Takeda Announces Acceptance of European Marketing Authorisation Application for Peginesatide, an Investigational Compound for the Treatment of Anemia Associated with Chronic Kidney Disease in Patients

London And Osaka, Japan (ots/PRNewswire) -

Takeda Pharmaceutical Company Limited (Takeda) today announced
that Takeda Global Research & Development Centre (Europe) Ltd
received confirmation of acceptance for assessment from the European
Medicines Agency (EMA) for a Marketing Authorisation Application
(MAA) for the investigational compound peginesatide for the treatment
of symptomatic anemia associated with chronic kidney disease (CKD) in
adult patients on dialysis. Takeda had submitted the MAA earlier this
month.

Peginesatide is a synthetic, PEGylated peptidic compound that
binds to and activates the erythropoietin receptor and thus acts as
an erythropoiesis stimulating agent (ESA) which results in the
increased formation of red blood cells. The agent was discovered by
Affymax, and if approved, will be co-marketed by Affymax and Takeda
in the United States, and by Takeda in the European Union.

The MAA submission for peginesatide was supported mainly by data
from two Phase 3 studies (EMERALD 1 and 2) that evaluated the
efficacy and safety of peginesatide, dosed once every four weeks,
compared to epoetin alfa or epoetin beta, dosed three times per week
(according to the product labels), in maintaining hemoglobin (Hb)
levels. The EMERALD studies were part of the largest Phase 3 clinical
program to support the initial registration of an ESA. The program
enrolled more than 2,600 patients, including approximately 1,600
dialysis patients. In the studies, CKD patients on dialysis who were
receiving stable doses of epoetin, were randomized to receive
once-monthly peginesatide or continue treatment with epoetin. The
EMERALD findings suggested that once-monthly peginesatide was similar
to epoetin in maintaining Hb levels in CKD patients on dialysis with
anemia. In addition the two groups had a similar safety profile.

In May 2011, Takeda's U.S. partner, Affymax, submitted a New Drug
Application for peginesatide to the U.S. Food and Drug Administration
(FDA). The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 15
to 1, with 1 abstention, that peginesatide demonstrated a favorable
benefit/risk profile for use in the treatment of dialysis patients
with anemia due to CKD in December 2011, and a Prescription Drug User
Fee Act (PDUFA) date of March 27, 2012, is scheduled for
peginesatide.

"This MAA represents a significant milestone for our company and
carries positive clinical implications for patients with anemia in
chronic kidney disease and the physicians who treat them," said
Stuart Dollow, M.D., managing director, Takeda Global Research &
Development Centre (Europe) Ltd. "Although anemia is a debilitating
condition for chronic kidney disease patients on dialysis,
appropriate management of this condition is onerous for patients and
healthcare professionals. Our program illustrates the potential of
peginesatide as an important once-monthly therapeutic option. We are
committed to bringing new treatments to patients with unmet needs,
and look forward to working with the EMA as they review the data
package for the peginesatide MAA."

[1] National Kidney and Urologic Diseases Information
Clearinghouse. "Anemia in Kidney Disease and Dialysis"

[2] Astor et al Association of Kidney Function with Anemia: The
Third National Health and Nutrition Examination Survey (1988-1992).
Archives of Internal Medicine 2002; 162: 1401-1408

[3] National Heart Lung and Blood Institute "What is Anemia." htt
p://www.nhlbi.nih.gov/health/dci/Diseases/anemia/anemia_what_is.html.

[4] Fishbane et al. "Hemoglobin Cycling in Hemodialysis Patients
Treated With Recombinant Human Erythropoietin." Kidney International
2005; Vol. 68 (2005), pp. 1337-1343

About Anemia in Chronic Kidney Disease (CKD)

Anemia is a common complication in CKD that impacts the overall
health and well-being of CKD patients and is associated with
increased rates of hospitalization and mortality.[1,2] ESAs are
medications commonly prescribed to treat anemia and stimulate red
blood cell production.[3] Research has shown that there may be
challenges with anemia management due to factors such as, Hb
variability and stability, among other concerns.[4]

About Peginesatide

Affymax and Takeda are collaborating on the development of
peginesatide and plan to co-commercialize the product if approved in
the United States. The product, upon approval, will be commercialized
outside the United States by Takeda. The most common adverse events
reported in the clinical studies were diarrhea, cough, dyspnea,
nausea, and muscle spasm.

About Takeda Global Research & Development Centre (Europe) Ltd

Based in London, England, Takeda Global Research & Development
Centre (Europe) Ltd, (TGRD Europe), is a subsidiary of Takeda
Pharmaceutical Company Limited, the largest pharmaceutical company in
Japan. TGRD Europe seeks to bring innovative products to patients
through a pipeline that includes compounds in development for
diabetes, cardiovascular disease, neurology, oncology and other
conditions.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global
company with its main focus on pharmaceuticals. As the largest
pharmaceutical company in Japan and one of the global leaders of the
industry, Takeda is committed to strive towards better health for
patients worldwide through leading innovation in medicine. Additional
information about Takeda is available through its corporate website,
http://www.takeda.com.

Contacts:

Rebekah Childers
TGRD Europe
+44-(0)-780-949-5101
Julia Ellwanger
Takeda Pharmaceuticals International, Inc.
+1-224-554-7681
Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
+81-3-3278-2037

ots Originaltext: Takeda Pharmaceutical Company Limited
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