Vertex Pharmaceuticals Inc (VRTX)

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Vertex shares rise on hepatitis C drug detail
Wednesday September 24, 5:44 pm ET
Vertex Pharmaceutical shares rise on midstage study detail for hepatitis C drug candidate

NEW YORK (AP) -- Shares of Vertex Pharmaceuticals Inc. rose Wednesday after the biotechnology company provided details that reaffirmed prior positive study results for its hepatitis C drug candidate telaprevir.

The stock gained $4.36, or 16 percent, to $31.66. Shares have traded between $13.84 and $39.48 over the past 52 weeks.

On Wednesday, the company said 85 percent of patients taking telaprevir twice a day with the drugs Pegasys and Ribavirin had undetectable levels of hepatitis C after four weeks, while 68 percent of those taking the drug with Peg-Intron and Ribavirin had undetectable levels. Taking the drug three times daily, the percentages were 82 percent for the Pegasys combination and 71 percent for the Peg-Intron combination, respectively. The midstage study involves 161 people.

The data were released to correct a mistake being published in the October supplement of the journal Hepatology. It will also be presented at the American Association for the Study of Liver Diseases' meeting in November.

Hepatitis C is a liver disease estimated to affect about 170 million people globally.

In August, the company said interim data showed that greater than 80 percent of patients in both portions of the study with Pegasys had undetectable levels of hepatitis C.

Citi analyst Dr. Yaron Werber reaffirmed a "Hold" rating and $41 price target on Vertex's stock, saying the positive data was expected.

"This data is overall in line with our expectations and signal that this market will be highly competitive over the long-term, albeit telaprevir has a two to three year lead," he said in a note to investors.

Schering-Plough Corp. makes Peg-Intron, and Roche makes Pegasys. Ribavirin is a generic drug made by several companies.

Meanwhile, Johnson & Johnson and Medivir are developing a hepatitis C drug, along with Boehringer Ingelheim, posing possible competitive threats.

[mlkrborn]

0ffering @ $25 per share!

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Vertex Pharmaceuticals Announces Pricing of its Public Offering of Common Stock
Thursday September 18, 8:46 am ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that it has entered into an agreement to sell 7,500,000 shares of its common stock in an underwritten offering at a price to the public of $25.50 per share, which would result in aggregate gross proceeds of approximately $191.3 million. Vertex has granted the underwriter an option to purchase up to an additional 1,125,000 shares of Vertex common stock on the same terms and conditions.

Goldman, Sachs & Co. is acting as the sole book-runner for the offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. An automatically effective shelf registration statement relating to the shares of common stock Vertex intends to sell has been filed with the Securities and Exchange Commission. Any offer of shares of common stock will be made only by means of a prospectus, including a prospectus supplement, forming a part of the automatically effective shelf registration statement. A copy of the prospectus for the offering can be obtained from Goldman, Sachs & Co.’s prospectus department, at 85 Broad Street, New York, New York 10004, Fax: [phone] or Email at [e-mail].

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Vertex Pharma's Ebb & Flow
Wednesday September 17, 1:14 pm ET
By Jason Napodano, CFA

Vertex Pharmaceuticals, Inc. (NasdaqGS: VRTX - News) represents an attractive long-term opportunity based on the potential blockbuster sales of telaprevir. Other pipeline candidates such as VX-702, VX-770, and VX-509 also look very interesting.

The financial situation is solid, considering the HIV royalty sales and the secondary debt and equity offering early in the year. That said, dilution still remains a concern given the high burn rate and the likely need for cash ahead of the telaprevir launch. Also, Vertex stock seems to react very negatively every time Schering-Plough (NYSE: SGP - News) releases data on its phase III candidate, boceprevir. As these issues ebb and flow we think Vertex's stock can be an effective trading vehicle. We would be buyers below $20 based on the strength of the pipeline.

We would look to lighten up on the position or take profits after a big run in the name, or when expectations seem unrealistically high. At less than $20 Vertex becomes a buy based on the attractiveness of telaprevir, or the notion that J&J may decide to acquire the entire company in order to obtain the U.S. rights to the drug. Biotech M&A has been hot so far this summer, and existing relationship deals seem to be en vogue given the Roche bid for Genentech (NYSE: DNA - News) and the Bristol (NYSE: BMY - News) bid for ImClone (NasdaqGS: IMCL - News).

This is a distinctive possibility in our view, although we believe Vertex management would be hesitant to sell without a big premium. We are hesitant to recommend the name despite what we see as a significantly opportunity for telaprevir. Timeline slippage and news out of Schering-Ploughs on boceprevir can cause a big move down in the stock. Plus, the stock is up 70% since March 2008 so it may be time for a breather. Our price target is $30 per share.

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Vertex Pharmaceuticals to Start Phase 3 'REALIZE' Trial with Telaprevir in Treatment-Failure HCV Patients
Tuesday August 19, 7:30 am ET
First HCV protease inhibitor in pivotal trial for this difficult to treat patient population
Trial to enroll all major treatment-failure patient groups, including null responders, partial responders and relapsers
Two telaprevir registration programs to address significant unmet need in treatment-naive and treatment-failure patients

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that the Company has reached agreement with U.S. and E.U. regulatory authorities to proceed with the REALIZE trial, a pivotal Phase 3 clinical trial with the hepatitis C virus (HCV) protease inhibitor telaprevir in combination therapy for patients with chronic HCV infection who failed to achieve a sustained viral response (SVR) with prior therapy. The trial will be conducted in the U.S. and E.U. and will enroll approximately 650 genotype 1 HCV patients who failed prior treatment with pegylated-interferon (peg-IFN) and ribavirin (RBV). The trial is designed to evaluate two 48-week telaprevir-based regimens in comparison with a 48-week control arm. Telaprevir will be dosed for 12 weeks. The primary endpoint of the trial is SVR, defined as undetectable HCV RNA (<10 IU/mL) 24 weeks after the completion of treatment.

"In Phase 2 clinical trials, telaprevir-based regimens have demonstrated the potential to increase sustained viral response rates across a broad spectrum of patients infected with the hepatitis C virus, including patients who failed to achieve SVR with previous pegylated interferon and ribavirin therapy, many of whom are at high risk for life-threatening HCV-related complications," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Medical College of Cornell University. "The REALIZE trial of telaprevir is a landmark Phase 3 trial of an investigational HCV protease inhibitor in null responder and other patients who failed prior treatment and will seek to generate additional data to demonstrate the benefit of telaprevir in this difficult to treat patient population."

"Approximately 6 million patients are chronically infected with hepatitis C in the U.S. and E.U. today, and approximately 650,000 of these patients have failed previous treatments of pegylated interferon and ribavirin therapy and are in need of a new therapeutic option to treat their disease," said Kurt C. Graves, Vertex’s Executive Vice President, Chief Commercial Officer and Head, Strategic Development. "Data generated from this Phase 3 trial in treatment-failure patients, as well as data from the ongoing Phase 3 ADVANCE trial in treatment-naïve patients, may further contribute to the emerging profile of telaprevir to address the significant medical need in both treatment-naïve and treatment-failure patients."

Global Phase 3 Trial in Patients who Failed to Achieve SVR with Prior Therapy

The REALIZE Trial (Re-treatment of Patients with Telaprevir-based Regimen to Optimize Outcomes) will enroll approximately 650 genotype 1 HCV patients and will be conducted by Tibotec at more than 100 centers in the U.S. and E.U. Tibotec expects to complete enrollment of the REALIZE trial in the first quarter of 2009. The trial will include the following patient groups:

- Null responders (defined as patients who achieved less than 2 log reduction in HCV RNA at Week 12 of prior therapy);

- Partial responders (defined as patients who achieved at least a 2 log reduction at Week 12, but failed to achieve undetectable HCV RNA by Week 24 of prior therapy); and

- Relapsers (defined as patients who had undetectable HCV RNA at the completion of at least 42 weeks of prior treatment, but relapsed during follow-up).

