Merck's Arthritis Resolution

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http://www.forbes.com/home_europe/2003/12/31/cx_al_1231mrk.html

 

Merck's Arthritis Resolution

Aude Lagorce, 12.31.03, 1:16 PM ET

 

NEW YORK - A little less than two years after it withdrew its application with

the U.S. Food and Drug Administration for painkiller and arthritis drug Arcoxia,

Merck has filed again for U.S. marketing approval.

 

Only this time the world's No. 3 drugmaker had better go all the

way. Not only is Arcoxia--which is already available in 38 countries in Europe,

Asia and Latin America--the company's next-generation painkiller, but it is also

the drugmaker's best hope to surpass Pfizer's (nyse: PFE - news - people ) rival

drugs Celebrex and Bextra and to counter declining sales of its own arthritis

drug Vioxx. And Merck (nyse: MRK - news - people ) may have even more

competition in 2005 from Novartis (nyse: NVS - news - people ), which is trying

to get approval from the FDA for Prexige.

 

Vioxx, which was launched in 1999, was expected to reach annual sales of $3.5

billion, but failed to meet expectations after possible risks of heart attack

and stroke tempered enthusiasm. Current sales of Vioxx are $2.5 billion per year

and are expected to reach a peak of $2.7 billion before its patent expires in

2013, according to Lehman Brothers analyst Ding Ding.

 

Although New Jersey-based Merck confidently said at the beginning of the month

that it expects combined sales of Vioxx and Arcoxia to reach between $2.6

billion and $2.8 billion next year, there's no guarantee that Arcoxia will

actually be on the market at that time. Still, the FDA's goal is to review 90%

of drug applications within ten months of their submission, so there's a good

chance it will hit the shelves in 2004. Ding expects a launch in the first

quarter of 2005, with peak sales of $5 billion. But so far, the drug's road to

U.S. pharmacies hasn't been smooth.

 

When Merck pulled its Arcoxia application in March 2002, it was the company's

first withdrawal in ten years. Merck claimed that it wanted to add more data so

that the FDA approval would be a sure thing. The company also needed Arcoxia to

be approved for chronic pain so it could beat rival products at Pfizer.

According to the latest data available, Pfizer's Celebrex accounted for 39% of

new prescriptions, trailed by Vioxx with 36% and Pfizer's Bextra at 25%.

 

Novartis filed its application for Prexige in November 2002. It said in

September that the FDA requested the submission of the final report of the

ongoing TARGET study, as well as additional clinical data for the indications of

osteoarthritis and acute pain, before marketing approval may be granted (see

" Novartis Feels Pain " ).

 

All the drugs, including Arcoxia, belong to a class of anti-inflammatory drugs

called Cox-2 inhibitors, which ease inflammation without causing the

gastrointestinal bleeding that can accompany older pain medicines like ibuprofen

and aspirin.

 

When Merck pulled the application, there were concerns over cardiovascular

problems, which are potential side effects of all Cox-2 inhibitors (see " Bad

News: Merck Withdraws Arcoxia Application " ). In 2002, both Merck and Novartis

launched massive outcome trials specifically targeted at identifying any cardiac

side effects of the drugs and aimed at allaying fear among patients.

 

But this time, Merck appears more self-assured. " We are confident that we

submitted a strong application, " said Merck, which refiled Dec. 30. And within

60 days, it should know whether the FDA will accept the new application.

 

 

 

 

 

 

 

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