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Vertex Pharmaceuticals: Great Pipeline, Valuation And Future
The past 6 months have proven that biotech mergers & acquisitions are soaring. Gilead (GILD) gobbled up Pharmasset (VRUS), and Bristol-Myers (BMY) bought Inhibitex (INHX), and dozens of companies are rumored to be next. The surge in M&A in this sector has inflated stock prices across the sector, as investors bet on the next deal. Yet one company has been ignored in this rally, and we think that it is time investors take note of it.
Vertex Pharmaceuticals (VRTX) is a biotech company that develops therapies for a wide range of diseases. Its primary product is Incivek, for the treatment of HCV (also known as HCV), and Lexiva, for HIV, which it sells in a partnership with GlaxoSmithKline (GSK). Incivek is one of the first new therapies for HCV in years, and it has been responsible for an almost 74% rise in Vertex's stock price over the last 10 years. Yet, as merger mania in the biotech sector heats up, Vertex has been left in the dust. We think that is a situation that cannot last for long, given the company's products and pipeline. Below we profile Vertex, its drugs, and its future.
Overview
Vertex received FDA approval to sell Incivek in May 2011, after nearly 15 years of development. The drug is on pace to break the record for the fastest product launch to reach sales of $1 billion. And just a quarter after launching the drug, Vertex announced that it has become profitable, posting EPS of $1.02 on revenues of $659 million in the third quarter of 2011. Many biotech companies spend years in the red even after launching their drugs. Yet despite all this, Vertex stock has languished over the past year.
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Over the past year, Vertex has lagged both the S&P 500 and the broader biotech sector (XBI), falling over 9%. There are two factors at play here. The first is takeover mania in the biotech sector. The second is concerns with Incivek.
Takeover mania: After it was revealed Bristol-Myers was buying Inhibitex, both Achillion Pharmaceuticals (ACHN) and Idenix (IDIX) rallied sharply. Achillion rallied 16% and Idenix soared 34%. And what about Vertex, the only biotech company with an actual HCV drug on the market? Its shares rose a paltry 4%. With a surge in M&A action, it would make sense that the company most likely to be pursued by big pharma would be a company with a profitable drug on the market and a promising pipeline. Rumors would suggest that Johnson & Johnson (JNJ), Vertex's partner on the Incivek, would be a good fit for the company. In addition, Abbot Labs (ABT) could also be looking to expand its own HCV franchise. But with a market capitalization of over $7.5 billion, Vertex carries a hefty price tag, even without the premium necessary to seal an acquisition. The fact that it would take much more work to buy out Vertex than its peers in the HCV space has depressed the stock. Yet as each biotech's scarcity value increases, the chances of someone paying top dollar for Vertex increases.
Incivek: Multiple companies are developing the next generation of HCV therapies, including Pharmasset, Inhibitex, Achillion, and Idenix, as well as Merck (MRK). The mania surrounding the HCV developers is due to the fact these companies, while having no product on the market, are developing therapies that do not use interferon. Interferon has been a staple of HCV treatment for years, but it comes with a host of unpleasant side effects, some of them worse than the symptoms themselves. As such, many patients simply do not get treatment. But the next generation of therapies work far differently than current treatments. These nucleosides and nucleotides have proven themselves in many clinical trials. Gilead paid an 84% premium for Pharmasset precisely because its HCV treatment uses no interferon. The same goes for Inhibitex, Idenix, and Achillion. Incivek, on the other hand, is an improvement on existing treatments, yet must still use interferon, diluting its "value" relative to the other drugs in development. As such, Vertex has seen its stock depressed since the launch of Incivek, as investors fret that new treatments will render its drug useless.
These 2 factors have depressed Vertex's stock, and we think that this creates an ideal time to buy the stock. Vertex's future is nowhere near as grim as investors currently believe it to be. There are 2 primary reasons for this. The first is that pessimism about the company's HCV franchise is overdone. The second is that Vertex is rapidly diversifying away into new markets.
HCV
Medical data from a variety of biotech companies proves that interferon-free therapy is simply more effective than Incivek. That is a reality that Vertex investors must accept. Merrill Lynch, in cutting its estimates for Vertex, laid bare the situation. It slashed sales estimates for Incivek, citing competition from interferon-free therapies and waning demand due to the side effects of interferon.
Global Incivek Prescriptions: Merrill Lynch
Estimates have been slashed dramatically for Incivek's global potential, particularly in 2014 and beyond. This is due to the fact that 2014 is the projected date for interferon-free therapies to hit the market, led by Gilead's PSI-977, the primary driver of the Pharmasset deal. A variety of studies have shown that these therapies are superior to Incivek. There is no denying that. But, until 2014, Incivek will remain a leading choice for HCV patients, for it is an incremental improvement on prior therapies. Incivek has already demonstrated that it can allow Vertex to acheive profitability after just several months on the market. This allows Vertex to fund its research internally, without diluting its shareholders or weakening the balance sheet, something many other biotechs must resort to, even after starting sales of their drugs.
While Vertex was the first biotech to launch an HCV therapy, Incivek is certainly not its last drug in development for this disease. Vertex is fully aware that interferon-free therapies are the future, and it is planning accordingly. The company's 2012 business plan highlights its plans for the HCV franchise. Vertex is set to begin Phase III trials of VX-222, the successor to Incivek. VX-222, when given in combination with Incivek, cuts the maximum treatment time to 24 weeks, versus up to 48 weeks of treatment with Incivek alone.
In addition, Vertex is not sitting idly by in the interferon-free subsector. Vertex is collaborating with Alios BioPharma in developing interferon-free therapies. ALS-2200 and ALS-2158 are currently in Phase I trials. Data is expected in the second quarter of 2012, with Phase II trials set to begin in the second half of the year. Vertex has worldwide rights to these therapies, and in its deal with Alios it must pay royalties on future sales. At this point, readers may be wondering what good this will do Vertex, for these therapies are at least several years away from commercialization, and by then Incivek could be rendered irrelevant. However, we think investors are too focused on Incivek. Even in 2016, Incivek will be a profitable drug, despite the competition on the market. And by then, Vertex will have branched out into an entirely new area of medicine: cystic fibrosis.
Cystic Fibrosis
This is a disease that affects around 30,000 people in the United States and 70,000 worldwide. It is a rare and life-threatening disease with no current cure. So what is Vertex doing to address this? VX-770, to be marketed as Kalydeco, targets an extremely rare subset of cystic fibrosis patients, who have a specific mutation in the G551D gene. Only about 1.6% of all cystic fibrosis patients have this mutation, making it extremely rare. That is why Kalydeco has been given orphan drug status, and is on a fast track review at both the FDA and the EMA (European Medicines Agency). A target review date of April 18, 2012 has been set by the FDA, and all indications are that Kalydeco will be approved in both the US and Europe.
