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�Amgen Inc. (NASDAQ: AMGN) announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nplate� (romiplostim), the first and only platelet producer for the handling of thrombopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first base FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a novel approaching for the long-term intervention of this chronic disease.

Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can buoy lead to serious bleeding events. Recognized as an orphan disease, chronic ITP affects an estimated 60,000 grownup patients in the U.S. and is considered an unmet demand by the FDA.

"Until now, patients suffering from chronic ITP have had limited available treatment options, many of which are often unsuitable for long-run use referable to slope effects and tolerability issues," said David J. Kuter, M.D., Chief of Hematology, Massachusetts General Hospital, Boston. "Nplate represents the first long-term handling for adult chronic ITP patients, providing a new treatment approach for this chronic disease."

The FDA approval of Nplate was based on efficacy and safety results from deuce pivotal Phase 3 studies of adult patients with chronic ITP, including both splenectomized and non-splenectomized patients. The overall response rate for Nplate was 83 percent (n=69/83, p

Specifically, in the Phase 3 studies, non-splenectomized patients had an 88 pct (n=36/41, p

"For those excruciation from ITP, the daily fear of experiencing a serious hemorrhage episode stool be emotionally stressful and extremely difficult for both patients and their families. We welcome the gain of new treatment options which offer new hope for the treatment of this life-threatening disease," aforementioned Craig Conway, executive director of the Platelet Disorder Support Association.

In accession to improved clinical benefits, described in the FDA labeling, Amgen believes Nplate offers patients a confirming net health benefit with fewer hospitalizations from bleeding events, as well as reduced motivation for emergency medications (IVIG and Win-Rho). Amgen expects the tote up costs of care for chronic ITP patients managed with Nplate to be less than or comparable to the total costs of tutelage with banner treatment regimens.

Amgen besides announced it will set in motion the Nplate� NEXUS (Network of EXperts Understanding and Supporting Nplate� and Patients) Program, a multi-faceted political program designed to provide comprehensive access, reinforcement and education for inveterate ITP patients, their caregivers and health care providers. The Nplate� NEXUS Program is part of the Risk Evaluation and Mitigation Strategy (REMS) developed by Amgen in partnership with the FDA to assure safe use of Nplate patch minimizing peril. The programme will help appropriate use of Nplate, provide patient support through education and resources and help with ongoing surveil up through safety data collection.

Through the Nplate� NEXUS Program, eligible patients who ar uninsured, underinsured, or ineffective to afford their insurance co-payments may be able to pick up reimbursement documentation and other assistance from Amgen. For example, ane such programme helps cover up to 50 percent of an eligible, commercially-insured patient's co-payments for Nplate. Recognizing that some patients may not have health care coverage, Amgen continues to offer another program for all of its innovative products, including Nplate, which provides product free of charge to eligible, low-income patients without insurance.

"Amgen is committed to forward-moving the discovery and exploitation of new therapies for grievous illnesses where there is unmet medical need," said Roger M. Perlmutter, M.D., Ph.D., executive frailty president of Research and Development at Amgen. "The FDA approval of Nplate is the result of more than 15 years of research and represents an of import biotechnology milepost as it is the first FDA-approved peptibody protein, an forward-looking platform for delivering targeted therapies."

Nplate was too approved for ITP by Australia's Therapeutic Goods Administration (TGA) in July 2008. Amgen has filed for regulatory blessing of Nplate in the European Union (EU), Canada, and Switzerland and these applications are currently under review. Nplate has also received orphan designation for ITP in the EU (2005), Switzerland (2005) and Japan (2006).

More information about the Nplate� NEXUS Program is available by calling 1-877-NPLATE1 (1-877-675-2831), or by visiting http://www.nplate.com.

About Adult ITP

Platelets are blood cells requisite to forestall bleeding. Low platelet counts leave adult ITP patients open to sudden serious bleeding events, making it impossible to arrest blood flow. The risk for serious bleeding events increases when thrombocyte counts drop to less than 30,000 platelets per microliter.

There are limited approved treatments (i.e., corticosteroids, immunoglobulins) or surgical therapy (removal of the spleen) available to adult patients with chronic ITP. Currently, there ar 140,000 treated chronic ITP patients in the U.S. and Europe. ITP affects around twice as many adult women as men.

