NBIX agreement re diabetes with Taisho Pharmaceutical:
biz.yahoo.com
Neurocrine Biosciences Inc. Executes Final Agreement and Receives an Undisclosed Signing Fee With Taisho Pharmaceutical Co. Ltd. for European and Asian Rights to APL Diabetes
Neurocrine Also Updates Clinical Progress With NBI-6024 for Type I Diabetes
SAN DIEGO--(BW HealthWire)--July 24, 2000-- Neurocrine Biosciences Inc. (Nasdaq:NBIX - news) Monday announced that it has completed its final exclusive agreement with Taisho Pharmaceutical Co., LTD and received an undisclosed signing fee.
The agreement provides Taisho the exclusive rights to NBI-6024, Neurocrine's altered peptide ligand (APL) for diabetes in Europe and Asia. Neurocrine will retain all rights in the rest of the world, including North America, and provide Taisho an option to obtain such rights. The collaboration, valued at $45 million, includes licensing and option fees, payments for certain development and regulatory milestones, and significant reimbursement of the worldwide development expenses. In addition, Neurocrine will receive royalties on product sales in Europe and Japan.
Neurocrine also announced the completion of a Phase I clinical study with APL compound NBI-6024 in patients with Type I Diabetes or insulin-dependent diabetes mellitus (IDDM). The Phase I study included twenty patients in a single dose, dose escalation study. Preliminary safety data from this study indicated that NBI-6024 was safe and well tolerated. Two additional clinical studies are planned to start in Q3, 2000. These studies will assess the safety and biological activity of multiple doses of NBI-6024 in both adult and pediatric patients with Type 1 Diabetes.
``Now that it is possible to predict almost a million individuals developing insulin-dependent diabetes mellitus, it is essential to develop a safe and effective preventive therapy. An important avenue in this regard are forms of immunologic vaccinations, such as the APL,'' said Dr. George Eisenbarth, executive director of the Barbara Davis Center for Childhood Diabetes, Professor, University of Colorado.
NBI-6024 is based on Neurocrine's proprietary APL technology platform which was discovered and developed by Neurocrine scientists and co-founder, Dr. Larry Steinman, M.D., Professor, Department of Neurology and Neurological Sciences, Stanford University School of Medicine.
``We are pleased with the progress of this clinical program and with the execution of the Taisho collaborative agreement. We look forward to working with Taisho to rapidly accelerate the clinical development of NBI-6024,'' said Gary Lyons, president and CEO of Neurocrine Biosciences Inc.
According to the American Diabetes Association, there are 15.7 million people, or 5.9% of the population in the United States, who have diabetes with incidences increasing. While an estimated 10.3 million patients have been diagnosed, the rest are not aware they have the disease. The National Diabetes Foundation reports that IDDM represents 5-10% of all diagnosed cases of diabetes or approximately 1.5 million recognized Type 1 diabetics in the U.S. and Europe. A significant additional market for APL Diabetics is the Type 1.5 diabetic patient. Recent refinements in diagnostic clinical metabolic assays for IDDM suggest that 5-10% of patients previously diagnosed as Type 2 diabetics may actually have IDDM. These misdiagnosed patients will substantially increase the market size for patients who could potentially benefit from immune-specific therapeutic agents designed for the prevention of IDDM. Approximately 3.2 million people in the U.S. and Europe would be included in this group.
Background on Neurocrine's APL Technology for Diabetes
In the case of IDDM the (beta)-islet pancreatic cells, which are responsible for the production of insulin, are the targets for immune mediated destruction. Working closely with leading diabetologists, Neurocrine scientists have engineered one of the dominant pancreatic antigens so that it is no longer recognized by the pathogenic, autoreactive immune cell. Moreover, the altered peptide is capable of generating the production of regulatory cells capable of controlling the pathogenic immune cell. In addition, this APL has been shown in preclinical models to elicit a protective immune response by down regulating the immune-mediated destructive process, thereby preserving the (beta)-islet cell and their producing capability.
In preclinical models, Neurocrine's APL clinical compound also has been shown to reduce the incidence of diabetes. In addition, immune cells from diabetic patients vigorously react to the region of insulin from which Neurocrine's APL was developed whereas immune cells from non-diabetic patients do not recognize the antigen. These data indicate that the APL has the potential to intervene in the disease process in humans. The preclinical data suggest that this therapeutic intervention, if administered prophylactically, may have the potential to prevent the onset of diabetes in those patients who are at high risk, such as first-degree relatives of patients with IDDM. In addition, there is the potential to intervene in newly diagnosed patients or patients who still have residual intact (beta)-islet cells function by preventing further destruction, and preserving endogenous insulin production, thereby mitigating disease progression. When combined with the commercialization of novel genetic screening and immune function diagnostic products for early identification of IDDM, this strategy will address both the primary cause and the development of a true cure for IDDM.
Neurocrine Biosciences is a leading neuroscience company focused on the discovery and development of novel therapeutics for neuropsychiatric, neuroinflammatory and neurodegenerative diseases and disorders. The company's neuroscience, endocrine and immunology disciplines provide a unique biological understanding of the molecular interaction between central nervous, immune and endocrine systems for the development of therapeutic interventions for anxiety, depression, insomnia, stroke, malignant brain tumors, multiple sclerosis, obesity and diabetes. [snip] |
