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Onyx Pharmaceuticals Announces Proteasome Inhibitor Data Presentations at 14th International Myeloma Workshop

Onyx Pharmaceuticals Announces Proteasome Inhibitor Data Presentations at 14th 
International Myeloma Workshop 
Data on Carfilzomib and Oprozomib to Be Presented 
SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 04/01/13 --  Onyx
Pharmaceuticals, Inc. (NASDAQ: ONXX) today highlighted the
presentation of three studies, among several, from its proteasome
inhibitor franchise at the 14th International Myeloma Workshop (IMW),
April 3-7, 2013, in Kyoto, Japan. New data will be presented on
carfilzomib in high-risk-smoldering myeloma and on oprozomib in
hematologic malignances.  
"The results being presented at the IMW continue to build our
clinical understanding of carfilzomib, a second-generation proteasome
inhibitor, and oprozomib, an oral proteasome inhibitor in early
development," said Pablo Cagnoni, M.D., Executive Vice President,
Global Research & Development and Technical Operations, Onyx
Pharmaceuticals. "Onyx is committed to the continued development of
both these proteasome inhibitors in multiple myeloma, as well as
other hematologic malignancies and to bringing these therapies to
patients globally as quickly as possible." 
Carfilzomib
 Clinical and
Correlative (Phase II) Pilot Study - Carfilzomib (CFZ), Lenalidomide
(LEN), and Dexamethasone (Dex) in High Risk Smoldering Multiple
Myeloma ("Early Myeloma") 


 
--  Dr. Ola Landgren, National Cancer Institute (NCI)
--  Saturday, April 6, 8:00-8:12 a.m. JST (Friday, April 5, 7:00-7:12 p.m.
    ET)
--  Plenary Session 1

  
Treatment (tx) with CRd -- carfilzomib (CFZ), lenalidomide (LEN) and
low-dose dexamethasone (dex) -- for elderly patients (pts) with newly
diagnosed multiple myeloma (NDMM) enrolled in a phase (Ph) 1/2 study 


 
--  Dr. Andrzej Jakubowiak, University of Chicago Medical Center
--  Saturday, April 6, 8:48-9:00 a.m. JST (Friday, April 5, 7:48-8:00 p.m.
    ET)
--  Plenary Session 1

  
Oprozomib 
Oprozomib Treatment in Patients With Hematologic Malignancies: Updated
Results From a Phase 1b/2 Trial 


 
--  Dr. Jonathan Kaufman, Winship Cancer Institute
--  Thursday, April 4, 5:00-9:00 p.m., Friday-Saturday, April 5-6 10:00
    a.m.-4:00 p.m. JST (Thursday, April 4 4:00-8:00 a.m. ET,
    Thursday-Friday, April 4-5 9:00 p.m.-3:00 a.m. ET)
--  Poster # P-225
--  Abstract # 
427

  
Important Indication and Safety Information Regarding Kyprolis(R)
(carfilzomib) for Injection 
 On July 20, 2012, the U.S. Food and
Drug Administration (FDA) granted accelerated approval of Kyprolis(R)
(carfilzomib) for Injection for the treatment of patients with
multiple myeloma who have received at least two prior therapies
including bortezomib and an immunomodulatory agent (IMiD), and have
demonstrated disease progression on or within 60 days of completion
of the last therapy. Approval was based on response rate. Clinical
benefit, such as improvement in survival or symptoms, has not been
verified. 
Safety data have been evaluated in 526 patients with relapsed and/or
refractory multiple myeloma who received single-agent Kyprolis. There
were 37 deaths in the phase 2 studies, or 7% of patients. The most
common causes of death, other than disease progression, were cardiac
(5 patients), end-organ failure (4 patients), and infection (4
patients). Important warnings and precautions include cardiac arrest,
congestive heart failure, myocardial ischemia; pulmonary
hypertension, pulmonary complications, infusion reactions, tumor
lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal
toxicity.  
Death due to cardiac arrest has occurred within a day of Kyprolis
administration. Patients with New York Heart Association Class III
and IV heart failure, myocardial infarction in the preceding 6
months, and conduction abnormalities uncontrolled by medications were
not eligible for the clinical trials. These patients may be at
greater risk for cardiac complications. 
Pulmonary arterial hypertension (PAH) was reported in 2% of patients
treated with Kyprolis and was Grade 3 or greater in less than 1% of
patients. Dyspnea was reported in 35% of patients enrolled in
clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 4 events,
and 1 death (Grade 5) was reported. 
Infusion reactions, characterized by a spectrum of systemic symptoms
including fever, chills, arthralgia, myalgia, facial flushing, facial
edema, vomiting, weakness, shortness of breath, hypotension, syncope,
chest tightness, or angina can occur immediately following or up to
24 hours after administration of Kyprolis. Administration of
dexamethasone prior to Kyprolis reduces the incidence and severity of
reactions. Tumor lysis syndrome (TLS) occurred following Kyprolis
administration in < 1% of patients. Patients with multiple myeloma
and a high tumor burden should be considered to be at greater risk
for TLS. 
Thrombocytopenia following Kyprolis administration resulted in a dose
reduction in 1% of patients and discontinuation of treatment with
Kyprolis in < 1% of patients.  
Cases of hepatic failure, including fatal cases, have been reported
(< 1%). Kyprolis can cause elevations of serum transaminases and
bilirubin. 
There are no adequate and well-controlled studies in pregnant women
using Kyprolis. Females of reproductive potential should be advised
to avoid becoming pregnant while being treated with Kyprolis. The
most common serious adverse reactions were pneumonia, acute renal
failure, pyrexia, and congestive heart failure. The most common
adverse reactions (incidence of 30% or greater) observed in clinical
trials of patients with multiple myeloma were fatigue, anemia,
nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia. Serious
adverse reactions were reported in 45% of patients.  
Full prescribing information is available at http://www.onyx.com. 
About Multiple Myeloma
 Multiple myeloma is the second most common
hematologic cancer and results from an abnormality of plasma cells,
usually in the bone marrow. In the United States, more than 50,000
people are living with multiple myeloma and approximately 20,000 new
cases are diagnosed annually.(1) Worldwide, more than 220,000 people
are living with multiple myeloma and approximately 100,000 new cases
are diagnosed annually.(2) 
About Onyx Pharmaceuticals, Inc.
 Based in South San Francisco,
California, Onyx Pharmaceuticals, Inc. 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. 
Forward-Looking Statements
 This news release contains
"forward-looking statements" of Onyx within the meaning of the
federal securities laws. These forward-looking statements include
without limitation, statements regarding the progress and results of
the clinical development, safety, regulatory processes,
commercialization efforts or commercial potential of Kyprolis
(carfilzomib) or oprozomib. These statements are subject to risks and
uncertainties that could cause actual results and events to differ
materially from those anticipated, including risks related to the
development and commercialization of pharmaceutical products. Any
statements contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements.
Reference should be made to Onyx's Annual Report on Form 10-K for the
year ended December 31, 2012, filed with the Securities and Exchange
Commission under the heading "Risk Factors" for a more detailed
description of such factors. Readers are cautioned not to place undue
reliance on these forward-looking statements that speak only as of
the date of this release. Onyx undertakes no obligation to update
publicly any forward-looking statements to reflect new information,
events, or circumstances after the date of this release except as
required by law. 
(1) American Cancer Society, Cancer Facts & Figures 2012 
(2) National Analysts & Kantar Health Market Research 
Contacts:
Investors 
Julianna Wood 
Vice President, Public Affairs 
(650) 266-2505  
Media
Lori Melancon
Senior Director, Corporate Communications
(650) 266-2394