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  wbur.org: Vertex Pharmaceuticals is on the verge of a new era. The Cambridge biotech company is widely expected to have its first major commercial drug approved Monday by the Food and Drug Administration. The drug is to treat hepatitis C, and it could be a blockbuster. But it will have to share a multibillion-dollar market with a competitor, another new hepatitis C drug from the pharmaceutical giant Merck. The stage is set for a battle between the Cambridge upstart and the industry heavyweight.
 
Boston Globe: In a statement, Vertex chairman, president, and chief executive Matthew Emmens said: "Today marks a turning point in the fight against hepatitis C, particularly for people who have been living with this silent disease for decades, hoping for a better chance of a viral cure. Vertex has been working on the treatment since 1993. Incivek will become the first drug commercialized solely by Vertex in its 22-year history. The company is gearing up to compete with a rival tablet from Merck & Co. in a market that analysts project will initially top $2 billion a year, and could grow to $10 billion or more. Blockbuster drugs are those that ring up more than $1 billion in annual revenue.
 
Reuters: Some industry analysts project Incivek sales will top $5 billion a year. n clinical studies, as many as 79 percent of patients taking Incivek experienced a sustained virologic response -- which is tantamount to a cure. Older drugs cure only about 40 percent of patients. But Incivek is expected to eventually control more of the market because it has shown a higher cure rate than Victrelis, which had a 66 percent cure rate in late-stage studies, although the two drugs have not been tested against each other. The most commonly reported side effects with Incivek include rash and anemia, the FDA said, adding that rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.
 
NEW YORK (Dow Jones)--The Food and Drug Administration approved a new hepatitis C drug from Vertex Pharmaceuticals Inc. (VRTX), marking the second such drug to be approved by the agency in less than two weeks after years without new treatments for the viral liver disease.
 
Vertex's drug, called Incivek, works in a similar manner to Merck & Co's (MRK) Victrelis, and the two are expected to begin a market share battle as patients and physicians have been awaiting the new treatment.
 
Both drugs have shown success in increasing the cure rates of the liver disease when added to current treatments, although Incivek has shown stronger effectiveness, simpler dosing and has a broader range of data.
 
It is difficult to directly compare different clinical studies and no head-to-head trials of the two drugs have been conducted.
 
The market for the drugs is large, with Goldman Sachs recently projecting it could triple to $12 billion (from Jules: I think $15 Bill) in annual sales in coming years. Analysts at the firm expect 75% of the new market to go Incivek, with Merck grabbing the remainder.
 
Shares of Vertex -- up about 57% this year -- recently slid 0.3% to $54.82, while Merck dropped 19 cents to $36.87, as the broader markets were down heavily.
 
Hepatitis C is caused by a virus and can lead to liver failure, liver cancer and/or the need for a transplant. About 3.2 million Americans have the disease.
 
Standard treatment is a combination of the drug pegylated interferon and ribavirin, curing less than 50% of patients, but adding the new drugs may improve cure rates and shorten the duration of treatment.
 
Both Incivek and Victrelis are known as protease inhibitors and are designed to block an enzyme that helps the hepatitis C virus replicate. Vertex developed Incivek and owns the North American rights; it would get a royalty on overseas sales from partner Johnson & Johnson (JNJ). Vertex said the drug will be available this week.
 
Vertex submitted two main studies to the FDA in support of Incivek, showing that more patients responded to treatment by achieving a so-called sustained virologic response -- essentially a cure -- and in a shorter period of time than current hepatitis C therapy. A third study looked at extending treatment with a telaprevir-based regimen.
 
In previously untreated patients, 79% of those on Incivek were cured. The cure rate for all patients treated with the drug was 20% to 45% higher than current standard of care, according to the FDA.
 
Incivek is given for 12 weeks with standard treatment, with all patients stopping the drug and getting continued treatment with pegylated-interferon and ribavirin alone for another 12 to 36 weeks. Studies show that the shorter regimen works in most patients.
 
Both Merck and Vertex have been pushing efforts to raise awareness of the disease and encourage testing to diagnose it.
 
Many patients like Michael Hood, who has failed three different treatments since his diagnosis in 1999, have been awaiting the approvals.
 
"I want to be fixed," said Mr. Hood, a 49-year-old electronics sales manager from Krum, Texas. Hood is near developing cirrhosis of the liver and suffers from fatigue and other hallmarks of the disease, said his doctor at the University of Texas Southwestern Medical Center in Dallas.
 
William Lee, Hood's doctor, said he has "at least 80 patients" ready to start the new treatments once they're approved and health plans agree to cover the expense.
 
Treatment will be costly. Dr. Lee said a year's current treatment is $28,000. Both new drugs will be used in addition to the two existing therapies, not in replacement of them.
 
Merck pegged the price of Victrelis at between $26,400 and $48,400 a patient, depending on the length of treatment needed. Vertex hasn't yet disclosed the price of Incivek.
 
Incivek was associated with a risk for skin reactions, such as severe rash, along with anemia, while Victrelis was also linked to anemia.
 
Health plans are expected to embrace reimbursing the new drugs, but their expected market dominance could be short-lived. Treating hepatitis C is a popular area for drug development at both biotechs and larger pharmaceutical companies, something that could bring a crop of new products in coming years.
 
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
 
(Jonathan D. Rockoff contributed to this story)
 
 
 
 
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