With ITP, platelets are destroyed by the patient's possess immune system. ITP has historically been considered a disease of platelet destruction. However, recent data too suggest that the body's natural thrombocyte production processes are unable to indemnify for low levels of platelets in the lineage. Increasing the rate of platelet production may address low thrombocyte levels associated with ITP.

About Nplate

Nplate, Amgen's first peptibody protein, is a novel engineered therapeutical fusion protein with attributes of both peptides and antibodies, simply is discrete from each. Nplate works similarly to thrombopoietin (TPO), a instinctive protein in the body. Nplate stimulates the TPO receptor, which is necessary for growth and ripening of bone marrow cells that produce platelets.

Important Safety Information

Serious untoward reactions associated with Nplate in clinical studies were bone marrow reticulin deposition and deterioration thrombocytopenia later Nplate discontinuation.

Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis

- Nplate presidential term increases the risk for development or progression of reticulin fiber deposition inside the off-white marrow.

- In clinical studies, Nplate was discontinued in four of the 271 patients because of pearl marrow reticulin deposition. Six additional patients had reticulin observed upon bone centre biopsy. All 10 patients with bone marrow reticulin deposition had received Nplate doses ? 5 mcg/kg, and 6 received doses ? 10 mcg/kg.

- Progression to marrow fibrosis with cytopenias was not reported in the controlled clinical studies. In the extension study, one patient with ITP and hemolytic genus Anemia developed marrow fibrosis with collagen during Nplate therapy.

- Clinical studies have non excluded a risk of bone marrow fibrosis with cytopenias.
- Prior to knowledgeability of Nplate examine the peripheral blood smear closely to establish a service line level of cellular structural abnormalities. Following identification of a stable Nplate cupid's disease, examine peripheral blood smears and CBCs monthly for new or worsening morphological abnormalities (eg, teardrop and nucleated red blood cells, immature egg white blood cells) or cytopenia(s).

- If the patient develops new or deterioration morphological abnormalities or cytopenia(s), discontinue treatment with RPLC195% and consider a bone marrow biopsy, including staining for fibrosis.

Worsened Thrombocytopenia After Cessation of Nplate

- Discontinuation of Nplate may result in thrombopenia of greater severity than was present prior to Nplate therapy. This worse thrombocytopenia crataegus laevigata increase the patient's risk of exposure of haemorrhage, particularly if Nplate is discontinued while the patient is on anticoagulants or antiplatelet agents.

- In clinical studies of patients with chronic ITP who had Nplate discontinued, four of 57 patients developed thrombocytopenia of greater severity than was deliver prior to Nplate therapy.

- This worsened thrombocytopenia resolved within 14 days.

- Following discontinuation of Nplate, obtain weekly CBCs, including platelet counts, for at least two weeks and consider alternative treatments for decline in quality thrombocytopenia, according to current treatment guidelines.

Thrombotic/thromboembolic Complications

- Thrombotic/thromboembolic complications may answer from unreasonable increases in platelet counts. Excessive doses of Nplate or medication errors that result in excessive Nplate doses whitethorn increase blood platelet counts to a level that produces thrombotic/thromboembolic complications. In controlled clinical studies, the incidence of thrombotic/thromboembolic complications was similar between Nplate and placebo.

- To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate in an attempt to "normalize" blood platelet counts. Follow the dose adjustment guidelines to achieve and maintain a platelet count of ? 50 x 109/L.

Lack or Loss of Response to Nplate

- Hyporesponsiveness or failure to maintain a platelet response with Nplate should actuate a hunt for causative factors, including neutralizing antibodies to Nplate or bone marrow fibrosis.

- To detect antibody shaping, submit blood samples to Amgen (1-800-772-6436). Amgen will assay these samples for antibodies to Nplate and thrombopoietin (TPO).

- Discontinue Nplate if the platelet matter does non increase to a level sufficient to avoid clinically important hemorrhage after 4 weeks at the highest weekly dose of 10 mcg/kg.

Hematological Malignancies and Progression of Malignancy in Patients with a Pre-existing Hematological Malignancy or Myelodysplastic Syndrome (MDS)

- Nplate stimulation of the TPO receptor on the surface of hematopoietic cells may growth the jeopardy for haematological malignancies. In controlled clinical studies among patients with chronic ITP, the incidence of haematological malignancy was low and similar betwixt Nplate and placebo.

- In a separate single-arm clinical study of 44 patients with myelodysplastic syndromes (MDS), 11 patients were reported as having possible disease progression, among whom 4 patients had confirmation of acute myelogenous leukemia (AML) during follow-up.

