�Genzyme Corp. (Nasdaq: GENZ) and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced that they get begun a phase 3 study of mipomersen in
patients with heterozygous familial hypercholesterolemia (heFH), a transmissible
disorder that causes exceptionally high levels of LDL cholesterol. It is
the first of four new trials the companies plan to pioneer by the end of
this year, and the second late-stage study of mipomersen, a novel
lipid-lowering drug that utilizes antisense technology.
The companies besides announced that the United States Patent and
Trademark Office granted the patent entitled "Antisense Modulation of
Apolipoprotein B (apoB) Expression," U.S. Patent No. 7,407,943. The patent
broadly covers the use of antisense compounds targeting the apoB messenger
RNA except a ribozyme.
"We are making excellent advance in implementing our comprehensive
development design for mipomersen," stated John P. Butler, president of
Genzyme's renal, endocrine and cardiovascular business units. "The start of
the heFH study puts us on track to meet our goal of beginning foursome new
mipomersen studies this year. In addition, the recent patent issuance
increases the overall value of mipomersen, which we believe has tremendous
potential to help patients."
The new trial volition evaluate the safety and efficacy of mipomersen in
patients wHO have heFH and coronary thrombosis artery disease. It is a randomised,
double-blind, placebo-controlled study taking place at approximately 30
sites in the U.S. and Canada, with an anticipated amount enrollment of
around one C patients. Patients on a stable venereal infection of other lipid-lowering
agents are organism randomized 2:1 to receive a 200 mg dose of mipomersen or
placebo weekly for 26 weeks. The primary endpoint will be percent simplification
in LDL cholesterol, and data ar expected to be available in 2010. The
run will add together to the body of clinical information on mipomersen and the overall
merchandise profile.
"This is an exciting instant for mipomersen, combining the initiation of
the phase 3 tribulation in heFH with a very broad patent leeway that expands
the patent coverage for the apoB franchise," aforesaid Stanley Crooke, chairman
and chief executive officer of Isis. "This comprehensive patent covers
methods of inhibiting apoB by targeting anyplace on the messenger RNA
including the site to which mipomersen binds, and all healing uses that
might event from lowering apoB."
Mipomersen Development Plan
The initial indicant sought for mipomersen will be for patients with
homozygous FH, and enrolment in a phase 3 trial in this affected role population
is expected to be completed by the end of this year. Data are expected to
be useable in mid-2009 and a U.S. filing for this indication is
anticipated during the second half of 2010.
Genzyme and Isis plan to begin trey additional trials evaluating
mipomersen's safety and efficacy in reducing LDL cholesterol in high-risk
patients during the second half of 2008. These trials will let in: one for
apheresis-eligible patients, and iI for bad, high cholesterin
patients. All three have anticipated trial designs that include a 2:1
randomization ratio of a 200 mg dose of mipomersen or placebo weekly for 26
weeks.
These trials volition continue to build the body of clinical evidence
around mipomersen's value in managing identical high risk of exposure patients. Data from
the trials testament also inform the design of the morbidity and mortality
result study for potential expansion of mipomersen's label to include a
broader group of at-risk, high cholesterol patients on maximally tolerated,
currently uncommitted therapies.
Following the finalization in June of the mipomersen permit and
quislingism agreement between Genzyme and Isis, the mipomersen IND and
all regulatory authority has been transferred to Genzyme. Now that this
transition has taken place, the companies are looking for forward to Genzyme
tics. As
an pioneer in RNA-based drug find and development, Isis is the owner
or exclusive licensee of over 1,500 issued patents world-wide. Additional
information about Isis is available at http://www.isispharm.com.
Genzyme Safe Harbor Statement
This press release contains modern statements, including
without limitation, statements concerning mipomersen's safety and benefits
for patients with high cholesterol, the development plan for mipomersen and
FDA's requirements for its approval. These statements are case to risks
and uncertainties that could cause real results to differ materially from
those forecasted. These risks and uncertainties include, among others: the
timing of farther discussions with FDA regarding the approving of
mipomersen; the timing and content of submissions to and decisions made by
the FDA relating to mipomersen; further analysis of clinical trial information;
the results of other studies; the actual efficacy and safety of mipomersen;
and the risks and uncertainties described in Genzyme's SEC reports filed
under the Securities Exchange Act of 1934, including the factors discussed
under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q
for the quarter all over March 31, 2008. Genzyme cautions investors not to
place substantial reliance on the innovative statements contained in
this press discharge. These statements speak only as of today's escort and
Genzyme undertakes no obligation to update or revise the statements.
Genzyme(R) is a registered trademark of Genzyme Corporation. All rights
reserved.
Isis Safe Harbor Statement
This press release includes forward-looking statements regarding Isis'
collaboration with Genzyme Corporation, its financial and business enterprise
development activities, and the development, bodily process, therapeutic
potentiality and safety of mipomersen in treating patients with high
cholesterol. Any program line describing Isis' goals, expectations, financial
or other projections, intentions or beliefs is a forward-looking statement
and should be considered an at-risk affirmation, including those statements
that are described as Isis' goals or projections. Such statements ar
subject to certain risks and uncertainties, particularly those inherent in
the process of discovering, developing and commercializing drugs that are
safe and effective for use as human therapeutics, in developing and
commercializing systems to identify infectious organisms that are in effect
and commercially attractive, and in the endeavor of building a business
about such products. Isis' forward looking statements also involve
assumptions that, if they never happen or shew correct, could cause
its results to differ materially from those expressed or implied by such
modern statements. Although Isis' advanced statements
reflect the upright faith sagacity of its management, these statements are
based just on facts and factors currently known by Isis. As a result, you
are cautioned not to rely on these forward-looking statements. These and
other risks concerning Isis' programs are described in additional detail in
Isis' yearly report on Form 10-K for the year all over December 31, 2007, and
its quarterly report on Form 10-Q for the quarter terminated March 31, 2008,
which are on file with the SEC. Copies of these and other documents are
usable from the Company.
Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals,
Inc. Ibis Biosciences and Ibis T5000 are trademarks of Ibis Biosciences,
Inc. Regulus Therapeutics is a stylemark of Regulus Therapeutics LLC.
Genzyme Corp
http://www.genzyme.com
More info
