Shionogi Receives National Health Insurance Drug Price Listing
for Carbapenem-Type Antibiotic, “Finibax® 0.5g for Intravenous Drip Infusion”
Osaka, Japan, September 22, 2011 - Shionogi & Co., Ltd. (Head Office: Osaka; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) today announced that it has received the National Health Insurance (NHI) drug price listing for the carbapenem-type antibiotic, “Finibax® 0.5g for Intravenous Drip Infusion” (generic name: doripenem hydrate), which received marketing and manufacturing approval on July 11, 2011.
“Finibax® 0.25g for Intravenous Drip Infusion”, launched in September, 2005 in Japan, and “Finibax® 0.25g Kit for Intravenous Drip Infusion”, in June, 2006, are parenteral infusion products of doripenem, a carbapenem-type antibiotic discovered and developed by Shionogi with a strong and broad antibacterial spectrum, covering gram-positive and gram-negative bacteria as well as aerobic and anaerobic bacteria. Since this drug has strong antibacterial activity against Pseudomonas aeruginosa, which is often a causal agent in serious and intractable infections, it has been prescribed with high frequency.
Finibax®/Doribax® has already been approved in 78 countries and its approval of the maximum daily dose of 3g in Japan in April 2011 was the first approval at this dose level in any country. The receipt of the NHI drug price listing and the launch of the new additional dosage of Finibax® will benefit patients with serious or intractable infections and will improve convenience of administration.
The product, which has been added to NHI drug price list, will be commercially available in or after November, 2011, the same time as the renamed existing products will be also launched.
Shionogi, as a leading company in the field of anti-infectives, continues to be dedicated to research and development and medical education to globally improve the treatment of infectious diseases, especially those of bacterial and viral origin.
Product name | Standard unit | NHI drug price | Listing date
Finibax® 0.5g for Intravenous Drip Infusion | 500mg, 1 vial | 1,617yen | September 22, 2011
Forward-Looking Statements
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products.
The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
For further information, contact:
Corporate Communications Department
Shionogi & Co., Ltd.
Telephone: +81-6-6209-7885
Fax: +81-6-6229-9596
