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Amgen Highlights Biomarker and Preclinical Data to be Presented at American Association for Cancer Research (AACR) Annual Meeting

April 12, 2010

THOUSAND OAKS, Calif., April 12 /PRNewswire-FirstCall/ — Amgen (Nasdaq: AMGN) today announced that results from several preclinical studies investigating potential new cancer agents and a comprehensive biomarker analysis will be presented at the American Association for Cancer Research (AACR) 101st Annual Meeting 2010 in Washington, D.C. from April 17 – 21, 2010.

Results from a biomarker analysis of the pivotal Phase 3 Vectibix® (panitumumab) “408″ trial will be presented. The trial used massively parallel, next-generation sequencing technology to investigate whether mutations in nine genes are predictive of response to Vectibix in metastatic colorectal cancer. In addition, results will be presented from a preclinical study of RANK ligand (RANKL) inhibitor against mammary tumor formation in mouse models.

Additional presentations include data from Amgen’s emerging oncology therapeutics portfolio, which provide further experience and biologic understanding from key research areas. Amgen currently has 16 molecules in development for oncology in preclinical through Phase 3 clinical trials.

“The data presented at AACR highlight the important scientific advances that are being made in cancer research,” said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. “We hope and expect that these important preclinical studies will permit us to develop dramatically improved therapies for patients suffering from malignant disease.”

Presentations and Abstracts of Interest

Abstracts are available and can be viewed on the AACR Web site at www.aacr.org. Identified below are selected abstracts of interest on Amgen research. Updated data will be presented at the meeting.


    --  EDUCATIONAL SESSION: RANK ligand (RANKL) inhibitors for the treatment
        of skeletal complications of cancer
        Amgen would like to invite AACR attendees to an education session
        chaired by Amgen researcher, William C. Dougall.
        Saturday, April 17, 2010 from 8:00 a.m. - 10:00 a.m.

    --  Use of massively parallel, next-generation sequencing to identify gene
        mutations beyond KRAS that predict response to panitumumab in a
        randomized, Phase 3, monotherapy study of metastatic colorectal cancer
        (mCRC)
        Lead author: Peeters, M.
        Abstract No. LB-174 (Monday, April 19, 2010, 4:15 p.m. - 4:25 p.m.)

    --  Late-breaker: A RANKL inhibitor, but not a bisphosphonate, zoledronic
        acid, reduces mammary tumor formation in a carcinogen- and
        hormone-dependent mouse model
        Lead author: Jacob, A. P.
        Abstract No. LB-156 (Monday, April 19, 2010, 2:00 p.m. - 5:00 p.m.)

    --  Antitumor activity of motesanib alone and in combination with
        chemotherapy in xenograft models of human non-small cell lung cancer
        Lead author: Ziegler, B.
        Abstract No. 1380 (Monday, April 19, 2010, 9:00 a.m. - 12:00 p.m.)

    --  Late-breaker: U3-1287 (AMG 888), a fully human anti-HER3 mAb, inhibits
        HER3 activation and induces HER3 internalization and degradation
        Lead author: Hettmann, T.
        Abstract No. LB-306 (Tuesday, April 20, 2010, 2:00 p.m. - 5:00 p.m.)

    --  Selective and potent inhibitors of the mutant B-Raf pathway
        paradoxically stimulate the MAPK pathway in wild type B-Raf cells
        Lead author: Carnahan, J.
        Abstract No. 21 (Sunday, April 18, 2010, 2:10 p.m. - 2:25 p.m.)

    --  Efficacy of a potent and select Raf inhibitor against human xenograft
        models displaying specific genetic mutations in the MAPK signaling
        pathway
        Lead author: Beltran, P.
        Abstract No. 2519 (Monday, April 19, 2010, 2:00 p.m. - 5:00 p.m.)

    --  Abnormal expression of the anaplastic lymphoma kinase (ALK) protein in
        ovarian carcinoma is associated with low copy number amplification of
        the 2p23 locus
        Lead author: Merkel, P.
        Abstract No. 3142 (Tuesday, April 20, 2010, 9:00 a.m. - 12:00 p.m.)

About Vectibix® (panitumumab)

Vectibix is the first fully human anti-EGFR approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer (mCRC). Vectibix was approved in the United States in September 2006 as a monotherapy for the treatment of patients with EGFR expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

In December 2007, the European Commission granted a conditional marketing authorization for Vectibix as monotherapy for the treatment of patients with EGFR-expressing mCRC with wild-type KRAS genes after failure of standard chemotherapy regimens. Vectibix has been launched in over 20 countries, including Switzerland, Australia and Canada. Applications in the rest of the world are pending.

The effectiveness of Vectibix as a single agent 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. Vectibix has not shown a treatment benefit for patients whose tumors had KRAS mutations in codon 12 or 13.

Important Product Safety Information

Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 or higher) in 12 percent of patients receiving Vectibix monotherapy.

Infusion Reactions: Severe infusion reactions occurred in approximately 1 percent of patients. Although not reported with Vectibix, fatal infusion reactions have occurred with other monoclonal antibody products.

The most common adverse events of Vectibix are skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, and diarrhea, including diarrhea resulting in dehydration.

The most serious adverse events of Vectibix are pulmonary fibrosis, pulmonary embolism, severe dermatologic toxicity complicated by infectious sequelae and septic death, infusion reactions, abdominal pain, hypomagnesemia, nausea, vomiting, and constipation.

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 http://www.amgen.com.

Forward-Looking Statements

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 April 12, 2010 and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product 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 us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop 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 we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

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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 U.S. Food and Drug Administration (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.


    CONTACT: Amgen, Thousand Oaks
    Ashleigh Koss: +1 (805) 313-6151 (media)
    Arvind Sood: +1 (805) 447-1060 (investors)

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SOURCE Amgen


Source: newswire