Ceregene and Genzyme Announce Partnership for the Development and Commercialization of Cere-120 for Parkinson's Disease
SAN DIEGO, Ca. and CAMBRIDGE, Mass., June 21 -- Ceregene, Inc. and Genzyme Corporation 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