THOUSAND OAKS, Calif. & BALTIMORE, Md., Mar 14, 2002 (BUSINESS WIRE) -- Amgen
(Nasdaq:AMGN), the world´s largest biotechnology company, has signed a
multi-year agreement with International Oncology Network (ION), the nation´s
largest community-based oncologist network. ION approached Amgen to include
Aranesp(TM) (darbepoetin alfa) as its preferred treatment for anemia, and
Neulasta(TM) (pegfilgrastim) and NEUPOGEN(R) (Filgrastim) as preferred therapies
for reducing the risk of chemotherapy-induced neutropenia.
"ION is constantly striving to improve all facets of patient care within our
network. We believe that having access to Amgen´s supportive therapies gives our
member physicians the flexibility needed to prevent and manage the devastating
effects of anemia and neutropenia," said Jeffrey Scott, MD, ION´s president and
national medical director.
In addition to preferred formulary inclusion for Aranesp, Neulasta and NEUPOGEN,
Amgen will work with ION to develop comprehensive physician and patient
educational services around ION´s comprehensive cancer care services. "Amgen is
a premier oncology franchise company sharing ION´s goal to ensure patient access
to quality care," continued Scott.
"ION offers exemplary care to cancer patients, and we are delighted to support
their efforts," said George Morrow, Amgen´s executive vice president of
worldwide marketing and sales. "This agreement is the latest evidence that
physicians are eager to embrace our products to improve patient care."
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 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.
ION is a leading premier group purchasing organization (GPO) specializing in the
support of community-based oncology practices. Members are committed to helping
promote quality cancer care where patients need it the most in their own
ION members range from solo practitioners to some of the country´s largest and
most renowned private practices. ION´s physician network includes more than
2,000 oncologists nationwide.
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-Q. 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 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)
Erin Mulgrew, 888/536-7697 (media)
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