Astellas Pharma Launches Kiklin Capsules, a Treatment for Hyperphosphatemia, in Japan
-Provides a New Option for Patients with
Hyperphosphatemia-
Tokyo, June 25, 2012 - Astellas Pharma Inc. (“Astellas
Pharma”; Tokyo:4503; President and CEO: Yoshihiko Hatanaka)
today announced that Kiklin
®Capsules 250mg (generic name:Bixalomar) will become available
in the Japanese market on June 26, 2012, for the indication of
hyperphosphatemia in patients on dialysis with chronic kidney
disease.
Hyperphosphatemia occurs in many patients receiving dialysis whose
renal function is reduced, because phosphorus is not sufficiently
excreted into urine via the kidneys and consequently accumulates in
the body. With continuous high blood phosphorus concentration, the
risk of renal osteodystrophy characterized by a high tendency of
bone pain and bone fracture is known to be increased. Additionally,
high blood phosphorus concentration is associated with increased
coronary artery calcification and subsequent cardiovascular events.
Therefore, it is considered extremely important to maintain the
serum phosphorus concentration at an appropriate level in dialysis
patients.
Kiklin Capsules are amine-functional polymers which decrease the
serum phosphorus concentration by binding to phosphate in the
gastrointestinal tract, thus inhibiting absorption of phosphate
into the human body. Phase III studies in patients on dialysis with
chronic kidney disease in Japan demonstrated Kiklin Capsules’
clinical efficacy in decreasing serum phosphorus concentration, as
well as a preferable long-term safety profile.
In April 2006, Astellas Pharma and Ilypsa, Inc., now a wholly-owned
subsidiary of Amgen Inc., entered into a license agreement that
gives Astellas exclusive rights to develop and market Kiklin
Capsules for the treatment of hyperphosphatemia in Japan. Since
then, Astellas Pharma has conducted development of Kiklin Capsules
in Japan.
Astellas Pharma expects to provide an additional therapeutic option
in treating hyperphosphatemia by introducing Kiklin Capsules into
the Japanese market. Under a strategic alliance established in
February 2012 between Astellas Pharma and Sanwa Kagaku Kenkyusho
Co., Ltd. for Japan’s pharmaceutical market in kidney
disease, both companies will co-promote Kiklin Capsules while
Astellas Pharma will oversee distribution. Astellas anticipates
that peak sales of Kiklin may reach 7 billion yen (based on the NHI
drug price) in FY2016.
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PRODUCT SUMMARY
Product name: Kiklin® Capsules 250mg
Generic name: Bixalomer
Indication: Treatment of hyperphosphatemia in the following
patients: Patients on dialysis with chronic kidney disease
Dosage regimen The usual starting dose of Bixalomer for
adults is 500mg three times daily just before meals. The dose can
be adjusted based on
symptoms and serum phosphorus concentration. The maximum daily dose
should not exceed 7,500mg.
Package: Kiklin® Capsules 250mg: 100 Capsules, 500
Capsules
Drug Price: Kiklin Capsules 250mg: 29.70Yen
Drug price listing date: 29
May, 2012
Sales commencement date: 26 June, 2012 (Plan)
For inquiries or additional information
Astellas Pharma Inc.
Corporate Communications
TEL: +81-3-3244-3201, FAX:+81-3-5201-7473
http://www.astellas.com/en
Posted: June 2012
