Vectibix is a recombinant, fully human IgG2 kappa monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR). Vectibix is approved in the US and EU as a monotherapy for the treatment of patients with EGFR-expressing metastatic CRC after disease progression on or following fluoropyrimidine, oxaliplatin and irinotecan-containing chemotherapy regimens. Currently Vectibix is in several Phase III trials investigating its use in other lines of metastatic CRC therapy, as well as metastatic head and neck cancer.

CRC is the third most common type of cancer and Datamonitor forecasts its incidence in the seven major pharmaceutical markets to be more than 478,000 in 2009. Cure is not possible for most patients with the disease, but chemotherapy with or without molecular targeted therapies may be used to improve symptoms and prolong life.

Previous PRIME study results for Vectibix presented at the European Society for Medical Oncology Congress in September 2009 were encouraging. Vectibix met its primary endpoint of increasing progression-free survival when administered in combination with FOLFOX in the PRIME study, and in the separate Phase III '181' trial, progression-free survival was improved when Vectibix was combined with FOLFIRI (leucovorin, 5-fluorouracil, irinotecan).

If approved for first-line metastatic CRC, Vectibix will be competing with Erbitux (cetuximab; Eli Lilly/Merck Serono/Bristol-Myers Squibb): another anti-EGFR monoclonal antibody. Results from the recent Phase III CRYSTAL trial evaluating Erbitux in combination with FOLFIRI (folinic acid, fluorouracil, irinotecan) demonstrated that patients in the Erbitux arm had a significantly improved overall survival (p=0.0094) compared to those receiving chemotherapy alone.

In the CRYSTAL trial, Erbitux improved median overall survival by 3.5 months. Despite not being statistically significant, Amgen will be encouraged by the median overall survival improvement of 4.2 months in the most recent PRIME trial. The company should consider further trials to further explore the drug's impact on survival and increase its chances of effectively competing with Erbitux.

http://www.datamonitor.com

Republication or redistribution, including by framing or similar means,
is expressly prohibited without prior written consent. Datamonitor shall 
not be liable for errors or delays in the content, or for any actions 
taken in reliance thereon

Amgen will honor a total of 34 teachers in states where Amgen has operating sites: California, Colorado, Kentucky, Massachusetts, Puerto Rico, Rhode Island, Washington and Canada (Alberta, British Columbia, Ontario and Quebec).

"Outstanding teachers motivate, inspire and prepare students for a better understanding of science and how it applies to the world around them," said Phyllis Piano, vice president, Corporate Communications and Philanthropy at Amgen. "Amgen is proud to honor educators in our communities who are dedicated to science teaching excellence and we look forward to recognizing their accomplishments."

The 34 selected winners within the United States, Puerto Rico and Canada will receive the following benefits:

    --  An unrestricted cash award of $5,000 USD or $5,000 CAD; and

    --  A restricted $5,000 USD or $5,000 CAD cash grant to the recipient's
        school for the expansion or enhancement of a school science program,
        science resources, or the professional development of the school's
        science teachers.

Applicants are required to submit an innovative lesson plan that they have successfully incorporated into their classroom and that can be shared with other teachers. A panel of independent judges will select the winners based on the following criteria: creativity and effectiveness of teaching methods; innovative lesson plan; and the plan for the use of grant money to improve science education resources in their schools.

A select number of the lesson plans submitted by 2010 AASTE Award winners will be posted to Amgen's Web site, with the intent that other teachers will benefit from these innovative materials. Select lesson plans from 2007 through 2009 AASTE Award winners are available for download at no cost; educators are encouraged to review and implement any of these plans into their own curriculum.

Those interested in applying should visit http://www.amgen.com/citizenship/aaste.html for more information. The application can be completed online and French and Spanish applications are available in PDF format. Applications must be submitted by Feb. 5, 2010 to be valid. Winners will be notified in between April and June 2010.

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.

    CONTACT:  Amgen, Thousand Oaks
              Kristen Davis, (805) 447-3008 (media)

(Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)

SOURCE Amgen

http://www.amgen.com

"As we previously announced, the 203 study met its primary endpoint of progression-free survival in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "While not statistically significant, we are also encouraged by the positive trend of the data for overall survival for these patients treated with Vectibix."

