Press Release

Amgen Recognized for Best Pipeline and Best New Drug at Scrip Awards

AmgenPosted on:24 Nov 09

THOUSAND OAKS, Calif., Nov. 23 /PRNewswire-FirstCall/ Amgen (Nasdaq: AMGN) was honored with two 2009 Scrip Awards, winning for Best Overall Pipeline and for Best New Drug for Nplate?? (romiplostim), at a Nov. 18 ceremony in London.


The Best Overall Pipeline award was presented to Amgen by Scrip in recognition of the size, quality, novelty and market potential of the company's pipeline, as well as its mix of candidates across development stages. According to the judges, Amgen's pipeline is notable for its focus on unmet clinical need.


"We are very pleased to be honored by our industry peers with these two awards," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Over the past decade, we have worked very hard to develop a robust pipeline that focuses on novel therapeutics to treat serious illnesses."


With more than 50 molecules in development, the majority of which target pathways that have not previously been addressed in humans, Amgen's pipeline includes potential new treatments for various cancers, asthma, diabetes, cardiovascular disease and many other life-threatening conditions. One of the most promising candidates in Amgen's pipeline, denosumab, is an in-house discovery that reflects a novel approach to treating bone loss and destruction. Amgen has filed for regulatory approval of denosumab in postmenopausal osteoporosis (PMO) and bone loss due to hormone ablation in breast and prostate cancer patients in the United States (U.S.), Europe, Switzerland, Canada and Australia. More information on Amgen's pipeline can be found at www.amgen.com.


Nplate won the Best New Drug honor because of its novel mode of action and its focus on an unmet medical need. Nplate is indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura (ITP), under specific conditions that are further described below.


Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. Nplate is the first platelet producer approved in both the U.S. and European Union (EU), and works by raising and sustaining platelet counts, representing a unique approach for the long-term treatment of this chronic disease.


The annual Scrip Awards are independently judged by a panel of senior industry experts and are given to biotechnology and pharmaceutical companies for their contribution to the improvement of health care. Amgen was one of the biggest winners among the dozen companies honored at the 2009 awards event for "outstanding achievements in the field of drug development," according to Scrip's press release. For more information, visit the Scrip website.


About Nplate

Nplate was the first platelet producer approved in the EU, Canada, Australia, Russia and the U.S. for chronic ITP. Nplate also has received orphan designation for chronic ITP in the U.S. (2003), the EU (2005), Switzerland (2005) and Japan (2006).


Nplate is the first treatment specifically developed for chronic ITP. It is also being investigated for potential use in pediatric ITP, myelodysplastic syndromes (MDS) and chemotherapy-induced thrombocytopenia (CIT).


In the U.S., Nplate is indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts.


In Europe, Nplate is indicated for the treatment of splenectomised adult chronic ITP patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Nplate may be considered as a second-line treatment for adult non-splenectomised ITP patients for whom surgery is contra-indicated.


Important U.S. Nplate Safety Information

Serious adverse reactions associated with Nplate in clinical studies were bone marrow reticulin deposition and worsening thrombocytopenia after Nplate discontinuation. Additional risks include bone marrow fibrosis, thrombotic/thromboembolic complications, lack or loss of response to Nplate, and hematological malignancies and progression of malignancy in patients with a pre-existing hematological malignancy or MDS.


Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP.


CBCs, including platelet counts and peripheral blood smears, should be monitored prior to initiation, throughout, and following discontinuation of Nplate therapy.


Nplate is available only through a restricted distribution program called Nplate?? NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program.


In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction.

For more information:
http://wwwext.amgen.com/media/media_pr_detail.jsp?year=2009&releaseID=1358564

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PharmiWeb Editor
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