Raritan, NJ (June 22, 2010) – Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) announced today it has signed an exclusive agreement with Diamyd Medical AB, a Swedish publicly traded company focusing on the development of pharmaceuticals for the treatment of autoimmune diabetes and its complications, to develop and commercialize their GAD65 antigen-based therapy for the treatment and prevention of type 1 diabetes and associated conditions. This investigational therapy is currently being evaluated in Phase 3 clinical studies in newly diagnosed type 1 diabetes patients for its ability to delay or prevent progression of the disease and its associated complications by delaying or preventing further destruction of pancreatic islet beta cells.
Under terms of the agreement, OMJPI will make an initial payment of $45 million to Diamyd and share costs of the ongoing research and development activities. OMJPI has the right to fully assume responsibility for the global development program upon reviewing results from the first of the two ongoing Phase 3 studies in the first half of 2011. Over the span of the program, Diamyd is eligible to receive further payments based upon certain development and regulatory milestones, and both royalties and sales-based milestones, if the product is approved. As part of the commercialization agreement, Diamyd retains the right to commercialize the product in the Nordic states.
“This approach has the potential to significantly improve the lives of patients with type 1 diabetes by focusing on beta cell function and improving glycemic control, which may potentially reduce the risk of long-term complications of this disease,” said Martin Fitchet, M.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, for OMJPI affiliate, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. “This program strengthens our development pipeline and reflects our commitment to build a leading portfolio of pharmaceutical treatments for the care of patients with diabetes.”
The transaction is expected to close in the third quarter of 2010, contingent upon clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act.
About Type 1 Diabetes
Type 1 diabetes was previously called insulin-dependent diabetes mellitus or juvenile-onset diabetes. Type 1 diabetes develops when the body’s immune system destroys pancreatic beta cells—the only cells in the body that make the hormone insulin, which regulates blood glucose. People with type 1 diabetes must have insulin delivered by injection or a pump. The disease can affect people of any age, but usually occurs in children or young adults. Risk factors for type 1 diabetes may be genetic or environmental, and there is no current therapy approved to prevent progression of the disease. Long-term complications of type 1 diabetes may be disabling or even life-threatening, and can include cardiovascular disease, and damage to the nerves, kidneys, eyes, and feet.
About Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) is a subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. The company provides medicines for an array of health concerns. The company strives to provide innovative, high quality, safe and effective treatments and continually seeks new opportunities to offer solutions for unmet health care needs. For more information, visit www.omjpi.com
Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from OMJPI’s and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. Neither OMJPI nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.
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Raritan, NJ (June 22, 2010) – Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) announced today it has signed an exclusive agreement with Diamyd Medical AB, a Swedish publicly traded company focusing on the development of pharmaceuticals for the treatment of autoimmune diabetes and its complications, to develop and commercialize their GAD65 antigen-based therapy for the treatment and prevention of type 1 diabetes and associated conditions. This investigational therapy is currently being evaluated in Phase 3 clinical studies in newly diagnosed type 1 diabetes patients for its ability to delay or prevent progression of the disease and its associated complications by delaying or preventing further destruction of pancreatic islet beta cells.
Under terms of the agreement, OMJPI will make an initial payment of $45 million to Diamyd and share costs of the ongoing research and development activities. OMJPI has the right to fully assume responsibility for the global development program upon reviewing results from the first of the two ongoing Phase 3 studies in the first half of 2011. Over the span of the program, Diamyd is eligible to receive further payments based upon certain development and regulatory milestones, and both royalties and sales-based milestones, if the product is approved. As part of the commercialization agreement, Diamyd retains the right to commercialize the product in the Nordic states.
“This approach has the potential to significantly improve the lives of patients with type 1 diabetes by focusing on beta cell function and improving glycemic control, which may potentially reduce the risk of long-term complications of this disease,” said Martin Fitchet, M.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, for OMJPI affiliate, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. “This program strengthens our development pipeline and reflects our commitment to build a leading portfolio of pharmaceutical treatments for the care of patients with diabetes.”
The transaction is expected to close in the third quarter of 2010, contingent upon clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act.
About Type 1 Diabetes
Type 1 diabetes was previously called insulin-dependent diabetes mellitus or juvenile-onset diabetes. Type 1 diabetes develops when the body’s immune system destroys pancreatic beta cells—the only cells in the body that make the hormone insulin, which regulates blood glucose. People with type 1 diabetes must have insulin delivered by injection or a pump. The disease can affect people of any age, but usually occurs in children or young adults. Risk factors for type 1 diabetes may be genetic or environmental, and there is no current therapy approved to prevent progression of the disease. Long-term complications of type 1 diabetes may be disabling or even life-threatening, and can include cardiovascular disease, and damage to the nerves, kidneys, eyes, and feet.
About Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) is a subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. The company provides medicines for an array of health concerns. The company strives to provide innovative, high quality, safe and effective treatments and continually seeks new opportunities to offer solutions for unmet health care needs. For more information, visit www.omjpi.com
Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from OMJPI’s and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. Neither OMJPI nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.
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