Amgen Signs Multi-Year Agreement With US Oncology for Aranesp, Neulasta and NEUPOGEN
THOUSAND OAKS, Calif. and HOUSTON, Mar 14, 2002 -- Amgen
(Nasdaq:AMGN), the world's largest biotechnology company, has signed a
multi-year agreement with US Oncology, Inc., (Nasdaq:USON), the nation's largest
health-care network dedicated exclusively to cancer services and research. The
agreement covers Aranesp(TM) (darbepoetin alfa), a new drug in the treatment for
anemia, and Neulasta(TM) (pegfilgrastim) and NEUPOGEN(R) (Filgrastim), both of
which reduce the risk of chemotherapy-induced neutropenia.
"US Oncology is always striving to provide patients access to the best and most
effective cancer care possible," said Michael Louviere, vice president, US
Oncology's Oncology Pharmaceutical Services division. "Aranesp, Neulasta and
Neupogen are important tools that give our member physicians a wide variety of
effective options for treating anemia and neutropenia and improve patient
outcomes and quality of life."
"With Aranesp and Neulasta, Amgen is advancing the management of some of the
most serious aspects of cancer care," said George Morrow, Amgen's executive vice
president -- worldwide marketing and sales. "We continue to make rapid progress
in bringing these benefits to physicians and patients across the country, and
our relationship with US Oncology is the latest step in translating scientific
advances into improved care for cancer patients."
Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September
2001 for the treatment of anemia related to chronic renal failure for patients
on dialysis and not on dialysis, and currently is under review by the FDA for
use in cancer patients receiving chemotherapy.
Neulasta(TM) was approved by the FDA in January 2002 for decreasing the
incidence of infection, as manifested by febrile neutropenia (fever associated
with a severe drop in infection-fighting white blood cells) in patients with
non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated
with a clinically significant incidence of febrile neutropenia. Neulasta is
administered as a single fixed dose per chemotherapy cycle.
NEUPOGEN(R) is indicated to decrease the incidence of infection, as manifested
by febrile neutropenia, in patients with non-myeloid malignancies receiving
myelosuppressive anti-cancer drugs associated with a significant incidence of
Febrile neutropenia is a serious and common complication of many cancer
chemotherapies. Up to half of cancer chemotherapy patients develop severe
neutropenia, and up to 40 percent of patients receiving certain types of
chemotherapy, who do not receive a white blood cell booster, will experience
neutropenia with fever. On average, less than 10 percent of cancer patients
receive proactive protection from neutropenia and thousands undergo unplanned
hospitalization for neutropenia and its complications each year.
US Oncology, Inc., headquartered in Houston, is a leading cancer-care services
company. The company supports the cancer-care community by providing oncology
pharmaceutical services, cancer center services, and cancer research services to
community-based practices. US Oncology is affiliated with more than 850
physicians operating in over 450 locations, including 77 outpatient cancer
centers, in 27 states.
Amgen is a global biotechnology company that discovers, develops, manufactures
and markets important human therapeutics based on advances in cellular and
This news release contains forward-looking statements that involve significant
risks and uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission reports filed by Amgen,
including our most recent Form 10-K. Amgen conducts research in the
biotechnology/pharmaceutical field where 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.
Furthermore, our research, testing, pricing, marketing and other operations are
subject to extensive regulation by domestic and foreign government regulatory
authorities. In addition, sales of our products are affected by reimbursement
policies imposed by third party payers, including governments, private insurance
plans and managed care providers. These government regulations and reimbursement
policies may affect the development, usage and pricing of our products. In
addition, while Amgen routinely obtains patents for our products and technology,
the protection offered by Amgen patents and patent applications may be
challenged, invalidated or circumvented by our competitors.
Because forward-looking statements involve risks and uncertainties, actual
results may differ materially from current results expected by Amgen. Amgen is
providing this information as of March 14, 2002 and expressly disclaims any duty
to update information contained in this press release.
Editor's Notes: Clinical studies showed Aranesp(TM) to be generally
well-tolerated. Serious adverse events were associated with increases in
hemoglobin greater than approximately 1.0 g/dL during any two-week period in
patients treated with Aranesp or Epoetin alfa in Aranesp clinical trials,
including increased incidence of cardiac arrest, neurologic events (including
seizures and stroke) and exacerbations of hypertension, congestive heart
failure, vascular thrombosis / ischemia / infarction, acute myocardial
infarction, and fluid overload/ edema were observed. There have been rare
reports of potentially serious allergic reactions including skin rash and
urticaria associated with Aranesp. The most commonly reported side effects in
Aranesp trials were infection, hypertension, hypotension, myalgia, headache, and
diarrhea. Some of the adverse events reported are typically associated with CRF,
or recognized complications of dialysis, and may not necessarily be attributable
to Aranesp therapy.
No important differences in adverse event rates between the Aranesp and Epoetin
alfa treatment groups were observed in the controlled studies. Aranesp is
contraindicated in patients with uncontrolled hypertension.
Clinical trials showed that Neulasta(TM) is safe and well-tolerated. The most
common adverse event attributed to Neulasta therapy following combination
chemotherapy in patients (n=465) with lymphoma and solid tumors was bone pain
reported in 26 percent of patients. In most cases, bone pain was controlled with
non-narcotic analgesics. The most serious adverse event attributed to Neulasta
was low oxygen in the blood, reported in one patient. While not reported in
patients receiving Neulasta, rare events of adult respiratory distress syndrome,
splenic rupture, and sickle cell crisis have been reported in patients receiving
the parent compound, NEUPOGEN(R).
In the phase 3 trial of NEUPOGEN(R) therapy following combination chemotherapy
in patients (n = 207) with small cell lung cancer, bone pain was reported in 22
percent of patients. In most cases, bone pain was controlled with non-narcotic
analgesics such as acetaminophen.
Full prescribing information for Aranesp(TM) is available at www.aranesp.com and
for Neulasta(TM) at www.neulasta.com.
An electronic version of this news release may be accessed via our web site at
www.amgen.com. Visit the Corporate Center and click on Amgen News. Journalists
and media representatives may sign up to receive all news releases
electronically at time of announcement by filling out a short form in the Amgen
News section of the web site.
CONTACT: Amgen, Thousand Oaks
Jeff Richardson, 805/447-3227 (media)
Cary Rosansky, 805/447-4634 (investors)
US Oncology, Houston
Steve Sievert, 832/601-6193 (media)
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