The REALIZE trial will dose telaprevir in combination with pegylated interferon alfa-2a (PEGASYS) and ribavirin. The REALIZE trial will enroll three 48-week trial arms:
1. Telaprevir dosed at 750 mg every eight hours (q8h) for 12 weeks in combination with standard doses of peg-IFN and RBV, followed by 36 weeks of treatment with peg-IFN and RBV alone;
2. Delayed start arm, comprised of 4 weeks of treatment with peg-IFN and RBV, followed by telaprevir dosed at 750 mg q8h for 12 weeks in combination with standard doses of peg-IFN and RBV, followed by another 32 weeks of peg-IFN and RBV alone; and
3. A control arm with standard doses of peg-IFN and RBV dosed for 48 weeks

Patients in all treatment arms will be followed for 24 weeks after completion of treatment to assess SVR.

Updates on the status of Vertex and Tibotec’s clinical trials of telaprevir are available at www.clinicaltrials.gov.

Pivotal Trial in Treatment-Naïve Patients

Vertex and Tibotec are also conducting the global 3-arm pivotal Phase 3 ADVANCE trial in treatment-naïve genotype 1 HCV patients that is focused on 24-week telaprevir-based regimens for patients achieving rapid viral response (HCV RNA <10 IU/mL at 4 weeks). Vertex is on track to complete enrollment of the ADVANCE trial during the fourth quarter of 2008 and expects to have sustained viral response (SVR) data from the trial in the first half of 2010.

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Vertex Pharmaceuticals cut to neutral at Susquehanna
By Simon Kennedy
Last update: 8:20 a.m. EDT Aug. 6, 2008
LONDON (MarketWatch) -- Susquehanna Financial downgraded Vertex Pharmaceuticals Inc. (VRTX:
Vertex Pharmaceuticals Inc

VRTX 31.16, -0.05, -0.2%) to neutral from positive, citing the Phase II trial results for Schering-Plough's boceprevir hepatitis C drug, which is a likely competitor to Vertex Pharma's telaprevir. The results could indicate that the efficacy advantage previously believed to be held by telaprevir will be diminished, Susquehanna said.

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Vertex narrows 2Q loss, but misses forecast
Friday August 1, 8:36 am ET
Vertex Pharmaceuticals' 2nd-quarter loss narrows, but falls short of Wall Street forecasts

CAMBRIDGE, Mass. (AP) -- Vertex Pharmaceuticals Inc. said late Thursday its second-quarter loss narrowed on a large milestone payment for development of its hepatitis C drug candidate telaprevir.
The company lost $91.3 million, or 66 cents per share, compared with a loss of $117.8 million, or 91 cents per share, during the same period a year earlier. Revenue rose 82 percent to $69.4 million from $38.2 million.

Analysts polled by Thomson Financial expected a loss of 60 cents per share on revenue of $68.7 million.

The company said it received a $45 million milestone payment from partner Johnson & Johnson for starting a late-stage study on telaprevir.

"Chronic hepatitis C is a major global unmet medical need with many patients at an increased risk for cirrhosis, liver failure, liver cancer and early death," Vertex President and Chief Executive Joshua Boger said in a statement.

He said the company continues to work on developing a multipronged program for telaprevir, which includes two late-stage studies including patients with various treatment backgrounds.

"With our commitment to addressing this broad need, we are working to establish a profile for telaprevir that has the potential to shorten treatment duration and increase sustained viral response rates for treatment-naive patients, and also the potential to provide a new treatment option for patients who failed to achieve sustained viral response with a prior course of pegylated interferon and ribavirin therapy."

The company also said increasing costs for its development program will mean a wider-than-expected full-year loss. It now expects a loss between $450 million and $470 million, excluding charges, which is wider than prior guidance of $380 million to $410 million.

Vertex shares closed at $34.50 Thursday.

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Biotech Notebook: Vertex, Medicines Co.

Will Vertex Pharmaceuticals (VRTX - Cramer's Take - Stockpickr) seek regulatory approval for its hepatitis C drug candidate telaprevir in 2009 -- one year earlier than Wall Street expects -- based on the positive results from the PROVE 3 clinical trial announced Monday?
That's the question most on the minds of Vertex investors, and one that I debated back and forth Monday with my colleague Justin Ferayorni in the Columnist Conversation section of RealMoney.com, a sister site to TheStreet.com.

For starters, we agreed that the telaprevir data in treatment-resistant hepatitis C patients were really impressive. Justin went further, predicting that Vertex could get telaprevir approved early based on these data because "these tough [patient] populations with objective endpoints (viral load reduction can be quantified) tend to have a low bar at the FDA."

Justin went on to make the point that the Food and Drug Administration moved quickly to approve new antiviral drugs for desperately ill HIV patients back in the mid-1990s. The situation with telaprevir in treatment-resistant hepatitis C patients is similar, which could prompt the FDA to be extra accommodating.

In response to Justin's comments, I said I wasn't as optimistic about an early FDA filing for telaprevir, despite my belief that the PROVE 3 data are great -- and strong enough for approval. (Assuming final data are as good as the interim look we got Monday.)

Unfortunately, the FDA doesn't ask my opinion, and these days, the agency seems so risk averse and unwilling to move with alacrity on anything that I fear regulators are likely to ask Vertex to run a phase III study before filing for approval. The PROVE 3 study is well-designed for a phase II trial, but for a phase III study, it's probably smaller than what regulators are comfortable with. It's also not entirely blinded between the treatment and control arms, which will make the FDA nervous.
more
http://www.thestreet.com/_yahoo/newsanalysis/biotech/10420648.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA




surf's up......crikey

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Vertex Reports 52% SVR 12 Rate for a 24-week Telaprevir-based Regimen in Genotype 1 Hepatitis C Patients Who Failed Prior Treatment
Monday June 9, 7:30 am ET
-- 73% of prior relapsers achieved SVR12 with 24-week telaprevir-based treatment
-- 41% of prior non-responders achieved SVR12 with 24-week telaprevir-based regimen

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced positive results from a planned interim analysis of PROVE 3, an ongoing Phase 2b study evaluating telaprevir-based treatment in patients with genotype 1 chronic hepatitis C virus (HCV) infection who did not achieve sustained virologic response (SVR) with at least one prior pegylated interferon (peg-IFN) and ribavirin (RBV) regimen. Vertex is developing telaprevir in collaboration with Tibotec.

In the interim analysis, 52% (60 of 115; intent-to-treat analysis) of patients randomized to receive treatment with a 24-week telaprevir-based regimen (12 weeks of telaprevir in combination with peg-IFN and RBV, followed by 12 weeks of peg-IFN and RBV alone) maintained undetectable HCV RNA 12 weeks post-treatment (SVR 12). In the interim analysis, adverse events were similar to those commonly observed with peg-IFN and RBV including fatigue, nausea, rash, headache, gastrointestinal disorders and anemia, and were consistent with those previously reported in patients being treated with telaprevir-based therapy in the PROVE 1 and 2 studies in treatment-naïve subjects.

Based on these data, Vertex and Tibotec plan to initiate a Phase 3 clinical trial in patients who have failed prior treatment with peg-IFN and RBV. Telaprevir (TVR) is the most advanced HCV protease inhibitor in clinical development targeting treatment of chronic hepatitis C, and is in Phase 3 clinical development in treatment-naïve patients. Hepatitis C is a disease that afflicts more than 3 million people in the United States alone, and 170 million worldwide.

Interim Analysis Results

PROVE 3 is a randomized, double-blind, placebo-controlled Phase 2b study that enrolled patients who failed prior treatment with peg-IFN and RBV. Patients enrolled in PROVE 3 included prior non-responders (including null responders), prior relapsers and prior breakthroughs to peg-IFN and RBV treatment. The interim analysis included 453 patients that were enrolled and received at least one dose of study drug. In the interim analysis, 52% (60 of 115) of patients randomized to receive a 24-week telaprevir-based regimen (12 weeks of telaprevir in combination with peg-IFN and RBV, followed by 12 weeks of peg-IFN and RBV alone) achieved undetectable HCV RNA (<10 IU/mL; Roche TaqMan) 12 weeks post-treatment (SVR12). Of the 115 patients, 66 were categorized as non-responders to prior treatment (defined as patients who never achieved undetectable HCV RNA during prior treatment, including null responders), 40 were prior relapsers (defined as patients who had undetectable HCV RNA at the completion of prior treatment, but relapsed during follow-up), and 9 were prior breakthroughs (defined as patients who had viral rebound during prior treatment). Among patients receiving the 24-week telaprevir-based regimen, 41% (27 of 66) of the prior non-responders, 73% (29 of 40) of prior relapsers, and 44% (4 of 9) of prior breakthroughs achieved SVR 12.

