Press Release Details

THOUSAND OAKS and SOUTH SAN FRANCISCO, Calif., Nov. 7, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and its subsidiary Onyx Pharmaceuticals, Inc. today announced that nearly 40 company-sponsored and investigator-sponsored investigational studies evaluating carfilzomib, a second-generation proteasome inhibitor, and oprozomib, an oral second-generation proteasome inhibitor in early development, will be presented at the 55^th American Society of Hematology (ASH) Annual Meeting and Exposition on December 7-10, 2013 at the Ernest N. Morial Convention Center in New Orleans, LA.

"We are encouraged by the breadth of data from our Proteasome Inhibitor franchise being presented this year at ASH, which add to the clinical data of carfilzomib in combination with other therapies and provide further insight into the level of response for carfilzomib at a molecular level. Additionally, data to be presented on oprozomib offer clinical insights instrumental in driving forward our clinical development program for the compound," said Pablo Cagnoni, M.D., President of Onyx Pharmaceuticals, Inc.  "We remain committed to bringing innovative therapies to patients in need, and we look forward to playing a continued role in advancing the scientific understanding of hematologic malignancies."

Among the presentations are five abstracts from the Proteasome Research and Integrative Science for Multiple Myeloma – Novel Therapies Program (PRISM NTP), a global research collaboration between Onyx, investigators at myeloma centers of excellence and partner companies with novel therapies in development. "The PRISM program further demonstrates our commitment to innovation and advancing science," said Homa Yeganegi, Vice President of Scientific Affairs at Onyx Pharmaceuticals, Inc.  "This program is a highly innovative approach to industry-academia collaboration, bringing together leaders from the myeloma research community in the service of a common goal: driving an integrated, personalized approach to the development and delivery of medicines to patients."

Company-sponsored carfilzomib and oprozomib abstracts:

A Phase 1, Dose-Escalation Study (CHAMPION-1) Investigating Weekly Carfilzomib in Combination with Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

• Dr. James R. Berenson, Institute for Myeloma & Bone Cancer Research
• Saturday, December 7, 5:30 pm - 7:30 pm CT, Hall G
• Poster presentation: Myeloma: Therapy, excluding Transplantation: Poster I
• Abstract # 1934

Association of Treatment Induced Peripheral Neuropathy (TIPN) with Treatment Patterns and Outcomes in Patients (pts) with Newly Diagnosed Multiple Myeloma (NDMM)

• Dr. Thomas Martin, University of California, San Francisco
• Saturday, December 7, 5:30 pm - 7:30 pm CT, Hall G
• Poster presentation: Health Services and Outcomes Research: Poster I
• Abstract # 1750

Relationship of Serum Free Light Chain Reduction to Best Overall Response in Phase 2 Single-Agent and Combination Studies of Carfilzomib in Patients with Relapsed or Relapsed and/or Refractory Multiple Myeloma

• Dr. Ravi Vij, Washington University School of Medicine, St. Louis, MO
• Saturday, December 7, 5:30 pm - 7:30 pm CT, Hall G
• Poster presentation: Myeloma: Therapy, excluding Transplantation: Poster I
• Abstract # 1965

Clinical Profile of Single-Agent Modified-Release Oprozomib Tablets in Patients (Pts) With Hematologic Malignancies: Updated Results From a Multicenter, Open-Label, Dose Escalation Phase 1b/2 Study

• Dr. Irene M. Ghobrial, Dana-Farber Cancer Institute
• Sunday, December 8, 6:30 pm - 8:30 pm CT, Hall G
• Poster presentation: Myeloma: Therapy, excluding Transplantation: Poster II
• Abstract # 3184

Select Investigator-Sponsored carfilzomib abstracts:

Dose Escalation Phase 2 Trial Of Carfilzomib Combined With Thalidomide and Low-Dose Dexamethasone In Newly Diagnosed, Transplant Eligible Patients With Multiple Myeloma. A Trial Of The European Myeloma Network

• Dr. Pieter Sonneveld, Erasmus Medical Center, Rotterdam, Netherlands
• Monday, December 9, 5:15 pm CT, 393-394
• Oral Presentation: Myeloma: Therapy, excluding Transplantation II
• Abstract # 688

A Phase II Study with Carfilzomib, Cyclophosphamide and Dexamethasone (CCd) for Newly Diagnosed Multiple Myeloma

• Dr. Sara Bringhen, Myeloma Unit, Division of Hematology, University of Torino, Torino, Italy
• Monday, December 9, 4:30 pm CT, 393-394
• Oral presentation: Myeloma: Therapy, excluding Transplantation II
• Abstract # 685

A simple score, based on geriatric assessment, improves prediction of survival, and risk of serious adverse events in elderly newly diagnosed multiple myeloma patients

• Dr. Alessandra Larocca, Myeloma Unit, Division of Hematology, University of Torino, Torino, Italy
• Monday, December 9, 5:00 pm CT, 393-394
• Oral presentation: Myeloma: Therapy, excluding Transplantation II
• Abstract # 687

Phase II Clinical and Correlative Study of Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Followed by Lenalidomide Extended Dosing (CRD-R) Induces High Rates of MRD Negativity in Newly Diagnosed Multiple Myeloma (MM) Patients

