leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage.

In people with CF who have a gating defect, CFTR proteins are present at the cell surface but do not function properly. The most common gating defect is caused by the G551D mutation. Approximately 4 percent of those with CF, or about 1,200 people in the United States and 1,000 people in Europe, are believed to have this mutation. KALYDECO is designed to keep the CFTR channels at the cell surface open longer to improve the transport of chloride ions across the cell membrane in people who have gating mutations. The U.S. application seeks approval for KALYDECO in people with the G551D mutation. The application submitted in Europe includes a request for all gating mutations.

The regulatory submissions are supported by results from two Phase 3 studies, STRIVE and ENVISION, in which people with CF who had at least one copy of the G551D mutation and were treated with KALYDECO experienced rapid, significant and sustained improvements across a variety of disease measures, including lung function. The majority of adverse events associated with KALYDECO were mild to moderate in severity and non-serious. Fewer people in the KALYDECO treatment groups than in the placebo groups discontinued treatment due to adverse events. These data showed that treating the underlying cause of CF may improve outcomes for people with the disease.

About KALYDECO

KALYDECO (ivacaftor, VX-770) is Vertex's lead medicine in development for the treatment of people with cystic fibrosis. Known as a CFTR potentiator, this oral medicine in development aims to help CFTR protein function more normally once it reaches the cell surface, which is believed to help hydrate and clear mucus from the airways. Vertex retains worldwide rights to develop and commercialize KALYDECO (kuh-LYE-deh-koh). The brand name KALYDECO has been approved by the EMA and provisionally approved by the FDA, but KALYDECO has not been granted marketing authorization or approval from any regulatory authority.

About Cystic Fibrosis

CF is a life-threatening genetic disease affecting approximately 30,000 people in the United States and 70,000 people worldwide. Today, the median predicted age of survival for a person with CF is approximately 38 years. According to the 2010 Cystic Fibrosis Foundation Patient Registry Annual Data Report, approximately 4 percent of the total CF patient population in the United States have at least one copy of the G551D mutation. The most common form of CF is caused by the F508del mutation, which is present in nearly 90 percent of people with the disease.

Collaborative History with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT)

Vertex initiated its CF research program in 1998 as part of a collaboration with CFFT, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation. This collaboration was expanded to support the accelerated discovery and development of Vertex's CFTR modulators.

About the Cystic Fibrosis Foundation

The Cystic Fibrosis Foundation is the world's leader in the search for a cure for cystic fibrosis. The Foundation funds more CF research than any other organization. Many of the CF treatments available today benefited from Foundation support. Based in Bethesda, Md., the Foundation also supports and accredits a national care center network that has been recognized by the National Institutes of Health as a model of care for a chronic disease. The CF Foundation is a donor-supported nonprofit organization. For more information, visit www.cff.org.

About Vertex

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.

Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada. Today, Vertex has more than 1,900 employees around the world, and Science magazine named Vertex number one on its 2011 list of Top Employers in the life sciences.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding (i) the FDA's target review date for the KALYDECO NDA, and (ii) the commitments by the FDA and EMA to expedite their reviews of our applications underscoring the significant potential of KALYDECO to help people living with cystic fibrosis. While the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that Vertex could experience unforeseen delays in obtaining approval to market KALYDECO; that future scientific, clinical, competitive or other market factors may adversely affect the potential for therapy with KALYDECO and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex's website at www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

Vertex Pharmaceuticals Incorporated
Media:
Megan Goulart
Dawn Kalmar
617-444-6992
[e-mail]
or
Investors:
Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755

Source: Vertex Pharmaceuticals Incorporated

News Provided by Acquire Media

http://investors.vrtx.com/releasedetail.cfm?ReleaseID=633574

[Stoxtrayder]

Schön, wie sich die Aktie vom Tief aus erholt hat. bin mit meinem ausgewählten OS CK41JH mit einem Mischkurs von ca. 2,90 mittlerweile schön im Plus. heute und die nächsten Tage evtl. Konosoliderung, dann kann's meinetwegen weiter nach oben gehen...

[Stoxtrayder]

na also, wer sagt's denn!?

Montag ist dann corporate presentation bei J.P. Morgan. vielleicht haben da heute schon einige mehr gewusst...?!

[kleinerna2]

Wer hat Vertex für 10,00 € aus Zürich angeboten bekommen, mit einer Haltefrist von 12 Monaten obwohl der Wert bei ca. 28,50 € steht ?

[Stoxtrayder]

hä? I don't understand...

btw gibts z.Zt. immerwiedermal aufkeimende Gerüchte in einschlägigen US-Boards an einer Übernahmen (durch Merck).

Zahlenwerk für 2011 wird Anfangs Februar präsentiert. Bestimmt besser als angenommen.

Werde meinen OS bis dahin auf jeden Fall halten, the Trend is your friend. Vorausgesetzt der Gesamtmarkt spielt mit.

[bennog]

Antwort auf Beitrag Nr.: 42.613.564 von Stoxtrayder am 19.01.12 00:14:53

Hallo stoxtrayder,

was macht dich so optimistisch dass sich die zahlen über gebühr präsentieren?? wie hoch schätzt du selbst die umsätze im 4.quartal?

was kleinerna meinte hab ich auch nicht kapiert...hier würde erklärungsbedarf bestehen.....!!???

[kleinerna2]

Hallo bennog,

werde schon seit einigen Wochen aus Zürich angerufen im Angebot Vertex für 10,00 € mit einer Haltefrist von 12 Monaten. Abzocker oder ist die Nummer bekannt? Bei zur Zeit ca. 27 € ein tolles Geschäft. Wer weiss mehr?

[clearasil]

Antwort auf Beitrag Nr.: 42.651.401 von kleinerna2 am 26.01.12 13:46:35

das kann nur betrug sein - there is no such thing as a free lunch - finger weg lassen.

[bennog]

Antwort auf Beitrag Nr.: 42.651.401 von kleinerna2 am 26.01.12 13:46:35

das sind definitiv nicht deine freunde...mich haben se eine zeitlang immer aus krefeld angerufen wg. watson pharma....dubiose options sollte ich "günstigst" bekommen.....
schadet aber denke ich der vertex nicht..damals watson auch nicht...die suchen sich einfach eine spannende hausnummer raus die allgemein auch phantasie hat wie unsre vertex eben....

so jungs..wie schauen eure umsatzschätzungen fürs IV. Quartal nun aus....anscheinend wurden sie ja etwas zusammengestutzt....würd mich interessieren...seit ihr mega opt. oder nur in line bei 350-400 mio???

