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Biotech / Medical : analysts and calls -- ML -- Ignore unavailable to you. Want to Upgrade?


To: tom pope who wrote (211)9/20/2006 12:35:26 PM
From: tom pope  Respond to of 238
 
Biomarin:

Serono highlights Phenoptin at London conference
BioMarin’s Phenoptin, in phase III development for the treatment of
phenylketonuria (PKU), and partnered ex-US and ex-Japan with Serono, was
highlighted today by Serono as one of its most promising pipeline candidates at
the Merrill Lynch Global Pharmaceutical, Biotech & Medtech conference in
London. Maintain BUY.
Expecting European Filing in mid-2007
Serono expects a regulatory filing in Europe for Phenoptin in mid-2007 based on
a package that will include the positive phase lll data in mild-moderate PKU
announced in March ’06, data from an ongoing 22-week open-label extension
study expected in 1Q07 and data from a diet liberalization study expected in early
‘07. Enrollment was completed in the open-label extension study and the ongoing
diet study is assessing how much PKU patients can relax their strict
phenylalanine-free diets while on phenoptin. We expect a U.S. filing in March
2007 and U.S. launch in early 2008.
Serono to leverage Saizen sales force
Commercially, Serono expects to leverage its Saizen (recombinant growth
hormone) sales force to market Phenoptin. Assuming approval, we estimate peak
sales of Phenoptin in Europe at about $125 mn, possibly more depending on
pricing, which is comparable to our estimate in the U.S. We estimate that
BioMarin would receive a high single digit royalty on Serono’s Phenoptin sales
and a $45mn milestone payment for European filing/approval.
BioMarin a top small-cap pick
Biomarin continues to be one of our top small cap picks. Our price objective of
$19 is based on a probability adjusted NPV analysis.