Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress

THOUSAND OAKS, Calif., Oct. 5 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced that results from several important studies from the Company’s oncology portfolio will be presented at the 35th European Society for Medical Oncology (ESMO) Congress, Oct. 8-12, 2010, in Milan, Italy.

“Cancer is a complex disease which requires innovative therapeutic approaches. Amgen is exploring numerous biologic pathways to develop novel therapies to treat cancer and lessen the side effects of cancer and its treatment,” said Willard Dere, M.D., senior vice president and international chief medical officer at Amgen. “The data being presented at this year’s ESMO Congress, including new denosumab and AMG 386 analyses, reflect the breadth and diversity of Amgen’s oncology portfolio.”

Abstracts will be available on the ESMO website at http://www.esmo.org following the meeting.

For the latest updates on Amgen’s presence at the ESMO Congress and other Amgen news, follow us on Twitter: @Amgen.

About Denosumab and Amgen’s Research in Bone Biology

Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that breakdown bone). The denosumab development program is the largest ever initiated by Amgen. Thisbroad and deep development program demonstrates Amgen’s commitment to researching anddelivering pioneering medicines to patients with unmet medical needs. Amgen is studyingdenosumab in numerous tumor types across the spectrum of cancer-related bone diseases.

Over 11,000 patients have been enrolled in the denosumab oncology clinical trials, testing the drug for the reduction of SREs in patients with breast and prostate cancer, as well as other solid tumors and multiple myeloma, for the amelioration of treatment-induced bone loss in patients with non-metastatic breast or prostate cancers, and for its potential to delay bone metastases in prostate and breast cancer.

Overall rates of adverse events and serious adverse events, including infections, were generally similar between the two arms. Osteonecrosis of the jaw was infrequent (52 patients receiving denosumab as compared with 37 patients receiving Zometa) and there was no statistically significant difference between treatment arms. As with previous studies in advanced cancer patients, hypocalcemia was more frequent in the denosumab arm. Both overall survival and the time to cancer progression were balanced.

About Vectibix

Vectibix is the first fully human anti-EGFR antibody approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of mCRC. Vectibix was approved in the U.S. 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 mCRC is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.

Retrospective subset analyses of mCRC trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Vectibix is not recommended for the treatment of colorectal cancer with these mutations.

In December 2007, the European Medicine Agency (EMA) granted a conditional marketing authorization for Vectibix as a monotherapy for the treatment of patients with EGFR-expressing mCRC with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. Vectibix has been launched in more than 20 European Union countries, Russia, Israel, Switzerland, Australia, Canada and Japan. Applications in the rest of the world are pending.

Important U.S. Product Safety Information

WARNING: DERMATOLOGIC TOXICITY and INFUSION REACTIONS

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. [See Dosage and Administration (2.1), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].

Infusion Reactions: Severe infusion reactions occurred in approximately 1 percent of patients. Fatal infusion reactions occurred in postmarketing experience [See Dosage and Administration (2.1), Warnings and Precautions (5.2), and Adverse Reactions (6.1, 6.3)].

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.

Important European Product Safety Information

For full prescribing information please see the Summary of Product Characteristics.

Vectibix is indicated as monotherapy for the treatment of patients with EGFR-expressing, metastatic colorectal carcinoma (mCRC) with nonmutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Vectibix is contraindicated in patients with a history of severe or life-threatening hypersensitivity reactions to the product and in patients with interstitial pneumonitis or pulmonary fibrosis.

Other common adverse events of special importance associated with Vectibix and/or EGFR monoclonal antibody therapies include dermatologic-related reactions, pulmonary complications, electrolyte disturbances and infusion-related reactions (including rare reports with fatal outcome). These events should be monitored carefully, see Summary of Product Characteristics for information on appropriate management of these adverse events. Acute renal failure has been observed in patients who develop severe diarrhoea and dehydration.

Vectibix should not be used in combination with IFL [bolus 5-fluorouracil (500 mg/m2), leucovorin (20 mg/m2) and irinotecan (125 mg/m2)] or in combination with bevacizumab containing chemotherapy.

Vectibix should not be administered in combination with oxaliplatin-containing chemotherapy to mCRC patients with mutant KRAS tumours or for whom KRAS tumour status is unknown.

About Neulasta and NEUPOGEN®

Neulasta (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

NEUPOGEN (filgrastim) is indicated to decrease the incidence of infection as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.