Overall survival appeared to be reduced in patients with KRAS mutant tumors receiving Vectibix. Although not statistically significant, this result emphasizes the importance, as described in product labeling, of ensuring that patients receiving Vectibix( )do not bear tumors containing KRAS mutations.

Overall, the adverse event profile was as anticipated for an anti-EGFR antibody in combination with oxaliplatin-based chemotherapy, including known events such as rash, diarrhea and hypomagnesemia. Vectibix-related grade 3 infusion reactions were reported for two patients (less than 1 percent).

Originally designed to compare the treatment effect in the overall population, the study was amended to analyze outcomes with respect to the presence or absence of activating mutations in KRAS in the tumor itself. Tumor KRAS status was ascertained in more than 90 percent of the 1,183 patients enrolled in the trial.

Available results from the trial were presented earlier this year at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany showing that Vectibix significantly improved median progression-free survival by 1.6 months (9.6 versus 8.0 months for patients treated with FOLFOX alone, in patients with KRAS wild-type mCRC (primary endpoint). Further, the addition of Vectibix to chemotherapy also improved response rate in the KRAS wild-type patient population as measured by blinded central review (55 percent versus 48 percent in the FOLFOX only arm).

The data for the 203 study has been submitted for consideration of presentation at the American Society of Clinical Oncology - The Gastrointestinal Cancers Symposium Meeting for 2010.

Study Design

Patients enrolled in the "203" or PRIME trial (Panitumumab Randomized trial in combination with chemotherapy for Metastatic colorectal cancer to determine Efficacy) were randomized to receive either 6.0 mg/kg of Vectibix and FOLFOX4 once every two weeks (Q2W) or FOLFOX4 alone Q2W. The primary endpoint of the study is progression-free survival by KRAS status and secondary endpoints include overall survival, objective response rate, time to progression, duration of response and safety.

About KRAS

Results from studies performed over the last twenty-five years indicate that KRAS plays an important role in cell growth regulation. In mCRC, EGFR transmits signals through a set of intracellular proteins. Upon reaching the nucleus, these signals instruct the cancer cell to reproduce and metastasize, leading to cancer progression. Anti-EGFR antibody therapies work by blocking the activation of EGFR, thereby inhibiting downstream events that lead to malignant signaling. However, it is hypothesized that in patients whose tumors harbor a mutated KRAS gene, the KRAS protein is always turned "on," regardless of whether the EGFR has been activated or therapeutically inhibited. KRAS mutations occur in approximately 40 - 50 percent of mCRC.

About Colorectal Cancer

Colorectal cancer is the fourth most common cancer in men and the third most common cancer in women worldwide. In 2007, approximately 1.2 million cases of colorectal cancer were expected to occur globally. With more than 630,000 deaths worldwide per year, it is the second leading cause of cancer-related death in the Western world. The highest incidence rates are found in Japan, North America, parts of Europe, New Zealand, and Australia, and rates are low in Africa and South-East Asia.( ) Rates are substantially higher in men than in women.

About Vectibix

Vectibix is the first fully human anti-EGFR antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of 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.

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.

In December 2007, the EMEA 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, Switzerland, Australia and Canada. Applications in the rest of the world are pending.

Important Product Safety Information

Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 and higher) in 12 percent of patients receiving Vectibix monotherapy. Withhold Vectibix for dermatologic toxicities that are grade 3 or higher or are considered intolerable. If toxicity does not improve to </= grade 2 within 1 month, permanently discontinue Vectibix. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Subsequent to the development of severe dermatologic toxicities, infectious complications, including sepsis, septic death, and abscesses requiring incisions and drainage were reported.

Infusion Reactions: Severe infusion reactions occurred in approximately 1 percent of patients. Severe infusion reactions included anaphylactic reactions, bronchospasm, and hypotension. Although not reported with Vectibix, fatal infusion reactions have occurred with other monoclonal antibody products. Stop infusion if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, permanently discontinue Vectibix.

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 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 Nov. 5, 2009 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.

In addition, sales of our 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 health care 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 our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.

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: 805-313-6151 (media)
    Arvind Sood: 805-447-1060 (investors)

(Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)

SOURCE Amgen

http://www.amgen.com