überlege nachzukaufen...vor den zahlen oder nach den zahlen....

[bennog]

Antwort auf Beitrag Nr.: 42.651.925 von bennog am 26.01.12 15:01:10

keiner eine meinung...??? schade

[Stoxtrayder]

sodala, kurstechnisch munteres Treiben heute (sogar kurz augesetzt! hatte schon kurzer Hand Panik wg. negativer Meldung...) nach dieser Hammer-Meldung:

Vertex Receives U.S. FDA Approval for Kalydeco to Treat Cystic Fibrosis

CAMBRIDGE (MASSACHUSETTS) (dpa-AFX) - Shares of Vertex Pharmaceuticals Inc. (VRTX) gained 8 percent Tuesday noon, after the US Food and Drug Administration approved Kalydeco as the first drug to treat the root cause of cystic fibrosis - a rare and incurable genetic disease that mostly affects the lungs, as also other bodily organs. Vertex plans shipping Kalydeco, a 150-mg twice daily tablet, to pharmacy stores in the US this week. Cystic fibrosis or CS, is a rare and malignant genetic disease caused by defective or missing cystic fibrosis transmembrane conductance regulator, or CFTR proteins due to mutations in the CFTR gene. The FDA approval for Kalydeco means CF patients aged 6 and above, who have at least one copy of the G551D mutation in the CFTR gene, can be administered the drug. About 1,200 people in the US, or 4 percent of those with CF, are said to have this mutation. Vertex discovered Kalydeco in a partnership with Cystic Fibrosis Foundation Therapeutics Inc., a nonprofit unit affiliated to the Cystic Fibrosis Foundation. The FDA had accepted the Kalydeco application last December and had granted a six-month priority review. The approval was based on data from two Phase 3 studies of people with CF who have at least one copy of the G551D mutation. Patients on Kalydeco showed strong and sustained improvements in lung function and other measures, compared to those on placebo. People on Kalydeco also experienced much fewer pulmonary exacerbations. Adverse events for Kalydeco included headache, upper respiratory tract infection, stomach pain, and diarrhea. A Persist Phase 3 96-week extension study is underway to assess the long-term safety and durability of treatment with Kalydeco, Vertex noted. Robert Beall, CEO of the Cystic Fibrosis Foundation, said, 'We now have a medicine that treats the underlying cause of the disease in people with the G551D mutation. Kalydeco also provides us with a roadmap for exploring additional targeted approaches to treatment for all people with cystic fibrosis.' Vertex retains worldwide rights to develop and sell Kalydeco. An European Medicines Agency accelerated review of Kalydeco is now in process after Vertex last October submitted a marketing authorization application. The company is planning more studies this year to assess Kalydeco in children with CF aged 2 years and in people with CF who have the R117H mutation or gating mutations that were not probed prior Phase 3 studies. Vertex is pinning hopes on becoming a viable drug company on the planned global launch of Kalydeco, and its hepatitis C drug Incivek that was approved in mid 2011. VRTX is trading at $37.80, up $3.06 or 8.81%, on a volume of 5.7 million shares on the Nasdaq.

kurzer Nachtrag meinerseits zu den Zahlen, warum ich recht optimistisch bin: das Teil hat sich recht kurzer Zeit vom Tief schön erholen könnnen (ca. 40% innerhalb von 6 Wochen), ich denke, da wissen/wussten schon einige mehr?! mehr weiß/ahne ich natürlich auch nicht.

mein CK41JH-OS hat sich heute jedenfalls um knapp 30% verteuert...

[bennog]

Antwort auf Beitrag Nr.: 42.676.416 von Stoxtrayder am 31.01.12 20:19:49

glaube auch dass die umsatzzahlen nicht enttäuschen werden...wahrscheinlich auch nicht über der line liegen aber dass passt dann schon ...die meldung gestern noch dazu....2012 dürfte für vertex ein ordentliches jahr werden...der titel hat einfach viel fantasie und die cash maschine wird ja jetzt erst richtig angeschmissen.....about 60 dollar mein ziel bis jahresende !!

[Stoxtrayder]

na also, geht doch...

Vertex Pharma Turns To Profit In Q4 On INCIVEK Net Revenues

CAMBRIDGE (MASSACHUSETTS) (dpa-AFX) - Vertex Pharmaceuticals Inc's (VRTX) GAAP net income for the fourth quarter of 2011 was $158.6 million, or $0.74 per share, compared to a net loss of $180.4 million, or $0.90 per share in the year ago quarter. Vertex's non-GAAP net income for the fourth quarter of 2011, was $185.2 million, or $0.86 per share. The non-GAAP net loss for the fourth quarter of 2010 was $148.5 million, or $0.74 per share. Total revenues for the fourth quarter of 2011 were $563.3 million, compared with $65.5 million in total revenues for the fourth quarter of 2010. The increase in total revenues for the fourth quarter of 2011 was primarily driven by INCIVEK net revenues of $456.8 million and a $65.0 million milestone payment from Mitsubishi Tanabe related to approval and commercialization of TELAVIC in Japan. Analysts polled by Thomson Reuters expected the company to report earnings of $0.70 per share on revenues of $518.36 million for the quarter. Analysts' estimates typically exclude special items. Vertex expects that full-year 2012 INCIVEK net revenues will be in the range of $1.5 billion to $1.7 billion. Vertex expects 2012 total operating expenses, excluding cost of revenues, stock-based compensation expense and Alios expenses related to the accounting for the collaboration with Vertex, to be in the range of $1.03 billion to $1.13 billion.


nachbörslich locker über die 40$-Marke geschossen! mein Tipp: Schlusskurs von 42$ morgen!

[Stoxtrayder]

bin ich denn im falschen Film?! dickes Minus heute...oder typisches sell on good News?!

oder auf Grund dieses Artikels?

http://localizedusa.com/2012/02/02/vertex-pharmaceuticals-vr…

SL setzte ich mal bei 35$. dann bin ich raus...

[pkera]

Nein leider nicht. Ich bin auch überrascht:

http://www.thestreet.com/story/11399517/1/gilead-woes-with-n…

http://www.thestreet.com/story/11400168/1/idenix-falls-casua…

Die Kombination verkürzt die behandlungszeit auf 4 Wochen.

