KW-0761 Studies Underway in Inflammation and Oncology
THOUSAND OAKS, CA, USA and TOKYO, Japan | March 5, 2008 | Kyowa Hakko Kogyo Co., Ltd (Kyowa Hakko) (TSE: 4151) and Amgen (NASDAQ: AMGN) today announced an agreement under which Amgen will receive an exclusive license to develop and commercialize Kyowa Hakko’s humanized monoclonal antibody KW-0761 worldwide, except in Japan, Korea, China and Taiwan. Kyowa Hakko will retain the development and commercialization rights in these countries.
Under the terms of the deal, Amgen will make an upfront payment to Kyowa Hakko of $100 million. Kyowa Hakko could receive up to $420 million in additional payments, including development, approval and sales milestones. Kyowa Hakko will also be entitled to receive double digit royalties on sales.
KW-0761 is currently being studied in inflammation and oncology settings. Kyowa Hakko has completed Phase 1 studies of KW-0761 in healthy volunteers and allergic rhinitis patients, and is currently conducting Phase 1 studies of KW-0761 in lymphoma patients.
Amgen will initially acquire rights in all non-oncology indications, and Kyowa Hakko will continue its development activities in oncology until the completion of Phase 2a. At that time, Amgen may elect to reimburse Kyowa Hakko for its oncology-related development costs, expand its license to include oncology and assume the development and commercialization of KW-0761 in oncology settings.
The agreement is subject to approval from the Federal Trade Commission and will be effective immediately upon such approval.
Financial guidance previously provided on Jan. 24, 2008 by Amgen for 2008 adjusted earnings per share will remain unchanged by this transaction.
About CCR4 and KW-0761
CCR4 is a chemokine receptor that binds specifically to its ligands TARC and MDC, and participates in the control of T cell migration. CCR4 is expressed mainly on Th2-type helper T cells and regulatory T cells in normal conditions. CCR4+ T cells are implicated in the pathology of asthma and other inflammatory diseases and T-cell malignancies.
KW-0761 is a humanized monoclonal antibody targeting CCR4 utilizing the POTELLIGENT(R) technology platform for the development of antibody-dependent cell-mediated cytotoxicity- (ADCC) enhanced antibodies.
About POTELLIGENT(R) Technology
ADCC activity is an important immune mechanism that permits immune cells to kill targets, e.g. cancer cells. Enhancement of this activity is one promising approach in the next generation of antibody technologies.
The POTELLIGENT(R) technology involves the reduction of the amount of fucose in the carbohydrate structure of an antibody. Research shows that POTELLIGENT(R) technology significantly enhances the ADCC activity of antibodies in vitro, thereby increasing the potential for improved activity in vivo.
About Kyowa Hakko
Kyowa Hakko is a biotechnology-based company focused on two businesses: pharmaceutical operations engaged in the research and development, manufacturing, and marketing of prescription drugs; and bio-chemical operations that handle a variety of products such as amino acids, nucleic acids, and nutritional supplements/healthcare products. Its pharmaceutical business places emphasis on research and development in the fields of oncology, allergy, and the central nervous system. In Japan, Kyowa Hakko is marketing medications for a wide range of diseases, including allergy, hypertension, angina pectoris, and cancer. With the aim of penetrating the global market, Kyowa Hakko has overseas development bases in the U.S. (Kyowa Pharmaceutical, Inc. and BioWa, Inc) and in the U.K. (Kyowa Hakko U.K. Ltd.). In the U.S., the U.K., and China, they are pushing ahead with the clinical development of new drug candidates as well as the therapeutic antibody business based on Kyowa Hakko’s proprietary technology (POTELLIGENT(R)) that enhances the activity of antibodies.
Last autumn, Kyowa Hakko announced that the Kyowa Hakko group and the Kirin group entered into an agreement to merge. Through this merger, the two groups will endeavor to build a global leader in the research and development-driven life sciences business based in Japan, which is centered on pharmaceutical operations with strengths in biotechnology. The new company "Kyowa Hakko Kirin Co., Ltd." will start operating on Oct. 1, 2008.
For more information on Kyowa Hakko, KW-0761 and POTELLIGENT(R) technology, visit http://www.kyowa.co.jp/eng/.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
Forward-Looking Statement: Amgen
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended Dec. 31, 2007, and in our periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen’s products after they are on the market. Amgen’s business may be impacted by government investigations, litigation and products liability claims. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.
In addition, sales of Amgen’s products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of Amgen’s products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen’s products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen’s ability to obtain or maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen’s stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen’s business and results of operations.
The scientific information discussed in this news release related to Amgen’s product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated.
