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This excerpt taken from the ELN 6-K filed Aug 28, 2009. Biopharmaceuticals
Business Update
Total revenue from our Biopharmaceuticals business increased by
15% to $246.0 million in the first half of 2009 from
$213.0 million for the same period of 2008. The increase
was driven by strong growth in Tysabri, which more than
compensated for reduced sales of Maxipime and Azactam.
The decline in sales of Maxipime was primarily due to
the impact of generic competition beginning in June 2007 when
the first generic product was introduced. The decline in sales
of Azactam was principally due to supply shortages.
Azactam lost its patent exclusivity in October 2005 and
its future sales are expected to be negatively impacted by
generic competition. However, no generic form of Azactam
has been approved to date. Our sole source for Azactam
has indicated they will cease the supply of product to us
beyond 2009. We are in discussions with this supplier with
respect to its obligations to supply. However, if we are unable
to resolve these differences with our supplier or are unable to
obtain an alternative source of supply, our sales of Azactam
will rapidly decrease.
Table of Contents
Total in-market sales of Tysabri were $481.3 million
in the first half of 2009, an increase of 34% over the
$359.7 million recorded for the same period of 2008,
reflecting strong patient demand across global markets. At the
end of June 2009, approximately 43,300 patients were on
therapy worldwide, including approximately 22,000 commercial
patients in the United States and approximately 20,700
commercial patients in rest of world (ROW), representing an
increase of 36% over the 31,800 patients who were on
therapy at the end of June 2008.
In the first half of 2009, Elan and PharmatrophiX, Inc.
(PharmatrophiX), a biotechnology company focused on the
development of small molecule ligands for growth factor
receptors relevant to neurological disorders, entered into an
exclusive collaboration to research, develop and commercialise
the neurologic indicators of PharmatrophiX’s portfolio of
compounds targeting the p75 neurotrophin receptor. The
PharmatrohiX portfolio of small molecule compounds, termed p75
ligands, mimic the activity of the neurotrophins, interacting
with and potentially protecting neurons that are susceptible to
loss in Alzheimer’s disease. There is also the potential
for applications to other neurodegenerative diseases, including
Parkinson’s disease and MS.
Also in the first half of 2009, Elan initiated a Phase 1 dose
escalation safety study of ELND002 in patients with hematologic
malignancies. ELND002 is a small molecule injectible inhibitor
of alpha 4 beta 1.
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