Man muss jetzt schauen wie schnell Gilead es auf dem Markt bringt.

Pkera

[Stoxtrayder]

aja, Danke pkera, interessant...

wäre die unerwartet schnelle Zulassung von Kalydeco diese Woche & die Topp-Zahlen nicht gewesen, ich glaube das Teile wäre direkt unter die 30$-Marke wieder gefallen.

wie gesagt, mein Stopp-Loss liegt nun bei 35$.

[bennog]

Antwort auf Beitrag Nr.: 42.701.512 von Stoxtrayder am 05.02.12 13:03:59

schaut doch sehr stabil aus......alles ohne news...nice performance

[joseluis]

Hat hier schon mal jemand etwas von der Züricher Vermögensverwaltung gehört? Die bieten derzeit im Rahmen eines "Private Placement" ein Vertex-Sonderkontingent für 17,50 Euro je Aktie an, Haltefrist 12 Monate. Was haltet Ihr davon?

[bennog]

Antwort auf Beitrag Nr.: 42.919.865 von joseluis am 18.03.12 16:17:27

warum sollte jemand 15 euro/share verschenken....?? Hirn bitte einschalten...würde dieses superschnäppchen nicht von mitarbeitern oder freunden der mitarbeiter oder zumindest bestehenden kunden absorbiert wenn es sauber wäre?

geschenkt wird im leben wenig

[Stoxtrayder]

hm, hab die Aktie (mal wieder) nach erfolgter Korrektur auf der Watchlist. Am 26.4. kommen Zahlen, die sollten eigentlich (wieder) ganz ordentlich ausfallen.

CK4TBS gefällt mir gehebelt ganz gut, (vergleichbar) geringes Aufgeld, 3er Hebel.

Meinungen?

[bre128]

May 7, 2012Interim Data from Phase 2 Combination Study of VX-809 and KALYDECO™ (ivacaftor) Showed Significant Improvements in Lung Function (FEV1) in People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation

- Interim analysis showed 46% of patients experienced at least 5% absolute improvement in lung function (FEV1) from baseline; 30% of patients experienced at least 10% absolute improvement -

- Vertex plans to start a pivotal study of VX-809 and KALYDECO to treat the underlying cause of CF in adults with two copies of the F508del mutation, pending final data and discussions with regulatory agencies -

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today an interim analysis of data from an ongoing Phase 2 study of VX-809 and KALYDECO™ (ivacaftor) that showed significant improvements in lung function (FEV1) among adults with cystic fibrosis (CF) who have two copies (homozygous) of the most common mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, F508del. A planned interim analysis was conducted after approximately half of the study patients had completed 56 days of treatment. Today's results are based on data from 37 homozygous F508del patients who completed treatment in the 56-day study and 11 patients with one or two copies of the F508del mutation who received placebo. There was a statistically significant improvement in lung function (absolute change in percent predicted FEV1) across the combined treatment groups relative to baseline compared to placebo (p=0.002). Of those who received VX-809 and KALYDECO (250mg, q12h), approximately 46 percent (17/37) experienced an absolute improvement from baseline to Day 56 in lung function of 5 percentage points or more, and approximately 30 percent (11/37) experienced an absolute improvement from baseline to Day 56 of 10 percentage points or more. None of the patients treated with placebo (0/11) achieved a 5-percentage point or more improvement from baseline to Day 56 in lung function. Most adverse events were mild or moderate in severity and comparable between treatment and placebo groups.

The study is ongoing and complete data, including statistical analyses for all patient groups, will be available in mid-2012. Vertex plans to start a pivotal study of VX-809 and KALYDECO in people with two copies of the F508del mutation, pending final study results and discussions with regulatory agencies. Evaluation of patients with one copy (heterozygous, n=21) of the F508del mutation is ongoing, but at the time of this interim analysis not enough patients had completed the study to make any conclusions. These complete data will be included in the final study analysis and will be used to determine next steps for the development of VX-809 and KALYDECO in heterozygous F508del patients. Vertex will host a conference call for investors and media today, May 7, 2012 at 8:30 a.m. ET to discuss this interim data analysis.

Cystic fibrosis is a rare, life threatening genetic disease affecting approximately 30,000 people in the United States and 70,000 people worldwide. Nearly half of those with CF are estimated to have two copies of the F508del mutation.

"For the past 14 years, our teams have focused on learning about the underlying cause of cystic fibrosis so we can develop new medicines to help as many patients as possible. Today we believe we're one step closer to this goal," said Chris Wright, M.D., Ph.D., Vertex's Senior Vice President, Global Medicines Development and Medical Affairs. "People with two copies of the F508del mutation have one of the most severe forms of cystic fibrosis. In these patients, the combination of VX-809 and KALYDECO led to significant improvements in lung function that exceeded our expectations. We look forward to beginning discussions with regulatory agencies later this year when we have full data from the study, with the goal of moving forward with a pivotal study as quickly as possible."

"Lung function is the single most important marker of disease progression for people with cystic fibrosis, and improvement in lung function is the goal of every new CF therapy," said Michael P. Boyle, M.D, FCCP, Associate Professor of Medicine, Director of the Johns Hopkins Adult Cystic Fibrosis Center, and lead investigator for this study. "While we still eagerly await the results from the remainder of the trial, we are definitely encouraged that this interim analysis showed a significant improvement in lung function in people with two copies of the F508del mutation who received VX-809 and KALYDECO."

Interim Results

Data from the first part of this study were announced in 2011. The interim data announced today are from the second part of the ongoing Phase 2 randomized, double-blind, placebo-controlled study. This part of the study enrolled 108 people with CF ages 18 and older with one or two copies of the F508del mutation who were divided into five treatment groups of approximately 20 patients each. Three groups of homozygous patients were randomized to receive VX-809 alone (200mg, 400mg or 600mg) for 28 days and then in combination with KALYDECO (250mg) for an additional 28 days. One group of heterozygous patients is receiving VX-809 alone (600mg) for 28 days and then in combination with KALYDECO (250mg) for an additional 28 days. The placebo group includes both homozygous and heterozygous patients.

Lung function: Progressive lung disease is a major source of illness and is the leading cause of death in people with CF. Typically people with CF lose 1 percent to 2 percent of their lung function (FEV1) each year.

