SHIONOGI & CO., LTD. 
By PRESS RELEASE
April 17, 2014
Tivicay® Tablets 50mg, HIV Integrase Inhibitor Launched in Japan New Treatment Option for Treatment-naïve Patients and Patients Requiring an Alternative to Current Treatment Regime
ViiV Healthcare K. K. (Head Office: Tokyo; President: Hirohisa Iriyama) announces the launch of its HIV Integrase Inhibitor Tivicay® Tablets 50mg (nonproprietary name: dolutegravir sodium) with an indication for the treatment of HIV infection on 17 April 2014 following NHI price listing on the same day.
ViiV and Shionogi & Co., Ltd. (Head Office: Osaka; President & CEO: Isao Teshirogi, Ph.D.), in accordance with the Co-promotion Agreement in Japan concluded as of December 16, 2013 for this product, have been jointly providing medical information on Tivicay® Tablets 50mg to medical institutions since the date of approval (24
March, 2014).
ViiV and Shionogi aim to contribute further to HIV treatment by providing Tivicay® Tablets 50mg to healthcare professionals and HIV patients in Japan as soon as possible through the co-promotion of this product following the launch today.
Product Characteristics of Tivicay® Tablets 50mg
Tivicay® Tablets 50mg, an integrase inhibitor, prevents replication of HIV by potently inhibiting the activity of integrase, which incorporates HIV DNA into the chromosomes of human immune cells.
Clinical studies outside Japan demonstrated favorable virological effect and tolerability of this product in patients previously treated or untreated with anti-HIV agents. There is evidence that it is less likely to cause drug-resistant viruses.
Tivicay® Tablets 50mg can be orally administered once daily1 without regard to meals, while eliminating the
necessity of adding pharmacokinetic booster; thus, improved adherence can be anticipated.
1 For patients resistant to HIV integrase inhibitors, 50 mg of dolutegravir should be orally administered twice daily.
About Tivicay® Tablets 50mg
Product name | Tivicay® Tablets 50mg |
Nonproprietary name | Dolutegravir sodium |
Date of approval | March 24, 2014 |
Indication | HIV infectious disease |
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Date of launch | April 17, 2014 |
NHI Price | 50mg Tablet：3,262.60yen |
Dosage and administration | Usually in adults, dolutegravir is orally given as described below. The drug may be given without regard to meals. It should be given with other anti-HIV drugs. 1. Treatment-naïve patients and patients who experienced treatment with other anti-HIV drugs than integrase inhibitors Dolutegravir is orally given at a dose of 50 mg once daily. 2. Patients with integrase inhibitor resistance Dolutegravir is orally given at a dose of 50 mg twice daily. In pediatric patients aged 12 years or older weighing 40 kg or more, who are treatment-naïve or treatment-experienced with anti-HIV drugs other than integrase inhibitors, dolutegravir may be orally given at a dose of 50 mg once daily. |
Marketing authorization holder | ViiV Healthcare K.K. |
Distributor | GlaxoSmithKline K.K. |
Co-promoter | Shionogi & Co., Ltd. |
Tivicay® Tablets 50mg is a novel HIV integrase inhibitor discovered through collaborative research and development by Shionogi, GlaxoSmithKline (GSK, Head Office: London; Chief Executive Officer: Andrew Witty) and ViiV Healthcare Ltd (Head Office: London; Chief Executive Officer: Dr. Dominique Limet). ViiV Healthcare Ltd holds the global development and sales rights of Tivicay® Tablets 50mg, which was approved in the U.S. in August 2013 and in Europe in January 2014, with an indication for the treatment of HIV infection. In Japan, it was designated by the MHLW as an orphan drug on September 13, 2013, with an expected indication for
the treatment of HIV infection, followed by filing of the marketing application by ViiV on December 5, 2013 for the treatment of HIV infection and approval on March 24, 2014.
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a 10% shareholder in October 2012. The company's aim is to take a deeper and broader
interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. ViiV Healthcare K. K. is the Japanese subsidiary of ViiV Healthcare in the UK. For more information on the company, please visit
http://glaxosmithkline.co.jp/viiv/.
Headquartered in Osaka, Japan, Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi's Research and Development currently targets three
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therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. The Company is the originator of innovative medicines which have been successfully delivered to millions of patients worldwide. In addition, Shionogi is engaged in new research areas such as allergy and cancer. Contributing to the health of patients around the world through development in these therapeutic areas is Shionogi's primary goal. For more details, please visit
www.shionogi.co.jp.
Media contacts: | ||
ViiV Healthcare K.K. GlaxoSmithKline K.K. | Tomoko Kurita Yuko Fuke | TEL: +81-3-5786-6043 TEL: +81-3-5786-5041 |
Shionogi & Co., Ltd., Corporate Communications
Osaka | TEL: +81-6-6209-7885 | FAX: +81-6-6229-9596 |
Tokyo | TEL: +81-3-3406-8164 | FAX: +81-3-3406-8099 |
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