Latest Drug Trial Data Pounds Vertex Pharma (Nasdaq: VRTX) Shares

Shawshank, VA 6/28/12 (StreetBeat) -- Vertex Pharmaceuticals (Nasdaq:VRTX) tumbled more than 10% in heavy trading early Thursday after the company reported positive trials results that were nonetheless not quite what investors were hoping for.

The company reported data on a phase-two study of cystic fibrosis patients taking Vertex's Kalydeco along with experimental drug candidate VX-809. The study found a 6.7% improvement in lung function after 56 days of treatment, slightly better than what Wall Street expected, according to ISI Group analyst Mark Schoenebaum. But he added that the results were only for the highest-dose group, whereas investors had been hoping for pooled data of all groups. Also, the responder data was not strictly comparable with the previously released interim data on the study.

"Thus, although the 'responder data' LOOK BETTER in the final analysis at the high dose than in the interim data, we would advise caution on over-interpreting this comparison," Schoenebaum wrote in a email to clients.

Investors seemed to take this heart, perhaps because they'd been burned before. In May the stock soared on strong data from the same trial, only to fall again when the companyrestated its results due to a statistical error.

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Vertex (Nasdaq: VRTX) corrects cystic fibrosis data; shares fall

Shawshank, VA 5/29/12 (StreetBeat) -- Vertex Pharmaceuticals Inc (Nasdaq: VRTX) released corrected data involving its cystic fibrosis treatments on Tuesday that lowered the number of patients who showed certain levels of improvedlung function, sending its shares down more than 22 percent.

The initial data, released earlier this month, sent Vertex shares soaring on hopes the company could have a multibillion-dollar franchise in the treatment of cystic fibrosis, a life-threatening genetic disorder that affects about 70,000 people worldwide.

"The corrected data appear weaker than the original data," ISI Group analyst Mark Schoenebaum said.

Vertex blamed the error on a misinterpretation of the data from a vendor involved in the statistical analysis.

"This mistake is very disappointing," Chief Executive Officer Jeffrey Leiden told analysts on a conference call. "It's unacceptable to us."

Still, Leiden said, the company's conclusions "haven't changed" and that it plans to move forward with a late-stage clinical trial.

Cystic fibrosis causes the thin layer of mucus that helps keep the lungs free of germs to become thick, clogging airways and leading to infections that damage the lungs.

The phase 2 study involves a combination of Vertex's new cystic fibrosis drug, Kalydeco, with an experimental drug called VX-809.

Kalydeco helps only about 4 percent of cystic fibrosis patients with a specific gene mutation. Vertex is testing combinations it hopes will eventually be able to address the larger CF population.

The study examined patient performance based on a measure of the maximum amount of air that can be exhaled in one second, known as FEV1.

On May 7, Vertex released data that it said showed that about 46 percent of patients experienced an improvement in lung function of 5 percentage points or more based on FEV1. On Tuesday, the company said that figure was actually about 35 percent.

The initial results also said about 30 percent of patients experienced an improvement of at least 10 percentage points. That number has been lowered to 19 percent.

The company also released data that showed patients on the combination saw an average absolute improvement in lung function of 8.5 percent compared to those taking a placebo.

That effect looked more pronounced in part because patients on a placebo saw a decline in lung function that was much greater than expected by Wall Street analysts.

Even with the placebo patients worsening, the improvement for patients on the Vertex treatments "is much higher than original Street expectations," Schoenebaum said in a research note.

Brian Abrahams, an analyst at Wells Fargo, said in a research note that the early drop in Vertex's shares seemed "excessive" and recommended buying the shares on weakness.

"While we are slightly disappointed by the less robust data, the Kalydeco/'809 combo still clearly appears active to us and we believe should still have multi-billion dollar potential."

Vertex plans to release final data from the Phase II study by the middle of the year.

Vertex shares fell more than 22 percent to $50.41 in early trading on Nasdaq.

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Tuesday’s biggest gaining and declining stocks

Shawshank, VA 5/29/12 (StreetBeat) -- Here are some of Tuesday’s biggest gaining and declining stocks:
Gainers

D.J. LeCroy (Nasdaq: LCRY +55.58%) shares jumped 56%. The firm said on Tuesday that it had agreed to be bought by Teledyne Technologies Inc. for $291 million.

Interline Brands (NYSE: IBI +39.80%) shares rose 42%. The firm said Tuesday that it is being bought by an investor group that includes Goldman Sachs Group Inc. for about $1.1 billion.

Shares of Peabody Energy Corp. (NYSE: BTU +4.81%) added 6.8% on Tuesday. Analysts at Goldman Sachs upgraded the shares to buy, saying the coal producer’s future in China, plus current valuations, make the shares attractive.

Decliners

Vertex Pharmaceuticals Inc. (Nasdaq: VRTX -16.15%) shares fell 19% on Tuesday. Earlier, the biotech firm said that it had revised study results for a recent clinical trial. The company said the trial showed 19% of patients experienced a 10 percentage point improvement or more, well below the 30% it had first seen.