Orphan drugs are ones that treat extremely rare diseases. Given that they meet an unmet medical need, companies developing orphan drugs are given a variety of incentives for developing them, such as longer exclusivity, clinical research tax credits, and fast reviews at the FDA. The current poster child for the success of orphan drugs is Alexion (ALXN), whose Soliris drug treats several extremely rare diseases. Any Alexion investor can tell you that they are very happy with how the company has done, given its 1,300% rise over the last 10 years.
Credit Suisse estimates that while Kalydeco can ultimately address just 5% of the cystic fibrosis market, it can charge up to $250,000 per patient per year, which translates into annual sales of around $1.9 billion. Vertex plans to expand the market for Kalydeco beyond the G551D mutation, and multiple trials are planned for 2012 to determine if this is possible. While this is healthy on its own, a potential combination treatment of Kalydeco and VX-809, a new cystic fibrosis treatment, could expand Vertex's sales to around $5 billion in this market by targeting more common forms of the disease. But, current data has been underwhelming regarding the efficacy of this combination. Further data, set to be released in 2012, will show whether this upside can be realized. Either way, sales of around $1.9 billion are still very healthy, and the downside risk to Vertex in the cystic fibrosis market is limited. But HCV and cystic fibrosis are not the only diseases Vertex is targeting.
Arthritis, Epilepsy, and Influenza
Even while investing huge sums of capital into HCV and cystic fibrosis, Vertex is working on these 3 diseases as well. VX-509 targets arthritis as well as several other inflammatory diseases, and VX-765 targets epilepsy. VX-509 and VX-765 are both in Phase II trials. A 6-month Phase IIb study of VX-509 is set to begin in the first quarter of 2012, and VX-765 is set to enter new testing phases as well. While it is a bit too early to gauge the financial impact of these products, existing clinical data on VX-509 is promising, with patients showing significant improvements relative to existing therapies. As for VX-765, clinical data shows that the drug is well-tolerated, and Vertex is continuing to invest in it, though more data is needed to specifically determine its efficacy. Vertex is also initiating more trials of VX-787, its investigative influenza treatment for both swine (H1N1) and bird (H5N1) flu. VX-787 is currently in Phase I trials, and data is expected in the second quarter of 2012.
Financials
What many people seem to forget is that Vertex is already profitable, unlike many of its peers with new drugs on the market, such as Dendreon (DNDN) and Human Genome Sciences (HGSI). Vertex posted EPS of $1.02 per share last quarter, on revenues of more than $659 million. The company has more than $250 million in net cash on the balance sheet, and has no need to tap the debt or equity markets anytime soon. Vertex trades at just 8.1x 2012 earnings estimates ($4.48 per share), and we do not see any reason why the shares should be this cheap. Vertex is trading at the same multiples as big pharma trades, yet 2012 earnings are set to grow over 1,559% over 2011. Below we provide an overview of Vertex's earnings and revenue estimates for the next 5 quarters. Vertex is set to report fourth quarter 2011 earnings on February 2.
Vertex Earnings & Revenue Estimates
Vertex faces no profitability issues in 2012, and most estimates do not include revenues (or profits) from Kalydeco. Given the strong need for new cystic fibrosis treatments, we see no reason why Kalydeco could not see the same rapid uptake as Incivek did. 2012 will be a great year for Vertex financially. 2013 and beyond would be even better as Kalydeco ramps up and Vertex's other drug candidates enter the market. The current Reuters average price target for Vertex is $48.05, representing upside of over 32% from current levels. And considering how badly analysts missed the last quarter (predicting Incivek sales of $300 million versus $420 million in actual sales), we think analysts are likely to raise price targets and earnings estimates in 2012 as Vertex proves its skeptics wrong.
This company's future is far brighter than many would believe. And at 8.1x 2012 earnings, the shares are far too low relative to Vertex's potential. We think now is an opportune time to add to or initiate positions in Vertex Pharmaceuticals. This company has demonstrated that in can successfully launch a major drug into the market. It has a great pipeline and the financial strength to translate that into commercial success. We think that the skepticism surrounding this company is far too great, and that investors who have faith in the company and its products will be rewarded greatly for their loyalty.
Disclosure: We are long VRTX on its own, and are long GILD, ALXN, HGSI, and DNDN via the First Trust NYSE Arca Biotech Index Fund, an ETF that tracks a basket of 20 biotech stocks We are long ABT, JNJ, and MRK via the PowerShares Dynamic Pharmaceuticals Portfolio. In addition, a mutual fund we own grants ALXN a weighting of 1.19%.
http://seekingalpha.com/article/321131-vertex-pharmaceuticals-great-pipeline-valuation-and-future?source=yahoo
VRTX has 2 competitors in Hep C field:
Biotech, Hepatitis C, Drugs
Vertex Stock Drops 17% Over Two Days, As Potent Hep C Rivals Emerge
Luke Timmerman 11/8/11
Cambridge, MA-based Vertex Pharmaceuticals has seen its stock take a whopping 17 percent hit in the past two days at a scientific meeting, as investors have had time to think about the implications of new clinical trial data from a couple of competitors in the hepatitis C field.
Vertex (NASDAQ: VRTX) saw its stock tumble from $36.63 at Friday’s close to $30.41 at today’s close—a 17 percent drop over two days of trading—as investors absorbed a flurry of news stories at the annual meeting of the American Association for the Study of Liver Disease (AASLD) in San Francisco. Vertex’s decline coincided with a boost in the stocks of of Alpharetta, GA-based Inhibitex (NASDAQ: INHX) and Princeton, NJ-based Pharmasset (NASDAQ: VRUS).
Vertex has been the reigning king of hepatitis C for the past year. Its protease inhibitor drug telaprevir (Incivek) was FDA approved as a new treatment that boosts cure rates to almost 80 percent, while shortening the time people need to take interferon and ribavirin, a standard combination that causes significant side effects. The company has handily beaten Wall Street sales estimates for its first couple quarters on the market, and turned profitable, while fending off competition from a protease inhibitor from Merck (NYSE: MRK). But researchers are pushing hard now to fight hepatitis C with a combination of new antiviral medicines, much like how HIV is controlled, and Vertex’s existing drug could end up being less important over time than other treatments.
Pharmasset, which is developing a nucleotide polymerase inhibitor, saw its stock climb at the meeting when it said its drug had cured all 40 patients in a clinical trial. Importantly, the Pharmasset drug produced cures whether patients got interferon or not—and although the number of patients was small, it would be a big advantage if Pharmasset’s drug could eliminate the need for interferon. The company is still at least a couple years away from challenging Vertex on the market, but analysts see this new drug and potentially another one from Inhibitex as becoming potent new options that might be able to reach a goal that has so far eluded Vertex—the elimination of interferon, and the flu-like symptoms it causes, from the standard treatment regimen for hepatitis.
Thomas Russo, an analyst with Robert W. Baird, downgraded Vertex to “neutral” today after going over the results from the liver meeting. One of the bullet points in his note today was headlined “AASLD event reveals Vertex itself uncertain, lacking convincing strategy to defend position 2014+.”
Russo said he applauded Vertex management for “sincere, credible” comments about how Pharmasset may have changed the hepatitis C paradigm, but he isn’t sure Vertex can fend off the challenge through its own internal development, or through an acquisition.
