FDA Approves Amgen's Neulasta for Serious and Frequent Chemotherapy Side Effect
THOUSAND OAKS, Calif., Jan 31, 2002 -- Amgen (Nasdaq:AMGN)
today announced that the U.S. Food and Drug Administration has approved
Neulasta(TM) (pegfilgrastim). Neulasta, administered as a single fixed dose per
chemotherapy cycle, 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.
Febrile neutropenia is a serious and common complication of many cancer
chemotherapies. Chemotherapy kills normal cells as well as cancer cells,
including those that protect against infection. This often results in
neutropenia, a severe drop in a type of white blood cell called a neutrophil
that plays a vital role in defending the body against most types of infection.
The clinical trials showed that Neulasta is safe and well-tolerated. In clinical
trials, the most common adverse event attributed to Neulasta therapy following
some forms of chemotherapy in patients (n = 465) was mild to moderate bone pain,
reported in 26 percent of patients. In most cases, bone pain was controlled with
non-narcotic pain relievers such as acetaminophen. The most serious adverse
event not attributed to the disease or the chemotherapy was a single case of
hypoxia (insufficient oxygen in the blood). Neulasta has not been studied in
peripheral blood progenitor cell mobilization and should not be used in this
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 payors, 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 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.
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 January 31, 2002 and expressly disclaims any
duty to update information contained in this press release.
The Neulasta prescribing information, a product photo and other media tools are
available at www.NEULASTA.com. Prescribing information is also available via fax
by calling (800) 772-6436. Consumers can call 866-611-DRUG (3784) or access
www.NEULASTA.com for more information about Neulasta.
CONTACT: Amgen, Thousand Oaks
Jeff Richardson, 805/447-3227
Rebecca Hamm, 805/447-3872 (media)
Cary Rosansky, 805/447-4634 (investors)