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Novartis Pegs Combined Market For Tasigna And Gleevec At $3.5 Billion

This article was originally published in The Pink Sheet Daily

Executive Summary

Firm says market for chronic myeloid leukemia therapies will be further differentiated pending additional studies of Tasigna.

Novartis will likely focus on Tasigna' s side effect profile as a way to differentiate nilotinib from Bristol-Myers Squibb's Sprycel (dasatinib) in what the company admits is a niche market for Gleevec -resistant chronic myeloid leukemia patients.

"It is indeed true that patients who have truly progressed on Gleevec, certainly to the accelerated or blast stage, is a small market, because patients do so very well on Gleevec," Novartis Oncology President David Epstein said during an April 23 first quarter earnings call.

Bristol has acknowledged resistance in uptake of Sprycel; in January, the firm reported modest worldwide revenues of $25 million since the compound's July 2006 launch (1 (Also see "Bristol To Overcome Sprycel Uptake “Resistance” By Encouraging Faster Switching" - Pink Sheet, 25 Jan, 2007.)).

However, Novartis believes Tasigna may enter a more favorable environment.

"I do believe Tasigna has a good combination of both efficacy and safety, which will allow physicians to consider using it when perhaps in some cases they are uncomfortable with the side effects of the competing drug," Epstein said.

Epstein's comments echo remarks made regarding Tasigna during a January interview with "The Pink Sheet" DAILY, in which he noted clinical data demonstrated the drug did not cause fluid retention or edema (2 (Also see "Novartis Oncology President David Epstein: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)" - Pink Sheet, 19 Jan, 2007.)).

Novartis announced the regulatory submission of its investigational CML treatment in the U.S. and Europe in November (3 (Also see "Novartis On The Move: Firm Files Tasigna, Aclasta Ahead Of Schedule" - Pink Sheet, 28 Nov, 2006.)).

Pending approval, the firm may launch Tasigna by summer. While the selective Bcr-Abl inhibitor could encroach on Gleevec sales, the firm is touting the products as a way for the company to enhance its presence in the overall CML market.

"I would encourage you to look at Gleevec and Tasigna together and look at the combined market potential, which we said could exceed $3.5 billion," Epstein stated.

"It is indeed difficult to tell you exactly how much of that market potential will be Tasigna and how much would be Gleevec," he noted, adding, "A lot will depend upon how Tasigna performs in the de novo and suboptimal studies that will start during the second quarter of this year."

Novartis also is investigating Tasigna in acute lymphoblastic leukemia and systemic mastocytosis.

- Brooke McManus ([email protected])

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