Please refer to the Important European Product Safety Information section for approved indications in the EU.

Important U.S. Product Safety Information

Do not administer Neulasta or NEUPOGEN to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. NEUPOGEN is contraindicated in patients with known hypersensitivity to E. coli-derived proteins, such as filgrastim.

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta or NEUPOGEN. Permanently discontinue Neulasta or NEUPOGEN in patients with serious allergic reactions.

Splenic rupture, including fatal cases, can occur following the administration of Neulasta and NEUPOGEN.

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta or NEUPOGEN.

Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization, has been reported in healthy donors undergoing peripheral blood progenitor cell mobilization, an unapproved use of NEUPOGEN. Hemoptysis resolved with discontinuation of NEUPOGEN.

Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients. In clinical trials involving NEUPOGEN, bone pain was most frequently reported adverse event.

Important European Product Safety Information

For full prescribing information please see the Summary of Product Characteristics for each product.

NEUPOGEN is indicated for reduction in duration of neutropenia and incidence of febrile neutropenia after established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes); reduction in duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of NEUPOGEN are similar in adults and children receiving cytotoxic chemotherapy. NEUPOGEN is indicated for mobilisation of peripheral blood progenitor cells (PBPCs); long-term treatment to increase neutrophil counts and reduce incidence and duration of infection-related events in patients with severe congenital, cyclic, or idiopathic neutropenia treatment of persistent neutropenia in patients with advanced HIV infection.

NEUPOGEN is contraindicated in patients with hypersensitivity to filgrastim or excipients. Not to be used for escalation of cytotoxic chemotherapy doses above established regimens or administered to patients with severe congenital neutropenia (Kostman’s Syndrome) with abnormal cytogenetics.

Administer NEUPOGEN with caution in secondary AML. Safety and efficacy of NEUPOGEN not established in de novo AML patients < 55 years with good cytogenetics (t(8;21), t(15;17) and inv(16)). The onset of pulmonary signs (cough, fever, dyspnoea) in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS). Discontinue NEUPOGEN and give appropriate treatment.

Other adverse events of special importance associated with NEUPOGEN include GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation, very rare cases of splenic rupture reported in healthy donors and patients, and hypersensitivity-type reactions in cancer patients. NEUPOGEN should be permanently discontinued in patients who experience a serious allergic reaction. NEUPOGEN is not recommended in period 24 hours before to 24 hours after chemotherapy.

Neulasta is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Neulasta is contraindicated in patients with hypersensitivity to pegfilgrastim or excipients.

Neulasta should not be used in patients with MDS, CML and secondary AML. The safety and efficacy of Neulasta administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.

Neulasta should be discontinued following preliminary signs of ARDS. Spleen size should be carefully monitored and caution exercised when administering in patients with sickle cell disease. Safety and efficacy of Neulasta for mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.

Other adverse events of special importance associated with Neulasta include bone pain, allergic-type reactions including anaphylaxis (pegfilgrastim should be permanently discontinued in patients who experience a serious allergic reaction) and very rare cases of splenic rupture including fatal cases. Neulasta should be administered approximately 24 hours after administration of cytotoxic chemotherapy.

About Aranesp

Aranesp was approved by the FDA in 2001 for the treatment of anemia associated with CRF for patients on dialysis and patients not on dialysis. The European Commission granted marketing authorization for the same indication in 2001 and subsequently updated it for CRF patients with symptomatic anemia in 2008.

In 2002, the FDA approved Aranesp for the treatment of anemia caused by concomitantly administered chemotherapy in patients with nonmyeloid malignancies. The European Commission authorized the treatment of anemia caused by concomitantly administered chemotherapy in patients with non-haematological malignancies in 2002 and extended it to include non-myeloid malignancies in patients receiving chemotherapy in 2003.

Important U.S. Product Safety Information

Aranesp is indicated for the treatment of anemia due to the effect of concomitantly administered chemotherapy based on studies that have shown a reduction in the need for red blood cell transfusions in patients with metastatic, non-myeloid malignancies. Studies to determine whether Aranesp increases mortality or decreases progression-free/recurrence-free survival are ongoing.

• Aranesp is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
• Aranesp is not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure due to the absence of studies that adequately characterize the impact of Aranesp on progression-free and overall survival.
• Aranesp use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being.

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE AND INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE

Cancer:

• ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
• To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusio