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Amgen (AMGN) and AstraZeneca PLC (AZN) Highlight Data to be Presented at 22nd Congress of the European Academy of Dermatology and Venereology


10/3/2013 6:40:45 AM

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THOUSAND OAKS, Calif. and GAITHERSBURG, Md., Oct. 3, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and AstraZeneca (AZN), with its biologics research and development arm MedImmune, today announced the upcoming presentation of several key studies evaluating brodalumab, a human monoclonal antibody targeting the interleukin-17 (IL-17) receptor, for the treatment of moderate to severe psoriasis at the 22nd Congress of the European Academy of Dermatology and Venereology (EADV) in Istanbul, Oct. 2-6, 2013.

"The Phase 2 data demonstrate that the primary and secondary end points were met, including many patients achieving and maintaining total skin clearance with continued brodalumab therapy," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to further investigating brodalumab for patients with moderate to severe psoriasis."

Dr. Bahija Jallal, executive vice president, MedImmune added, "We're very encouraged by these results and the initiation of our Phase 3 program."

In Oct. 2012, the companies announced the start of the Phase 3 program in moderate to severe psoriasis for brodalumab. The program consists of three Phase 3 studies evaluating treatment with brodalumab compared with ustekinumab and/or placebo.

Abstracts will be presented during the poster session on Friday, Oct. 4, 2013.

Abstracts of Interest Include:

  • Maintenance of Clinical Response with Long-Term Brodalumab (AMG 827) Therapy for Psoriasis: Week 96 Results from an Open-Label Extension Study(Poster IST13-0686)
  • Difference in Health-Related Quality of Life (HRQoL) with Increased Improvements in Psoriasis Area and Severity Index (PASI) and Maintenance of Skin Clearance(Poster 1030)
  • Impact of Treatment with Brodalumab on Psoriasis Symptom Severity: Use of a Novel Patient-Reported Outcome Measure, the Psoriasis Symptom Inventory (PSI) (Poster 1640)

About Brodalumab (AMG 827)

Brodalumab is a highly-selective human monoclonal antibody that binds to and blocks signaling via the interleukin-17 (IL-17) receptor. The IL-17 pathway plays an important role in inducing and promoting inflammatory disease processes. Blocking inflammatory signaling at the IL-17 receptor may be beneficial in the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and potentially other immune-mediated diseases.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

About MedImmune

MedImmune is the worldwide biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca's three global R&D centers. For more information, please visit www.medimmune.com.

Amgen Forward-Looking Statements

This news release contains forward-looking statements that are based on Amgen's current expectations and beliefs and are subject 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 forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, 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 involve 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 any subsequent periodic 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 Amgen's business. Unless otherwise noted, Amgen is providing this information as of Oct. 2, 2013 and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product 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 Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops 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 effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen's products after they are on the market. Amgen's business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.

In addition, sales of Amgen's products are affected by the reimbursement policies imposed by third-party payers, 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 Amgen's products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's ability to obtain or maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen's business and results of operations.

The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are 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.

CONTACT: Amgen, Thousand Oaks
Ashleigh Koss, 805-313-6151 (media)
Arvind Sood, 805-447-1060 (investors)

CONTACT: MedImmune / AstraZeneca
Tracy Rossin, 301-398-1468 (media)
Karl Hard, +44 20 7604 812 (investors)
Colleen Proctor, 302-886-1842 (investors)

(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

(Logo: http://photos.prnewswire.com/prnh/20120329/LA79025LOGO)

SOURCE Amgen



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