Improvements in lung function (absolute change in percent predicted FEV1) were observed in all combination treatment dose groups in homozygous patients. The percent of patients who experienced absolute improvement from baseline in lung function was as follows:

Treatment Group Absolute Improvement from Baseline in Lung Function (FEV1)
(Baseline — Day 56)



≥ 5 percentage points ≥ 10 percentage points
VX-809 alone (200mg, 400mg or 600mg)
for 28 days followed by KALYDECO
(250mg, q12h) + VX-809 (200mg, 400mg,
600mg dose groups combined) for 28 days
46% (17/37)
30% (11/37)
Placebo 0 (0/11) 0 (0/11)


Sweat chloride: Elevated sweat chloride levels are a diagnostic hallmark in CF and are the result of CFTR protein dysfunction. Although not a clinically validated endpoint, a reduction in sweat chloride is considered to be a biomarker of improved CFTR function in the skin.

One of the two primary endpoints in this study is change in sweat chloride from Day 28 to Day 56. Reductions in sweat chloride were observed between Day 28 and Day 56 in homozygous patients treated with VX-809 and KALYDECO. At the time of this interim analysis, these reductions were not statistically significant.

A statistically significant reduction in sweat chloride was observed in patients treated with VX-809 alone (baseline — Day 28).

Safety: A co-primary endpoint in this study is safety. Safety results reported today include data from all patients who had started treatment prior to this interim analysis. VX-809 was generally well tolerated alone and in combination with KALYDECO. The most common adverse events were pulmonary in nature. Most adverse events were mild or moderate in severity and comparable between treatment and placebo groups. The rate of serious adverse events was similar between treatment and placebo groups.

Cystic fibrosis is caused by defective or missing CFTR proteins resulting from mutations in the CFTR gene. Located at the surface of cells, CFTR proteins act as channels to regulate the flow of salt and water into and out of the cells. In people with the F508del mutation in the CFTR gene, little to no CFTR protein reaches the cell surface. As a result, thick, sticky mucus builds up and blocks the passages in many organs, leading to a variety of symptoms. In particular, mucus builds up and clogs the airways in the lungs, causing chronic lung infections and progressive lung damage. VX-809, known as a CFTR corrector, is believed to help CFTR proteins reach the cell surface. KALYDECO, known as a CFTR potentiator, keeps the CFTR protein channels open longer to increase the flow of salt and water into and out of the cell.

VX-809 and KALYDECO were discovered as part of collaboration with Cystic Fibrosis Foundation Therapeutics, Inc., the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation.

Conference Call for Media and Investors

Vertex will host a conference call and webcast today, May 7, 2012 at 8:30 a.m. ET to discuss this interim data analysis. The conference call will be webcast live and a link to the webcast may be accessed from the ‘Events & Presentations' page of the Vertex website at www.vrtx.com.

To listen to the live call on the telephone, dial 1-866-501-1537 (United States and Canada) or 1-720-545-0001 (International). To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.

The conference ID number for the live call and replay is 78832581.

The call will be available for replay via telephone commencing May 7, 2012 at 11:30 a.m. ET running through 5:00 p.m. ET on May 14, 2012. The replay phone number for the United States and Canada is 1-855-859-2056. The international replay number is 1-404-537-3406.

Following the live webcast, an archived version will be available on Vertex's website until 5:00 p.m. ET on May 21, 2012. Vertex is also providing a podcast MP3 file available for download on the Vertex website at www.vrtx.com.

About Cystic Fibrosis

Cystic fibrosis is a rare, life-threatening genetic disease affecting approximately 30,000 people in the United States and 70,000 people worldwide. Today, the median predicted age of survival for a person with CF is approximately 38 years but the median age of death remains in the mid-20s. There are more than 1,800 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic, or genotyping test, lead to CF by creating non-working or too few CFTR proteins at the cell surface. The absence of working CFTR proteins results in poor flow of salt and water into and out of the cell in a number of organs, including the lungs.

In people with the most common mutation in the CFTR gene, F508del, little to no CFTR protein reaches the cell surface. Globally, nearly half (46 percent) of people with CF have two copies of the F508del mutation and one-third (33 percent) have one copy of the F508del mutation.

About KALYDECO

KALYDECO™ (ivacaftor) is the first treatment to target the underlying cause of CF. KALYDECO (150mg, q12h) was approved by the U.S. Food and Drug Administration (FDA) in January 2012 for use in people with CF ages 6 and older who have at least one copy of the G551D mutation in the CFTR gene.

Vertex retains worldwide rights to develop and commercialize KALYDECO. In October 2011, Vertex submitted a marketing authorization application to the European Medicines Agency (EMA) for KALYDECO and has received agreement from the EMA for accelerated assessment in Europe. The EMA regulatory review is ongoing.

Indication and Important Safety Information

KALYDECO (150mg, q12h) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a certain mutation in their CFTR gene called the G551D mutation.

KALYDECO is not for use in people with CF due to other mutations in the CFTR gene. It is not effective in CF patients with two copies of the F508del mutation (F508del/F508del) in the CFTR gene.

It is not known if KALYDECO is safe and effective in children under 6 years of age.

KALYDECO should not be used with certain medicines, including the antibiotics rifampin and rifabutin; seizure medications (phenobarbital, carbamazepine, or phenytoin); and the herbal supplement St. John's Wort.

KALYDECO can cause serious side effects. High liver enzymes in the blood have occurred in patients taking KALYDECO as well as those receiving placebo. Regular assessment is recommended.

The most common side effects associated with KALYDECO include headache; upper respiratory tract infection (common cold) including sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness.

These are not all the possible side effects of KALYDECO. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.

Please see full Prescribing Information for KALYDECO at www.KALYDECO.com.

Collaborative History with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT)

Vertex initiated its CF research program in 1998 as part of a collaboration with CFFT, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation. This collaboration was expanded to support the accelerated discovery and development of Vertex's CFTR modulators.

About the Cystic Fibrosis Foundation

The Cystic Fibrosis Foundation is the world's leader in the search for a cure for cystic fibrosis. The Foundation funds more CF research than any other organization and nearly every CF drug available today was made possible because of Foundation support. Based in Bethesda, Md., the Foundation also supports and accredits a national care center network that has been recognized by the National Institutes of Health as a model of care for a chronic disease. The CF Foundation is a donor-supported nonprofit organization. For more information, visit www.cff.org.

About Vertex

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.

Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada. Today, Vertex has more than 2,000 employees around the world, and Science magazine named Vertex number one on its 2011 list of Top Employers in the life sciences.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including Dr. Wright's and Dr. Boyle's statements in the fourth and fifth paragraphs of this press release, and statements regarding (i) Vertex's plan to start a pivotal study of VX-809 and KALYDECO in people with two copies of the F508del mutation, pending final data and discussions with regulatory agencies, (ii) the expected availability of complete data from the study in mid-2012 and (iii) the expectation that the final data that will become available in mid-2012 will be used to determine next steps for the development of VX-809 and KALYDECO in heterozygous F508del patients. While Vertex believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the final outcomes of this clinical trial or future clinical trials of VX-809 and KALYDECO may be less favorable than the interim analysis reported today, or may not be favorable at all, that final data from heterozygous patients may not be favorable or may be less favorable than the data from homozygous patients, that final data and/or discussions with regulatory agencies regarding the scope and design of future clinical trials may result in additional clinical trials needing to be conducted before Vertex can initiate the first pivotal clinical trials evaluating VX-809 in combination with KALYDECO and other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through the company's website at www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)



Vertex Pharmaceuticals Incorporated
Media:
Zach Barber
Megan Goulart
Dawn Kalmar
617-444-6992
[e-mail]
or
Investors:
Michael Partridge, 617-444-6108

Source: Vertex Pharmaceuticals Incorporated


News Provided by Acquire Media

http://investors.vrtx.com/releasedetail.cfm?ReleaseID=670755

Grüße
bre128

[BarfuSs]

Hi,

...wo geht die Reise?

GruSs BarfuSs

[Stoxtrayder]

ganz großes Kino. hauptsache man hat den Wert NICHT in seinem Depot, sondern auf der Watchliste...

Glückwunsch allen Investierten!

[bennog]

Antwort auf Beitrag Nr.: 43.132.771 von Stoxtrayder am 07.05.12 22:10:44

den vogel hab ich abgeschossen...hatte mit vertex wirklich mal einen wert TIEF abgefischt mit 20,40 euro vor ein paar monaten.....ende april bin ich dann in die Green Mountain Coffe Roaster rein mit dem VertexVERKAUF....GMCR gut 50% abschlag...nach zahlen und das vertex baby nun gut 50% nach oben.... dass sind schon brutale Fehlentscheidungen!

[BarfuSs]

Wann sollte man das teil shorten?

[bennog]

Antwort auf Beitrag Nr.: 43.138.087 von BarfuSs am 08.05.12 21:47:34

schau auf den celegene langfristchart...könnte eine blaupause für vertex die nächsten 10 jahre sein.....die zeiten der hoffnung sind bei vertex nun vorbei.....zum shorten gibts andre kandidaten

[Raigro]

Mir bietet Hermes Asset Management http://www.hermes-assets.com/ derzeit im Rahmen eines "Private Placement" ein Vertex-Sonderkontingent für 20,00 Euro je Aktie an, Haltefrist 12 Monate. Was haltet Ihr davon?

[Raigro]

Meine Frage hat sich wohl erledigt. Meine Recherchen im Internet ergaben nichts verdächtiges zu Hermes Asset Management, aber die Adresse, zu der das Geld überwiesen werden sollte, tauchte auf einer Anlegerschutzseite auf, weil dort eine vorbestrafte Dame Ihr Unwesen treibt.

Schön wär es gewesen!

[bre128]

May 17, 2012
The Crohn's and Colitis Foundation of Canada and Vertex Announce Collaboration to Fund Research in Inflammatory Bowel Disease
-Unique collaboration between a biotech company, nonprofit organization and academic centres to focus on underlying biology of IBD-
-Collaboration complements Vertex's ongoing IBD research efforts at its Canadian research and development site-

Toronto, Ontario and Laval, Quebec, May 17, 2012 - Vertex Pharmaceuticals Incorporated and the Crohn's and Colitis Foundation of Canada (CCFC) today announced a new collaboration to fund novel research aimed at identifying the underlying disease mechanisms and drivers of inflammatory bowel disease (IBD), specifically Crohn's disease and ulcerative colitis.

The announcement coincides with World IBD Day - May 19 - a day when people with IBD and patient organizations around the world unite to raise awareness about the global impact of Crohn's and ulcerative colitis.

This agreement represents a unique model of collaboration between a biotech company and a national healthcare charity, where Vertex and CCFC will provide joint funding to leading scientists at three Canadian academic centres. The three-year collaboration includes two rounds of grant funding, with recipients chosen based on their approach to developing a new understanding of the underlying biology of IBD and on the potential for the research to lead to future medicines for IBD.

Vertex established a research site in Laval, Quebec in 2009, and since that time, more than 45 scientists have been focused on IBD research, among other discovery and development activities for Vertex. This team will lead the Vertex efforts in this collaboration.

"Vertex scientists are focused on understanding the root cause of IBD, and the research undertaken through this collaboration will complement our own ongoing research efforts in this disease being conducted at our Laval site," said Louise Proulx, Ph.D., Vice President and Site Head of Vertex Canada. "We recognize CCFC's leadership to advance research in IBD, a disease that hits Canadians particularly hard. This collaboration will provide both organizations with the opportunity to gain further insights into IBD by supporting innovative research at some of the country's leading academic institutions."

"With more than 200,000 Canadians living with Crohn's disease or ulcerative colitis, the Canadian IBD community welcomes Vertex's commitment to exploring new potential causes," said Dr. Kevin Glasgow, Chief Executive Officer of CCFC. "Medical research is the best chance for finding a cure for IBD, and this new model of collaboration offers great hope for future treatments."

"Being able to work closely with other world-class scientists at Vertex and CCFC represents a promising new model for medical research," said Scott Gray-Owen, Ph.D., Professor, Molecular Genetics at the University of Toronto. "We're excited to have been chosen for this grant because it provides an opportunity to advance our understanding of a disease that affects so many Canadians."

Recipients of grants from Vertex and CCFC were selected after a rigorous peer-review process. Top investigators at leading academic institutes across Canada applied for funding. Following an in-depth assessment of the scientific merit and translational research potential by an expert and independent advisory board, Vertex and CCFC awarded grants to three academic institutions. The selected laboratories are led by Dr. François Boudreau, Université de Sherbrooke, Dr. Brian Coombes, McMaster University, and Dr. Scott Gray-Owen, University of Toronto. Their projects will investigate the role of bacteria in IBD and the body's response to an imbalance of these bacteria in order to identify potential targets for future IBD therapies.

