SAN DIEGO, Ca. and CAMBRIDGE, Mass., June 21 /PRNewswire-FirstCall/ --
Ceregene, Inc. and Genzyme Corporation (Nasdaq: GENZ) today announced that
they have entered into a partnership for the development and
commercialization of CERE-120, Ceregene's proprietary lead program for the
treatment of Parkinson's disease.
Under the terms of the agreement, Genzyme will pay Ceregene a $25
million up-front payment in exchange for certain partnership-related
expenses. Ceregene will also be entitled to development-related milestone
payments of up to $125 million and 50 percent reimbursement of the
worldwide Phase 3 development costs. Genzyme will gain marketing rights in
all markets outside of the US and Canada, and Genzyme will pay Ceregene
tiered royalties based on sales in markets where it has rights. Ceregene
will retain exclusive rights to CERE-120 in the US and Canada.
"We are pleased to be partnering CERE-120 with Genzyme-a company with a
strong international presence and marketing expertise that will enable us
to maximize the worldwide commercialization of CERE-120," stated Jeffrey M.
Ostrove, Ph.D., president and chief executive officer of Ceregene.
"CERE-120, which is currently undergoing a controlled Phase 2 trial in the
United States that is being partially funded by the Michael J. Fox
Foundation, has demonstrated strong clinical and preclinical data to date
and may have the ability to both improve Parkinson's disease symptoms and
slow the disease progression. The resources provided by our new partnership
with Genzyme, together with the greater than $27 million initial closing of
our Series C financing, which was led by Investor Growth Capital and closed
in the first quarter, provides the funding we currently need to advance
CERE-120 toward commercialization."
"We are very enthusiastic about the potential that CERE-120 may have to
improve the lives of people with Parkinson's disease, which currently
affects at least one million Americans," said David Meeker, president,
Lysosomal Storage Disorders unit, Genzyme Corporation. "We look forward to
helping further the development of this exciting approach, building on our
long-term commitment to gene therapy and neurodegenerative diseases. This
program - which is focused on preserving neuronal function - will
complement our existing Parkinson's clinical trial that is currently
underway."
"We look forward to working with Genzyme to accelerate the development
of CERE-120 in Europe and other areas outside North America," stated
Raymond T. Bartus, Ph.D., Ceregene's senior vice president of clinical and
preclinical R&D and chief operating officer, as well as chairman of the
partnership's joint steering committee. "Strong synergies and complementary
skills and experience exist between Ceregene and Genzyme. Their deep
infrastructure in developing and commercializing innovative therapeutic
products and their experience working with international regulatory
agencies will be invaluable as we expand the development of CERE-120."
In a complementary program, Genzyme is conducting a separate Phase 1-2
clinical trial of a gene therapy for Parkinson's disease designed to
restore the therapeutic effectiveness of levo-Dopa by enhancing the brain's
ability to convert it into dopamine. In addition, Genzyme has an extensive
gene therapy portfolio that includes two additional ongoing clinical
trials.
About CERE-120
CERE-120 is composed of an adeno-associated virus (AAV) vector carrying
the gene for neurturin (NTN), a naturally occurring protein known to repair
damaged and dying dopamine-secreting neurons, keeping them alive and
functioning normally. NTN is a member of the same protein family as glial
cell-derived neurotrophic factor (GDNF). The two molecules have similar
pharmacological properties, and both have been shown to benefit the
midbrain dopamine neurons that degenerate in Parkinson's disease and are
responsible for the major motor impairments. CERE-120 is delivered by
stereotactic injection to the affected area of the brain, providing stable,
long-lasting expression of NTN in a highly targeted fashion.
About CERE-120 Clinical Trials
Ceregene is currently conducting a Phase 2 clinical trial, which is in
the process of enrolling 51 patients with advanced Parkinson's disease at
nine medical centers in the United States. In a Phase 1 trial, CERE-120
demonstrated a 36 percent (p<0.001) reduction in Parkinson's symptoms at 12
months after administration, as measured by the Unified Parkinson's Disease
Rating Scale (UPDRS) motor "off" score ("motor off" meaning patients were
off Parkinson's medication at evaluation time). CERE-120 was also shown to
be well tolerated in the study. The 12-month results were presented at the
American Association of Neurological Surgeons (AANS) annual meeting in
April 2007.
About Parkinson's Disease
Parkinson's disease is a progressive movement disorder that affects at
least one million people in the United States. It is caused by a reduction
in dopamine containing nerve cells of the midbrain. Dopamine is a
neurotransmitter involved in controlling movement and coordination, so
Parkinson's patients experiencing a reduction of dopamine-producing nerve
cells exhibit the progressive inability to initiate and control physical
movements. There is currently no cure for Parkinson's disease.
About Ceregene
Ceregene, Inc. is a San Diego-based biotechnology company focused on
the development of gene therapies for neurodegenerative disorders. Ceregene
is in the clinic with CERE-110, an AAV2 based vector expressing nerve
growth factor that is being tested as a treatment for Alzheimer's disease,
and with CERE-120 for Parkinson's disease. CERE-130 is in late preclinical
development for amyotrophic lateral sclerosis (ALS). Ceregene was launched
in January 2001 and is a former subsidiary of Cell Genesys, Inc. (Nasdaq:
CEGE), which is headquartered in South San Francisco, CA. Ceregene's
investors include Alta Partners, MPM Capital, Investor Growth Capital and
Cell Genesys, as well as Hamilton BioVentures and California Technology
Partners.
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 9,000 employees in locations
spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been
selected by FORTUNE as one of the "100 Best Companies to Work for" in the
United States.
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.
Contacts: Jeffrey M. Ostrove, Ph.D.
President and CEO
Ceregene, Inc.
(858) 458-8808
Erin Emlock
Media
Genzyme Corporation
(617) 768-6923
Carol Miceli
Investors
Genzyme Corporation
(617) 768-6602
SOURCE Genzyme Corporation; Ceregene, Inc.
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Related links:
http://www.genzyme.com/
http://www.prnewswire.com/comp/113803.html/
CONTACT:
Jeffrey M. Ostrove, Ph.D., President and CEO
of Ceregene, Inc., +1-858-458-8808; or Media, Erin Emlock of
Genzyme Corporation, +1-617-768-6923; or Investors, Carol Miceli
of Genzyme Corporation, +1-617-768-6602
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