“We remain positive on cystic fibrosis catalysts in the first half of 2012, but investors first need confidence in the HCV floor, and we’ve lost conviction this stock can “thread the needle” in an environment of new uncertainty (and resignation?) coming from the company itself,” Russo wrote.
Besides the nucleotide inhibitors in the works, other pharma companies are developing so-called non-nucleoside inhibitors as a third class of antiviral medicine that could go into combinations. Roche recently agreed to acquire San Diego-based Anadys Pharmaceuticals (NASDAQ: ANDS) for $230 million to get its “non-nuc,” while Abbott Laboratories is also pursuing a drug in that category.
http://www.xconomy.com/boston/2011/11/08/vertex-stock-drops-17-past-two-days-as-potent-hep-c-rivals-emerge/
9:35AM Vertex Pharm: Phase 3 study of KALYDECO in children ages 6 to 11 with a specific type of cystic fibrosis showed significant improvements in lung function and other measures of disease sustained through 48 weeks (VRTX) 37.28 -0.38 : Results from ENVISION showed that children who received KALYDECO experienced rapid and sustained improvements in lung function and other key measures of disease, including weight gain and a reduction in sweat chloride, throughout the 48-week study compared to those treated with a placebo. Patients in the study who received KALYDECO experienced a mean absolute improvement from baseline in lung function of 12.5 percentage points through week 24 and a mean relative improvement from baseline in lung function of 17.4 percent compared to placebo. Through 48 weeks, the mean absolute improvement in lung function for children treated with KALYDECO was 10 percentage points compared to placebo and the relative mean improvement was 15.1 percent from baseline compared to placebo. Phase 3 results and product labeling for currently available CF medicines generally describe relative improvements in lung function. The most commonly reported adverse events were respiratory in nature and comparable across treatment groups
Either CBS or NBC evening news had a nice segment on use of K to treat CF. I did not see VRTX identified. Patients were interviewed and expressed great improvement within a couple days of treatment inception, particularly ease of breathing.
5:09PM Vertex Pharm: New England Journal of Medicine publishes data from Phase 3 STRIVE study of KALYDECOTM in people ages 12 and older - Study shows that treating CF by targeting the underlying cause of the disease leads to significant clinical benefits (VRTX) 36.90 -0.88 : Co announced that the New England Journal of Medicine published data from a Phase 3 study of KALYDECO, a medicine in development that targets the defective protein that causes cystic fibrosis. In this study, called STRIVE, people with CF ages 12 and older with at least one copy of the G551D mutation who were treated with KALYDECO experienced significant improvements in lung function and other measures of disease. Improvements in lung function were seen as early as week two and were sustained throughout the 48-week study. The most commonly reported adverse events were respiratory in nature and comparable across treatment groups. Data from STRIVE will be published along with an accompanying editorial in the November 3, 2011 issue of NEJM.
Zacks Industry Outlook Highlights: Vertex Pharma, AstraZeneca, Abbott Labs, Allergan and Onyx Pharmaceuticals
For Immediate Release
Chicago, IL – September 23, 2011 – Today, Zacks Equity Research discusses the Pharmaceuticals, including Vertex Pharma (NasdaqGS: VRTX - News), AstraZeneca (NYSE: AZN - News), Abbott Labs (NYSE: ABT - News), Allergan (NYSE: AGN - News) and Onyx Pharmaceuticals (NasdaqGS: ONXX - News).
A synopsis of today’s Industry Outlook is presented below. The full article can be read at http://www.zacks.com/stock/news/61553/Pharmaceuticals+Stock+Outlook+-+Sept.+2011
Emerging markets are slowly and steadily gaining in importance, and several companies are now shifting their focus to these areas. Emerging markets should see strong sales thanks to increased demand for medicines. Several factors like government initiatives for healthcare, new patient population, and increasing use of generics should help drive demand. Growth in emerging markets could help stabilize the base business during the industry's 2010-15 patent cliff.
According to the IMS Institute, spending on medicines in emerging markets will double to $285-$315 billion in the next five years from $151 billion in 2010, driven by strong economic growth coupled with endeavors of concerned governments to expand access to healthcare. This will catapult "pharmerging" markets to the second position by 2015 where spending on medicines is concerned.
Branded Drugs Market Share to Decline
According to the IMS Institute, market share for branded drugs will continue declining over the next five years. Branded drugs market share, which declined from 70% in 2005 to 64% in 2010, is expected to decline to 53% by 2015. The decline will be driven by patent expiries, with generics accounting for a significant part of pharma spending. Spending on branded medicines in 2015 is expected to remain at the same level as in 2010.
OPPORTUNITIES
We currently have a Neutral outlook on large-cap pharma stocks (Zacks #3 Rank). While the companies will continue to face challenges like pricing pressure and genericization, growth in emerging markets and product approvals could help reduce the impact.
According to the IMS Institute, 44 new branded products were launched in 2010. However, the new product approval mix was more towards orphan drugs and medicines with the same mechanism of action as existing therapies.
Important product approvals in 2011 so far include the approval of Johnson & Johnson's prostate cancer therapy, Zytiga, Merck's hepatitis C virus (HCV) treatment, Victrelis, Bristol-Myers Squibb's melanoma treatment, Yervoy, and kidney transplant therapy Nulojix, Vertex Pharma's (NasdaqGS: VRTX - News) HCV treatment, Incivek and AstraZeneca’s (NYSE: AZN - News) blood thinner Brilinta, among others.
We currently have Neutral recommendations on companies like Abbott Labs (NYSE: ABT - News), Johnson & Johnson, Allergan (NYSE: AGN - News) and Pfizer. We believe that Allergan's presence across different segments and geographies will help maintain decent growth going forward.
In spite of the Neutral stance on the stock, we are positive on Bristol-Myers. Earnings estimates have been upped by majority of the analysts covering the stock after its strong second quarter results. 2011 has been a fruitful year for Bristol-Myers so far, with many key drugs getting approved. Growth in the coming quarters is expected to be driven by new product launches and acquisitions and deals.
WEAKNESSES
We recommend avoiding names that offer little growth or opportunity for a take-out. These include companies which are developing drugs that are likely to face regulatory hurdles. The US Food and Drug Administration (FDA) has been exercising more caution in granting approval to new products and several candidates are facing delays in receiving final approval.
We advise investors to avoid names such as Onyx Pharmaceuticals (NasdaqGS: ONXX - News) on which we have an Underperform recommendation. The company delivered lackluster results in the second quarter of 2011 due to lower revenues and higher operating expenses.
Zacks "Profit from the Pros" e-mail newsletter provides highlights of the latest analysis from Zacks Equity Research. Subscribe to this free newsletter today by visiting http://at.zacks.com/?id=2679.
