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Amgen to Appeal CHMP Opinion on Vectibix(TM) (Panitumumab)
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--May 25, 2007--Amgen (NASDAQ:AMGN) today issued the following statement:
Amgen has received notice from the European Medicines Agency (EMEA) that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion for Amgen's marketing authorization application (MAA) for Vectibix(TM) (panitumumab) for patients with metastatic colorectal cancer (mCRC) who have failed chemotherapy.
In accordance with European regulations, Amgen intends to request re-examination of the CHMP opinion through the appeal procedure. Notwithstanding the CHMP's initial view, Amgen is confident that the available data demonstrates that Vectibix improves progression-free survival (PFS) for mCRC patients who have progressed on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Vectibix is the first fully human IgG2 monoclonal antibody (MAb) that targets the epidermal growth factor receptor (EGFr), a protein that plays an important role in cancer cell signalling, a well validated target in oncology. Vectibix was approved by the United States Food and Drug Administration (FDA) in September 2006. The FDA approval of Vectibix was based on a progression-free survival endpoint.
Vectibix is indicated in the United States for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens. The effectiveness of Vectibix for the treatment of EGFr-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Important Product Safety Information
Dermatologic toxicities, related to Vectibix blockade of EGF binding and subsequent inhibition of EGF receptor-mediated signaling pathways, included but were not limited to dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Dermatologic toxicities were reported in 89 percent of patients treated with Vectibix and were severe in 12 percent of patients. Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Vectibix may need to be withheld or discontinued for severe dermatologic toxicities.
Severe infusion reactions occurred with Vectibix in approximately 1 percent of patients. Severe infusion reactions were identified as anaphylactic reactions, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix, they have occurred with other monoclonal antibody products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing Vectibix, depending on the severity and/or persistence of the reaction.
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 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 vital medicines, visit www.amgen.com.
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of May 25, 2007 and expressly disclaims any duty to update information contained in this news release.
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Christine Regan, 805-447-5476 (US media, oncology)
Sabeena Ahmad, + 41 41 3692 530 (EU media, oncology)
Arvind Sood, 805-447-1060 (investors)