Amgen's Nplate(R) Rapidly Increased Platelet Counts in Adults With Primary ITP

By Amgen, PRNE
Thursday, June 9, 2011

ZUG, Switzerland, June 10, 2011 -

- Interim Results From Largest Study Of Adult ITP Patients To Date

Amgen today announced interim results from an international, single-arm
study ("209 study") evaluating the safety and efficacy of Nplate(R)
(romiplostim) in adults with primary immune thrombocytopenia (ITP) - a rare
blood disorder - demonstrated that Nplate induced a rapid platelet response
with a good safety profile in adult ITP patients with low platelet counts and
bleeding symptoms (Abstract #0223).

"This is the largest ever study in adult ITP with over 400 patients
enrolled. These interim data highlight again Nplate's ability to treat adult
patients successfully, including those with varying severity of the
condition," said Dr Ann Janssens, Department of Hematology, University
Hospitals Leuven, Belgium. "Nplate has consistently demonstrated that it can
significantly increase and maintain platelet counts in adult ITP patients,
highlighting its importance as a well-tolerated treatment option."

    Interim results from the first 235 patients show:

    - Nplate was able to induce a platelet response in a large majority of
      adult patients (90 percent) with primary ITP treated with Nplate for
      up to 201 weeks.

    - Median time to response was one week.

    - Over the course of the study, a doubling of the platelet count to
      greater than or equal to 50,000 platelets per microliter was achieved
      by 86 percent of patients who received Nplate.

    - A platelet count increase of greater than or equal to 20,000 platelets
      per microliter from baseline was achieved by 91 percent of patients who
      received Nplate.

Incidence and type of adverse events (AEs) in patients treated with
Nplate were consistent with those reported in previous studies. The most
common side effects were mild and included headache (28 percent of patients),
fatigue (23 percent) and arthralgia (19 percent). No neutralizing antibodies
to Nplate or thrombopoietin (TPO) or hematopoieitic malignancies or MDS
events were reported.

209 Study Design

This is an open-label, single-arm study of Nplate for the treatment of
adults with primary ITP. Nplate was administered once weekly, with dose
adjustments to maintain platelet counts of greater than or equal to 50,000
platelets per microliter. The primary study objective was incidence of AEs
and antibody formation. Secondary study objectives were to evaluate platelet
responses defined as either (1) doubling of baseline count and a platelet
count greater than or equal to 50,000 platelets per microliter or (2) a
platelet count increase of greater than or equal 20,000 platelets per
microliter from baseline.(1) As of June 2009, 235 patients had been treated
for a median of 18 weeks with a maximum duration of 201 weeks. Sixty percent
of patients had previously undergone splenectomy.

About Adult ITP

In patients with ITP, platelets - blood elements needed to prevent
bleeding - are destroyed by the patient's own immune system. Recent data also
suggest that low platelet counts in the blood may be caused by the inability
of the body's natural processes to produce platelets. Low platelet counts
leave adult ITP patients open to sudden serious bleeding events. The risk for
serious bleeding events increases when platelet counts drop to less than
30,000 platelets per microliter; normal counts range from 150,000 to 400,000
platelets per microliter. ITP has historically been considered a disease of
platelet destruction although recent data suggest that the body's natural
platelet production processes in ITP are unable to compensate for low levels
of platelets in the blood. Increasing the rate of platelet production may
address low platelet levels associated with ITP. Adult chronic ITP has an
incidence of 5.8-6.6 per 100,000 in the United States and an estimated 2.0
per 100,000 in the European Union.(2,3)

For more information about ITP please visit itpvillage.com

About Nplate

Nplate is the first platelet producer approved in most regions, including
the European Union (EU), Canada, Australia, Russia, Mexico, Switzerland and
the U.S. Nplate also has received orphan designation for chronic ITP in the
U.S. (2003), the EU (2005), Switzerland (2005), Japan (2006) and Mexico
(2010).

Nplate is the first FDA approved treatment specifically for adult chronic
ITP. It is also being investigated for potential use in children ages 12
months to 18 years old with persistent severe thrombocytopenia,
myelodysplastic syndromes (MDS) and chemotherapy-induced thrombocytopenia
(CIT).

In the EU, Nplate is indicated for the treatment of splenectomized adult
chronic ITP patients who are refractory to other treatments (e.g.
corticosteroids, immunoglobulins). Nplate may be considered as a second-line
treatment for adult non-splenectomized ITP patients for whom surgery is
contraindicated.

For more information about Nplate, please visit www.Nplate.com.

Important EU Nplate Safety Information

The most common side effects are headache, fatigue, arthralgia, myalgia,
injection site bruising, injection site pain, oedema peripheral, dizziness,
muscle spasms, nausea, contusion, diarrhoea, bone marrow disorder,
influenza-like illness, insomnia and pruritus.