About Inflammatory Bowel Disease (IBD)

IBD causes the intestines to become inflamed and ulcerated because of an abnormal response to the body's immune system. IBD describes a condition that can be either Crohn's disease (CD) or ulcerative colitis (UC). CD can affect any part of the gastrointestinal tract, and patches of inflammation occur, leaving healthy tissue between the diseased areas. UC affects only the inner layer of the colon, or large bowel. It always starts in the rectum and may extend as continuous inflammation from there into the rest of the colon.1

Currently, there is no cure for IBD, and therapy is directed at achieving and maintaining freedom from symptoms. Most people require ongoing medication; when this fails, surgery is often required.2,3 IBD is a lifelong disease, usually starting in early adulthood in otherwise healthy, active individuals, and it imposes a significant impact on quality of life.4

About the Crohn's and Colitis Foundation of Canada (CCFC)

CCFC is a volunteer-based registered charity dedicated to finding the cure for IBD. To achieve that mission, the Foundation is committed to raising funds for medical research and educating patients and their families, medical professionals and the general public about these conditions.

CCFC invests over $5 million in new and ongoing research each year and is one of the world's leading sources of non-governmental funding of IBD research.

Canada has among the highest incidence and prevalence rates of IBD in the world, affecting over 200,000 Canadians.5

For more information about World IBD Day, please visit www.worldibdday.org

About Vertex

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.

Vertex's operations in Canada share a similar commitment to science and the same vision of transformational medicine. In 2009, Vertex established one of its five global scientific research sites in Laval, Quebec, where Vertex's Canadian team is focused on research activities related to inflammatory bowel diseases (IBD). The IBD research team is working to gain a deeper understanding of human IBD genetics and the human microbiome project as it applies to IBD.

Vertex currently employs approximately 60 people at the Laval site, including more than 45 scientists focused on drug discovery and development activities. In addition to its focus on IBD, Vertex's Laval site is also a center for exploratory drug discovery efforts and early development activities for Vertex. The company is also supporting the use of its first approved medicine in Canada through recently formed commercial and medical affairs teams.

Vertex's press releases are available at www.vrtx.com.

(VRTX-GEN)

References

1 Crohn's and Colitis Foundation of Canada. (2011) Surviving and Thriving with Crohn's Disease and Ulcerative Colitis : A Guide to Inflammatory Bowel Disease [Brochure].

2 Crohn's and Colitis Foundation of Canada. (2011). The Cutting Edge : Surgery and Inflammatory Bowel Disease [Brochure].

3 Crohn's and Colitis Foundation of Canada. (2011). Prescriptions for Health : Medication and Inflammatory Bowel Disease [Brochure].

4 Crohn's and Colitis Foundation of Canada. (2011) Surviving and Thriving with Crohn's Disease and Ulcerative Colitis : A Guide to Inflammatory Bowel Disease [Brochure].

5 Crohn's and Colitis Foundation of Canada. (2008). The Burden of Inflammatory Bowel Disease (IBD) in Canada. Toronto, ON.

Vertex Contacts:

Media
Kristina Coppola, 617-444-6776
[e-mail]

GCI Communications
Carolyn Schulz, 416-486-7272

or

For French-speaking press, please contact:
Morin Relations Publiques
Steven Ross, 514-289-8688, poste 236
[e-mail]

CCFC Contacts:

Jacqueline Waldorf
416-920-5035/800-387-1479 ext 241
647-882-4758
[e-mail]

http://investors.vrtx.com/releasedetail.cfm?ReleaseID=674536

[Birkey]

Liebe Wallstreet-Gemeinde,
leider bin ich auf Eure Hinweise viel zu spät aufmerksam geworden, so dass ich mich trotz anfänglicher Bedenken auf das durch die "Siss Asset Management AG" vertriebene Private Placement der Vertex Pharmaceuticals Inc. eingelassen habe.

Das Resultat, wie sollte es auch anders sein: 20.000 Euro futsch. Die Swiss Asset Management AG ist über alle Berge. Der Fall liegt aktuell der Kriminalpolizei München vor.

Wer nähere Informationen wünscht kann bei Gelegenheit folgenden Beitrag aufrufen: http://www.investmentgesellschaft.info/betrug-www-sam-ch-ch-swiss-asset-management-ag-vertex-pharmaceuticals-inc

Darin ist die Betrugsmasche ausführlich geschildert worden.

Leider, und so wird es auch sein, gibt es neben mir sicherlich noch viele weitere Opfer, die den Betrug allerdings erst nach Ablauf der 12-monatigen Haltefrist aufdecken werden.

Über jeden weiterführenden Hinweis oder Tipp bin ich dankbar!!

[Birkey]

Liebe Wallstreet-Gemeinde,
leider bin ich auf Eure Hinweise viel zu spät aufmerksam geworden, so dass ich mich trotz anfänglicher Bedenken auf das durch die "Siss Asset Management AG" vertriebene Private Placement der Vertex Pharmaceuticals Inc. eingelassen habe.

Das Resultat, wie sollte es auch anders sein: 20.000 Euro futsch. Die Swiss Asset Management AG ist über alle Berge. Der Fall liegt aktuell der Kriminalpolizei München vor.

Wer nähere Informationen wünscht kann bei Gelegenheit folgenden Beitrag aufrufen:

investmentgesellschaft.info/betrug-www-sam-ch-ch-swiss-asset-management-ag-vertex-pharmaceuticals-inc

Darin ist die Betrugsmasche ausführlich geschildert worden.

Leider, und so wird es auch sein, gibt es neben mir sicherlich noch viele weitere Opfer, die den Betrug allerdings erst nach Ablauf der 12-monatigen Haltefrist aufdecken werden.

Über jeden weiterführenden Hinweis oder Tipp bin ich dankbar!!