“Patients who have not achieved a sustained virologic response with one or more courses of prior interferon-based therapy represent a significant unmet medical need. These patients have few or no available treatment options and they are at increased risk for progressive liver disease,” said John McHutchison, M.D., Principal Investigator for the PROVE 3 Study and Associate Director of Duke Clinical Research Institute.

A summary of available on-treatment and post-treatment antiviral data from the 24-week telaprevir-based regimen is presented below:

Undetectable HCV-RNA by Response to Prior Peg-IFN/RBV Treatment (PROVE 3 24-week regimen; 12 weeks telaprevir+peg-IFN+RBV, followed by 12 weeks peg-IFN+RBV); intent-to-treat analysis
Week 12 Week 24 (end of treatment) SVR 12 (week 36; 12 weeks post-treatment)
Non-responders (n=66) 71% 65% 41%
Relapsers (n=40) 88% 83% 73%
Breakthroughs (n=9) 44% 44% 44%
Total (n=115) 75% 70% 52%

In the control arm (n=114), which is evaluating 48 weeks of peg-IFN and RBV only, available data indicate that 8% of patients had undetectable HCV RNA at week 12, and 30% had undetectable HCV RNA at week 36 on-treatment (intent-to-treat analysis). In prior studies of peg-IFN and RBV in treatment-failure patients, the proportion of patients who had undetectable HCV RNA at week 36 of treatment has been significantly higher than the proportion who ultimately achieved SVR. End-of-treatment and post-treatment data (including SVR rates) are not yet available for this study arm in PROVE 3.

In addition to the 24-week telaprevir-based regimen that includes ribavirin and the 48 week control arm described above, two other treatment regimens are being evaluated in PROVE 3: a 24-week telaprevir treatment arm without ribavirin, and a 48-week treatment arm that includes 24 weeks of telaprevir dosing in combination with peg-IFN and RBV. The interim analysis supports the inclusion of ribavirin in future studies of telaprevir-based regimens in treatment-failure patients, similar to what has been observed in treatment-naïve subjects. In addition, available on-treatment results suggest that additional dosing of telaprevir beyond 12 weeks does not confer additional benefit to patients. Patient dosing has now been completed in PROVE 3 and all patients are now being followed post-treatment. Vertex anticipates that PROVE 3 data will be the subject of a presentation at a medical conference later in 2008.

“These are the first data to show the potential of a STAT-C agent to have this degree of antiviral response in patients—including both non-responders and relapsers—who did not achieve SVR with prior treatment. The interim data suggest that a telaprevir-based regimen could be an important future treatment option for genotype 1 hepatitis C patients who have failed a prior course of treatment,” said John Alam, M.D., Executive Vice President, Medicines Development, and Chief Medical Officer of Vertex. “We are now planning to begin a Phase 3 clinical trial with telaprevir in patients who failed prior peg-IFN and ribavirin treatment.”

In the interim analysis, adverse events were similar to those commonly observed with peg-IFN and RBV including fatigue, nausea, rash, headache, gastrointestinal disorders and anemia, and were also consistent with those previously reported in patients being treated with telaprevir-based therapy in the PROVE 1 and 2 studies in treatment-naïve subjects. Thirteen patients (11%) receiving the 24-week telaprevir based treatment regimen (12 weeks of telaprevir in combination with peg-IFN and RBV, followed by 12 weeks of peg-IFN and RBV alone) discontinued treatment due to adverse events. The most common reason for discontinuation among patients receiving this 24-week telaprevir–based treatment regimen was rash (7% of patients). In the control arm, 5 patients (4%) discontinued treatment prior to week 36 due to adverse events.

Phase 3 Study in Patients Who Failed Prior Treatment

Vertex and Tibotec plan to initiate a Phase 3 clinical trial in genotype 1 HCV patients who have failed prior treatment with peg-IFN and RBV in the third quarter, which will be led by Tibotec. The randomized, double-blind and placebo-controlled study will focus on regimens of 48 weeks total treatment duration, in which telaprevir is administered for 12 weeks, with a goal of maximizing SVR rates. The study is planned to be conducted at more than 50 centers in the U.S., E.U. and certain other countries.

Updates on the status of Vertex and Tibotec's clinical trials of telaprevir are available at www.clinicaltrials.gov.

About PROVE 3

PROVE 3 is an ongoing, four-arm, Phase 2b clinical trial of 453 genotype 1 HCV patients who did not achieve an SVR with a prior course of peg-IFN and RBV treatment. The study includes patients with compensated cirrhosis. The study is assessing patients who receive telaprevir-based treatment regimens of 24 and 48-week total duration, compared to a 48-week control arm of peg-IFN and RBV. PROVE 3 is being conducted at 50 clinical centers in the U.S. and the E.U.

About Telaprevir (VX-950)

Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is the most advanced investigational agent in development that specifically targets HCV. Telaprevir is the first hepatitis C protease inhibitor in Phase 3 clinical trials. The Phase 3 ADVANCE trial is expected to enroll 1,050 treatment-naïve genotype 1 HCV patients and will evaluate two 24-week telaprevir-based regimens in comparison to a 48-week control arm. Vertex is also conducting a global Phase 2b clinical development program of telaprevir, including PROVE 1 and PROVE 2 in treatment-naïve genotype 1 HCV patients, and PROVE 3 in genotype 1 HCV patients who have not achieved SVR with a prior course of pegylated interferon-based therapy.

Vertex retains commercial rights to telaprevir in North America. Vertex and Tibotec are collaborating to develop and commercialize telaprevir in Europe, South America, Australia, the Middle East, and other countries. Vertex is collaborating with Mitsubishi Pharma to develop and commercialize telaprevir in Japan and certain Far East countries.

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5-Jun-08 Cowen & Co Upgraded
VRTX from Neutral to Outperform

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4-Jun-08 JMP Securities
Downgraded VRTX from
Market Outperform to Market Perform



surf's up......crikey

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Vertex Pharmaceuticals Sells HIV Product Royalty Stream for $160 Million
Tuesday June 3, 8:30 am ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that it has sold its rights to future royalties in Lexiva® and Agenerase® under its 1993 license agreement with GlaxoSmithKline plc (GSK) in the field of HIV protease inhibitors for a one-time cash payment of $160 million.

In 2007, Vertex received net HIV royalty revenue of $34.1 million, based on royalties of $48.0 million from GSK, and $13.9 million in royalty payments made by Vertex to a third party with respect to this license agreement. As a result of the sale of the future royalties, Vertex will no longer make royalty payments to the third party with respect to Lexiva and Agenerase.

“The sale of this non-core financial asset provides us with significant capital and strengthens our financial position to support investment into key programs and future initiatives for our business,” stated Ian Smith, Executive Vice President and Chief Financial Officer of Vertex Pharmaceuticals. “In particular, this transaction will provide us with additional capital to support and advance our leadership position in hepatitis C drug development.”

Morgan Stanley acted as exclusive financial advisor to Vertex in connection with this transaction.

About Lexiva

Lexiva (marketed under the name Telzir in the European Union) is an HIV protease inhibitor for the treatment of HIV/AIDS infection sold by GSK worldwide. Lexiva is currently approved for sale in approximately 45 countries. Agenerase was the first product developed and commercialized under the collaboration with GSK and has been largely replaced in worldwide markets by Lexiva.

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Vertex drops as rival's hepatitis drug advances
Wednesday May 21, 3:41 pm ET
Vertex falls and Schering-Plough rises as Schering moves hepatitis C drug into late testing

NEW YORK (AP) -- Shares of Vertex Pharmaceuticals Inc. fell Wednesday after Schering-Plough Corp. said it is starting late-stage clinical testing of boceprevir, a hepatitis C drug candidate and a rival to Vertex's drug telaprevir.

Schering-Plough said it is starting two late-stage studies of boceprevir. One will test the drug's effectiveness in previously untreated patients, and the other will test the drug on patients who have not responded to other treatments or relapsed.

The first study will include more than 1,000 patients, while the second will include about 375 non-responsive or relapsed patients. Both studies will combine boceprevir after four weeks of treatment with two of Schering-Plough's older drugs, Peg-Intron and Rebetol.

