tasigna approved, page-6

Malmanu - thanks for the in-depth analysis but again not very well researched. See below for the clinical trial results comparing tasigna to gleevec - tasigna shows a clear mortality benefit over gleevec which would indicate that it will be prescribed by docs over gleevec. The analysts think that 80% of new patients will be using tasigna instead of gleevec by 2012.

JM - not wanting to be a bully but want some value to be added to this forum, not just parroting what the company says. Its a legitimate question that I asked -if no one can answer it that is fine. Perhaps if we were more concerned about producing quality analysis and less concerned about hurting each others feelings, we would have a more efficient market in Australian biotech.

for iformaional sharing purposes here is what the analysts have to say about tasigna -

Novartis pre-releases progression/survival in 1st line CML
Novartis pre-released headline data from the 18-month analysis of ENESTnd investigating Novartis's Tasigna vs its Gleevec in 1st line Chronic Myeloid Leukemia (CML) due to be presented Monday at the American Society of Clinical Oncology meeting. Headline results confirm earlier superiority versus Gleevec in terms of the number of patients progressing to more advanced disease and provide first insight into a potential mortality benefit with Tasigna over Gleevec. With Gleevec due to lose patent protection in 2015 the data remain important for driving a switch of Novartis's CML franchise from Gleevec to Tasigna and underpin our existing Tasigna 2015 sales forecast of $1bn. Maintain Buy.

Full ENESTnd 18m data due Monday at ASCO
As a reminder, the initial 12-month ENESTnd data were presented at the American Society of Hematology meeting in December showing superior patients responses and statistically significant improvement in patients progressing to more advanced disease for Tasigna vs Gleevec (Table 1 overleaf). The 18-month update is due to be presented at 9.45am (Central US time) on Monday at ASCO.

Headline 18m data confirm superior progression data
However, headline data released by Novartis today shows two things: 1) It confirms the superior progression data seen at 12m with no further patients having progressed at 18m (1pt on 400mg and 2pts on 300mg) whereas another patient had progressed on the Gleevec arm of the study (12pts vs 11pts at 12m). Although p-values will only be disclosed on Monday, we expect this difference to be statistically significant given the difference at 12m was significant (300mg Tasigna vs Gleevec p=0.0095, 400mg vs Gleevec p=0.0037).

First look at potential mortality benefit
The headline release also gives the first hint of a potential mortality benefit with Tasigna vs Gleevec, important given Gleevec's 94% 7-year median survival for newly diagnosed CML patients. The release indicates only one CML related death on Tasigna 400mg, two on Tasigna 300mg versus eight on Gleevec.

Data underpins Tasigna $1bn sales forecast 2015
Our forecast assumes Tasigna gains 30% of newly diagnosed CML patients post mid-2010 approval, rising to 80% by 2012. We see further upside in the event of positive data 2011/2012 in Gleevec inadequate responders.

Sprycel remains the key threat to Gleevec/Tasigna
The Phase III DASISION study (Sprycel head to head v Gleevec in 1st line CML) expected Monday is likely to show superior responses. However in the absence of mature progression/survival data, any emergence of toxicities such as pleural effusion seen with Sprycel in more advanced stages of the disease would limit its penetration into front line CML in our view (see detailed analysis in our a separate report published this morning here: Opportunities and threats at ASCO 2010