[bre128]

Hier haben wir den Grund für den Kursrutsch:

May 29, 2012
Vertex Corrects and Provides Additional Data from Recent Interim Analysis of Phase 2 Combination Study of VX-809 and KALYDECO™ (ivacaftor) in People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation

- Corrected Data: Responder analysis showed 35% of patients experienced an absolute improvement in lung function (FEV1) of at least 5 percentage points and 19% had at least a 10 percentage-point improvement when treated with VX-809 and KALYDECO -

- Additional Data: Patients treated with VX-809 and KALYDECO experienced an 8.5 percentage point mean absolute improvement in lung function compared to patients treated with placebo (p=0.002) -

- Vertex plans to start a pivotal study of this combination to treat the underlying cause of CF in adults with two copies of the F508del mutation, pending final data and discussions with regulatory agencies -

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today a correction to the previously reported responder analysis, as well as additional data from, the recent interim analysis of an ongoing Phase 2 study of VX-809 and KALYDECO™ (ivacaftor) that showed significant improvements in lung function (forced expiratory volume in one second, FEV1) among adults with cystic fibrosis (CF) who have two copies (homozygous) of the most common mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, F508del. As previously announced, there was a statistically significant improvement in lung function (absolute change in percent predicted FEV1) across the combined treatment groups relative to baseline compared to placebo (p=0.002). Today's announcement provides a correction to the responder analysis (n=37) for the absolute improvement in lung function compared to baseline and, for the first time, provides the mean absolute improvement in lung function compared to placebo observed among patients who received VX-809 (200mg, 400mg, 600mg; QD) and KALYDECO (250mg; q12h). The data reported today and earlier this month are based on 37 patients who completed 56 days of treatment with VX-809 and KALYDECO and 11 patients with one or two copies of the F508del mutation who received placebo. Vertex will host a conference call for investors and media today, May 29, 2012 at 8:00 a.m. ET, to discuss the correction and additional data.

On May 7, 2012, the company announced that approximately 46 percent (17/37) of patients with two copies of the F508del mutation experienced an improvement in lung function (FEV1) of 5 percentage points or more and approximately 30 percent (11/37) experienced an improvement of 10 percentage points or more from baseline to Day 56 when treated with the combination of VX-809 and KALYDECO. These results were relative improvements, not absolute improvements as originally reported.

The actual absolute improvements in lung function for these patients are: approximately 35 percent (13/37) experienced an absolute improvement of 5 percentage points or more and approximately 19 percent (7/37) experienced an absolute improvement of 10 percentage points or more from baseline to Day 56. As previously announced, none of the patients treated with placebo (0/11) achieved a 5 percentage-point or more mean absolute improvement in lung function from baseline to Day 56.

Additional data from the interim analysis are provided today for people with two copies of the F508del mutation. A mean absolute improvement in lung function of 8.5 percentage points was observed among those who were treated with VX-809 and KALYDECO compared to placebo (p=0.002). In addition, the within-group mean absolute improvement from baseline to Day 56 was 4.0 percentage points (p=0.002) for patients treated with the combination. From baseline to Day 56, those treated with placebo experienced a mean absolute decrease in lung function of 4.6 percentage points (p=0.04).

These data are from a planned interim analysis that was conducted after approximately half of the patients completed 56 days of treatment. Evaluation of patients with one copy (heterozygous, n=21) of the F508del mutation is ongoing. All patients have now completed dosing. Analyses are ongoing and complete data, including statistical analyses for all patient groups, will be available mid-year. Vertex plans to start a pivotal study of VX-809 and KALYDECO in people with two copies of the F508del mutation, pending final study results and discussions with regulatory agencies.

Interim Lung Function Data
VX-809 alone (200mg, 400mg or 600mg; QD) for 28 days followed by the addition of KALYDECO (250mg, q12h) for 28 days (n=37) Placebo

(n=11)
Mean absolute change in FEV1 from baseline to Day 56 compared to placebo 8.5 (p=0.002) N/A
Mean absolute change in FEV1 from baseline to Day 56 for pooled treatment and placebo groups 4.0 (p=0.002) -4.6 (p=0.04)
≥ 5 percentage point absolute improvement from baseline to Day 56 35% (13/37) * 0%
≥ 10 percentage point absolute improvement from baseline to Day 56 19% (7/37) * 0%
* On May 7, 2012, Vertex announced that approximately 46 percent (17/37) experienced an improvement from baseline to Day 56 in lung function of 5 percentage points or more, and approximately 30 percent (11/37) experienced an improvement from baseline to Day 56 of 10 percentage points or more. These results were relative improvements, not absolute improvements as originally reported.


"The improvements in lung function seen to date in this study exceeded our expectations. We're continuing to move forward as quickly as possible toward a pivotal study of VX-809 and KALYDECO in people with two copies of the F508del mutation," said Chris Wright, M.D., Ph.D., Vertex's Senior Vice President, Global Medicines Development and Medical Affairs.

Safety results are the same as those announced on May 7, 2012 and include data from all patients who had started treatment prior to this interim analysis. VX-809 was generally well tolerated alone and in combination with KALYDECO. The most common adverse events were pulmonary in nature. Most adverse events were mild or moderate in severity and comparable between treatment and placebo groups. The rate of serious adverse events was similar between treatment and placebo groups.

About this Phase 2 Study

Data from the first part of this study were announced in 2011. The interim data announced this month are from the second part of the ongoing Phase 2 randomized, double-blind, placebo-controlled study. This part of the study enrolled 108 people with CF ages 18 and older with one or two copies of the F508del mutation who were divided into five treatment groups of approximately 20 patients each. Three groups of homozygous patients were randomized to receive VX-809 alone (200mg, 400mg or 600mg) for 28 days and then in combination with KALYDECO (250mg) for an additional 28 days. One group of heterozygous patients received VX-809 alone (600mg) for 28 days and then in combination with KALYDECO (250mg) for an additional 28 days. The improvements in lung function were primarily observed following the addition of KALYDECO from Day 28 and maintained through Day 56. The placebo group includes both homozygous and heterozygous patients.

Cystic fibrosis is caused by defective or missing CFTR proteins resulting from mutations in the CFTR gene. Located at the surface of cells, CFTR proteins act as channels to regulate the flow of salt and water into and out of the cells. In people with the F508del mutation in the CFTR gene, little to no CFTR protein reaches the cell surface. As a result, thick, sticky mucus builds up and blocks the passages in many organs, leading to a variety of symptoms. In particular, mucus builds up and clogs the airways in the lungs, causing chronic lung infections and progressive lung damage. VX-809, known as a CFTR corrector, is believed to help CFTR proteins reach the cell surface. KALYDECO, known as a CFTR potentiator, keeps the CFTR protein channels open longer to increase the flow of salt and water into and out of the cell.

VX-809 and KALYDECO were discovered as part of a collaboration with Cystic Fibrosis Foundation Therapeutics, Inc., the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation.