In the larger trial, patients will be treated for either 28 weeks or 48 weeks to measure their rapid or sustained response to the drugs. In the second trial, patients will be treated for 36 or 48 weeks. In both trials, the combination of boceprevir, Peg-Intron and Rebetol will be compared to Peg-Intron and Rebetol alone.

Telaprevir is already in late-stage testing, but analysts said the boceprevir trials are starting sooner than they expected. Vertex stock lost $1.73, or 6.3 percent, to $25.75 in afternoon trading. Schering-Plough shares rose 18 cents to $19.44.

Oppenheimer analyst Brian Abrahams said the "race" between telaprevir and boceprevir is closer than he thought, but he believes telaprevir is likely to be more effective in both relapsed and untreated patients, and telaprevir's dosing also may be more favorable.

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Vertex Pharmaceuticals Announces Webcasts of its Presentations at Two Investor Conferences
Tuesday May 6, 4:15 pm ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that it will webcast its corporate presentations at the Bank of America 2008 Health Care Conference on Tuesday, May 13, 2008 at 1:20 p.m. PDT and at Robert W. Baird & Co.’s 2008 Growth Stock Conference on Wednesday, May 14, 2008 at 1:50 p.m. CDT.

The presentation will be webcast live and may be accessed from ‘Events & Presentations’ on the home page of Vertex’s website at www.vrtx.com. A replay of the webcast will also be available on the Company’s website for two weeks following the presentation. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.

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, inflammation, autoimmune diseases, cancer, pain and cystic fibrosis. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

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

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

(VRTX-WEB)


Contact:

Vertex Pharmaceuticals Incorporated
Lora Pike, 617-444-6755
Manager, Investor Relations

[surf1944]

Vertex Silences the Critics

http://www.fool.com/investing/high-growth/2008/04/25/vertex-silences-the-critics.aspx

[surf1944]

Vertex Announces Positive Interim Results with Telaprevir-based Therapy in Genotype 1 Chronic Hepatitis C Patients who Failed to Achieve SVR with Previous Pegylated Interferon & Ribavirin Treatment
Thursday April 24, 12:01 am ET
-Interim results to be presented in late-breaker poster presentation at EASL on April 24-
-Significant early on-treatment viral response from patients who previously failed therapy-

MILAN, Italy--(BUSINESS WIRE)--In a late-breaker poster presentation at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL), researchers today will present data from an interim analysis of telaprevir (VX-950) in combination with pegylated interferon and ribavirin in genotype 1 chronic hepatitis C patients who failed to achieve SVR with a previous pegylated interferon and ribavirin treatment regimen. The interim results are from the 107 study, an ongoing, open-label study which was designed to provide access to telaprevir in patients who met on-treatment criteria for null or partial response, or relapsed after the completion of 48 weeks of pegylated-interferon (peg-IFN) and ribavirin (RBV), in the control arms of the telaprevir Phase 2b PROVE studies. Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) is developing telaprevir in collaboration with Tibotec.

In the interim analysis, patients treated with telaprevir in combination with peg-IFN and RBV demonstrated a high rate of viral response at week 4 (49 of 60 patients achieved HCV RNA <25 IU/mL). This response appears to have been maintained, with no viral breakthrough observed to date in the 36 patients who have completed 4 weeks of treatment and continued out to 8 weeks and in the 16 of those patients who have continued out to 12 weeks of treatment.

“While early, these results are very promising. Patients who have not achieved SVR with prior treatment represent the largest unmet medical need in hepatitis C, as typically only 10% to 15% of those re-treated with current therapies achieve sustained virologic responses. The fact that the most difficult-to-treat patients showed such a profound early response is very encouraging,” said Fred Poordad, M.D., study author of the PROVE 1 and 107 studies, and Chief of Hepatology at the Cedars-Sinai Center for Liver Disease and Transplantation.

The results will be presented in a late-breaker poster titled, “A Study of Telaprevir (TVR) with Peginterferon alfa-2A (P) and Ribavirin (R) in Subjects with Well-documented Prior P/R Null Response, Non-Response or Relapse: Preliminary Results" starting today.

Interim Data Analysis Summary – 107 Study

The 107 study results presented at EASL represent an interim analysis for patients who received telaprevir-based therapy. Patients could enroll in the 107 study if they did not achieve SVR in the control arms of the Phase 2b telaprevir studies - PROVE 1, 2 and 3. These patients were followed closely in the PROVE studies and can be well-characterized as null responders, partial responders or relapsers to standard treatment. Null responders are defined as patients who had less than a 1 log10 decrease in HCV RNA at week four or less than a 2 log10 decrease in HCV RNA at week 12. Partial responders are defined as patients who had a greater than 2 log10 decrease in HCV RNA at week 12, but had detectable HCV RNA at week 24. Relapsers are defined as patients who had undetectable HCV RNA at the end of treatment but reverted to detectable levels of HCV RNA after stopping treatment.

The results include data from all enrolled patients in study 107 who received at least one dose of telaprevir-based treatment and who completed the week 4 assessment. At the time of analysis, 72 patients had received at least one dose of study drug and 60 patients had completed week 4. Patients continued treatment at week 4 and 12 if they did not meet the stopping rule criteria, defined as HCV RNA >25 IU/mL (Roche Taqman assay, version 2.0) at either of those time points. Nine patients discontinued all study treatment prior to week 12, including 5 patients who met the week 4 stopping rule, 2 patients who experienced breakthrough (both at week 2), 1 patient who discontinued due to an adverse event, and 1 patient who discontinued due to an adverse event and also met the week 4 stopping rule.

A high proportion of patients, regardless of the patient’s degree of non-response to prior treatment, achieved HCV RNA <25 IU/mL at week four of treatment, and available data as of the interim analysis indicate that in patients who continued past week four, response has been maintained through week 12. Week 4, 8 and 12 on-treatment antiviral responses are summarized in the table below:

Prior Virologic Response in Phase 2 control arm studies1
Interim HCV RNA Results in Patients Reaching Week 4, 8 and 12 Assessments
Week 4

<25 IU/mL
Week 4

<10 IU/mL
Week 8

<10 IU/mL
Week 12

<10 IU/mL

Week 4 null-responder2
18 of 24 8 of 24 10 of 15 8 of 9

Week 12 null-responder2
7 of 10 5 of 10 5 of 5 3 of 3

Partial responder3
18 of 19 15 of 19 9 of 9 1 of 1

Breakthrough4
1 of 1 1 of 1 - 1 of 1

Relapsers5
5 of 6a

4 of 5b
6 of 6 2 of 2

1 Each category represents a separate patient group

2 Null responders defined as non-response week 4 (<1 log10 drop in HCV RNA at week 4) or as non-response week 12 (<2 log10 drop in HCV RNA by week 12)

3 Partial responder defined as 2 log10 drop at week 24; detectable HCV RNA at week 24

4 Breakthrough defined as detectable HCV RNA during treatment after achieving undetectable HCV RNA

5 Relapsers defined as undetectable HCV RNA at end of treatment, but relapsed

a One sample not obtained b Does not include missing sample

A low rate of on-treatment viral breakthrough was observed. Two patients at week 2 experienced viral breakthrough, defined as an increase in HCV RNA on treatment of >1 log10 above HCV RNA nadir or an increase to >100 IU/mL in previously undetectable patients. Viral breakthrough has not been observed in any other patients as of this interim data analysis.

“These data provide the first demonstration of the potential for an HCV protease inhibitor-based regimen to provide significant antiviral activity in patients who have not achieved SVR with current treatments,” said John Alam, M.D., Executive Vice President, Medicines Development, and Chief Medical Officer of Vertex. “While further follow-up data are needed to fully understand telaprevir’s role in the re-treatment of HCV patients, we are very pleased with these early results. This is an important step forward in exploring the opportunity for telaprevir in this important patient population.”

Safety Findings

In the interim analysis, adverse events were similar to those commonly observed with peg-IFN and RBV including fatigue, nausea, rash, headache, gastrointestinal disorders and anemia, and consistent with those previously reported in patients being treated with telaprevir-based therapy in the PROVE studies. Two patients discontinued treatment due to adverse events, including one discontinuation due to pleuritis/costochondritis and one due to generalized rash.