• Dr. Neha Korde, Multiple Myeloma Section, National Cancer Institute, National Institutes of Health
• Monday, December 9, 3:30 pm CT, 393-394
• Oral presentation: Myeloma: Therapy, excluding Transplantation: Treatment Options for Newly Diagnosed Multiple Myeloma Patients
• Abstract # 538

Serum Heavy-Light Chains (HLC) and Free Light Chains (FLC) As Predictors For Early CR In Newly Diagnosed Myeloma Patients Treated With Carfilzomib, Lenalidomide, and Dexamethasone (CRd)

• Dr. Manisha Bhutani, Multiple Myeloma Section, National Cancer Institute, National Institutes of Health
• Monday, December 9, 7:30 pm CT, 393-394
• Oral presentation: Myeloma: Therapy, excluding Transplantation: Advances in Multiple Myeloma and Plasma Cell Leukemia
• Abstract # 762

Phase I/II Dose Expansion of a Multi-Center Trial of Carfilzomib and Pomalidomide with Dexamethasone (Car-Pom-d) in Patients with Relapsed/Refractory Multiple Myeloma

• Dr. Jatin Shah, The University of Texas MD Anderson Cancer Center
• Monday, December 9, 5:45 pm CT, 393-394
• Oral presentation: Myeloma: Therapy, excluding Transplantation II
• Abstract # 690

Carfilzomib, Rituximab and Dexamethasone (CaRD) is highly active and offers a neuropathy sparing approach for proteasome-inhibitor based therapy in Waldenstrom's Macroglobulinemia

• Dr. Steven Peter Treon, Bing Center for Waldenstrom Macroglobulinemia, Dana-Farber Cancer Institute
• Monday, December 9, 6:15 pm CT, 393-394
• Oral presentation: Myeloma: Therapy, excluding Transplantation: Advances in Multiple Myeloma and Plasma Cell Leukemia
• Abstract # 757

PRISM data highlights:

A Novel Bruton's Tyrosine Kinase Inhibitor CC-292 in Combination with the Proteasome Inhibitor Carfilzomib Impacts Multiple Myeloma Bone Microenviroment with Resultant Anti-myeloma Activity

• Dr. Homare Eda, MGH Cancer Center, Massachusetts General Hospital
• Monday, December 9, 5:15 pm CT, 388-390
• Oral presentation: Myeloma: Biology and Pathophysiology, excluding Therapy: Bone Marrow Microenvironment and Myeloma Session
• Abstract # 682

Phase 1 Study of the Novel Kinesin Spindle Protein Inhibitor ARRY-520 + Carfilzomib (Car) in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM)

• Dr. Jatin Shah, The University of Texas MD Anderson Cancer Center
• Saturday, December 7, 5:30 pm - 7:30 pm CT, Hall G
• Poster presentation: Myeloma: Therapy, excluding Transplantation: Poster I
• Abstract # 1982

Inhibition of Autophagy by ACY-1215, a Selective HDAC 6 Inhibitor Accelerates Carfilzomib-Induced Cell Death in Multiple Myeloma

• Dr. Yuko Mishima, Massachusetts General Hospital Cancer Center
• Monday, December 9, 6:00 pm - 8:00 pm CT, Hall G
• Poster presentation: Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster III
• Abstract # 4431

Dual Inhibition of Mcl-1 By The Combination Of Carfilzomib and TG02 In Multiple Myeloma

• Dr. Katelyn Barnhart, Cancer Biology Graduate Program, Emory University
• Sunday, December 8, 6:30 pm - 8:30 pm CT, Hall G
• Poster presentation: Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II
• Abstract # 3171

Combined Carfilzomib and Selective PI3Kδ Inhibition (TGR1202) Results in Enhanced Myeloma Cell Apoptosis

• Dr. Claire Torre, Winship Cancer Institute, Emory University
• Sunday, December 8, 6:30 pm - 8:30 pm CT, Hall G
• Poster presentation: Myeloma: Therapy, excluding Transplantation: Poster II
• Abstract # 3224

About PRISM

PRISM NTP (Proteasome Research and Integrative Science for Multiple Myeloma - Novel Therapies Program) is a global research collaboration between Onyx, investigators at myeloma centers of excellence and partner companies with novel therapies in development. PRISM NTP members come from five centers in the United States (Dana-Farber Cancer Institute/Partners, Emory, MD Anderson Cancer Center, Mayo Clinic Scottsdale and Mayo Clinic Rochester) and seven countries in Europe (France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom). The program co-chairs are Dr. Kenneth C. Anderson, Dana-Farber Cancer Institute, Boston and Dr. Jesus San Miguel, University of Navarra, Spain.  There are three working groups led by experts for each area of focus: molecular profiling, pre-clinical and clinical trial. 

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 Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc., an Amgen subsidiary, is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com.

Onyx Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm.

Amgen Forward Looking Statements
This news release contains forward-looking statements that are based on management'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 our business.  Unless otherwise noted, Amgen is providing this information as of Oct. 4, 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 we project.  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 us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop 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 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 are on the market.  Our 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.  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, sales of our 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 our products.  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.  We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have 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 there 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 maintain the commercial success of our existing products.  Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates.  Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse 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 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. 

Contacts:

Onyx Pharmaceuticals, Inc.
Danielle Bertrand (media)
1-650-266-2114

Amgen
Ashleigh Koss, 1-805-313-6151 (media)
Arvind Sood, 1-805-447-1060 (investors)

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SOURCE Onyx Pharmaceuticals, Inc.; Amgen