Conference Call for Media and Investors

Vertex will host a conference call and webcast today, May 29, 2012 at 8:00 a.m. ET to discuss this interim data analysis. The conference call will be webcast live and a link to the webcast may be accessed from the ‘Events & Presentations' page of the Vertex website at www.vrtx.com.

To listen to the live call on the telephone, dial 1-866-516-1003 (United States and Canada) or 1-973-200-3090 (International). To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.

The conference ID number for the live call and replay is 86428080.

The call will be available for replay via telephone commencing May 29, 2012 at 12:00 p.m. ET running through 5:00 p.m. ET on June 5, 2012. The replay phone number for the United States and Canada is 1-855-859-2056. The international replay number is 1-404-537-3406.

Following the live webcast, an archived version will be available on Vertex's website until 5:00 p.m. ET on June 12, 2012. Vertex is also providing a podcast MP3 file available for download on the Vertex website at www.vrtx.com.

About Cystic Fibrosis

Cystic fibrosis is a rare, life-threatening genetic disease affecting approximately 30,000 people in the United States and 70,000 people worldwide. Today, the median predicted age of survival for a person with CF is approximately 38 years but the median age of death remains in the mid-20s. There are more than 1,800 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic, or genotyping test, lead to CF by creating non-working or too few CFTR proteins at the cell surface. The absence of working CFTR proteins results in poor flow of salt and water into and out of the cell in a number of organs, including the lungs.

In people with the most common mutation in the CFTR gene, F508del, little to no CFTR protein reaches the cell surface. Globally, nearly half (46 percent) of people with CF have two copies of the F508del mutation and one-third (33 percent) have one copy of the F508del mutation.

About KALYDECO

KALYDECO™ (ivacaftor) is the first treatment to target the underlying cause of CF. KALYDECO (150mg, q12h) was approved by the U.S. Food and Drug Administration (FDA) in January 2012 for use in people with CF ages 6 and older who have at least one copy of the G551D mutation in the CFTR gene. On May 25, 2012, Vertex received a positive European CHMP opinion for KALYDECO.

Vertex retains worldwide rights to develop and commercialize KALYDECO.

Indication and Important Safety Information

KALYDECO (150mg, q12h) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a certain mutation in their CFTR gene called the G551D mutation.

KALYDECO is not for use in people with CF due to other mutations in the CFTR gene. It is not effective in CF patients with two copies of the F508del mutation (F508del/F508del) in the CFTR gene.

It is not known if KALYDECO is safe and effective in children under 6 years of age.

KALYDECO should not be used with certain medicines, including the antibiotics rifampin and rifabutin; seizure medications (phenobarbital, carbamazepine, or phenytoin); and the herbal supplement St. John's Wort.

KALYDECO can cause serious side effects. High liver enzymes in the blood have occurred in patients taking KALYDECO as well as those receiving placebo. Regular assessment is recommended.

The most common side effects associated with KALYDECO include headache; upper respiratory tract infection (common cold) including sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness.

These are not all the possible side effects of KALYDECO. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.

Please see full Prescribing Information for KALYDECO at www.KALYDECO.com.

Collaborative History with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT)

Vertex initiated its CF research program in 1998 as part of a collaboration with CFFT, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation. This collaboration was expanded to support the accelerated discovery and development of Vertex's CFTR modulators.

About the Cystic Fibrosis Foundation

The Cystic Fibrosis Foundation is the world's leader in the search for a cure for cystic fibrosis. The Foundation funds more CF research than any other organization and nearly every CF drug available today was made possible because of Foundation support. Based in Bethesda, Md., the Foundation also supports and accredits a national care center network that has been recognized by the National Institutes of Health as a model of care for a chronic disease. The CF Foundation is a donor-supported nonprofit organization. For more information, visit www.cff.org.

About Vertex

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.

Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada. Today, Vertex has more than 2,000 employees around the world, and Science magazine named Vertex number one on its 2011 list of Top Employers in the life sciences.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including Dr. Wright's statements in the sixth paragraph of this press release, and statements regarding (i) Vertex's plan to start a pivotal study of VX-809 and KALYDECO in people with two copies of the F508del mutation, pending final data and discussions with regulatory agencies, (ii) the expected availability of complete data from the study in mid-2012 and (iii) the evaluation of patients with one copy of the F508del mutation being ongoing. While Vertex believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the final outcomes of this clinical trial or future clinical trials of VX-809 and KALYDECO may be less favorable than the interim analysis reported today, or may not be favorable at all, that final data from heterozygous patients may not be favorable or may be less favorable than the data from homozygous patients, that final data and/or discussions with regulatory agencies regarding the scope and design of future clinical trials may result in additional clinical trials needing to be conducted before Vertex can initiate the first pivotal clinical trials evaluating VX-809 in combination with KALYDECO and other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through the company's website at www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

Vertex Pharmaceuticals Incorporated
Media:
Zach Barber
Dawn Kalmar
617-444-6992
[e-mail]
or
Investors:
Michael Partridge, 617-444-6108

Source: Vertex Pharmaceuticals Incorporated

http://investors.vrtx.com/releasedetail.cfm?ReleaseID=677520

[kleinerna2]

Antwort auf Beitrag Nr.: 43.217.961 von Birkey am 28.05.12 16:04:03

Hallo Birkey,

hab vor einiger Zeit zu dem Thema geschrieben, ich hatte das Angebot für 10€ zu kaufen. Anbieter waren auch aus Zürich die Konto-Nr. für die Geldüberweisung war die gleiche.

Eine andere Frage falls du Ahnung hast,
ich habe in Frankfurt Aktien um 9.00 Uhr gekauft am Mittag wurde der Handel eingestellt. Es ist genau 4 Wochen her was kann man machen ? Anruf bei Börse leider ohne konkrete Hilfe.

[tesaa4]

Gibt's Gründe warum hier schon so lange keiner mehr geschrieben hat ?

[Is_doch_so]

Eigentlich nicht.Ich bin schon sehr sehr lange dabei und habe
richtig Kohle mit dem Wert gemacht.Habe den grandiosen Aufstieg ..Split
usw mit gemacht.Hatte dass "Glück" im fast richtigen Augenblick zu verkaufen
und die Nase im richtigen wieder zu kaufen.Ich habe aber auch gelernt einfach nur zu genießen.Die Aktie läuft von alleine.