About the Phase 2a 107 Clinical Study

The 107 study is an ongoing, open-label study which was designed to provide access to telaprevir in patients who met on-treatment criteria for null or partial response, or relapsed after the completion of 48 weeks of peg-IFN and RBV in the control arms of the three telaprevir Phase 2b studies. This study provides an opportunity to correlate within individual patients the antiviral response of telaprevir, peg-IFN and RBV to that of their original responses to peg-IFN and RBV.

At the time of enrollment into the 107 study, patients were assigned to receive 12 weeks of telaprevir (750 mg q8 hour) in combination with peg-IFN and RBV at standard doses, followed by 12 weeks of peg-IFN and RBV alone. Patients who discontinued because of adverse events in the PROVE studies were not eligible to enroll in the 107 study.

Based on the results of the PROVE 1 and PROVE 2 clinical studies, which demonstrated a correlation between RVR and SVR in a 24-week telaprevir-based regimen, and the on-treatment antiviral response observed to date in study 107, the study 107 dosing regimen is currently being modified. Partial responders and relapsers, who in the current analysis appear to have a response similar to that of treatment-naïve patients, will receive the response-driven dosing regimen that is being utilized in the Phase 3 ADVANCE study. These patients will be treated for a period of 24 or 48 weeks utilizing a week 4 and week 12 undetectable HCV RNA criteria to determine which patients can stop all treatment at week 24. Partial responders and relapsers who do not achieve undetectable HCV RNA at both weeks 4 and 12 will receive 48 weeks of peg-IFN and RBV at standard doses. In order to maximize potential SVR rates in the substantial number of prior null responders who, to date, have achieved a viral response in study 107, prior null responders will be treated with 12 weeks of telaprevir-based treatment (telaprevir in combination with peg-IFN and RBV) followed by 36 weeks of peg-IFN and RBV alone.

About Telaprevir (VX-950)

Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is the most advanced investigational agent in development that specifically targets HCV. Telaprevir is the first hepatitis C protease inhibitor in Phase 3 clinical trials. The Phase 3 ADVANCE trial is expected to enroll 1,050 treatment-naïve genotype 1 HCV patients and will evaluate two 24-week telaprevir-based regimens in comparison to a 48-week control arm. Vertex is also conducting a global Phase 2b clinical development program of telaprevir, including PROVE 1 and PROVE 2 in treatment-naïve genotype 1 HCV patients, and PROVE 3 in genotype 1 HCV patients who have not achieved SVR with a prior course of pegylated interferon-based therapy.

Vertex retains commercial rights to telaprevir in North America. Vertex and Tibotec are collaborating to develop and commercialize telaprevir in Europe, South America, Australia, the Middle East, and other countries. Vertex is collaborating with Mitsubishi Pharma to develop and commercialize telaprevir in Japan and certain Far East countries.

http://biz.yahoo.com/bw/080424/20080423006420.html?.v=1

[surf1944]

Telaprevir-Based PROVE Studies Show Significantly Higher SVR Rates in Treatment-Naive Genotype 1 Hepatitis C Patients in Half the Time of Current Treatments
Wednesday April 23, 8:00 am ET
- High sustained virologic response (SVR) rates of 61% in PROVE 1 and 68% in PROVE 2 with 24-week telaprevir-based treatment regimen -
- Telaprevir first and only investigational HCV protease inhibitor in Phase 3, ADVANCE trial underway -

MILAN, Italy--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced data from two large Phase 2b clinical trials evaluating the investigational hepatitis C virus (HCV) protease inhibitor telaprevir (VX-950), dosed in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) in treatment-naïve, genotype 1-infected HCV patients. Final results from PROVE 1 and further interim analysis from PROVE 2 showed consistently higher SVR rates and antiviral response in the 24-week telaprevir arms -- 61% of patients in PROVE 1 and 68% of patients in PROVE 2 achieving SVR, compared with 41% of patients in the PROVE 1 control arm achieving SVR and 48% of patients in the PROVE 2 control arm having undetectable HCV RNA at 12 weeks post-treatment. These data will be presented at the 43rd Annual Meeting of the European Association for the Study of the Liver in Milan, Italy from April 23-27, 2008.

“Patients in the completed PROVE 1 study, and those thus far reported in an interim assessment of PROVE 2 who received a telaprevir-based regimen for 12 weeks, followed by 12 weeks of pegylated interferon and ribavirin, achieved SVR rates approximately 20% higher than the SVR 24 (PROVE 1) or SVR 12 (PROVE 2) seen in the 48-week control arms and demonstrated the potential of telaprevir to produce sustained viral responses in greater numbers of patients,” said John McHutchison, M.D., Principal Investigator for the PROVE 1 trial and Associate Director of the Duke Clinical Research Institute. “In the Phase 3 ADVANCE trial we will further evaluate the potential of telaprevir to increase SVR and shorten duration."

Low Relapse Rates Observed with 24-week Telaprevir-Based Regimens

In PROVE 1 and PROVE 2, a combined relapse rate of 5% (2% in PROVE 1 and 7% in PROVE 2) was reported in patients treated with a 24-week telaprevir-based treatment regimen who were undetectable at week 4 and week 12 (HCV RNA <10 IU/mL). In the 48-week control arms, a relapse rate of 23% was observed in PROVE 1 at 24 weeks post-treatment and a relapse rate of 20% was observed in PROVE 2 at 12 weeks post-treatment. At the time of the analysis, only 12-week post-treatment relapse data were available for patients in the PROVE 2 control arm. SVR calculations include some patients who did not complete the full course of therapy, and therefore are not included in the relapse rate calculation.

“In the treatment arms that included telaprevir, pegylated interferon and ribavirin, a high percentage of patients who had undetectable virus at week 4 and 12 developed a sustained viral response,” said Dr. Geoffrey M. Dusheiko, Investigator for PROVE 2 and Professor of Medicine at Royal Free Hospital and University College London Institute of Hepatology. “If these results are validated in Phase 3 studies, shorter courses of treatment for a larger percentage of treatment-naïve hepatitis C genotype 1 infected patients may be possible.”

Telaprevir Safety & Tolerability Consistent with Prior Analyses

In Phase 2 clinical studies to date, more than 700 patients have received a telaprevir containing regimen, and the adverse event profile is generally consistent across studies and prior analyses. In the PROVE 1 and PROVE 2 studies, telaprevir is being evaluated in combination with Peginterferon alfa-2a and Ribavirin for the treatment of patients chronically infected with hepatitis C virus (HCV) genotype 1. In these placebo-controlled studies, the most common adverse events reported more frequently in the telaprevir treatment arms compared to the placebo arms were gastrointestinal events, skin events (rash, pruritus) and anemia. Other adverse events reported were similar in type and frequency to those seen currently with peg-IFN/RBV treatment.

Treatment discontinuation rates in the combined data through week 24 of treatment due to adverse events were 17% in the telaprevir treatment arms. In the control arms, 10% of patients discontinued treatment during the 48-week treatment period. The most common adverse event leading to discontinuation in the telaprevir arms was rash in 7% of patients across both PROVE 1 and PROVE 2. Investigators have reported that the rash resolves upon discontinuation of telaprevir.

Telaprevir Data Presentations at EASL Meeting

Oral Presentations:

“PROVE 1: Results From a Phase 2 Study of Telaprevir with Peginterferon alfa-2a and Ribavirin in Treatment-Naïve Subjects with Hepatitis C,” on Thursday, April 24th at 3:45 p.m. CEST (9:45 a.m. EDT).

“Treatment of Chronic Hepatitis C with Telaprevir (TVR) in Combination with Peginterferon-alfa-2a with or without Ribavirin: Further Interim Analysis Results of the PROVE2 Study,” on Friday, April 25th at 11:45 a.m. CEST (5:45 a.m. EDT).

Late-Breaker Poster Presentation:

"A Study of Telaprevir (TVR) with Peginterferon alfa-2A (P) and Ribavirin (R) in Subjects with Well-documented Prior P/R Null Response, Non-Response or Relapse: Preliminary Results" starting on Thursday, April 24.

Poster Presentation:

“Natural Prevalence Of HCV Variants with Decreased Susceptibility to NS34a Protease Inhibitors in Treatment-Naïve Subjects,” starting on Thursday, April 24.