7:35AM Vertex Pharm provides Interim Data from Phase 2 Study (VRTX) 49.45 : Co announces interim results from ZENITH, an ongoing Phase 2 study designed to assess the safety, tolerability and efficacy of multiple 12- and 24-week response-guided treatment regimens with VX-222, its lead polymerase inhibitor in development, in combination with INCIVEK tablets, pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment. This is an interim analysis from patients in the four-drug treatment arms and was conducted after these patients completed their assigned treatment. Results showed that 50% of people in the study who received VX-222 in combination with INCIVEK, pegylated-interferon and ribavirin were eligible to stop all treatment at week 12, and 93 percent of these patients had undetectable hepatitis C virus 12 weeks after treatment ended. Patients from the VX-222 treatment arm who were not eligible to stop all treatment at week 12 received an additional 12 weeks of pegylated-interferon and ribavirin alone for 24 total weeks of treatment. The hepatitis C virus was undetectable in 100% of these patients at the end of 24 weeks. In this study, VX-222, INCIVEK and ribavirin were given twice daily. Interim safety results from the four-drug treatment arms showed that mild gastrointestinal symptoms and mild fatigue were the most frequently reported adverse events. Side effects consistent with the known safety profile of INCIVEK combination treatment also were observed.
Vertex Pharmaceuticals
Reporting date: July 28, after market close.
Current consensus: Net loss of 95 cents a share on total revenue of $53.67 million.
The launch of Vertex's hepatitis C drug Incivek (and how well it competes against Merck's Hep C drug Victrelis) is a big-ticket event for the second-quarter earnings season.
It's hard to nail down one agreed-upon consensus estimate for Incivek U.S. sales during the second quarter. Vertex's own sell-side analyst survey came back with $21 million, but Thomson Reuters is at $23 million and Bloomberg is at $42 million. Some sell-side analysts have not published second-quarter estimates for Incivek sales, which explains the discrepancy.
Institutional investors surveyed last week expect Incivek sales of $35 million in the quarter, according to ISI Group biotech analyst Mark Schoenebaum, who conducted the survey of 224 investors, of which 25% were from long/short funds.
http://www.thestreet.com/story/11187316/3/5-biotech-drug-launch-stocks-to-watch.html
Vertex Pharmaceuticals (VRTX) and Alios BioPharma announced an exclusive worldwide licensing agreement that will add two distinct nucleotide analogues to Vertex's hepatitis C portfolio.
11:00AM Vertex Pharm reports Phase 3 STRIVE Study of VX-770 showed durable improvements in lung function and other measures of disease among people with a specific type of cystic fibrosis (VRTX) 48.53 +0.48 : Co 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. 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.
VRTX down $5 to $48 with data on fibrosis
Minyanville > Markets
Vertex Sinks on Cystic Fibrosis Study
By Brett Chase Jun 09, 2011 1:30 pm
The stock is oversold after a combination therapy for the chronic lung disease doesn't meet investors' expectations.
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VRTX 47.96 -5.18 (-9.75%)
MRK 35.96 +0.17 (+0.47%)
The Vertex Pharmaceuticals (VRTX) press release this morning seemed to deliver promising news for cystic fibrosis patients. Two drugs in development were shown to attack the genetic cause of the chronic lung disease and were generally safe for the patients.
"These data open the door to the possibility of treating people with the most common form of cystic fibrosis by using two medicines together that target the defective protein that causes the disease," Vertex’s chief scientist Peter Mueller says in a statement.
The problem is the results don’t show a highly effective outcome and that’s why investors are selling off the shares today.
In midday trading, the stock is down 10% to $47.87 a share. It was down even more in earlier trading. The stock is up by more than a third this year on hopes for the company’s recently approved drug Incivek for hepatitis C. That drug is a potential blockbuster and it is, by far, the biggest catalyst for the stock. (See Vertex’s Hepatitis C Drug Approved.)
As for cystic fibrosis, Vertex expects to file an application later this year to sell one of its experimental drugs, VX-770, as a stand-alone treatment. Approval of that drug could be worth about $7 a share, estimates Robert W. Baird analyst Thomas Russo.
The company hopes to prove that it can treat a broader patient population by combining two of its cystic fibrosis drug candidates, VX-770 and VX-809. The study of that drug combination is in the middles stages of human trials. While the disappointing results of the study are hitting the stock hard, the shares may be oversold.
Russo recommends buying Vertex shares but not because he thinks the combination of those two developmental drugs will be a success.
“A longer-term view can find some encouraging data points here, but that requires patience and some leaps of faith,” Russo says of the Vertex study results released Thursday.
Rather, Russo points to the more likely near-term approval of VX-770 and the successful launch of Incivek. Vertex faces competition from Merck’s (MRK) rival drug Victrelis, which was approved for sale in the US the same week as Incivek.
Russo sets a 12-month price target of $62 a share for Vertex based mostly on Incivek’s success but partly on VX-770.
He’s not alone among analysts. Two other bullish analysts weighed in on the sell-off.
Leerink Swann analyst Howard Liang reiterated his buy recommendation with a $66 price target over the next 12 months.
RBC Capital Markets analyst Jason Kantor also recommends buying the shares and has a $59 price target. Kantor’s price target is based solely on Incivek and VX-770.
Date Research Firm Action From To
May 24, 2011 MP Advisors Downgrade Outperform Market Perform
May 4, 2011 Brean Murray Downgrade Buy Hold
Feb 24, 2011 Wedbush Upgrade Neutral Outperform
Jan 28, 2011 Brean Murray Initiated Buy
Oct 7, 2010 Dawson James Initiated Buy
Sep 8, 2010 JMP Securities Downgrade Mkt Outperform Mkt Perform
May 26, 2010 Wedbush Upgrade Underperform Neutral
May 26, 2010 Mehta Partners Upgrade Market Perform Outperform
May 4, 2010 Mehta Partners Initiated Market Perform
Apr 12, 2010 JP Morgan Downgrade Overweight Neutral
Vertex: With New Drug Approval Shares May Still Have Room to Run
http://seekingalpha.com/article/272523-vertex-with-new-drug-approval-shares-may-still-have-room-to-run?source=yahoo
7:03AM Vertex Pharm interim Phase 2 data showed a combination of VX-770 and VX-809 improved function of the defective protein that causes cystic fibrosis in people with the most common form of the disease (VRTX) 53.14 : Co announces interim results from the first part of a Phase 2 study designed to evaluate multiple combination regimens of VX-770 and VX-809, Vertex's lead medicines in development that aim to treat the defective protein that causes cystic fibrosis. The first part of the study met its two primary endpoints: (1) safety and tolerability of the combination regimen and (2) the effect of the combination of VX-770 and VX-809 on CFTR function as measured by sweat chloride, a key measure of the function of the CFTR protein. There were no serious adverse events reported, and the adverse event profile during the combination-dosing portion of the study (Day 14 to Day 21) was similar to that during the VX-809 monotherapy-dosing portion (Day 0 to 14). In the arm that evaluated VX-809 (200 mg) followed by dosing of VX-770 (250 mg) in combination with VX-809, a statistically significant reduction in sweat chloride of -13.17 mmol/L (p<0.001) was observed from baseline (Day 0) through Day 21. In this arm, a -9.10 mmol/L (p<0.001) reduction was observed after VX-770 (250 mg) was added to VX-809 (200 mg) for seven days (Day 14 to 21). Vertex intends to initiate the second part of this study in the fourth quarter of 2011 after the completion of further analyses of data from Part 1. The most commonly reported adverse events were respiratory in nature and occurred in approximately half of people across all arms of the study. One person receiving VX-809 in the monotherapy portion of the study discontinued treatment due to an increase in respiratory symptoms during the first 7 days of the study.
