June 3, 2010 / 3:54 PM / 9 years ago

PREVIEW-Novartis, Bristol battle for poll position in CML

* Companies seeking to develop Glivec replacement in CML

* Target is first-line chronic myeloid leukaemia treatment

* Phase III data on Sprycel vs Glivec due at ASCO

* Experts eye more data on Tasigna vs Glivec

By Katie Reid

ZURICH, June 3 (Reuters) - Bristol-Myers Squibb (BMY.N) and Novartis NOVN.VX 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.


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 David Cowell

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