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Chugai to Launch HIV Protease Inhibitor Invirase(R) Tablet 500mg on September 15
TOKYO, JAPAN -- September 14, 2006 -- Chugai Pharmaceutical Co., Ltd. announced today the launch of a new drug for HIV (Human Immunodeficiency Virus) infection, HIV Protease inhibitor Invirase® Tablet 500 mg (saquinavir mesilate), on September 15. The NHI price will be 422.30 JPY per tablet (1689.20 JPY per day).
Invirase® Capsule 200 mg (hereinafter, "Invirase®"), launched in September 1997 in Japan, is the world's first HIV protease inhibitor developed by Roche UK. Since its approval in December 1995 in the USA, Invirase® has been approved in more than 80 countries.
With the accumulation of post-marketing data concerning concomitant administration of Invirase® and other drugs, it was found that concomitant use with HIV protease inhibitor ritonavir (Norvir®) caused significant increase of blood Invirase® concentration. In response to this fact, the guidelines of the US Department of Health Human Services (DHHS) began to recommend that Invirase® 1000 mg be administered concomitantly with ritonavir 100 mg twice a day. The dosage and administration were approved in September 2002 in Europe and in December 2003 in the USA.
On the other hand, the manufacturer, F. Hoffmann-La Roche Ltd. developed Invirase® Tablet 500 mg to reduce the burden of patients and improve drug compliance*, recognizing that adherence to the recommended dosage and administration of Invirase® results in an increase in the number of capsules that patients have to take at one time. Since approval in December 2004 in the USA, and May 2005 in Europe, Invirase® Tablet 500 mg has been approved in more than 50 countries.
In light of the level of use overseas, Chugai applied to the Ministry of Health, Labour and Welfare on July 20 2006 for manufacturing and marketing approval of Invirase® Tablet 500 mg for concomitant use with HIV protease inhibitor ritonavir and an additional drug form. Invirase® Tablet 500 mg was approved on September 1, 2006 and added to the NHI price listing on September 4.
Dosage and administration:
For oral use, the usual adult dosage is 1000 mg of saquinavir twice a day and 100 mg of ritonavir twice a day. Both drugs should be concurrently administered within 2 hours after meals, and other anti-HIV drug must be coadministered with them.
* The term "compliance" means the patient's attitude to participate actively in the orientation of treatment and to keep receiving the treatment based on their own decision.
Invirase® is a registered trademark of F Hoffmann-La Roche Ltd. (Switzerland).
SOURCE: Chugai Pharmaceutical Co.
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