December 12, 2014 Announcement of the Launch of “SALAGEN^® Granules 0.5%” for the Treatment of Dry Mouth Symptoms

Kissei Pharmaceutical Co., Ltd.

Kissei Pharmaceutical Co., Ltd. [Head Office: Matsumoto-city, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa (“Kissei”)] announced today the launch of “SALAGEN^® Granules 0.5%,” a new formulation of “SALAGEN^®” (generic name: pilocarpine hydrochloride) for the treatment of symptoms of dry mouth.

Since 2005, “SALAGEN^® Tab.” has been marketed for the indication of “improvement of dry mouth symptoms associated with radiotherapy to the head and neck”. In 2007, the indication of “improvement of dry mouth symptoms in patients with Sjogren's syndrome” was added.

Dry mouth symptoms in patients with Sjogren's syndrome, as well as a decrease in salivation associated with radiotherapy to the head and neck, can cause chewing and swallowing difficulties. In addition, tumor growth can render oral administration of drugs difficult in patients with head and neck cancer. As a result of the development of easily swallowed granules for patients facing difficulties in swallowing regular tablets, Kissei received approval for the new formulation in August 2014.

SALAGEN^® improves the symptoms of dry mouth promptly after administration for a long time by inducing physiological salivation via stimulation of muscarinic receptors (M3 receptors) in the salivary glands, which will contribute to improvement in patients’ quality of life (QOL). Kissei will enhance convenience for patients with this new formulation as well as make further efforts to contribute to the treatment of dry mouth symptoms.


〈SALAGEN^® Granules product reference〉

Brand Name：
SALAGEN^® Granules 0.5％

Generic name：
Pilocarpine hydrochloride

Indications：
1. Improvement of dry mouth symptoms associated with radiotherapy to the head and neck
2. Improvement of dry mouth symptoms in patients with Sjogren's syndrome

Dosage and Usage：
Usually, for adults, SALAGEN^® Granules is orally administrated in a single dose of 5mg as Pilocarpine hydrochloride, three times a day, just after each meal.

NHI price：
SALAGEN^® Granules 1g1package ¥133.70

Packing：
84g(1g×84package)

Manufactured and Distributed by:
KISSEI PHARMACEUTICAL CO., LTD.