Saturday, July 27, 2013

Sprycel May Have Slight Edge Over Tasigna

Bristol-Myers Squibb: Sprycel May Have Slight Edge Over Tasigna; 55% of Newly Diagnosed CML Patients Will 
Likely Choose Either Sprycel (30% Share) or Tasigna (25%) 

While there are several factors working in favor of each drug (Sprycel and Tasigna), we believe Sprycel stands to have an
edge over Tasigna for the following reasons.

Factors favoring Sprycel: 
• No black-box warning: Tasigna’s label includes a black-box warning for QT prolongation. It excluded patients
with uncontrolled cardiovascular (CV) disease in its Phase III as did Sprycel. Given the exclusion criteria in Phase
III for both products, we would not be surprised if their Phase III CV risk profiles look similar; however, given
Tasigna’s black-box warning, we would expect Sprycel to be viewed more favorably.
• More convenient dosing: Sprycel has a clear dose advantage over Tasigna (QD vs. BID). Additionally, Sprycel
does not have food restrictions like Tasigna. Patients taking Tasigna are required to avoid food 2 hours before and
1 hour after taking medication.
• Lower price point: While both Tasigna ($265/day) and Sprycel ($230/day) are expected to be priced at a
premium to Gleevec ($210/day), Sprycel is likely to have some pricing advantage vs. Tasigna.
Factors favoring Tasigna:
• Potential 6 month head-start: The PDUFA date for Tasigna’s application is in late June, while we assume
Bristol will file around mid-2010 and request a priority review status. If it were to get priority review status, we
would expect an FDA decision around the end of the year. This scenario would give Tasigna a 6 month head-start
over Sprycel.
• Novartis currently owns the market: Since Novartis currently owns the 1st line market with Gleevec, we would
not be surprised if Novartis has a strategy in place to aggressively convert patients to Tasigna especially since
Gleevec is going generic in 2015.

If Data Plays Out, We Believe Sprycel Sales Could Top $2.5B by 2015:
Switch from newly diagnosed patients: From 2011 onwards newly diagnosed, 1st-line CML patients representing about
11% of the total 1st-line population will have a choice among three front line therapies – Gleevec, Tasigna and Sprycel.
We believe that 55% of these newly diagnosed patients will choose either Tasigna or Sprycel due to their more
benign side effect profiles. Sprycel could take 30% share and Tasigna to take 25% share.
Switch from Gleevec maintenance therapy patients: Both Bristol-Myers and Novartis have ongoing studies evaluating the
switch of patients that are suboptimally treated with Gleevec. The Novartis studies (LASOR and ENESTcmr) will begin
to report data in 2011. Bristol-Myers also has a switch study on which we are waiting for an update from the company.
We estimate that about 20% of the patients on Gleevec maintenance therapy will switch to either Tasigna or
Sprycel starting in 2011, with the rate rising to 45% by 2015. For now we assume that these switch patients will be
shared equally by Sprycel and Tasigna until we get more data.
In 2nd-line, we estimate that the ~2:1 market share ratio between Sprycel and Tasigna will decline as Sprycel gains greater
share in front-line treatment. In 3rd-line, we estimate Sprycel’s market share will somewhat decline (as will Tasigna’s
share) over time as it gains share in earlier lines of therapy; however, we assume that it will still continue to dominate the
market.
Based on these assumptions, we estimate Sprycel’s global sales to grow from about $420M in 2009 to about $2.6B in
2015.
Source: UBS/Goodman, May 18, 2010
Oncology Indication: Hematologic
Keyword: Market Overview

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