Conference call to be held today at 10 a.m. EDT
CAMBRIDGE, Mass., and CARLSBAD, Calif., June 24 /PRNewswire-FirstCall/ --
Genzyme Corp. (Nasdaq: GENZ) and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS)
today announced the finalization of the license and collaboration agreement
for mipomersen. The collaboration provides Genzyme with exclusive worldwide
rights to mipomersen, a novel lipid-lowering drug discovered and developed by
Isis that is in phase 3 clinical development. During the second half of this
year, enrollment is expected to be completed in a pivotal study of mipomersen
in homozygous familial hypercholesterolemia, and a new trial in
apheresis-eligible patients is expected to begin.
As part of the agreement, Isis will receive a $175 million license fee for
mipomersen. In February, Isis received a $150 million payment from Genzyme to
purchase 5 million shares of Isis common stock at $30 per share.
The companies have updated the deal terms so that Isis will contribute up
to $50 million in additional development funding for mipomersen, bringing
Isis' development funding commitment up to $125 million. Thereafter Isis and
Genzyme will share development costs equally. The initial Isis development
funding commitment and the shared funding will end when the program is
profitable. In exchange for this additional contribution, Isis has the
opportunity to receive $75 million in milestone payments early.
'Mipomersen is an innovative treatment that has the potential to change
the standard of care for severely ill patients whose needs cannot be addressed
by current cholesterol-lowering therapies,' said Henri A. Termeer, Genzyme's
chairman and chief executive officer. 'This treatment is an important
addition to Genzyme's robust late-stage pipeline. We will manage the clinical
development of mipomersen within our current R&D budget and financial
guidance.'
Over the next 30 days, the companies will transition the mipomersen IND
and all regulatory authority to Genzyme. As the sponsor of mipomersen,
Genzyme will take the lead on discussions with regulatory agencies and
filings. In response to guidance received from the FDA, the companies have
modified the initial development plan for mipomersen, subject to further
discussions with the agency.
The key changes to the plan include:
-- The addition of clinical studies of mipomersen in apheresis-eligible
patients.
-- Consolidation of the planned filings for heterozygous FH patients and
other high-risk, high cholesterol patients into a single registration in the
U.S.
-- Acceleration of the planned outcome study so that it can be used to
support the above mentioned consolidated U.S. filing.
'Mipomersen is an important drug that demonstrates the power and precision
of antisense drugs. We believe now, as we did in January, that Genzyme is the
ideal partner for mipomersen,' said Stanley Crooke, Chairman and Chief
Executive Officer of Isis. 'We will continue to work with Genzyme on a
development plan that is responsive to the FDA and other regulatory agencies,
and maximizes the value of the drug. In addition, we look forward to
exploring new areas of therapeutic opportunity with Genzyme in CNS and certain
rare diseases as part of this alliance.'
Deal Terms
As a result of the changes in the development plan and consistent with the
premise of the transaction in which the companies are sharing the value of
mipomersen, the following changes to the original financial terms of the deal
have been made:
-- Isis will contribute up to the first $125 million in development
funding, reflecting an additional contribution of up to $50 million.
Thereafter Isis and Genzyme will share development costs equally. The initial
Isis development funding commitment and the shared funding will end when the
program is profitable. In exchange for this additional contribution, Isis has
the opportunity to receive certain milestone payments early.
-- $75 million of the $150 million milestone associated with the
heterozygous FH indication (the portion related to U.S. registration) may be
accelerated, to be paid $25 million at annual product revenue of $250 million
and $50 million at annual product revenue of $500 million. The $75 million
milestone for European approval of the heterozygous FH indication remains the
same.
All other financial terms of the transaction remain unchanged.