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Vertex (Nasdaq: VRTX) shares soar on cystic fibrosis drug data

Atlanta, GA 5/7/12 (StreetBeat) -- Vertex Pharmaceuticals Inc's (Nasdaq: VRTX) new cystic fibrosis drug Kalydeco, when combined with its experimental treatment for the disease led to significant improvement in lung function in a mid-stage study, sending Vertex shares soaring 57 percent.

Kalydeco, which in January became the first approved drug to treat the underlying cause rather than symptoms of the life-shortening lung disease, helps only about 4 percent of cystic fibrosis patients with a specific gene mutation. Vertex is testing combinations it hopes will eventually be able to address the larger CF population.

The interim analysis of the study looked at 37 patients who completed 56 days of treatment with the Kalydeco/VX-809 combination, and 11 patients who received a placebo. It found a statistically significant lung function improvement for those on the study drugs.

"These improvements were clinically very, very meaningful for these patients," said Brian Skorney, an analyst with Brean Murray, Carret & Co. "This is really a game-changing combination therapy."

The data could be the clearest sign yet that Vertex will soon be as well known for its cystic fibrosis medicines as its hepatitis C treatments. Vertex's Incivek has transformed care for hepatitis C patients in the past year, but investors are concerned a new generation of drugs will unseat the Vertex drug for addressing the infectious disease in the next few years.

In the data released on Monday, about 46 percent of patients who received the drugs experienced lung function improvement of 5 percentage points or more based on FEV1 -- a measure of the maximum amount of air that can be exhaled in one second, Vertex said.

About 30 percent who received Kalydeco and VX-809 had a lung function improvement of at least 10 percentage points. None of the placebo patients achieved a 5 percent improvement from baseline to day 56, the company said.

"The fact that it showed improvements in lung function in this small-sized trial I think is very impressive," Skorney said.

Complete data from the Phase II study are expected to be available in the middle of this year, Vertex said.

Cystic fibrosis, a life threatening genetic disorder, affects about 30,000 people in the United States and 70,000 worldwide.

The drugs were generally well tolerated with serious adverse events similar between the treatment and placebo groups, the company said.
Vertex shares soared 57.2 percent to $58.80 in premarket trading on Monday.

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Vertex Pharmaceutical's (Nasdaq: VRTX) drug approved to treat cystic fibrosis' root cause

Northern, WI 1/31/12 (StreetBeat) -- The first drug that treats the root cause of cystic fibrosis won approval Tuesday, offering a life-changing treatment for a handful of patients with the deadly illness and broader hope for thousands more patients with the inherited disease.

About 30,000 Americans live with cystic fibrosis, a disease that causes sticky mucus buildup in the lungs and other organs, leading to infections, digestive problems and death in young adulthood. The typical life expectancy is about 37 years, according to the Cystic Fibrosis Foundation.

The Food and Drug approved Vertex Pharmaceuticals Inc.'s (Nasdaq: VRTX) Kalydeco to improve lung function and reduce other symptoms in patients with a rare variant of the disease that affects just 1,200 people in the U.S., about 4 percent of affected population nationwide. These patients have a protein defect that prevents their cells from properly absorbing and excreting salt and water.

"Even though this drug isn't for the majority of people, it proves that you can look at the mistake in the genes and design a drug in a rational way that will fix the problem," said Dr. Drucy Borowitz of the State University of New York at Buffalo, where she directs the cystic fibrosis program.

Kalydeco is among the first drugs designed to a correct a specific genetic defect. Its development characterizes both the promise and challenges of that approach. Scientists first identified the gene that causes cystic fibrosis in 1989, but it took more than two decades and more than $75 million in outside funding to develop a drug to treat the disease.

Borowitz enrolled several of her patients in the key study for Kalydeco, which showed that patients taking the drug increased their lung strength more than 10 percent when compared with patients taking a placebo. Patients also had fewer infections and gained nearly seven pounds on average, a significant amount for patients who typically have trouble retaining weight. All patients in the study continued taking older medications that help loosen mucus.

"Two weeks after using the drug my lung tests were above average for a healthy 15-year-old who didn't have cystic fibrosis," said Nick Mangano, 17, a Borowitz patient who has been taking the drug for two years. Before starting on Kalydeco, Mangano said he was hospitalized for lung infections five times in four years. Now he says he usually recovers from a cold within a week or two.

"I don't really need medicine for it anymore, it's totally different," said Mangano, who is considering leaving Buffalo for college next year — a step he hadn't previously considered because of his dependence on his family and physicians.

Only a few decades ago, children with cystic fibrosis seldom survived elementary school. Today, thanks to earlier diagnosis and new focus on diet and physical therapy, 47 percent live to be 18 or older.

The FDA approved the drug for patients six years old and up, though Vertex is also studying the drug in younger patients. Researchers hope that by using the drug earlier they will be able to prevent permanent lung damage, which is the primary cause of death for cystic fibrosis patients.