About PROVE 1 and PROVE 2

PROVE 1 is a four-arm, Phase 2b clinical trial of 250 treatment-naïve genotype 1 HCV patients with a primary objective to assess the proportion of patients who achieve SVR, defined as undetectable (less than 10 IU/mL, as measured by the Roche TaqMan® assay) HCV RNA 24 weeks after the completion of dosing. The study is assessing patients who receive telaprevir-based treatment regimens of 12, 24 and 48-week durations, compared to a 48-week control arm of pegylated interferon and ribavirin. PROVE 1 is being conducted at 37 clinical centers in the U.S.

PROVE 2 is an ongoing, four-arm, Phase 2b clinical trial of 323 treatment-naïve genotype 1 HCV patients with a primary objective to assess the proportion of patients who achieve SVR. The study is assessing patients who receive telaprevir-based treatment regimens of 12 and 24-week durations and a 12-week arm without ribavirin, compared to a 48-week control arm of pegylated interferon and ribavirin. PROVE 2 is being conducted at 28 clinical centers in Europe.

About Telaprevir and ADVANCE Phase 3 Clinical Development

Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is the most advanced investigational agent in development that specifically targets HCV. Telaprevir is the first hepatitis C protease inhibitor in Phase 3 clinical development. The ongoing ADVANCE trial is a global, 3-arm pivotal controlled trial designed to evaluate two 24-week telaprevir-based regimens in approximately 1050 treatment-naïve genotype 1 HCV patients. In this study, extended RVR criteria (undetectable HCV RNA at week 4 and week 12) will be used to determine which telaprevir patients can stop all treatment at 24 weeks. In addition to ADVANCE, Vertex is conducting a global Phase 2b clinical development program of telaprevir, including PROVE 1 and PROVE 2 in treatment-naïve genotype 1 HCV patients, and PROVE 3 in genotype 1 HCV patients who have not achieved SVR with a prior course of pegylated interferon-based therapy. In these clinical trials, telaprevir is being dosed as 750 mg every eight hours in combination with pegylated interferon alfa-2a (Pegasys®) both with and without ribavirin (Copegus®).

Vertex retains commercial rights to telaprevir in North America. Vertex and Tibotec are collaborating to develop and commercialize telaprevir in Europe, South America, Australia, the Middle East and other countries. Vertex is collaborating with Mitsubishi Pharma to develop and commercialize telaprevir in Japan and certain Far East countries.

[surf1944]

Zacks.com
Buy Vertex Pharma Below $20
Tuesday April 22, 2:34 pm ET
By Jason Napodano, CFA

Vertex Pharmaceuticals, Inc.'s (NasdaqGS: VRTX - News) stock has had a wild ride over the past several months -- it was previously down big as timeline slippage for the filing of Telaprevir and increasing cash burn rates have frustrated shareholders. However, the clinical data on Telaprevir and other pipeline candidates continues to look very strong.

There is little doubt in our mind that Telaprevir has blockbuster sales potential. The burn rate and high expectations will probably keep the shares from breaking out to the upside until the approval of the drug perhaps in 2011. In the meantime, Vertex's stock can probably be traded effectively, buying when the name goes below $20 and selling after a strong run-up.

Vertex represents an attractive long-term opportunity based on the potential blockbuster sales of Telaprevir. Other pipeline candidates such as VX-702, VX-770, and VX-509 also look very interesting. However, catalysts seem limited until the second half of the year and Vertex is burning cash at a significant rate. The financial situation is solid, considering the recent secondary debt and equity offering to raise over $400 million, but dilution remains a concern.

As these issues ebb and flow we think Vertex's stock can be an effective trading vehicle. We would be buyers below $20 based on the strength of the pipeline. We would look to lighten up on the position or take profits after a big run in the name, or when expectations seem unrealistically high.

At less than $20 Vertex becomes a Buy based on the attractiveness of Telaprevir, or the notion that Johnson & Johnson (NYSE: JNJ - News) may decide to acquire the entire company in order to obtain the U.S. rights to the drug. This is a distinct possibility, in our view, although we believe Vertex management would be hesitant to sell at that depressed of a level.

Our price target is $30 per share. Selling the HIV royalty, guidance that the FDA will accept the PROVE-3 study as part of the registration program, or the potential for lower cash burn rates in 2009 and 2010 are all things that could keep the shares moving higher.

[surf1944]

Vertex Pharmaceuticals Reviews Clinical Advancements and Reports First Quarter 2008 Financial Results
Monday April 21, 4:01 pm ET
--Telaprevir data in HCV patients who failed current therapies to be presented at EASL--
--Pharmacokinetic analyses in HCV patients show potential for twice-daily dosing of telaprevir--
--VX-770 for cystic fibrosis to advance based on positive results reported in March 2008--


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today reported consolidated financial results for the quarter ended March 31, 2008.
http://biz.yahoo.com/bw/080421/20080421006287.html?.v=1

[surf1944]

Vertex's Telaprevir May Become a Multi-Billion Dollar Drug:

On Monday, March 31st, Vertex (VRTX) announced, through an abstract, the interim results of an open-label phase 2 trial for Telaprevir for treatment of Hepatitis C. 26 of 32 patients who previously failed other therapies (81%) experienced rapid virologic response [RVR] after four weeks of treatment. Even though these rates may not be sustained in longer term, chances are a good portion of these patients will be cured.

The release of these results has prompted analysts who disliked the company and the stock last week to suddenly change their minds. I was surprised at the timing of this news as I was expecting some results released in the second half of this year.

If you read through some of my past articles, you will find that I have violated almost every rule of investing when it comes to Vertex Pharmaceutical's stock. In fact, I have even called my behavior stubborn, which always guarantees significant losses when trading or investing.

But my fascination has always been with Telaprevir, not the stock or the company. I have always believed that this drug had the best potency, efficacy and side effect profile which would make it a standard therapy for Hepatitis C, a disease with poor standard of care therapy. I won't get into the biochemical details but this is not something easily reproducible by other pharmaceutical companies. This partially explains why other similar products have failed or have had major setbacks in the clinic.

Some people have blamed the recent volatility in the stock price on the management of promising results. In fact there have been some class action lawsuits filed. I am not a legal expert but I doubt they will serve any purpose besides costing the taxpayers some money and making some lawyers rich. The lawsuits will end up getting thrown out. I wish someday the laws will change to stop this ridiculous and destructive behavior!

But, I blame investors (they should really be called wall street traders who manipulate stock prices) who don't understand drugs and drug development. I blame traders and fund managers who have a 1-2 quarter outlook on returns with alarmingly high turnover rates in their portfolio. However, I don't blame anyone but myself for my losses (and gains). I fully understand that the risks of investments are sometimes equivalent to the risks of a casino game!

The stock may fluctuate 50-60% in a year but the story remains the same. Telaprevir is the first Hepatitis C Protease inhibitor in Phase III clinical trials. It is the only drug to show significant improvement to standard of care in both treatment naive and non-responding patients and it will be the first one on the market as early as late 2009 (maybe!). It has the potential of becoming a multi-billion dollar drug, and for that VRTX should be valued no less than 5 billion dollars or about 50% higher than its current price of $25.4. I am basing this on other blockbuster phase III products such as Celgene's (CELG) Revlimid.

Bottom line: Buy Vertex for the long term for a once in a lifetime return!

http://seekingalpha.com/article/70868-vertex-s-telaprevir-may-become-a-multi-billion-dollar-drug?source=yahoo

[surf1944]

Vertex Pharmaceuticals Announces Acceptance of Late-Breaker Abstract on Telaprevir, Investigational HCV Protease Inhibitor, for Presentation at EASL Annual Meeting
Monday March 31, 8:31 am ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that data related to its investigational hepatitis C protease inhibitor telaprevir will be featured in a late-breaker poster presentation during the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL) in Milan, April 23-27, 2008.

The title of the abstract is "A Study of Telaprevir (TVR) with Peginterferon alfa-2A (P) and Ribavirin (R) in Subjects with Well-documented Prior P/R Null Response, Non-Response or Relapse: Preliminary Results" and will be presented at EASL starting on Thursday, April 24. Accepted late-breaker abstracts for the EASL meeting are now available on the EASL website. Information contained in the late-breaker poster abstract has also been filed by Vertex with the U.S. Securities and Exchange Commission on a Form 8-K.

