Vertex’s hepatitis C drug aces review

[Guest guest]

Vertex’s hepatitis C drug aces review

Telaprevir cures more people more quickly than current options

By Weisman

Globe Staff / April 27, 2011

A drug developed by Vertex Pharmaceuticals Inc. cures more patients with the

hepatitis C virus in less time than existing therapies, according to a briefing

document filed yesterday by Food and Drug Administration staffers who reviewed

the company’s application for approval.

Shares of Cambridge-based Vertex vaulted $4.88, or 10.1 percent, to $52.92

yesterday, a 10-year high, as the FDA’s preliminary findings indicated the drug,

called telaprevir, may have a higher cure rate than previously thought.

But the regulators’ briefing paper also cited two side effects previously

reported by Vertex that present safety concerns. It noted that telaprevir, which

will be given a new brand name if approved, caused anemia and skin rashes in

some patients during trials.

The briefing document was released in advance of a daylong hearing tomorrow by

an FDA advisory committee that will recommend whether the agency should approve

the drug. A recommendation for approval would be a key milestone in the

decadelong development of telaprevir, but final approval is not expected until

next month.

Telaprevir would be the first drug commercialized by Vertex, which was founded

in 1989. The company has been hiring hundreds of sales and marketing employees

in anticipation of its launch.

The Vertex tablet would be used in combination with a pair of current therapies.

Together, the three-drug cocktail proved more effective in clinical trials than

the older medications by themselves, the briefing paper said.

Today, the same FDA advisory committee will consider a rival hepatitis C

treatment, boceprevir, developed by the drug giant Merck & Co.

Both drugs act to inhibit the protease enzyme that enables the virus to

replicate, and both will target a market projected by some securities analysts

to exceed $2 billion annually.

Merck’s tablet, which it plans to market under the name Victrelis, also

represents an advance over the current standard of care. Like the Vertex drug,

Merck’s medicine would be taken with other drugs, versions of which are

currently sold by Merck. Merck’s new drug also caused side effects, including

anemia and blood disorders, in clinical trials.

Analysts have said the benefits of both drugs are likely to outweigh the safety

risks as the FDA considers approval of the treatments.

Shares of Merck climbed 75 cents, or nearly 2.2 percent, to $35.80 yesterday.

The analysis by FDA staffers used different criteria than Vertex used for

assessing the hepatitis C cure rate based on the clinical trial data. Because of

that, yesterday’s briefing document calculated the cure rate at 79 percent for

the drug regimen Vertex is proposing — higher than the 75 percent the company

reported last May.

That compared to a 46 percent cure rate for patients taking the older drugs

alone. A FDA briefing report prepared for Merck’s new drug calculated a cure

rate of 66 percent for a similar population group.

Yesterday’s reported 79 percent cure rate represents “a clear upside to Vertex’s

case for approval of telaprevir, which is likely to provide additional tailwind

in a head-to-head competition with [Merck’s] boceprevir in case of approval,’’

Geoffrey C. Porges, senior analyst at Bernstein Research in New York, wrote in a

note to investors.

Weisman can be reached at weisman@....

© Copyright 2011 Globe Newspaper Company.

[Guest guest]

Vertex’s hepatitis C drug aces review

Telaprevir cures more people more quickly than current options

By Weisman

Globe Staff / April 27, 2011

A drug developed by Vertex Pharmaceuticals Inc. cures more patients with the

hepatitis C virus in less time than existing therapies, according to a briefing

document filed yesterday by Food and Drug Administration staffers who reviewed

the company’s application for approval.

Shares of Cambridge-based Vertex vaulted $4.88, or 10.1 percent, to $52.92

yesterday, a 10-year high, as the FDA’s preliminary findings indicated the drug,

called telaprevir, may have a higher cure rate than previously thought.

But the regulators’ briefing paper also cited two side effects previously

reported by Vertex that present safety concerns. It noted that telaprevir, which

will be given a new brand name if approved, caused anemia and skin rashes in

some patients during trials.

The briefing document was released in advance of a daylong hearing tomorrow by

an FDA advisory committee that will recommend whether the agency should approve

the drug. A recommendation for approval would be a key milestone in the

decadelong development of telaprevir, but final approval is not expected until

next month.

Telaprevir would be the first drug commercialized by Vertex, which was founded

in 1989. The company has been hiring hundreds of sales and marketing employees

in anticipation of its launch.

The Vertex tablet would be used in combination with a pair of current therapies.

Together, the three-drug cocktail proved more effective in clinical trials than

the older medications by themselves, the briefing paper said.

Today, the same FDA advisory committee will consider a rival hepatitis C

treatment, boceprevir, developed by the drug giant Merck & Co.

Both drugs act to inhibit the protease enzyme that enables the virus to

replicate, and both will target a market projected by some securities analysts

to exceed $2 billion annually.

Merck’s tablet, which it plans to market under the name Victrelis, also

represents an advance over the current standard of care. Like the Vertex drug,

Merck’s medicine would be taken with other drugs, versions of which are

currently sold by Merck. Merck’s new drug also caused side effects, including

anemia and blood disorders, in clinical trials.

Analysts have said the benefits of both drugs are likely to outweigh the safety

risks as the FDA considers approval of the treatments.

Shares of Merck climbed 75 cents, or nearly 2.2 percent, to $35.80 yesterday.

The analysis by FDA staffers used different criteria than Vertex used for

assessing the hepatitis C cure rate based on the clinical trial data. Because of

that, yesterday’s briefing document calculated the cure rate at 79 percent for

the drug regimen Vertex is proposing — higher than the 75 percent the company

reported last May.

That compared to a 46 percent cure rate for patients taking the older drugs

alone. A FDA briefing report prepared for Merck’s new drug calculated a cure

rate of 66 percent for a similar population group.

Yesterday’s reported 79 percent cure rate represents “a clear upside to Vertex’s

case for approval of telaprevir, which is likely to provide additional tailwind

in a head-to-head competition with [Merck’s] boceprevir in case of approval,’’

Geoffrey C. Porges, senior analyst at Bernstein Research in New York, wrote in a

note to investors.

Weisman can be reached at weisman@....

© Copyright 2011 Globe Newspaper Company.