Mangano and others with the so-called G551D mutation have a defective protein that fails to balance the flow of chloride and water across the cell wall, leading to the buildup of internal mucus. The vast majority of cystic fibrosis patients have a different genetic defect, in which the protein does not reach the cell wall. Vertex is developing another drug to try and address that problem. Study data for that drug is expected later this year.
Kalydeco is part of a growing number of new medicines that target rare genetic variations found in subgroups of patients. Last year Pfizer (NYSE: PFE) launched a new lung cancer drug called Xalkori, which targets cancer linked to a genetic mutation found in less than 7 percent of patients.

After scientists identified the genetic sequence that causes cystic fibrosis in 1989, many experts hoped the disease could be cured by replacing the gene with a normal one. However, attempts at so-called gene therapy proved unsuccessful, and researchers began looking for ways to correct the genetic defect.

"I think it took the field about a decade to realize we had to look for other options," said Paul Negulescu, vice president of research at Vertex Pharmaceuticals.

In 1998, the Cystic Fibrosis Foundation approached Aurora BioSciences, now part of Vertex, to help screen potential drug candidates for a cystic fibrosis drug. In 2000, the foundation awarded the company more than $45 million to study and commercialize an experimental drug for the disease, the largest grant of its kind by a nonprofit disease group. To date, Vertex has received over $75 million in research and development funding from the Cystic Fibrosis Foundation.

Cambridge, Mass.-based Vertex has only one other drug on the market, the hepatitis C drug Incivek, which launched last May.

The most common side effects with Kalydeco were headache, stomach ache, rash diarrhea and dizziness.

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Hepatitis C Virus (HCV) Biotech/Pharma Stocks: (OTC: AEMD), (Nasdaq:VRUS), (VRTX)

Palm Beach, FL 11/28/11 (StreetBeat) -- www.InvestorIdeas.com, a global investor research portal for independent investors, issues a biotech/pharma investor snapshot for stocks involved in the treatment of Hepatitis C Virus (HCV). Over 170 million people worldwide are chronically infected with Hepatitis C. The sector made headlines earlier this week as Pharmasset, Inc. (Nasdaq:VRUS ), traded up over 84% on acquisition news.

Gilead Sciences, Inc. (Nasdaq:GILD) and Pharmasset, Inc. (Nasdaq:VRUS) reported the companies have signed a definitive agreement under which Gilead will acquire Pharmasset for $137 per share in cash.

What does this mean for the sector? Are there other potential acquisitions? Some say this acquisition makes Vertex Pharmaceuticals Inc (VRTX ) look relatively cheap.

Pharmasset (Nasdaq:VRUS ) has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials in various populations. The company’s lead product candidate, PSI-7977, an unpartnered uracil nucleotide analog, has recently been advanced into two Phase 3 studies in genotype 2 and 3 patients. Both studies will utilize 12 weeks of treatment with PSI-7977 in combination with ribavirin. One study will compare this all-oral regimen against 24 weeks of the standard-of-care pegylated interferon/ribavirin in treatment-naïve patients, and the second study will compare the all-oral regimen to placebo in interferon-intolerant/ineligible patients. A third Phase 3 study in genotype 1 patients will be initiated in the second half of 2012, the design of which is dependent on the outcome of Phase 2 studies which are evaluating PSI-7977 in various combinations in genotype 1-infected patients. If successful, this strategy could lead to an initial U.S. regulatory approval of PSI-7977 in 2014. PSI-938, an unpartnered guanosine nucleotide analog, is being tested in a Phase 2b interferon-free trial as monotherapy and in combination with PSI-7977 in subjects with HCV of all viral genotypes. Mericitabine (RG7128), a cytidine nucleoside analog, is partnered with Roche and is being evaluated in three Phase 2b trials. Roche is responsible for all aspects of the development of mericitabine.

Gilead’s research and development portfolio includes seven unique molecules in various stages of clinical development for the treatment of HCV.

James A. Joyce, Chairman and CEO of Aethlon Medical, Inc. (OTCBB: AEMD) recently updated shareholders on November 16th, “Our Hemopurifier® has demonstrated broad-spectrum capabilities against viral pathogens, including HCV, the human immunodeficiency virus (HIV), and a variety of tested bioterror and pandemic threats. Specific to treating HCV, we previously conducted studies that demonstrated the safe administration of our Hemopurifier® in HCV-infected dialysis patients whose average viral load reductions exceeded 50% during each four-hour treatment. These results were obtained in the absence of any drug therapy.”

Vertex Pharmaceuticals Inc (Nasdaq: VRTX) announced earlier in November its 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 (100mg or 400mg), its lead polymerase inhibitor in development, in combination with INCIVEK™ (telaprevir ) tablets, pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment. On the basis of the results announced today and previously announced data from other treatment arms of the ZENITH study, Vertex intends to start a Phase 3 study to evaluate a total treatment duration of 12 weeks with this four-drug regimen in treatment naïve and relapser patients with genotype 1 chronic hepatitis C.

More about Aethlon Medical (OTCBB: AEMD)
The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.

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