FDA approves Victrelis (boceprevir) with broad label:
#msg-63098013
Obviously not the best outcome for VRTX.
sorry a tad trigger happy lol,am sure it will
Not yet, but I'm sure it will be approved soon.
VRTX Hep C drug approved
http://www.pharmiweb.com/Features/feature.asp?ROW_ID=1354
Vertex Pharm VRTX Dawson James Buy $48 » $67
Read more: http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm#ixzz1LTtNpTTC
Good time to take some chips off the table, IMO: #msg-62454465.
That post is already a bit out of date even though it’s only a month old. Things change quickly in the HCV arena :- )
Two new hep C drugs garner rave reviews ahead of approval
March 31, 2011 — 11:27am ET | By John Carroll
* Merck scoots past Vertex in blockbuster race for hep C drug approval
* Merck's boceprevir scores high in PhIII hep C trial
* Schering-Plough posts positive hep C data
* Vertex boosted by new round of promising telaprevir data
* Vertex trims a telaprevir study from its slate of hep C work
There are no sure things in drug development, but physicians across the country are clearly waiting in expectation of the near-term approval of two new hepatitis C drugs--telaprevir and boceprevir--which promise to revolutionize treatment of the disease. And that bodes well for Vertex and Merck, which developed two of the hottest drug prospects now up for an approval.
While most developers facing an FDA decision go through a nail-biting episode of extreme uncertainty, Vertex and Merck are being treated to a pre-approval round of celebratory reports in a host of media outlets.
"This is opening up a new door" for treatment of hepatitis C, Dr. Raymond Koff of the University of Connecticut School of Medicine tells the Los Angeles Times. Dr. Stuart Gordon, a hepatitis C researcher at Detroit's Henry Ford Hospital, tells the Detroit Free Press that the two drugs represent "a major advance in the cure of a very common disease."
The rave reviews are likely to help pave a short path to blockbuster sales for the two companies. With patients and physicians anxiously awaiting approval, the initial demand for both therapies will be strong.
- read the story from the Los Angeles Times
- here's the report from the Detroit Free Press
Related Articles:
Vertex boosted by new round of promising telaprevir data
Vertex wins an expedited review of telaprevir app
Merck scoots past Vertex in blockbuster race for hep C drug approval
Merck's boceprevir scores high in PhIII hep C trial
TMC435 phase-2b results look good: #msg-60210162. This is shaping up to be the most consequential second-generation competition to Telaprevir.
8:01AM Vertex Pharm: Phase 3 Study of VX-770 Shows Marked Improvement in Lung Function Among People with Cystic Fibrosis with G551D Mutation (VRTX) 38.22 : The Cystic Fibrosis Foundation and Vertex Pharmaceuticals announced today that VX-770, an oral medicine in development that targets the defective protein that causes cystic fibrosis, showed promising results in a Phase 3 clinical trial. The trial was designed to evaluate patients age 12 and up who carry at least one copy of a CF mutation called G551D. The study included 161 patients who received at least one dose of VX-770 or placebo. Patients who took the drug, compared to those on placebo, showed a marked improvement in lung function at 24 weeks, which was sustained for the duration of the 48-week trial. Patients also showed improvement across all key secondary endpoints in the study, including reduced likelihood of experiencing a pulmonary exacerbation, decreased respiratory symptoms and improved weight gain. Each of these areas is critically important to the health of people with CF.
7:03AM Vertex Pharm says Phase 3 ILLUMINATE study supports 24-week Telaprevir-based therapy within a response-guided regimen for people with hepatitis C who had not received prior treatment (VRTX) 37.00 : Co announces results from the Phase 3 ILLUMINATE study, which was designed to evaluate whether there was any benefit to extending therapy from 24 to 48 weeks in people whose hepatitis C virus was undetectable at weeks 4 and 12 of treatment. The safety and tolerability profile of the telaprevir-based regimen was consistent with results reported previously from the pivotal Phase 3 ADVANCE study.
#msg-52470566 is modestly bullish for VRTX, among other companies. Regards, Dew
Vertex: A New Era In HCV Drug Development
http://seekingalpha.com/article/215184-vertex-a-new-era-in-hcv-drug-development?source=yahoo
Here’s a handy table of the phase-3 results: #msg-50595752.
Regards, Dew
4:03PM Vertex Pharm: 75% of treatment-naive patients with chronic hepatitis C achieve SVR (Viral Cure) with Telaprevir-Based treatment in phase 3 trial (VRTX) 33.94 -0.31 : Co announced that 75% of people chronically infected with genotype 1 hepatitis C virus achieved a sustained viral response after receiving a 12-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone, in the Phase 3 ADVANCE trial. The safety and tolerability profile of telaprevir in the ADVANCE trial was consistent with the profile reported in Phase 2 studies, with an improvement in treatment discontinuation rates due to adverse events
4:13PM Vertex Pharm beats by $0.10, misses on revs (VRTX) 39.35 -1.15 : Reports Q1 (Mar) loss of $0.70 per share, $0.10 better than the Thomson Reuters consensus of ($0.80); revenues fell 6.7% year/year to $22.4 mln vs the $29.7 mln consensus. Vertex Pharm reaffirmed its 2010 non-GAAP net loss of ~$600 million, as provided on Feb 4, 2010.
Vertex Broadens its Commitment to Improving HCV Care with Clinical Trial to Evaluate Combination Regimens Based on Oral Antiviral Therapies
-Trial will evaluate safety and SVR rates with multiple 12-week response-guided regimens of telaprevir/VX-222-based combination therapy, including two-drug regimens of telaprevir and VX-222-
-Interim clinical data expected in the second half of 2010-
-Multiple clinical trial sites in the U.S. to enroll patients-
Press Release Source: Vertex Pharmaceuticals Incorporated On Monday March 1, 2010, 7:30 am
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that it is initiating the first clinical trial evaluating Vertex’s lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, dosed in combination with the company’s lead investigational HCV polymerase inhibitor, VX-222. This Phase 2 trial will evaluate sustained viral response rates (SVR; defined as undetectable HCV RNA 24 weeks after the end of treatment) using multiple 12-week response-guided regimens of telaprevir/VX-222-based combination therapy, including two-drug regimens that contain only telaprevir and VX-222. The trial is expected to enroll approximately 100 treatment-naïve genotype 1 HCV patients at multiple clinical trial sites, the majority of which will be located in the U.S. Enrollment is expected to be completed in the second quarter of 2010. Vertex expects to obtain interim clinical data, including safety and viral kinetic data, from this trial in the second half of 2010.
