First Quarter 2008 Investor Fact Sheet
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This fact sheet is a summary of a more detailed disclosure that can be found in Amgen’s U.S. Securities and Exchange Commission (SEC) filings and press releases. This fact sheet contains forward-looking statements that involve significant risks and uncertainties, discussed on here.. Unless otherwise indicated, the information in this fact sheet is given as of the date of the referenced documents, and Amgen does not undertake any obligation to update any information in these documents.
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 novel medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people 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.
Selected Press Releases
A list of all recent press releases can be found on Amgen’s web site here.
Amgen’s Principal Products
See Form 10-K for the year ended December 31, 2007.
These descriptions are intended to provide only an overview of Amgen’s products; for more information, please refer to Amgen’s most recent annual report, Form 10-K, press releases and other public information. Amgen is providing this information as of Apr 24, 2008 and expressly disclaims any duty to update information contained on this fact sheet.
Aranesp®
Introduced in 2001, Aranesp® (darbepoetin alfa) is approved in the United States, most countries in Europe, Canada, Australia, and New Zealand for the treatment of anemia associated with chronic renal failure in patients both on dialysis and not on dialysis. In 2002, Aranesp was also approved in the United States and Europe for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. Aranesp use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being. Aranesp is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy. Aranesp is a recombinant erythropoietic protein that stimulates production of oxygen-carrying red blood cells, with a longer half-life than Epoetin alfa.
| WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION.
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
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Aranesp® is contraindicated in patients with uncontrolled hypertension.
Enbrel®
Enbrel® (etanercept) is a fully human anti-TNF receptor approved for use to reduce the signs and symptoms and inhibit the progression of structural damage in patients with moderately to severely active Rheumatoid Arthritis (RA). It is also approved to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis, moderately to severely active polyarticular-course juvenile idiopathic arthritis (JIA) in patients ages 2 and older, ankylosing spondylitis, and chronic moderate to severe plaque psoriasis. ENBREL acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins that play an important role in both normal immune function and the cascade of reactions that causes the inflammatory process.
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WARNING Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation) has been observed in patients receiving TNF-blocking agents, including ENBREL. Tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection. Data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with ENBREL than with TNF-blocking monoclonal antibodies. Nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including ENBREL. Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to initiating ENBREL and during treatment. Treatment of latent tuberculosis infection should be initiated prior to therapy with ENBREL. Treatment of latent tuberculosis in patients with a reactive tuberculin test reduces the risk of tuberculosis reactivation in patients receiving TNF blockers. Some patients who tested negative for latent tuberculosis prior to receiving ENBREL have developed active tuberculosis. Physicians should monitor patients receiving ENBREL for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection. Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation) has been observed in patients receiving TNF-blocking agents, including ENBREL. Tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection. Data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with ENBREL than with TNF-blocking monoclonal antibodies. Nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including ENBREL. Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to initiating ENBREL and during treatment. Treatment of latent tuberculosis infection should be initiated prior to therapy with ENBREL. Treatment of latent tuberculosis in patients with a reactive tuberculin test reduces the risk of tuberculosis reactivation in patients receiving TNF blockers. Some patients who tested negative for latent tuberculosis prior to receiving ENBREL have developed active tuberculosis. Physicians should monitor patients receiving ENBREL for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection. |
EPOGEN®
Amgen launched EPOGEN® (Epoetin alfa), one of the first biologically derived human therapeutics, into the U.S. medical marketplace in 1989, for the treatment of anemia in patients with chronic renal failure on dialysis. EPOGEN is also indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions in these patients. EPOGEN is a recombinant protein with the same mechanism of action as endogenous human erythropoietin, a protein produced by the kidneys to stimulate the production of oxygen-transporting red blood cells.
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WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and Tumor Progression. Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Perisurgery: EPOGEN® increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis. |
EPOGEN is contraindicated in patients with uncontrolled hypertension.
Neulasta®
Neulasta® (pegfilgrastim) received approval in 2002 in the United States and Europe. Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Neulasta is a longer-acting form of Filgrastim than NEUPOGEN®.
