Gilead Notches Victory in Hepatitis C Drug Race

By Dow Jones Business News, 
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U.K. Drug Panel Backs Gilead's Hepatitis Drug at a Discount


LONDON--The U.K. agency that evaluates the cost-effectiveness of drugs has recommended that the English health system pay for the Sovaldi hepatitis C treatment sold by Gilead Sciences Inc., at a discount of roughly 30% from its U.S. price.

Separately, Gilead said Friday that it scored a key victory in securing the rights to Sovaldi, after a U.S. arbitration panel ruled in the company's favor over Roche's claims on the lucrative drug.

Sovaldi was approved by U.S. regulators in December, and so far has been one of the most successful drug launches ever, racking up sales of $5.75 billion through the first six months.

The drug cures nine out of 10 patients with the most common form of hepatitis C and can avoid the need for more costly treatments like liver transplants. Still, its high price has drawn sharp criticism from U.S. insurers and politicians.

In the U.S., Sovaldi costs around $1,000 a day for a 12-week course of treatment. In the U.K. it is being offered at a cost of around $690 a day.

At that price, the U.K. agency--the National Institute for Health and Care Excellence, or Nice--is recommending that the English health-care system use the drug. The panel will make its final decision on the treatment next month. While the guidance applies only to England, health-care agencies in Wales, Scotland and Northern Ireland often follow Nice recommendations.

Hepatitis C is a virus that affects the liver and can lead to cirrhosis, where normal liver tissue is replaced by scar tissue. A small percentage of people with hepatitis C and cirrhosis also develop liver cancer.

In the U.S., an arbitration panel ruled that Roche failed to establish any of its claims to sofosbuvir, the key ingredient in Sovaldi, according to a filing from Gilead.

A Roche representative said the company is disappointed in the arbitration decision.

Roche claimed it had exclusive rights to the drug because in 2004 it collaborated on research with Pharmasset, which developed the drug. Gilead bought Pharmasset in 2012 for $11 billion, and Roche proceeded with its arbitration case last year. The hearing was held in June, Gilead said.

With several other hepatitis C drugs in development, a number of big pharmaceutical companies have been waging legal battles to secure their patent rights over the lucrative new market.

In addition to Roche, Merck & Co. has claimed that Sovaldi infringes on its patents and rights, while AbbVie Inc. has received patents in the U.S. that cover drug combinations to treat hepatitis C--including Gilead's Sovaldi and experimental drug ledipasvir. AbbVie filed a lawsuit in February claiming that it would be entitled to damages if Gilead brought the combination to market.

As for the U.K., Nice is recommending that Sovaldi be used in combination with two other drugs for adults with the most common form of hepatitis C--called genotype 1--which accounts for almost half of all cases in the U.K, and for patients with another form of the disease who have cirrhosis of the liver.

Figures from 2012 suggest that around 160,000 people are chronically affected with the virus in England. Many don't know they are infected because they have only mild symptoms or no symptoms at all.

Nice said the side effects of current treatments mean many people don't complete the course of treatment or are reluctant to seek medical care in the first place.

Nice often takes a hard line with pricey medicines. The agency rejected Roche Holding AG's drug Kadcyla--for women with an aggressive form of breast cancer--last month on the grounds that it is too expensive. Kadcyla can extend patients' life by an average of six months, but costs around $151,000 a year.

Michael Calia contributed to this report.

Write to Hester Plumridge at Hester.Plumridge@wsj.com and Ed Silverman at Ed.Silverman@wsj.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires


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