“Vertex is committed to improving patient care in HCV, and the announcement of this clinical trial combining two oral agents, telaprevir and VX-222, signifies our first exploration into this combination regimen’s potential role to further improve the treatment of HCV,” said Peter Mueller, Ph.D., Vertex’s Chief Scientific Officer and Executive Vice President, Global Research and Development.
“The completion of the Phase 3 development program for telaprevir remains our primary focus, and we are on track to submit a New Drug Application for telaprevir in the second half of 2010. We believe telaprevir could represent a significant opportunity to improve the treatment of HCV, and simultaneously, we are focused on evaluating additional opportunities to potentially enhance HCV therapy even more in the years ahead using novel combination regimens based on oral antiviral agents. We believe the trial announced today will inform the development path for telaprevir/VX-222-based combination therapy, and we look forward to obtaining the first clinical data from the trial later this year,” continued Dr. Mueller.
About the Phase 2 Trial of Telaprevir and VX-222
The randomized, parallel-group, dose-ranging trial announced today is designed to evaluate the safety and antiviral activity, including SVR, of multiple 12-week response-guided telaprevir/VX-222-based combination regimens. The primary endpoint of this trial is to assess safety and tolerability of telaprevir/VX-222-based combination therapy. A secondary endpoint of this study is to assess the proportion of patients in each study arm who achieve SVR. The trial is expected to enroll approximately 100 treatment-naïve genotype 1 HCV patients at approximately 20 clinical trial sites, predominantly in the U.S. Vertex expects to complete enrollment for the trial in the second quarter of 2010. The trial will consist of four arms, as noted below:
12-Week Treatment Regimens Patient Enrollment
Telaprevir (1125 mg BID) + VX-222 (100 mg BID) 25
Telaprevir (1125 mg BID) + VX-222 (400 mg BID) 25
Telaprevir (1125 mg BID) + VX-222 (100 mg BID) + peg-IFN + RBV 25
Telaprevir (1125 mg BID) + VX-222 (400 mg BID) + peg-IFN + RBV 25
BID = twice daily, peg-IFN = pegylated interferon, RBV = ribavirin
Response-Guided Trial Design
The trial will utilize response-guided criteria aimed at evaluating shorter-duration treatment regimens. All patients, regardless of treatment group, whose HCV RNA levels are undetectable (<10 IU/mL) at week 2 and week 8 of treatment, will stop their assigned treatment at week 12. Patients who do not meet these criteria will complete their assigned treatment and at week 12, those in the dual-drug regimen will receive follow-on therapy of 24 weeks of pegylated-interferon (peg-IFN) and ribavirin (RBV), for a total of 36 weeks of treatment. Patients in the quad-therapy regimens who do not meet these criteria at week 12 will receive an additional 12 weeks of follow-on therapy with peg-IFN and RBV for a total of 24 weeks of peg-IFN and RBV therapy.
Potential Additional Arms of Telaprevir/VX-222-based Combination Treatment
Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm.
Recent Clinical Trials Support Evaluation of Telaprevir/VX-222-based Combination Regimens
Phase 1b/2a Clinical Trial of VX-222 in HCV Patients
Interim clinical results from a two-part Phase 1b/2a clinical trial of VX-222 showed that in the multiple-dose Phase 1b viral kinetic portion of the trial (Part A), VX-222 was well-tolerated across four VX-222 dose groups with no serious adverse events reported. Part A enrolled 32 genotype 1 HCV patients to receive three days of dosing, and a mean HCV RNA decline of greater than 3 log10 was observed across all four VX-222 dose groups. An increasing dose response was observed across the four dose groups, with the results with 500 mg and 750 mg BID, and 1500 mg QD (once-daily) being very similar. The mean HCV RNA decline achieved after three days of dosing with 250 mg, 500 mg, and 750 mg of VX-222 every 12 hours (q12h) was 3.1 log10, 3.4 log10, and 3.2 log10, respectively. Additionally, the mean HCV RNA decline achieved after three days of dosing with 1500 mg of VX-222 every 24 hours (QD) was 3.4 log10. For patients who received placebo, the mean HCV RNA decline after three days of dosing was 0.1 log10. The majority of the patients enrolled in Part A had genotype 1a chronic HCV infection. Full results including the final safety analysis from Part A of this trial are expected to be presented at a medical meeting in 2010.
The interim results of Part A of this trial are consistent with the findings from a previously-conducted three-day, five-patient viral kinetic study of VX-222. Part B of the study, which will be initiated shortly will evaluate 12 weeks of VX-222 dosed in combination with peg-IFN and RBV in treatment-naïve HCV patients.
Drug-Drug Interaction Study of Telaprevir and VX-222 in Healthy Volunteers
Vertex also recently completed a Phase 1 study of telaprevir and VX-222 designed to evaluate the safety, tolerability and drug-drug interaction of telaprevir and VX-222 in approximately 20 healthy volunteers. In the study, the 10-day telaprevir/VX-222-based combination regimens were well-tolerated with no serious adverse events reported.
In this study, an increase in the plasma exposure of VX-222 was observed when dosed in combination with telaprevir, while the plasma exposure of telaprevir was not affected when dosed in combination with VX-222. Based on this observation, Vertex selected VX-222 doses of 100 mg twice-daily BID and 400 mg BID for evaluation in the Phase 2 trial of telaprevir/VX-222-based combination therapy announced today. The VX-222 doses of 100 mg BID and 400 mg BID are expected to provide plasma exposures similar to those observed with doses of 250 mg BID and 750 mg BID, respectively, in the previously conducted viral kinetic studies of VX-222 monotherapy in HCV patients.
The results of both the three-day viral kinetic study of VX-222 and the drug-drug interaction study of telaprevir/VX-222-based regimens support the Phase 2 combination trial of telaprevir and VX-222 in HCV patients, as announced today.
i happen to find this on:
Found this newsletter on www.otcstockreview.com/cpbm.htm
Hepatitis C stocks:
Cyplasin Biomedical Ltd. (OTCBB: CPBM)Human Genome Sciences (NASDAQ: HGSI)Idenix Pharmaceuticals (NASDAQ: IDIX)Intermune (NASDAQ: ITMN)Schering-Plough (NYSE: SGP)ViroPharma (NASDAQ: VPHM)Vertex Pharmaceuticals (NASDAQ: VRTX)
8:09AM Vertex Pharm Announces Results from Phase 2a Trial of VX-809; was well-tolerated at all dose levels when dosed once daily for 28 days (VRTX) 40.49 : Co announces results from a preliminary analysis of data from a 28-day Phase 2a clinical trial of VX-809 in patients with cystic fibrosis who are homozygous for the F508del mutation. VX-809, an oral investigational Cystic Fibrosis Transmembrane Conductance Regulator protein corrector, was well-tolerated across all four dose groups studied. In the trial, VX-809 showed a statistically significant decline in sweat chloride at both the 100 mg and 200 mg once-daily doses, suggesting that the activity of the CFTR protein was increased in patients during dosing. Additionally, VX-809 demonstrated a dose response in change in sweat chloride across the four dose groups. On the basis of these results, Vertex plans to initiate a combination trial of VX-809 and VX-770, an investigational CFTR potentiator, in the second half of 2010. VX-809 and VX-770 were developed with support from Cystic Fibrosis Foundation Therapeutics, Inc., the nonprofit affiliate of the Cystic Fibrosis Foundation.