Splenic rupture (including fatal cases), acute respiratory distress syndrome, and sickle cell crises have been reported. Allergic reactions, including anaphylaxis, have also been reported. The majority of these reactions occurred upon initial exposure. However, in rare cases, allergic reactions, including anaphylaxis, recurred within days after discontinuing anti-allergic treatment.
In a placebo-controlled trial, bone pain occurred at a higher incidence in Neulasta®-treated patients as compared to placebo-treated patients (31% vs 26%). The most common adverse events reported in either placebo- or active-controlled trials were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain.
NEUPOGEN®
NEUPOGEN® (Filgrastim), launched in 1991 in the U.S. and Europe, is a recombinant version of a human protein that stimulates the production of infection-fighting white blood cells, called neutrophils. It is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelo-suppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
Splenic rupture and sickle cell crises have been reported in patients receiving NEUPOGEN®; some cases have been fatal. Acute respiratory distress syndrome and allergic reactions have also been reported. Allergic reactions occurred with initial or subsequent treatment. 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®. In clinical trials of patients with cancer who received myelosuppressive chemotherapy, the most common adverse event was bone pain, reported in approximately 24% of patients.
Sensipar®
Approved by the Food and Drug Administration (FDA) in March 2004, Sensipar® (cinacalcet) is an oral medication for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis and for the treatment of elevated levels of calcium in patients with parathyroid carcinoma. To regulate parathyroid hormone (PTH), Sensipar acts directly on the parathyroid gland calcium-sensing receptor.
Sensipar lowers serum calcium; therefore, it is important that patients have a serum calcium > 8.4 mg/dL when initiating therapy. Significant reductions in calcium may lower the threshold for seizures. Secondary HPT patients, particularly those with a history of seizure disorder, should be carefully monitored for the occurrence of low serum calcium or symptoms of hypocalcemia.
In Sensipar® postmarketing use, isolated, idiosyncratic cases of hypotension and/or worsening heart failure were reported in patients with impaired cardiac function. The causal relationship to Sensipar® therapy could not be completely excluded and may be mediated by reductions in serum calcium levels.
The most commonly reported side effects were nausea, vomiting, and diarrhea.
Vectibix®
Approved by the FDA in September 2006, Vectibix® (panitumumab) is indicated as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) with 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®.
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WARNINGS Infusion Reactions: Severe infusion reactions occurred with the administration of Vectibix® in approximately 1% of patients. Severe infusion reactions were identified by reports of anaphylactic reaction, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix®, fatalities 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®. |
Product and Product Candidate Update (as of Apr 24, 2008)
The Company provides the following updates on selected late-stage clinical programs (Aranesp, denosumab, and Nplate).
Aranesp®
The Trial to Reduce Cardiovascular Events with Aranesp® Therapy (“TREAT”) phase 3 study, initiated in 2004, is a large (4,000 patient), multi-center, randomized, double-blind, controlled trial designed to determine the impact of anemia therapy with darbepoetin alfa on mortality and non-fatal cardiovascular events in patients with CKD, anemia and type 2 diabetes. In December 2007, the TREAT study completed enrollment. In April 2008, we disclosed that the independent Data Safety Monitoring Committee (“DSMC”) completed a pre-specified, unblinded review of the data at a point where 60% of the targeted number of fully adjudicated events had been recorded. The DSMC recommended that the study continue without modification.
The Reduction of Events with darbepoetin alfa in Heart Failure (“RED-HF™”) Trial phase 3 study, initiated in 2006, is a large (3,400 patient), global, randomized, double-blind, placebo- controlled study to evaluate the effect of treatment of anemia with darbepoetin alfa on morbidity and mortality in patients with symptomatic left ventricular heart failure. The RED- HF™ Trial continues to enroll patients.