SOURCE: Amgen
Post Views: 122
KW-0761 Studies Underway in Inflammation and Oncology
THOUSAND OAKS, CA, USA and TOKYO, Japan | March 5, 2008 | Kyowa Hakko Kogyo Co., Ltd (Kyowa Hakko) (TSE: 4151) and Amgen (NASDAQ: AMGN) today announced an agreement under which Amgen will receive an exclusive license to develop and commercialize Kyowa Hakko’s humanized monoclonal antibody KW-0761 worldwide, except in Japan, Korea, China and Taiwan. Kyowa Hakko will retain the development and commercialization rights in these countries.
Under the terms of the deal, Amgen will make an upfront payment to Kyowa Hakko of $100 million. Kyowa Hakko could receive up to $420 million in additional payments, including development, approval and sales milestones. Kyowa Hakko will also be entitled to receive double digit royalties on sales.
KW-0761 is currently being studied in inflammation and oncology settings. Kyowa Hakko has completed Phase 1 studies of KW-0761 in healthy volunteers and allergic rhinitis patients, and is currently conducting Phase 1 studies of KW-0761 in lymphoma patients.
Amgen will initially acquire rights in all non-oncology indications, and Kyowa Hakko will continue its development activities in oncology until the completion of Phase 2a. At that time, Amgen may elect to reimburse Kyowa Hakko for its oncology-related development costs, expand its license to include oncology and assume the development and commercialization of KW-0761 in oncology settings.
The agreement is subject to approval from the Federal Trade Commission and will be effective immediately upon such approval.
Financial guidance previously provided on Jan. 24, 2008 by Amgen for 2008 adjusted earnings per share will remain unchanged by this transaction.
About CCR4 and KW-0761
CCR4 is a chemokine receptor that binds specifically to its ligands TARC and MDC, and participates in the control of T cell migration. CCR4 is expressed mainly on Th2-type helper T cells and regulatory T cells in normal conditions. CCR4+ T cells are implicated in the pathology of asthma and other inflammatory diseases and T-cell malignancies.
KW-0761 is a humanized monoclonal antibody targeting CCR4 utilizing the POTELLIGENT(R) technology platform for the development of antibody-dependent cell-mediated cytotoxicity- (ADCC) enhanced antibodies.
About POTELLIGENT(R) Technology
ADCC activity is an important immune mechanism that permits immune cells to kill targets, e.g. cancer cells. Enhancement of this activity is one promising approach in the next generation of antibody technologies.
The POTELLIGENT(R) technology involves the reduction of the amount of fucose in the carbohydrate structure of an antibody. Research shows that POTELLIGENT(R) technology significantly enhances the ADCC activity of antibodies in vitro, thereby increasing the potential for improved activity in vivo.
About Kyowa Hakko
Kyowa Hakko is a biotechnology-based company focused on two businesses: pharmaceutical operations engaged in the research and development, manufacturing, and marketing of prescription drugs; and bio-chemical operations that handle a variety of products such as amino acids, nucleic acids, and nutritional supplements/healthcare products. Its pharmaceutical business places emphasis on research and development in the fields of oncology, allergy, and the central nervous system. In Japan, Kyowa Hakko is marketing medications for a wide range of diseases, including allergy, hypertension, angina pectoris, and cancer. With the aim of penetrating the global market, Kyowa Hakko has overseas development bases in the U.S. (Kyowa Pharmaceutical, Inc. and BioWa, Inc) and in the U.K. (Kyowa Hakko U.K. Ltd.). In the U.S., the U.K., and China, they are pushing ahead with the clinical development of new drug candidates as well as the therapeutic antibody business based on Kyowa Hakko’s proprietary technology (POTELLIGENT(R)) that enhances the activity of antibodies.
Last autumn, Kyowa Hakko announced that the Kyowa Hakko group and the Kirin group entered into an agreement to merge. Through this merger, the two groups will endeavor to build a global leader in the research and development-driven life sciences business based in Japan, which is centered on pharmaceutical operations with strengths in biotechnology. The new company "Kyowa Hakko Kirin Co., Ltd." will start operating on Oct. 1, 2008.
For more information on Kyowa Hakko, KW-0761 and POTELLIGENT(R) technology, visit http://www.kyowa.co.jp/eng/.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
Forward-Looking Statement: Amgen
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended Dec. 31, 2007, and in our periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen’s products after they are on the market. Amgen’s business may be impacted by government investigations, litigation and products liability claims. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.
In addition, sales of Amgen’s products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of Amgen’s products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen’s products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen’s ability to obtain or maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen’s stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen’s business and results of operations.
The scientific information discussed in this news release related to Amgen’s product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated.
SOURCE: Amgen
Post Views: 122
