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Novartis, Bristol battle for poll position in CML

Thu, Jun 3 2010

By Reid

ZURICH, June 3 (Reuters) - Bristol-Myers Squibb (BMY.N: Quote, Profile,

Research, Stock Buzz) and Novartis (NOVN.VX: Quote, Profile, Research, Stock

Buzz) are set to lock horns at a key cancer meeting as they seek to push their

drugs forward as the next first-line treatment for chronic myeloid leukaemia.

Data from a late-stage trial is expected to show Bristol's drug Sprycel offers a

benefit when compared with Novartis' Glivec, the current standard of care for

the blood cancer, helping Bristol bolster its oncology unit.

Novartis has already shown its drug Tasigna is better at preventing disease

progression than Glivec and the Swiss group is banking on Tasigna to replace

Glivec, its second best selling drug, as it loses patent protection over the

next few years. [iD:nGEE5B71KS]

" Investors and physicians will try to judge how Sprycel might compare with

Tasigna and we will try to figure out how far it might lead to either company

having the marketing edge for the first-line therapy, " said WestLB analyst

Oliver Kaemmerer.

The market for the first-line treatment of patients with newly diagnosed chronic

myeloid leukaemia is between $2.5 billion and $3 billion, Kaemmerer said.

Analysts have said it is too early to predict which drug is likely to emerge as

the winner in a global therapy area that is seen growing 5 percent each year

between 2011 and 2014, according to Citigroup.

" (We) believe that there will be little to choose between Tasigna and Sprycel in

terms of efficacy, with convenience and side effects most likely determining the

market split, " analysts at Citi said.

Chronic myeloid leukaemia is a cancer of the white blood cells and usually

develops very slowly over several years and in the early stages of the disease

there may not be any symptoms.

It is responsible for around 10 to 15 percent of all adult cases of leukaemia

and has an incidence of one to two cases per 100,000 people per year.

TASIGNA ON TRACK

Novartis will present 18-month data on Tasigna at this year's American Society

of Clinical Oncology (ASCO), which is likely to further underscore the drug's

efficacy.

" We anticipate getting the indication for first-line well ahead of the

competition, " Herve Hoppenot, head of Novartis' oncology unit, told Reuters,

adding the group was also looking into which patients could benefit from

switching to Tasigna from Glivec, also sold as Gleevec.

" Over a period of a few years, Tasigna will be established as a standard of care

in chronic myeloid leukaemia (CML), " Hoppenot said.

Tasigna was on track to get approval later this month in the United States and

in Europe in the second half of the year as the first-line treatment of the

disease, Hoppenot said.

Tasigna has so far been gaining market share in the second-line setting for CML

and peak sales of the drug could be higher than the consensus forecast of around

$1.2 billion, Hoppenot said.

" Tasigna was approved in most countries after Sprycel in the second-line setting

and we are still launching in a number of countries so we are still in the phase

where we continue to have a lot of growth potential, " Hoppenot said.

" In a number of countries we have a market share higher than 50 percent, " he

said.

But Kepler Capital Markets analyst Tero Weckroth expects Sprycel to end

Novartis' monopoly in CML as it makes its way into first-line treatment for the

disease, while the Citi analysts expect Bristol-Myers to have the edge after

ASCO.

" Bristol-Myers should exit ASCO with Sprycel in a much better position to

compete on safety and efficacy versus Novartis' franchise, " the Citi analysts

said.

Bristol-Myers expects to seek approval this year for Sprycel as first-line

treatment for CML. The drug is currently approved to treat the disease only in

patients who were previously treated with or could not tolerate Glivec.

(Editing by Cowell)

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