Isis to Host Conference Call Today at 8 a.m. EDT
CARLSBAD, Calif. and CAMBRIDGE, Mass., April 25 /PRNewswire/ -- Isis
Pharmaceuticals, Inc. (Nasdaq: ISIS) and Genzyme Corp. (Nasdaq: GENZ)
announced today that the FDA has provided guidance regarding approval
requirements for mipomersen. The FDA has indicated that reduction of
LDL-cholesterol is an acceptable surrogate endpoint for accelerated
approval of mipomersen for use in patients with homozygous familial
hypercholesterolemia (hoFH). The FDA will require data from two ongoing
preclinical studies for carcinogenicity to be included in the hoFH filing,
which is now anticipated to take place in 2010. A phase 3 study of
mipomersen in hoFH is currently enrolling patients.
The companies plan to conduct an outcome trial to support full approval
of mipomersen for hoFH and to expand its indication to include other
patients with high cholesterol who are at high risk for cardiovascular
events. In response to the FDA's guidance, the companies are revising the
development plan for mipomersen to accelerate plans for an outcome study.
Isis and Genzyme plan to communicate further details of the revised
development plan as they are finalized.
"Because our development plan, and our joint plan with Genzyme, has
always included outcome studies to maximize the profile and commercial
potential of mipomersen, this FDA guidance accelerates these planned
studies and simplifies the overall development path for mipomersen," said
Dr Stan Crooke, Chairman and Chief Executive Officer of Isis. "Conducting
an outcome study in parallel with our continued evaluation of the effects
of mipomersen on atherogenic lipids will allow us to submit a much stronger
NDA for high risk patients. We are confident that mipomersen will bring
benefit to patients with high cholesterol and remain committed to its
development and commercialization."
"We are pleased that the FDA has given clear direction on what will be
required for the approval of mipomersen, and has acknowledged its potential
to help high risk patients whose needs are not being met by current
therapies," said Henri A. Termeer, Genzyme's chairman and chief executive
officer. "Having outcome data earlier on in the development process will be
important to patients and serve to enhance the value of this treatment. We
plan to engage in discussions with regulatory agencies in Europe and the
rest of the world, and look forward to receiving their feedback."
ABOUT MIPOMERSEN
In early 2008, Isis and Genzyme announced that they had entered into a
strategic alliance in which Genzyme will develop and commercialize
mipomersen. Final contracts are still being negotiated and are expected to
be completed this quarter.
Mipomersen is a second-generation antisense drug that reduces the
production of apoB-100, a protein critical to the synthesis and transport
of "bad" cholesterol. Cholesterol can be carried in the bloodstream in a
variety of forms, with high-density lipoprotein, or HDL-cholesterol, being
the good form, and low-density lipoproteins, or LDL-cholesterol, and very
low-density lipoproteins, or VLDL-cholesterol, being bad forms directly
involved in heart disease. Collectively lowering LDL-cholesterol,
VLDL-cholesterol, and other bad forms of cholesterol are a key component in
the prevention and management of cardiovascular disease.
Mipomersen is currently in phase 3 development for patients with
homozygous familial hypercholesterolemia, a disease which creates a greatly
increased risk of premature cardiovascular disease (CVD) and CVD-related
death. In phase 2 studies, mipomersen, a weekly injectable therapeutic, was
observed to reduce cholesterol and other atherogenic lipids beyond
reductions achieved with standard lipid-lowering drugs.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its expertise in RNA to discover and develop novel
drugs for its product pipeline and for its partners. The Company has
successfully commercialized the world's first antisense drug and has 18
drugs in development. Isis' drug development programs are focused on
treating cardiovascular and metabolic diseases. Isis' partners are
developing antisense drugs invented by Isis to treat a wide variety of
diseases. Ibis Biosciences, Inc., Isis' majority-owned subsidiary, is
developing and commercializing the Ibis T5000(TM) Biosensor System, a
revolutionary system to identify infectious organisms. Isis is a joint
owner of Regulus Therapeutics LLC, a joint venture focused on the
discovery, development and commercialization of microRNA therapeutics. As
an innovator in RNA-based drug discovery and development, Isis is the owner
or exclusive licensee of over 1,500 issued patents worldwide. Additional
information about Isis is available at http://www.isispharm.com.
