Novartis Painkiller Beats Rival

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Novartis Painkiller Beats Rival

Tue Oct 1,10:01 AM ET

By Ben Hirschler, European Pharmaceuticals Correspondent

LONDON (Reuters) - Swiss-based Novartis AG's new drug Prexige is more

effective than a key rival in controlling arthritis pain at high doses,

according to data from a late-stage study made available on Tuesday.

Prexige, which analysts at Lehman Brothers believe will generate peak annual

sales of $2.2 billion, is designed to compete in the blockbuster COX-2

inhibitor medicine market and is a key component of the group's new drug

pipeline.

Novartis plans to file Prexige for U.S. and European regulatory approval

later this year.

Results from the 13-week trial, published as an abstract on the American

College of Rheumatology's Web site ( www.rheumatology.com), showed Prexige

at 400 milligrams was better than Pharmacia Corp's Celebrex at a standard

dose of 200 mg in helping patients with osteoarthritis of the knee.

Researchers said 400 mg Prexige showed an overall analgesic effect

significantly superior to 200 mg Celebrex after two, four and eight weeks of

treatment. The product was also superior throughout the trial on average

pain relief and patients' assessment of disease activity, while side effects

were similar.

Efficacy at 200mg was comparable to Celebrex.

The effects of the drug were most pronounced in the first two months of

treatment, suggesting Prexige may be faster to act than rivals.

" This more rapid onset of action of Prexige may provide a good marketing

hook for Novartis in a category that will be fiercely competitive, " Lehman

analysts said.

The brokerage increased the probability of Prexige successfully getting to

market to 60 percent from 50 percent in the light of the trial news.

MORE DATA NEEDED

Other industry analysts were wary, arguing that the different doses of

Prexige and Celebrex given in the study and its short duration meant more

information was needed.

" Whilst the clinical data today is encouraging, one has to be aware that you

are not potentially comparing like-for-like, " said Nigel of Merill

Lynch.

Shares in Novartis rose 1.1 percent to 58.90 Swiss francs by 9:30 a.m. EDT

as investors gave a cautious welcome to the first Phase III clinical data on

the product.

One analyst with another major U.S. brokerage also pointed out the trial had

not looked at possible cardiovascular side effects.

" It's still early data. We need longer-term trial information to understand

the cardiovascular risk profile of this molecule, " the analyst said.

There have been a number of concerns recently that COX-2 drugs may increase

the risk of cardiovascular problems like heart attacks and strokes in some

patients.

Novartis has carried out a range of Phase III studies into Prexige and more

information about the product is expected to be released when the company

hosts an R & D day on October 17.

Other trials are also expected to compare Prexige against Merck and Co Inc's

Vioxx medicine. ($1=1.475 Swiss Franc)