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Biotech / Medical : analysts and calls -- ML

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From: tom pope9/1/2006 12:20:32 PM
   of 238
 
GSK - I wouldn't call GSK oversold

GlaxoSmithKline
 Company Update; Upcoming DREAM data a potential catalyst
Avandia DREAM data at EASD on Sept 15th could be catalyst
Presentation of the DREAM study, investigating the effect of GSK's Avandia's on
the prevention of diabetes onset in pre-diabetic patients, is expected at the EASD
(European Association for the Study Diabetes) annual meeting on Sept 15th. In
our view, the data could act as an important catalyst for GSK shares, which have
become oversold lately
, as it could potentially open up a significant new market
opportunity for Avandia. We believe the study has a high likelihood of meeting its
primary endpoint, based on data from previous clinical trials but see limited
downside from a negative or mixed outcome. Inclusion of the data on the Avandia
label could add $1.4bn to existing '12E sales forecasts and 3-4% to EPS. Buy.
Pre-diabetes a $15bn addressable market
There are currently no marketed therapies for pre-diabetes. Should Avandia
achieve appropriate labeling, it could be the first agent indicated for the prevention
of diabetes onset in pre-diabetes patients. We estimate this could represent a
global addressable market of c$15bn based on a population of 7m high-risk
patients out of a total pre-diabetic population of 41m.
Hurdles to penetrating market; $1.4bn upside to 2012E
However, even if the DREAM data is positive, we believe that substantial hurdles
to accessing the pre-diabetes market exist and we and therefore estimate realistic
upside to 2012E sales forecasts of c$1.4bn representing 3-4% potential uplift to
EPS. Key hurdles include: 1) Physician perception of superiority of Avandia
relative to other therapies (e.g. lifestyle/metformin); 2) Low diagnosis and
treatment rates expected in pre-diabetics; 3) Numerous labeling and marketing
challenges and 4) Avandia's side effect profile (weight gain, oedma) a deterrent to
early usage in the context of the low severity of the disease.
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