ABOUT GENZYME
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people with
serious diseases. Since 1981, the company has grown from a small start-up
to a diversified enterprise with more than 10,000 employees in locations
spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was
chosen to receive the National Medal of Technology, the highest honor
awarded by the President of the United States for technological innovation.
With many established products and services helping patients in nearly
90 countries, Genzyme is a leader in the effort to develop and apply the
most advanced technologies in the life sciences. The company's products and
services are focused on rare inherited disorders, kidney disease,
orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's
commitment to innovation continues today with a substantial development
program focused on these fields, as well as immune disease, infectious
disease, and other areas of unmet medical need.
Genzyme's press releases and other company information are available at
http://www.genzyme.com and by calling Genzyme's investor information line
at 1-800-905-4369 within the United States or 1-678-999-4572 outside the
United States.
ISIS SAFE HARBOR STATEMENT
This press release includes forward-looking statements regarding the
development, activity, therapeutic potential and safety of mipomersen in
treating patients with high cholesterol. Any statement describing Isis'
goals, expectations, financial or other projections, intentions or beliefs
is a forward-looking statement and should be considered an at-risk
statement, including those statements that are described as Isis' goals.
Such statements are 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, and in the endeavor of building a business around such
products. Isis' forward-looking statements also involve assumptions that,
if they never materialize or prove correct, could cause its results to
differ materially from those expressed or implied by such forward-looking
statements. Although Isis' forward-looking statements reflect the good
faith judgment of its management, these statements are based only 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' annual report on
Form 10-K for the year ended December 31, 2007, which is on file with the
SEC. Copies of this and other documents are available 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 trademark of Regulus Therapeutics LLC.
GENZYME SAFE HARBOR STATEMENT
This press release contains forward-looking statements, including
without limitation, statements concerning mipomersen's benefits for
patients with high cholesterol, the development plan for mipomersen and
FDA's requirements for its approval. These statements are subject to risks
and uncertainties that could cause actual results to differ materially from
those forecasted. These risks and uncertainties include, among others: the
timing of further discussions with FDA regarding the approval of
mipomersen; the timing and content of submissions to and decisions made by
the FDA relating to mipomersen; further analysis of clinical trial data;
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 2007 Annual Report on Form
10K. Genzyme cautions investors not to place substantial reliance on the
forward-looking statements contained in this press release. These
statements speak only as of today's date and Genzyme undertakes no
obligation to update or revise the statements.
Genzyme(R) is a registered trademark of Genzyme Corporation. All rights
reserved.
CONFERENCE CALL INFORMATION
At 8:00 a.m. Eastern Time Friday, April 25, Isis will conduct a live
webcast conference call to discuss the mipomersen regulatory update.
Interested parties may access the webcast at http://www.isispharm.com or
listen to the call by dialing 877-604-9669. A webcast replay will be
available for a limited time.
Isis Pharmaceuticals' Contacts:
Kristina Lemonidis (Investors) Amy Blackley, Ph.D. (Media)
760-603-2490 760-603-2772
Genzyme Contacts:
Patrick Flanigan (Investors) Erin Emlock (Media)
617-768-6563 617-768-6923
SOURCE Genzyme Corp. and Isis Pharmaceuticals, Inc.
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Related links:
http://www.genzyme.com
http://www.isispharm.com
http://www.prnewswire.com/comp/113803.html/
CONTACT:
Investors, Kristina Lemonidis,
+1-760-603-2490, or Media, Amy Blackley, Ph.D., +1-760-603-2772,
both of Isis Pharmaceuticals; or Investors, Patrick Flanigan,
+1-617-768-6563, or Media, Erin Emlock, +1-617-768-6923, both of
Genzyme Corp.
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