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.
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.
Important EU Nplate Safety Information
The most common side effects are headache, fatigue, arthralgia, myalgia, injection site bruising, injection site pain, peripheral oedema, dizziness, muscle spasms, nausea, contusion, diarrhea, bone marrow disorder, influenza like illness, insomnia and pruritus.
Reoccurrence of thrombocytopenia and bleeding after cessation of treatment and increased bone marrow reticulin have been associated with romiplostim treatment in the clinical trials. Thrombotic/thromboembolic complications, progression of existing hematopoietic malignancies or MDS, and effects on red and white blood cells are all potential risks associated with romiplostim treatment. As with all therapeutic proteins, patients may develop antibodies to the therapeutic protein.
In February 2009, the U.S. Food and Drug Administration (FDA) accepted the Biologic License Applications (BLA), submitted by Amgen for Prolia(TM) (denosumab) for the treatment and prevention of osteoporosis in postmenopausal women and treatment and prevention of bone loss in women and men receiving hormone therapy for either breast cancer or prostate cancer. On October 2009, the FDA issued Complete Response Letters for the BLA application for denosumab requesting additional information needed to complete the review of the applications for approval, including updated safety data. The FDA also requested a new clinical program to support approval of denosumab for the prevention of PMO and additional adequate and well-controlled clinical trials demonstrating the denosumab has no detrimental effects on either time-to disease progression or overall survival for cancer treatment-induced bone loss (in breast cancer and prostate cancer patients).
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Denosumab is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. It is being studied in a range of other bone loss conditions including rheumatoid arthritis, and cancer treatment-induced bone loss (in breast cancer and prostate cancer patients), as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer.
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.
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended December 31, 2008, and in our periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company's results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments (domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or foreign), difficulties or delays in manufacturing our products. In addition, sales of our products are affected by 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 healthcare 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. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. 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. Further, 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. 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, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers.
CONTACT: Amgen, Thousand Oaks Mary Klem: (805) 447-6979 (media) John Shutter: (805) 447-1060 (investors)
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