THOUSAND OAKS, Calif.--(BUSINESS WIRE)--June 12, 2006--Amgen (Nasdaq:AMGN), the world's largest biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for panitumumab, an investigational fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr) and has granted Priority Review. The BLA was submitted for the treatment of metastatic colorectal cancer patients who have failed prior chemotherapy, including oxaliplatin and/or irinotecan containing regimens. A Priority Review designation means that the FDA will target an Agency action within six months of the application's submission date.
Priority Review status is assigned by the FDA to those applications the Agency has deemed to have the potential to provide a significant therapeutic advance for patients. The rolling BLA submission for panitumumab was initiated in December 2005 and completed in March 2006. Panitumumab received Fast Track designation from the FDA in July 2005. In April 2006, marketing applications were submitted to the European Medicines Agency (EMEA) and Health Canada and in May 2006 in Australia and Switzerland.
Patients and physicians can access www.amgentrials.com for more information about ongoing panitumumab clinical trials.
About Panitumumab
Panitumumab is an investigational fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr), a protein that plays an important role in cancer cell signaling. Panitumumab, an IgG2 monoclonal antibody, binds with high affinity to the EGFr. Panitumumab was generated with XenoMouse(R) technology, which creates a fully human monoclonal antibody that contains no murine (mouse) protein. The body's immune system can recognize the mouse protein found in chimeric and humanized antibodies as foreign and may launch an immune response. The goal of developing fully human monoclonal antibodies is to offer effective targeted therapies with minimum risk of immune response against these agents.
Panitumumab is being evaluated in clinical trials as both a monotherapy and in combination with other agents for the treatment of various types of cancer, including colorectal, lung and head and neck.
About the Epidermal Growth Factor Receptor (EGFr)
Although EGFr normally helps regulate the growth of many different cells in the body, EGFr also can stimulate cancer cells to grow. In fact, many cancer cells actually require signals mediated by EGFr for their survival. Residing on the surface of these tumor cells, EGFr is activated when naturally occurring proteins in the body, such as epidermal growth factor (EGF) or transforming growth factor alpha (TGF-alpha), bind to it. This binding changes the shape of EGFr, which, in turn, triggers internal cellular signals that stimulate tumor cell growth. Panitumumab binds to EGFr, preventing the natural ligands such as EGF and TGF-alpha from binding to the receptor and interfering with the signals that would otherwise stimulate growth of the cancer cell and allow it to survive.
About Colorectal Cancer
Colorectal cancer is the third most common cancer diagnosed in men and in women in the United States. The American Cancer Society estimates that about 106,680 new cases of colon cancer and 41,930 new cases of rectal cancer will be diagnosed in 2006.
About Amgen
Amgen discovers, develops 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 broad and deep 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
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2005, and in Amgen's 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.
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The scientific information discussed in this news release related to our 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.
Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
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CONTACT: Amgen Trish Hawkins, 805-447-4587 (media) Arvind Sood, 805-447-1060 (investors) SOURCE: Amgen Inc.