Reoccurrence of thrombocytopenia and bleeding after cessation of
treatment and increased bone marrow reticulin have been associated with
Nplate treatment in the clinical trials. Thrombotic/thromboembolic
complications, progression of existing hematopoietic malignancies or MDS, and
effects on red and white blood cells are all potential risks associated with
Nplate treatment. As with all therapeutic proteins, patients may develop
antibodies to the therapeutic protein.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first
companies to realize the new science's promise by bringing safe and effective
medicines from lab, to manufacturing plant, to patient. Amgen therapeutics
have changed the practice of medicine, helping millions of people around the
world in the fight against cancer, kidney disease, rheumatoid arthritis and
other serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to dramatically
improve people's lives. To learn more about our pioneering science and our
vital medicines, visit www.amgen.com.

Forward-Looking Statements

This news release contains forward-looking statements that are based on
management's current expectations and beliefs and are subject to a number of
risks, uncertainties and assumptions that could cause actual results to
differ materially from those described. All statements, other than statements
of historical fact, are statements that could be deemed forward-looking
statements, including estimates of revenues, operating margins, capital
expenditures, cash, other financial metrics, expected legal, arbitration,
political, regulatory or clinical results or practices, customer and
prescriber patterns or practices, reimbursement activities and outcomes and
other such estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed below and more
fully described in the Securities and Exchange Commission (SEC) reports filed
by Amgen, including Amgen's most recent annual report on Form 10-K and most
recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's
most recent Forms 10-K, 10-Q and 8-K for additional information on the
uncertainties and risk factors related to our business. Unless otherwise
noted, Amgen is providing this information as of 10 June 2011 and expressly
disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may
differ materially from those we project. Discovery or identification of new
product candidates or development of new indications for existing products
cannot be guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product candidate
or development of a new indication for an existing product will be successful
and become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in humans. The
complexity of the human body cannot be perfectly, or sometimes, even
adequately modeled by computer or cell culture systems or animal models. The
length of time that it takes for us to complete clinical trials and obtain
regulatory approval for product marketing has in the past varied and we
expect similar variability in the future. We develop product candidates
internally and through licensing collaborations, partnerships and joint
ventures. Product candidates that are derived from relationships may be
subject to disputes between the parties or may prove to be not as effective
or as safe as we may have believed at the time of entering into such
relationship. Also, we or others could identify safety, side effects or
manufacturing problems with our products after they are on the market. Our
business may be impacted by government investigations, litigation and
products liability claims. We depend on third parties for a significant
portion of our manufacturing capacity for the supply of certain of our
current and future products and limits on supply may constrain sales of
certain of our current products and product candidate development.

In addition, sales of our products are affected by the reimbursement
policies imposed by third-party payors, including governments, private
insurance plans and managed care providers and may be affected by regulatory,
clinical and guideline developments, domestic and international trends toward
managed care and health care cost containment as well as U.S. legislation
affecting pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development, usage and
pricing of our products. In addition, we compete with other companies with
respect to some of our marketed products as well as for the discovery and
development of new products. We believe that some of our newer products,
product candidates or new indications for existing products, may face
competition when and as they are approved and marketed. Our products may
compete against products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are otherwise
competitive with 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 and there can be no guarantee of our ability to obtain or
maintain patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful products or
maintain the commercial success of our existing products. Our stock price may
be affected by actual or perceived market opportunity, competitive position,
and success or failure of our products or product candidates. Further, the
discovery of significant problems with a product similar to one of our
products that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our business and
results of operations.

The scientific information discussed in this news release relating to new
indications for our products is preliminary and investigative and is not part
of the labeling approved by the FDA for the products. The products are not
approved for the investigational use(s) discussed in this news release, and
no conclusions can or should be drawn regarding the safety or effectiveness
of the products for these uses. Only the FDA can determine whether the
products are safe and effective for these uses. Healthcare professionals
should refer to and rely upon the FDA-approved labeling for the products, and
not the information discussed in this news release.

References

(1) Data on file. Interim Results from an International Multi-center,
Single-arm Study Evaluating the Safety and Efficacy of Romiplostim in Adults
with Primary Immune Thrombocytopenia (ITP). Abstract# 0223

(2) McMillan R. Therapy for Adults with Refractory Chronic Immune
Thrombocytopenic Purpura. Ann Intern Med 1997;126:307-314

(3) Fogarty PF et al. Curr Opin Hematol 2007;14:515-519.

Carrie Deverell, +41-41-3690-308 (E.U. media), or Christine Regan, +1-805-447-5476 (U.S. media), both of Amgen

Health News

Amgen News

YOUR VIEW POINT
NAME : (REQUIRED)
MAIL : (REQUIRED)
will not be displayed
WEBSITE : (OPTIONAL)
YOUR
COMMENT :