Denosumab
We are conducting a number of phase 3 studies of denosumab in the treatment of PMO. In 2007, we disclosed that the 48 month data from our phase 2 PMO treatment study met primary and all secondary endpoints. We also disclosed that the phase 3 PMO prevention study met primary and all secondary endpoints. In January 2008, we disclosed that the head-to-head study comparing the effects of twice-yearly subcutaneous injections of denosumab versus weekly oral doses of alendronate (FOSAMAX®) on bone mineral density (“BMD”) in postmenopausal women with low BMD met primary and all secondary endpoints. In the second half of 2008, we expect to receive data from additional PMO trials including the phase 3 fracture study. In April 2008 we announced the publication of 24-month data from our pivotal phase 3 PMO study that showed that denosumab increased Bone Density at multiple skeletal sites in early and later stage postmenopausal women.
Denosumab is also being studied in patients with breast cancer, prostate cancer, other solid tumors or multiple myeloma for treatment to prevent skeletal related events (“SRE”). All of the phase 3 SRE clinical studies are ongoing. The phase 3 study evaluating denosumab in patients with non-metastatic prostate cancer to prevent bone metastases is also ongoing. Denosumab is also being evaluated in bone loss induced by hormone ablation therapy (“HALT”) for breast cancer and prostate cancer. In 2007, we disclosed that the phase 3 HALT breast cancer study met primary and all secondary endpoints. In 2008, we expect to receive data from our phase 3 HALT prostate cancer study.
Nplate™ (romiplostim)
The FDA has granted priority review for Nplate™. At the March 12 meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC), the ODAC voted unanimously that the data from our two phase 3 clinical studies evaluating Nplate™ (romiplostim) for the treatment of thrombocytopenia in immune (idiopathic) thrombocytopenic purpura (“ITP”), which met both primary and secondary endpoints, support a positive risk/benefit profile for Nplate™. The ODAC is an advisory committee and FDA officials are not bound to or limited by their recommendations. Following the ODAC meeting, the FDA required us to submit a Risk Evaluation and Mitigation Strategy (“REMS”) as part of the biologic license application (“BLA”) for Nplate™. In April we announced that the FDA considered the REMS information to be a major amendment to the BLA, which triggered an extension of the Prescription Drug User Fee Act (“PDUFA”) date from April 23, 2008 to July 23, 2008Selected Medical Meetings
This is a list of selected medical meetings in areas in which Amgen conducts research and clinical development activities. Amgen is providing this information as of April 24, 2008, and does not undertake any obligation to update any of this information as a result of new information, future events or otherwise.
May 30-June 3 American Society of Clinical Oncology (Chicago, IL)
June 6-10 American Diabetes Association (San Francisco, CA)
June 11-14 European Congress of Rheumatology (Paris, France)
Sept 12-16 American Society of Bone & Mineral Research (Montreal, Quebec)
Oct 24-29 American College of Rheumatology (San Francisco, CA)
Nov 4-9 American Society of Nephrology (Philadelphia, PA)
Dec 6-9 American Society of Hematology (San Francisco, CA)
Dec 11-14 San Antonio Breast Cancer Symposium (San Antonio, TX)
Q1 2008 Financial Update
Amgen April 24, 2008 Press Release
| $ in millions except EPS |
Q1 Sales | YOY% Growth |
| Aranesp® | $761 | (25)% |
| EPOGEN® | $554 | (11)% |
| Neulasta® / NEUPOGEN® | $1,086 | 7% |
| ENBREL® | $951 | 30% |
| Sensipar® | $133 | 27% |
| Vectibix® | $34 | (33)% |
| Total Product Sales | $3,537 | (1)% |
| Adjusted EPS* | $1.12 | 4% |
* Non-GAAP financial measure. See reconciliations of non-GAAP financial measures to Generally Accepted Accounting Principles (GAAP)
Historical Financials
2008 Selected Guidance†
Product Sales
($ billions)Revenues
($ billions)Adjusted R&D Expenses†
($ millions)Adjusted Net Income†
($ millions)Adjusted EPS†
(in dollars)† Non-GAAP financial measure.
See reconciliations.
| Total Revenue | $14.2 - $14.6 Billion |
| Adjusted EPS* | $4.00 – $4.30 |
†Guidance is as of April 24, 2008 and is not being updated at this time.
* Non-GAAP Financial measure. See reconciliations.
