Thousand Oaks, CA and South San Francisco, CA (Press Release) - 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 55th 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 inno­va­t 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 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.

Source: Amgen.