Vertex Pharm VRTX Oppenheimer upgraded today from Perform to Outperform $47
Time to get in on a new up and coming Hep C product.
Check out news from jan.13. on cpbm pink sheet.
1:28AM Vertex Pharma reviews 2010 business priorities (VRTX) 40.67 : Co provides an update on key 2010 business priorities in conjunction with the J.P. Morgan Healthcare Conference. Co also discusses recent progress in its lead development programs in hepatitis C virus infection and cystic fibrosis and outlined proof-of-concept clinical trials planned in other serious diseases for 2010. HCV: New Drug Application planned for telaprevir in second half of 2010, commercialization and launch preparedness activities ongoing. Cystic Fibrosis: Advancing development efforts in orphan disease of cystic fibrosis; Phase 3 STRIVE trial with VX-770 completes planned enrollment, VX-809 Phase 2 data expected in first quarter 2010. Pipeline: Proof-of-concept clinical trials planned for 2010 with novel combination regimens for hepatitis C and cystic fibrosis and with compounds for rheumatoid arthritis and epilepsy.
8:40AM Vertex Pharm downgraded to Underperform at Wedbush Morgan; tgt $45 (VRTX) 44.24 : Wedbush Morgan downgrades VRTX to Underperform from Neutral and sets target price at $45. The firm believes that the recent run of the stock to the $43 range leaves limited upside to their price target of $45.
CAMBRIDGE, Mass. (TheStreet) -- Vertex Pharmaceuticals'(VRTX Quote) experimental hepatitis C drug telaprevir was the star of last week's big hepatitis C research meeting, according to a well-respected doctor in the field who briefed institutional investors this afternoon.
* More from Adam Feuerstein
* Blood Cancer Meeting Abstracts Released: BioBuzz
* Bristol Licenses Arthritis Drug: BioBuzz
* Celgene in ASH Abstract Spotlight: BioBuzz
* Xoma Waffles on Timing of Drug Partnership: BioBuzz
* Ariad Upgraded, Xenoport Drug Delayed: BioBuzz
* Oculus, Bianco and Cel-Sci Oh My!: BioBuzz
* Biotech Stock Mailbag: Poniard Predictions
* BioCryst Competition for IV Flu Drug: BioBuzz
* BioCryst Winners and Losers: BioBuzz
* Cel-Sci's Lawyer Speaks: BioBuzz
* Market Activity
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InterMune Incorporated| ITMN
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Human Genome Sciences Inc.| HGSI
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Pharmasset Incorporated| VRUS
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Dr. Stefan Zeuzem of the Saarland University Hospital in Germany was the featured speaker on an investor conference call sponsored by JMP Securities Monday. JMP analyst Liisa Bayko asked Zeuzem to offer his thoughts on the hits and misses coming from last week's annual meeting of the American Association for the Study of Liver Disease.
Zeuzem is a key opinion leader in Hep C, works with most if not all of the experimental drugs in clinical trials, and is therefore widely sought out by professional investors for insights into what's working -- or what's not -- in Hep C drug development.
Among Zeuzem's comments on Monday's conference call:
* Data from Vertex's telaprevir was the most important and discussed during the meeting. The high cure rates seen in the so-called C208 study of treatment-experienced patients were probably as high as the field will ever see with a protease inhibitor. Zeuzem also called the data on twice-daily dosing of telaprevir "convincing," but he's still cautious and would like to see additional, confirmatory data from a larger study.
* The Hep C field is moving quickly to test treatment with two direct anti-virals against the Hep C virus, and hopefully eliminate the need for long-acting interferon and ribavirin -- the current standard of care for the disease.
Zeuzem was impressed with the two-week antiviral activity shown in the so-called INFORM-1 study in both treatment-naïve and treatment-experienced patients. This study treats patients with a combination of InterMune's(ITMN Quote) RG7227 and Pharmasset's(VRUS Quote) RG7128. (The study is being co-sponsored by Roche, which co-owns development rights to both drugs.)
He also noted that other companies, including Vertex and Bristol-Myers Squibb(BMY Quote), plan to begin their own two-drug direct anti-viral combi
Partnership with JJ pushed price higher!
Vertex Pharm VRTX Deutsche Securities started with a Buy rating with $39 price target
Vertex Hep C Drug Improves Cure Rates
By Adam Feuerstein 10/28/09 - 07:01 AM EDT
CAMBRIDGE, Mass. (TheStreet) -- Vertex Pharmaceuticals(VRTX Quote) released additional clinical data Wednesday demonstrating the potential for its experimental hepatitis C drug telaprevir to significantly improve the cure rates in patients who failed prior treatment.
Vertex Pharmaceuticals Incorporated| VRTX
UP
Interim data from an ongoing phase II study showed that treatment with a telaprevir-based regimen resulted in rates of sustained viral responses (SVR), or hepatitis C cures, ranging from 55% to 90% across four different patient groups, all of whom failed to respond to prior therapy to varying degrees.
To put these results in perspective, last March, Vertex presented data from a different phase II study that treated patients who also failed prior therapies. In that study, 55% of patients re-treated with a telaprevir-containing regimen achieved an SVR, or cure, compared with 14% of patients who were re-treated with current standard of care.
The new data released Wednesday, therefore, appear to bolster Vertex's claim that telaprevir can improve the cure rate for even the most difficult-to-treat patients -- those who don't respond to standard hepatitis C therapy of long-acting interferon and ribavirin.
Vertex Set to See More Volatility on Hepatitis Drug Data Release
http://seekingalpha.com/article/158135-vertex-set-to-see-more-volatility-on-hepatitis-drug-data-release?source=yahoo
Vertex Pharmaceuticals Reports Second Quarter 2009 Financial Results and Highlights Recent Clinical Progress and Business Development Activity
- Telaprevir Phase 3 registration program in hepatitis C on track; NDA submission anticipated in second half of 2010 -
- Vertex advancing two drug candidates aimed at the underlying disease mechanism of the orphan disorder cystic fibrosis -
- Vertex ends second quarter with $754 million of cash, cash equivalents and marketable securities; Vertex will add to this position with $105 million of cash through an amended agreement with Mitsubishi Tanabe Pharma Corporation -
Press Release
Source: Vertex Pharmaceuticals Incorporated
On Wednesday August 5, 2009, 4:01 pm EDT
Companies:Vertex Pharmaceuticals Incorporated
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today reviewed recent business and clinical progress and reported consolidated financial results for the quarter ended June 30, 2009.