In addition to the late-breaker abstract, three additional abstracts on telaprevir have been accepted for presentation during EASL:

Oral Presentations:

PROVE 1: Results From a Phase 2 Study of Telaprevir with Peginterferon alfa-2a and Ribavirin in Treatment-Naïve Subjects with Hepatitis C; Thursday; April 24 at 3:45 p.m. CET (9:45 a.m EDT).

Treatment of Chronic Hepatitis C with Telaprevir (TVR) in Combination with Peginterferon-alfa-2a with or without Ribavirin: Further Interim Analysis Results of the PROVE2 Study; Friday, April 25 at 11:45 a.m. CET (6:45 a.m EDT).

Poster Presentation:

Natural Prevalence Of HCV Variants with Decreased Susceptibility to NS3•4a Protease Inhibitors in Treatment-Naïve Subjects; starting Thursday, April 24 at 7:00 p.m. CET (1:00 p.m EDT).

http://biz.yahoo.com/bw/080331/20080331005774.html?.v=1

[surf1944]

Vertex Announces Positive Results for VX-770, an Oral Investigational Agent That Targets a Defective Protein Responsible for Cystic Fibrosis
Thursday March 27, 7:30 am ET
--Interim analysis of 14-day study of VX-770 shows a significant improvement in lung function --
--Lung function data supported by corresponding improvements in disease-related biomarkers--
--Results to be shared with health authorities in order to identify the most rapid path forward --

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced results from a planned interim analysis of an ongoing Phase 2a clinical trial in patients who carry the G551D mutation in the gene that causes cystic fibrosis (CF). The interim analysis showed that dosing of VX-770, an investigational CF potentiator, as an oral agent for 14 days resulted in improved lung function and in improved function of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein as measured by changes in sweat chloride levels and changes in nasal potential difference (NPD). Results from the interim analysis support the hypothesis that improving chloride ion transport in CF patients may correlate to improvements in lung function and provide benefit to patients. Results are being shared with regulatory authorities and leading CF investigators in order to identify the most rapid path forward for the compound.

“While these are early data, it is unprecedented for an investigational oral compound for the treatment of CF to have such a marked effect on multiple measures of CF disease activity. We saw an average improvement in lung function of 10 percent in patients receiving the highest dose, compared to no observed improvement in patients who received placebo,” said Frank Accurso, M.D., Director of the Cystic Fibrosis Center and Professor of Pediatrics at the University of Colorado School of Medicine in Denver. “These data suggest that VX-770 may be able to improve lung function by targeting an underlying defect in CFTR that causes the disease. In patients with CF, inadequately functioning or missing CFTR is believed to result in abnormal balance of fluid and salt in the airways. These are early clinical data in a subset of patients with malfunctioning CFTR, but an important proof-of-concept, and we look forward to evaluating the longer-term safety and efficacy of VX-770 in additional studies.”

Interim Analysis Summary

The results being reported are from 20 patients with the G551D mutation in CFTR who received either VX-770 or placebo in addition to standard therapies for 14 days as part of a blinded, randomized, two-period crossover study design. Four subjects received placebo during both 14-day dosing periods; 8 subjects received 25 mg of VX-770 twice-daily during one period and 75 mg in the other; and 8 subjects received 75 mg of VX-770 twice-daily during one period and 150 mg, the highest dose in the study, during the other dosing period. There was a one to four week wash-out between each dosing period.

* Safety: In the 14-day trial, VX-770 appeared to be well-tolerated. Observed adverse events were similar between VX-770 and placebo treatment. Two serious adverse events were observed in one patient and were not attributed to VX-770.
* Lung Function: In the Phase 2a trial, lung function in patients was assessed with FEV1, a standard test that measures the amount of air that can be exhaled in one second. FEV1 is the lung function test most commonly used to monitor progression of airway disease in CF patients. Patients with CF typically experience a decline in lung function of 1-2% per year during their life, as measured by FEV1. Over the 14-day dosing period in the Phase 2a study, patients receiving the highest dose of VX-770 (150mg twice daily) showed a mean increase from baseline in FEV1 of 10.1%, or 0.22L (p<0.008). In contrast, patients receiving placebo showed a slight decrease in FEV1 (less than 1%; 0.03L) over the 14-day period.
* Sweat Chloride: Elevated sweat chloride levels are a diagnostic hallmark that occur in all CF patients and result directly from defective CFTR activity in epithelial cells in the sweat duct. The amount of chloride in the sweat is measured using a standard skin test. Patients with CF typically have sweat chloride levels in excess of 60 mmol/L, while normal values are <40 mmol/L. In patients receiving the highest dose of VX-770 (150mg twice daily) in the Phase 2a study, sweat chloride decreased from a mean 95.5 mmol/L at baseline to 53.2 mmol/L over the 14-day dosing period (p<0.0001). Six of 8 patients in the 150 mg dose group achieved a decrease in sweat chloride to below 60 mmol/L. There was no notable change in sweat chloride in patients receiving placebo.
* Nasal Potential Difference (NPD): NPD assesses several aspects of ion channel activity by measuring voltage changes across the nasal epithelia and is used as a direct measure of CFTR activity and chloride ion movement in upper airway epithelial cells. Typical assessments of CF patients using NPD show very low chloride ion secretion in the nasal passage. After 14 days of dosing, patients receiving the highest dose of VX-770 (150 mg twice daily) showed a significant mean change from baseline in chloride ion secretion in NPD of –5.4 mV (p=.01). In contrast, in those treated with placebo, a mean change of -1.74 mV was observed.

Robert J. Beall, Ph.D., President and Chief Executive Officer of the Cystic Fibrosis Foundation, said, “More than 10 years ago, the Cystic Fibrosis Foundation believed that Vertex’s approach to treating CF by directly targeting CFTR function - the underlying mechanism of the disease - was an important opportunity to meaningfully change the course of cystic fibrosis. Today, we are highly encouraged by the early clinical data for VX-770, as these results represent a significant step forward in understanding the potential for new treatment approaches for the more than 70,000 cystic fibrosis patients worldwide.”

“These early data provide clinical proof-of-concept that a CFTR modulator such as VX-770 can have a direct effect on CFTR activity in patients with CF and potentially improve lung function,” said John Alam, M.D., Executive Vice President, Medicines Development, and Chief Medical Officer of Vertex. “While additional data and evaluation are needed to fully understand VX-770’s clinical profile and its disease-modifying potential in CF, we are pleased to see these early results. We look forward to moving into the second part of this Phase 2 trial for VX-770, which will enroll approximately 16 patients for dosing of VX-770 or placebo for 28 days, beginning in the second quarter of 2008. This result further supports the collaborative approach that the Cystic Fibrosis Foundation and Vertex have taken to finding drugs that treat the underlying defect responsible for the disease.”

Based on the results of the interim analysis, in addition to proceeding to Part 2 of the Phase 2a study, Vertex plans to meet with regulatory authorities and leading CF investigators in order to identify the most rapid path forward for the compound.

About the Phase 2a Clinical Trial

Results reported today are from an interim analysis of Part 1 of an ongoing Phase 2a clinical trial evaluating the safety and pharmacokinetics of VX-770, and investigating the effect of VX-770 on clinical measures of lung function and CFTR activity in patients 18 years of age or older who possess the G551D mutation. In Part 1 of the trial, 20 patients with the G551D mutation in CFTR received either VX-770 or placebo in addition to standard therapies for 14 days as part of the trial’s blinded, randomized, crossover design. Based on the interim results, Vertex expects to proceed to Part 2 of the trial, which will enroll approximately 16 patients for dosing of VX-770 or placebo for 28 days, beginning in the second quarter of 2008. In the trial, VX-770 is being dosed as an oral therapy. Vertex expects to present the interim results from Part 1 of this trial at a medical forum in 2008.
http://biz.yahoo.com/bw/080327/20080327005273.html?.v=1

[surf1944]

Vertex Pharmaceuticals and Tibotec Announce Start of Phase 3 'ADVANCE' Study with Telaprevir in Treatment-Naive, Genotype 1 HCV Patients
Thursday March 13, 8:00 am ET
- First hepatitis C protease inhibitor to begin Phase 3 clinical development -
- Trial designed to confirm potential of telaprevir to increase sustained viral response (SVR) rates with 24-week treatment duration -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) and Tibotec today announced that patient screening has begun in the ADVANCE study, a pivotal Phase 3 clinical study with the hepatitis C virus (HCV) protease inhibitor telaprevir in combination therapy for treatment-naïve patients with chronic HCV infection. Telaprevir is the most advanced HCV protease inhibitor in clinical development targeting treatment of hepatitis C, a disease that afflicts more than 3 million people in the United States alone, and 170 million worldwide. The ADVANCE trial will enroll 1,050 treatment-naïve genotype 1 HCV patients and will evaluate two 24-week telaprevir-based regimens in comparison to a 48-week control arm. The primary endpoint of the study is sustained viral response (SVR), defined as undetectable HCV RNA (<10 IU/mL) 24 weeks after the completion of treatment. In this study, rapid viral response (RVR) criteria will be used to determine which telaprevir patients can stop all treatment at 24 weeks.

