(Tokyo, January 7, 2008) - Mochida Pharmaceutical Co., Ltd. (Head Office: Shinjuku-ku, Tokyo, Japan; President: Naoyuki Mochida) will launch “Dinagest Tab. 1mg” (dienogest), a therapeutic agent for endometriosis on January 21, 2008.
“Dinagest Tab. 1mg” was in-licensed from Bayer Schering Pharma AG, and has been developed as a therapeutic agent for endometriosis by Mochida in Japan. This is a novel, oral drug that activates selectively progesterone receptors, and demonstrates its therapeutic effect by inhibiting ovarian function and proliferation of endometrial cells. The results obtained during a long-term clinical trial (for 52 weeks) showed that it did not excessively lower the level of estradiol in the blood, thus preventing the occurrence of low estradiol-induced climacteric symptoms, and no cumulative decrease in bone density and variations in body weight were observed.
Endometriosis is classically defined as the presence of tissues resembling endometrium – the mucosa lining the uterine cavity – outside the uterus, and its lesions may cause hemorrhage and inflammation along with the menstrual cycle, leading to adhesions with surrounding peritoneal tissues. The disease affects a negative impact on quality of life of women by producing symptoms such as dysmenorrhea, pelvic pain, fatigue and infertility. The number of patients with endometriosis is said to be increasing, because the disease is believed to progress with repeated menstruation and women experience shorter periods of amenorrhea due to later marriage and fewer fertilization in recent years.
Mochida Pharmaceutical is committed to improving female health, with a focus on obstetrics and gynaecology as one of its key areas. “Dinagest Tab. 1mg” is expected to improve quality of life of patients by offering a new treatment option for endometriosis.
For Reference
Brand Name: Dinagest Tab. 1mg
Nonproprietary name: Dienogest
Indication: Endometriosis
Ingredients and Contents: 1 mg dienogest per tablet
Dosage and Administration: Usually, to adults, 2 mg of dienogest is orally administered daily in 2 divided doses, starting from day 2-5 of the menstrual cycle.
NHI (National Health Insurance) price: 468.40 Yen per tablet
Package: 100 tablets
Date of Approval: October 19, 2007
Date of NHI price listing: December 14, 2007
Date of Launch: January 21, 2008
Manufacturer/Distributor: Mochida Pharmaceutical Co., Ltd.