- Nplate is not indicated for the treatment of thrombocytopenia due to MDS or whatever cause of thrombocytopenia early than chronic ITP.

Laboratory Monitoring

- Monitor CBCs, including platelet counts and peripheral blood smears, prior to initiation, end-to-end, and following discontinuation of Nplate therapy.

- Prior to the initiation of Nplate, examine the peripheral profligate differential to establish the baseline extent of redness and patrick White blood cell abnormalities.

- Obtain CBCs, including platelet counts and peripheral blood smears, weekly during the dosage adjustment phase of Nplate therapy and then monthly following ecesis of a stable Nplate dose. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Nplate.

Nplate Distribution Program

- Nplate is available only through and through a restricted distribution program called Nplate� NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program. Under the Nplate� NEXUS Program, only prescribers and patients registered with the program are able to dictate, administer, and receive Nplate. This program provides educational materials and a mechanism for the proper function of Nplate. To enter in the Nplate� NEXUS Program, call off 1-877-NPLATE1 (1-877-675-2831).

General Safety

- In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction, occurring in 35 percent of patients receiving Nplate and 32 percent of patients receiving placebo. Headaches were usually of mild or moderate rigour.

- Most coarse adverse reactions (? 5 per centum higher patient incidence in Nplate versus placebo) were Arthralgia (26 percent, 20 percent), Dizziness (17 percent, 0 pct), Insomnia (16 percent, 7 percent), Myalgia (14 percentage, 2 percentage), Pain in Extremity (13 percent, 5 percent) , Abdominal Pain (11 percent, 0 percent), Shoulder Pain (8 percent, 0 percent), Dyspepsia (7 pct, 0 per centum), and Paresthesia (6 pct, 0 per centum).

- As with all therapeutic proteins, patients may evolve antibodies to the sanative protein.

About Amgen

Amgen discovers, develops, manufactures and delivers modern human therapeutics. A bioengineering pioneer since 1980, Amgen was i of the first companies to actualize the new science's promise by bringing safe and effective medicines from research lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, serving millions of people around the worldly concern in the fight against cancer, kidney disease, rheumatic arthritis and other serious illnesses. With a deep and unsubtle pipeline of potential new medicines, Amgen remains committed to forward-moving science to dramatically better people's lives. To learn more about our pioneering science and our full of life medicines, visit http://www.amgen.com.

Forward-Looking Statements

This news program release contains forward-looking statements that are based on management's current expectations and beliefs and are matter 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 modern statements, including estimates of revenues, in operation margins, capital expenditures, immediate payment, 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 need 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 nearly recent periodical 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 August 22, 2008 and expressly disclaims whatsoever duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may take issue materially from those we project. Discovery or designation of new product candidates or exploitation of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can buoy be no guarantee that any particular product campaigner or development of a new meter reading for an existing mathematical product will be successful and become a commercial production. Further, preclinical results do not insure safe and effective performance of merchandise 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 receive regulatory approval for product marketing has in the past varied and we expect interchangeable variability in the next. We modernize 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 effectual 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 ar on the market. Our business may be wedged by political science investigations, judicial proceeding and products liability claims. We depend on third parties for a significant portion of our manufacture capacity for the furnish of certain of our current and future products and limits on supply may cumber sales of certain of our stream products and product prospect development.

In addition, gross sales of our products are affected by the reimbursement policies imposed by third party payors, including governments, secret insurance plans and managed care providers and english hawthorn be affected by regulative, clinical and guideline developments, domestic and international trends toward managed care and health care cost containment as well as U.S. legislation touching pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies crataegus oxycantha affect the development, custom 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 breakthrough and developing of new products. We believe that some of our newer products, cartesian product candidates or new indications for existent products, may face contender when and as they are approved and marketed. Our products may compete against products that get 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 on that point 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 defend the commercial-grade success of our existing products. Our stock price may be affected by actual or perceived market place opportunity, competitory position, and success or failure of our products or product candidates. Further, the discovery of substantial problems with a product similar to one of our products that implicate an entire class of products could have a material contrary effect on sales of the affected products and on our business and results of operations.

The scientific information discussed in this news release related to our product candidates is prelim and investigative. Such intersection candidates ar 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 specify 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 fact-finding and is not piece of the labeling sanctioned by the 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 throne determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and swear upon the FDA-approved labeling for the products, and not the information discussed in this news release.

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