Mipomersen, the most advanced drug in Isis' cardiovascular pipeline,
will be evaluated in a broad Phase 3 program in patients with high
cholesterol at high risk for cardiovascular disease including an
ongoing Phase 3 study in patients with homozygous Familial
o Isis reported updated safety data on mipomersen from an ongoing
open-label extension study in 20 patients with FH that showed that
mipomersen continues to be well tolerated and maintains activity in
o Isis reported the results of two preclinical studies in which the
lowering of apoB-100 resulted in the dramatic reduction of
atherosclerotic plaques in murine models of atherosclerosis.
o In April, Isis received guidance from the FDA on approval
requirements for mipomersen.
o Isis licensed mipomersen to Genzyme as part of a strategic alliance
for which the contracts are being finalized and the transaction is
expected to be completed this quarter. The deal included:
-- A $175 million mipomersen licensing fee
-- A $150 million equity investment (at $30 per share)
-- Over $1.5 billion in milestone payments for mipomersen
-- A share of profits on mipomersen and follow-on drug(s) ranging
from 30 to 50 percent of all commercial sales.
-- A preferred partner relationship for the development and
commercialization of antisense drugs for CNS and certain rare
-- Pipeline Highlights
o Isis expanded its cardiovascular disease franchise with the addition
of a development candidate that targets PCSK9.
-- Isis received a $2 million milestone payment with the se
|SOURCE Isis Pharmaceuticals, Inc.|
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