“This is the first Phase 3 study conducted to evaluate whether an investigational medicine for HCV may be able to both increase the rate of sustained viral response and shorten the duration of therapy to 24 weeks in patients with genotype 1 HCV infection compared to current treatment of 48 weeks. This is important given the expectation that approximately 40 to 50 percent of people with genotype 1 HCV who undergo treatment with current therapies achieve SVR,” said John McHutchison, M.D., Associate Director, Duke Clinical Research Institute and a principal investigator for the ADVANCE study. “We’re interested to see whether this trial will confirm the encouraging results seen thus far in Phase 2 studies of telaprevir. This study is another important step forward in the evaluation of novel medicines for the treatment of HCV.”

“Following discussions with the U.S. FDA in January, we have been able to rapidly finalize the Phase 3 pivotal trial protocol and begin patient screening at the first sites,” said John Alam, M.D., Executive Vice President, Medicines Development and Chief Medical Officer of Vertex. “The initiation of the ADVANCE trial underscores our commitment to evaluating the potential for telaprevir to address significant unmet medical needs in HCV.”

The ADVANCE Study

The ADVANCE study (A New Direction in HCV Care: A Study of Treatment-Naive Hepatitis C Patients with telaprevir) will be conducted at more than 100 centers in the U.S., E.U. and certain other countries. Patient recruitment is being initiated in the U.S., while sites in other countries will start recruitment as national Clinical Trial Applications (CTAs) for each country are approved. The study arms will include:

* 24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) for 12 weeks in combination with standard doses of pegylated interferon alfa-2a (peg-IFN) and ribavirin (RBV) for 12 weeks, then continuing for another 12 weeks with peg-IFN and RBV alone;
* 24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) for 8 weeks in combination with standard doses of peg-IFN and RBV for 8 weeks, then continuing for another 16 weeks with peg-IFN and RBV alone; and
* A control arm with standard doses of peg-IFN and RBV dosed for 48 weeks.

Patients in both telaprevir arms who achieve RVR, defined in this study as undetectable (less than 10 IU/mL) HCV RNA levels by the end of week 4, and who stay undetectable at week 12 will receive 24 weeks of treatment. Patients in these treatment arms who do not meet these RVR criteria but are undetectable at week 24 will continue on peg-IFN and RBV for a total duration of 48 weeks.

Updates on the status of Vertex and Tibotec’s clinical trials of telaprevir are available at www.clinicaltrials.gov.

About Telaprevir

Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is one of the most advanced investigational antiviral agents in development that specifically targets HCV. The types of adverse events that have been commonly observed with peg-IFN and RBV were seen across all treatment arms in Phase 2b trials of telaprevir. The most common adverse events, regardless of treatment assignment, were fatigue, rash, headache and nausea, with rash being the most common reason for treatment discontinuation. Gastrointestinal disorders, skin adverse events (rash, pruritus) and anemia were more common in the telaprevir arms compared to the control arm over the dosing period.

[surf1944]

Vertex Pharmaceuticals Announces Exercise of Over-Allotment Options by Underwriters of its Concurrent Public Offerings of Common Stock and Convertible Senior Subordinated Notes
Wednesday February 13, 10:14 pm ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that the underwriters for its concurrent offerings of common stock and convertible senior subordinated notes have exercised in full their over-allotment option to purchase 900,000 shares of common stock at a public offering price of $17.14 per share and their over-allotment option to purchase an additional $37.5 million aggregate principal amount of 4.75% convertible senior subordinated notes due 2013.

The exercise of the over-allotment options brings the total shares of common stock sold by Vertex in the common stock offering to 6,900,000 shares and the total aggregate principal amount of notes sold in the note offering to $287.5 million. Vertex expects to receive gross proceeds from the common stock offering and the note offering, before commissions and expenses, of $405.8 million.

The common stock offering and the note offering are being conducted as separate public offerings, and the closing of each offering is not contingent upon the other.

Merrill Lynch, Pierce, Fenner & Smith Incorporated acted as the sole book-runner, with Morgan Stanley & Co. Incorporated, Goldman Sachs & Co. and J.P. Morgan Securities, Inc. acting as co-managers, for the offerings.

This press release does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. A copy of the prospectus for each of the offerings can be obtained from Merrill Lynch’s prospectus department, at 4 World Financial Center, New York, NY 10080, 212-449-1000.

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of 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, inflammation, autoimmune diseases, cancer, pain and bacterial infection. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

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

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

[surf1944]

Vertex Pharma to Raise Up to $405.8M
Wednesday February 13, 7:52 am ET
Vertex Pharma to Raise Up to $405.8 Million in Sale of Shares and Notes

CAMBRIDGE, Mass. (AP) -- Vertex Pharmaceuticals Inc. said Wednesday it will sell both senior convertible notes and 6 million shares of common stock at $17.14 each.

If the maximum number of notes and shares are sold, gross receipts would total roughly $405.8 million. Shares rose 41 cents, or 2.4 percent, to $17.55 in premarket trading.

Besides the 6 million shares, the biotechnology company granted the underwriters an option to buy up to an additional 900,000 shares of common stock on the same terms and conditions to cover over-allotments, if any. As of Feb. 6, the company had 133 million shares of common stock outstanding.

Vertex also agreed to sell $250 million aggregate principal amount of 4.75 percent convertible senior subordinated notes due 2013 and granted the underwriters an option to buy up to an additional $37.5 million aggregate principal amount of notes.

The notes will be convertible into shares of Vertex common stock at an initial conversion rate of 43.2171 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of about $23.14 per share.

The common stock offering and the note offering are being conducted as separate public offerings, and the closing of each is not contingent upon the other.

Merrill Lynch, Pierce, Fenner & Smith Inc. is acting as the sole book-runner, with Morgan Stanley & Co. Inc., Goldman, Sachs & Co. and JP Morgan Securities Inc. acting as co-managers, for the offerings.

[surf1944]

Earnings Preview: Vertex Pharmaceuticals

Vertex Pharmaceuticals (VRTX) is expected to report Q4 earnings Monday with a conference call scheduled for 5:00 p.m. ET.

Guidance
Analysts are looking for a loss of (66c) on revenue of $67M. The consensus range is (45c) to (90c) for EPS, and revenue of $43M to $102M, according to First Call. Vertex announced that they most likely wouldn't file for approval of Telaprevir in previously untreated Hepatitis-C patients until after 2010. On a positive note, Vertex is looking to get a combination Telaprevir study approved.

Analyst Views
Recently, JMP Securities said the stock has reached a trough and that Vertex will have positive momentum in 2008. They initiated the stock with a Market Outperform and gave the shares a $25 price target. Lazard lowered their target on the shares to $13 from $16, and maintains a Sell rating. They expect competition to increase, with other Hepatitis drugs gaining market share.

http://seekingalpha.com/article/63933-earnings-preview-vertex-pharmaceuticals

[surf1944]

Vertex Pharmaceuticals Reviews 2008 Business Priorities and Reports 2007 Financial Results
Monday February 11, 4:00 pm ET
-- Focused on first-to-market opportunity with HCV protease inhibitor telaprevir --
-- Additional drug candidates directed at HCV, cystic fibrosis and immune-mediated diseases--

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today reviewed its 2008 business priorities and reported consolidated financial results for the year ended December 31, 2007.

http://biz.yahoo.com/bw/080211/20080211006421.html?.v=1

[JamaicaBaby]

a friendly welcome from the um, competition...

http://www.investorshub.com/boards/board.asp?board_id=8637

LOL


good luck........

[The_Pink_Lawyer]

Welcome the VRTX Board! I'll be updating it over the weekend.