“Our top priority is to execute on the telaprevir Phase 3 registration program in hepatitis C and to prepare for a New Drug Application submission in the second half of 2010,” said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex Pharmaceuticals. “Beyond HCV, we are now conducting a comprehensive program in cystic fibrosis - a life-threatening orphan disorder - with two novel therapies that target the underlying disease mechanism. With the advancement of our pipeline and continued research productivity, we are moving closer to fulfilling our corporate vision of building a profitable, fully-capable biopharmaceutical company focused on improving patient outcomes in areas of serious unmet medical need.”
Mr. Emmens continued, "Vertex enters the second half of 2009 in a strong financial position that will enable continued investment into late-stage development opportunities for HCV and CF and into product creation from research. We continue to closely manage our cash investment in the Company and will add $105 million to our financial position through an amended agreement with Mitsubishi Tanabe for the development and commercialization of telaprevir in Asia.”
Broad Commitment to Hepatitis C
Telaprevir Phase 3 registration program on track
Treatment-naïve Phase 3 trials
Vertex is conducting the Phase 3 ADVANCE study, which is evaluating the hepatitis C virus (HCV) protease inhibitor telaprevir, or placebo, as part of a 24-week combination regimen with pegylated interferon (peg-IFN) and ribavirin (RBV) in more than 1,050 genotype 1 treatment-naïve HCV patients. Based upon the completion of enrollment in October 2008, the telaprevir dosing portion of the ADVANCE trial is complete, and all patients are now beyond week 24 of the study. Patients receiving telaprevir-based regimens in the ADVANCE study will receive 24 or 48 weeks of total therapy, depending on whether they have undetectable virus levels at weeks 4 and 12 of treatment. The ADVANCE trial will remain blinded through the last patient completing week 72 in the study. The Company expects sustained viral response (SVR) 24 data to become available from ADVANCE in the first half of 2010.
Vertex is also conducting ILLUMINATE, a global two-arm trial that is evaluating response-guided telaprevir-based regimens in approximately 500 genotype 1 treatment-naïve HCV patients. This trial is designed to supplement SVR data obtained from the pivotal Phase 3 ADVANCE trial. The aim of the ILLUMINATE trial is to characterize whether there is an additional benefit to extending treatment from 24 to 48 weeks in treatment-naïve patients who achieved undetectable virus levels at weeks 4 and 12 of treatment (eRVR). Based upon the completion of enrollment in January 2009, the telaprevir dosing portion of the ILLUMINATE trial is complete, and all patients are now beyond week 24 of the study. The Company expects SVR24 data to become available from ILLUMINATE in the first half of 2010.
Treatment-failure Phase 3 trial
Vertex’s collaborator Tibotec is conducting the Phase 3 REALIZE trial, which is evaluating treatment with telaprevir-based regimens in more than 650 patients with genotype 1 HCV who did not achieve an SVR with a previous peg-IFN-based treatment, and which enrolled all major treatment-failure groups including null responders. Based upon the completion of enrollment in February 2009, the telaprevir dosing portion of the REALIZE trial is complete, and all patients are now beyond week 20 of the study. The Company expects SVR24 data to become available from REALIZE in mid-2010.
Telaprevir twice-daily evaluation
Vertex expects that final SVR24 data from Study C208, which is evaluating twice-daily telaprevir dosing, will be presented at a Presidential Plenary session at the upcoming Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Oct. 30 - Nov. 3 in Boston. Study C208 is a Phase 2, open-label clinical study being conducted by Tibotec in Europe that is evaluating a twice-daily (1125mg q12h) dosing schedule of telaprevir in combination with peg-IFN-alfa-2a (PEGASYS®) or peg-IFN-alfa-2b (PEGINTRON™) and RBV, as compared to the current three-times-daily (750mg q8h) telaprevir dosing schedule. All dosing of study medications was completed in Study C208 in April. Patients are now in the post-treatment follow-up phase to determine the number of patients who achieve an SVR24 with twice-daily compared to three-times-daily dosing of telaprevir.
Additional telaprevir clinical studies
Vertex has completed PROVE 3, a Phase 2b clinical trial of telaprevir-based combination therapy in patients with genotype 1 HCV who did not achieve an SVR with a previous peg-IFN-based treatment. Full data from PROVE 3 have been provided to the U.S. Food and Drug Administration.
All patients in Study 107, an open-label Phase 2 study to evaluate telaprevir-based combination regimens in patients who did not achieve an SVR in the 48-week control arms of the Phase 2 PROVE studies, have completed 24 weeks of dosing. In the study, telaprevir was given in combination with peg-IFN and RBV for 12 weeks followed by peg-IFN and RBV for 12 weeks or 36 weeks depending on the patient’s antiviral response to telaprevir in Study 107 and whether the patient was a prior non-responder, partial-responder or relapser. Vertex anticipates that additional data, including SVR24 data, from Study 107 will become available in 2010.
STAT-C combination therapies
Vertex is seeking to advance HCV therapy through the development of novel combinations of Specifically-Targeted Antiviral Therapies for hepatitis C (STAT-Cs). The Company plans to begin a combination trial of telaprevir with the HCV polymerase inhibitor VX-222 (formerly VCH-222) in patients with genotype 1 HCV as early as the fourth quarter of 2009.
Vertex expects data from this first STAT-C combination study to become available in the first half of 2010.
Vertex is currently conducting a three-day, multiple-dose viral kinetic study to evaluate the antiviral activity, safety, tolerability and pharmacokinetics of VX-222 dosed as a monotherapy in 32 treatment-naïve patients with genotype 1 HCV infection. This study is scheduled for completion in the third quarter of 2009. Additionally, Vertex expects to initiate a drug-drug interaction study with VX-222 and telaprevir in healthy volunteers in the third quarter of 2009.
Additional HCV compounds in clinical development
Vertex is conducting early-stage development activities with novel HCV compounds, including the additional HCV protease inhibitors VX-813 and VX-985 as well as the HCV polymerase inhibitor VX-759 (formerly VCH-759). Vertex also has an NS5A inhibitor program in preclinical development. The goal of these programs is to identify compounds that are appropriate for further development, including combination therapy.
http://finance.yahoo.com/news/Vertex-Pharmaceuticals-bw-2048055068.html?x=0&.v=1
6:06AM Vertex Pharma announces intention to sell its rights to European milestone payments for telaprevir (VRTX) 33.39 : Co announces its intention to sell the rights to certain milestone payments tied to the future regulatory filing, approval and market launch of its hepatitis C virus protease inhibitor drug candidate, telaprevir, in Europe. As part of a collaboration signed in June 2006 to develop and commercialize telaprevir for the treatment of HCV, Janssen Pharmaceutica N.V., a Johnson & Johnson (JNJ) co, agreed to pay Vertex a total of $250 mln in aggregate milestone payments for successful development and launch of telaprevir in the European Union. The milestones anticipated for telaprevir in Europe include $100 mln related to regulatory filing and approval and $150 mln related to launch of telaprevir. Vertex anticipates, based on projected development and commercial timelines for telaprevir, and assuming successful development, that it will earn these milestones prior to April 2012.
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