PRINCETON, N.J., Oct. 5 /PRNewswire-FirstCall/ -- Medarex, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for MDX-010 in combination with MDX-1379, a melanoma vaccine, for the treatment of previously treated, unresectable Stage III and Stage IV metastatic melanoma. Medarex is currently conducting a Phase III clinical trial with MDX-010 and MDX-1379 combination therapy in Stage III and IV melanoma at multiple sites within the United States.
Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological product means that the FDA has determined that the drug or biologic is intended for the treatment of a serious or life-threatening condition that demonstrates the potential to address unmet medical needs for such a condition, and that the FDA will facilitate and expedite the development and review of the application for the approval of the product.
"We are pleased that the FDA has recognized the unmet medical need of those who suffer from metastatic melanoma, and we believe that this fast track designation for MDX-010 may be an important step towards bringing this product more rapidly to the market," said Donald L. Drakeman, President and CEO of Medarex.
About MDX-010
MDX-010 is a fully human antibody against human CTLA-4, a molecule on T cells that is believed to be responsible for suppressing the immune response. Medarex believes that the use of MDX-010 to block CTLA-4 also has the potential to enable the immune systems of cancer patients to more effectively fight tumors. In June 2004, MDX-010 received orphan drug designation from the FDA for the treatment of high risk Stage II, III and IV melanoma. In August 2004, Medarex reached a Special Protocol Assessment (SPA) agreement with the FDA for the initiation of the Phase III clinical trial. In addition to the Phase III clinical trial in melanoma patients, MDX-010 is currently being studied in a number of Phase II clinical trials in other oncology indications, including prostate cancer, breast cancer and renal cancer. An MDX-010 study for the treatment of HIV is also ongoing. Further information regarding Medarex's MDX-010 program can be found in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC).
About MDX-1379
MDX-1379 vaccine consists of two gp100 melanoma peptides. These peptides are part of a protein normally found on melanocytes, or pigmented skin cells, and are also present on melanoma cells. These melanoma peptides are recognized by cytotoxic T cells in melanoma patients that are positive for HLA-A2, a human immune system compatibility antigen that is expressed in approximately half of the melanoma population. Medarex has in-licensed the MDX-1379 vaccine peptides from the National Cancer Institute (NCI).
About the Phase III Clinical Trial
In the Phase III trial, approximately 750 patients with previously treated Stage III or Stage IV metastatic melanoma are expected to be enrolled. The patients will be randomized to receive one of three regimens: MDX-010 in combination with MDX-1379, MDX-010 alone or MDX-1379 alone. The randomization will be done on a 3:1:1 basis, with 60%, or approximately 450, of the patients receiving the MDX-010/MDX-1379 antibody/vaccine combination. All patients receiving MDX-010 will receive a dose of three mg/kg every three weeks for up to four doses. Best objective response rate (complete and partial responses) will be used as the basis for an expected initial Biologics License Application (BLA) submission under 21 CFR 601 Subpart E, which provides for early approval based upon a surrogate endpoint in life-threatening or severely debilitating illnesses. Disease progression and survival data will continue to be collected from patients being followed in the Phase III trial. Treatment assignment will be blinded, with oversight by an independent Data Monitoring Committee (DMC).
About Malignant Melanoma
According to the American Cancer Society, cancer of the skin is the most common of all cancers. Melanoma accounts for about 4% of skin cancer cases, but it causes about 80% of skin cancer deaths. The American Cancer Society estimates that in 2004 there will be about 55,100 new cases of melanoma in the U.S., and approximately 14% of these cases will be diagnosed with late stage metastatic melanoma. In the US, nearly 8,000 people are expected to die of melanoma in 2004. Worldwide there are approximately 160,000 people who are diagnosed with melanoma annually, and approximately 40,000 people are expected to die of the disease each year.
About Medarex, Inc.
Medarex is a biopharmaceutical company focused on the discovery and development of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune and infectious diseases. Medarex applies its UltiMAb(TM) technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody products for itself and its partners. Twenty of these therapeutic products derived from Medarex technology are currently in human clinical testing, with the most advanced candidate currently in a Phase III clinical trial. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world's unmet healthcare needs. For more information about Medarex, visit its website at http://www.medarex.com/.
Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of MDX-010 and MDX-1379 in patients, uncertainties related to product manufacturing as well as risks detailed from time to time in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2003 and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such development efforts will succeed, that MDX-010 or other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Copies of Medarex's public disclosure filings are available from its investor relations department.
Medarex(R) and the Medarex logo are registered trademarks of Medarex, Inc. UltiMAb(TM) is a trademark of Medarex, Inc. All rights are reserved.
Medarex, Inc.
Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological product means that the FDA has determined that the drug or biologic is intended for the treatment of a serious or life-threatening condition that demonstrates the potential to address unmet medical needs for such a condition, and that the FDA will facilitate and expedite the development and review of the application for the approval of the product.
"We are pleased that the FDA has recognized the unmet medical need of those who suffer from metastatic melanoma, and we believe that this fast track designation for MDX-010 may be an important step towards bringing this product more rapidly to the market," said Donald L. Drakeman, President and CEO of Medarex.
About MDX-010
MDX-010 is a fully human antibody against human CTLA-4, a molecule on T cells that is believed to be responsible for suppressing the immune response. Medarex believes that the use of MDX-010 to block CTLA-4 also has the potential to enable the immune systems of cancer patients to more effectively fight tumors. In June 2004, MDX-010 received orphan drug designation from the FDA for the treatment of high risk Stage II, III and IV melanoma. In August 2004, Medarex reached a Special Protocol Assessment (SPA) agreement with the FDA for the initiation of the Phase III clinical trial. In addition to the Phase III clinical trial in melanoma patients, MDX-010 is currently being studied in a number of Phase II clinical trials in other oncology indications, including prostate cancer, breast cancer and renal cancer. An MDX-010 study for the treatment of HIV is also ongoing. Further information regarding Medarex's MDX-010 program can be found in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC).
About MDX-1379
MDX-1379 vaccine consists of two gp100 melanoma peptides. These peptides are part of a protein normally found on melanocytes, or pigmented skin cells, and are also present on melanoma cells. These melanoma peptides are recognized by cytotoxic T cells in melanoma patients that are positive for HLA-A2, a human immune system compatibility antigen that is expressed in approximately half of the melanoma population. Medarex has in-licensed the MDX-1379 vaccine peptides from the National Cancer Institute (NCI).
About the Phase III Clinical Trial
In the Phase III trial, approximately 750 patients with previously treated Stage III or Stage IV metastatic melanoma are expected to be enrolled. The patients will be randomized to receive one of three regimens: MDX-010 in combination with MDX-1379, MDX-010 alone or MDX-1379 alone. The randomization will be done on a 3:1:1 basis, with 60%, or approximately 450, of the patients receiving the MDX-010/MDX-1379 antibody/vaccine combination. All patients receiving MDX-010 will receive a dose of three mg/kg every three weeks for up to four doses. Best objective response rate (complete and partial responses) will be used as the basis for an expected initial Biologics License Application (BLA) submission under 21 CFR 601 Subpart E, which provides for early approval based upon a surrogate endpoint in life-threatening or severely debilitating illnesses. Disease progression and survival data will continue to be collected from patients being followed in the Phase III trial. Treatment assignment will be blinded, with oversight by an independent Data Monitoring Committee (DMC).
About Malignant Melanoma
According to the American Cancer Society, cancer of the skin is the most common of all cancers. Melanoma accounts for about 4% of skin cancer cases, but it causes about 80% of skin cancer deaths. The American Cancer Society estimates that in 2004 there will be about 55,100 new cases of melanoma in the U.S., and approximately 14% of these cases will be diagnosed with late stage metastatic melanoma. In the US, nearly 8,000 people are expected to die of melanoma in 2004. Worldwide there are approximately 160,000 people who are diagnosed with melanoma annually, and approximately 40,000 people are expected to die of the disease each year.
About Medarex, Inc.
Medarex is a biopharmaceutical company focused on the discovery and development of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune and infectious diseases. Medarex applies its UltiMAb(TM) technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody products for itself and its partners. Twenty of these therapeutic products derived from Medarex technology are currently in human clinical testing, with the most advanced candidate currently in a Phase III clinical trial. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world's unmet healthcare needs. For more information about Medarex, visit its website at http://www.medarex.com/.
Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of MDX-010 and MDX-1379 in patients, uncertainties related to product manufacturing as well as risks detailed from time to time in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2003 and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such development efforts will succeed, that MDX-010 or other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Copies of Medarex's public disclosure filings are available from its investor relations department.
Medarex(R) and the Medarex logo are registered trademarks of Medarex, Inc. UltiMAb(TM) is a trademark of Medarex, Inc. All rights are reserved.
Medarex, Inc.
