EPO Background from Amgen 10k

[James Love <love@cptech.org>]

>From the Amgen 10k For the fiscal year ended December31, 1996 
......
Recombinant human erythropoietin

EPOGEN® (proper name - Epoetinalfa) is Amgen's trademark for its
recombinant human erythropoietin product, a protein that stimulates red
blood cell production. Red blood cells transport oxygen to all cells of
the body. Without adequate amounts of erythropoietin, the red blood cell
count is reduced thereby diminishing the ability of the blood to deliver
sufficient amounts of oxygen to the body, resulting in anemia. People
with chronic renal failure suffer from anemia because they do not
produce sufficient amounts of erythropoietin. EPOGEN® is effective in
the treatment of anemia associated with chronic renal failure for
patients on dialysis and is indicated to elevate or maintain the red
blood cell level (as manifested by hematocrit or hemoglobin
determinations) and to decrease the need for blood transfusions in these
patients.

In the United States, Amgen was granted rights to market recombinant
human erythropoietin under a licensing agreement with Kirin-Amgen (see
"Joint Ventures and Business Relationships - Kirin Brewery Company,
Limited").The Company began selling EPOGEN® in 1989 when the FDA gave
clearance for its use in the treatment of anemia associated with chronic
renal failure. The FDA designated EPOGEN® as an orphan drug, and such
designation expired in 1996. In 1994, the FDA cleared a supplement to
the Epoetin alfa product license which included an expanded target
hematocrit range for patients with chronic renal failure. The target
hematocrit, or percentage of red blood cells, was expanded to a range of
30 to 36 percent from the previously indicated range of 30 to 33
percent.

The Company filed an additional license supplement with the FDA for the
use of EPOGEN® in pediatric dialysis patients in 1996. Also during 1996,
the Company discontinued the EPOGEN® Normal Hematocrit study. In this
study, patients with symptomatic heart disease were randomized to a
control group targeted at a hematocrit of 30 percent or an intervention
group targeted toward a hematocrit of 42 percent(the average hematocrit
level of people not undergoing dialysis treatment). In the 631 patient
control group, 185 died compared with 221 of 634 in the intervention
group. Subsequently, the Company revised the EPOGEN® package insert to
incorporate language pertaining to the related mortality risks in
dialysis patients with heart disease being treated with EPOGEN®. The
revised package insert states that hemodialysis patients with heart
disease receiving EPOGEN® should have their hematocrit maintained
carefully not to exceed 36 percent.

The Company has retained exclusive rights to market EPOGEN® in the
United States for dialysis patients. Amgen has granted Ortho
Pharmaceutical Corporation, a subsidiary of Johnson & Johnson, hereafter
referred to as"Johnson & Johnson", a license to pursue commercialization
of recombinant human erythropoietin as a human therapeutic in the United
States in all markets other than dialysis and diagnostics. See Note 1 to
the Consolidated Financial Statements - "Product sales" and Note 4 to
the Consolidated Financial Statements- "Johnson & Johnson arbitrations".

In Japan, Kirin was granted rights to market recombinant human
erythropoietin under a licensing agreement with Kirin-Amgen (see "Joint
Ventures and Business Relationships- Kirin Brewery Company, Limited").
Kirin markets its recombinanthuman erythropoietin product under the
trademark ESPO®.

In countries other than the United States (except as described above),
the People's Republic of China and Japan, Johnson & Johnson was granted
rights to pursue the commercialization of erythropoietin as a human
therapeutic under a licensing agreement with Kirin-Amgen. Affiliates of
Johnson& Johnson market erythropoietin for treatment of anemia
associated with chronic renal failure under the trademark EPREX® in
several countries.

In August 1996, the U.S. Patent and Trademark Office issued to the
Company a patent covering product rights to erythropoietin or EPOGEN®.
This patent provides broad protection against unauthorized making,
importation, use or sale of erythropoietin in the United States until
2013. Previously issued patents cover aspects of DNA and host cells and
the manufacturing process for erythropoietin.						

For the years ended December 31,1996, 1995 and 1994, sales of EPOGEN®
accounted for approximately48%, 46% and 44%, respectively, of total
revenues. 

-- 
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
love@cptech.org | http://www.cptech.org
voice 202.387.8030, fax 202.234.5176