GSK China committed to making newly launched treatment Tivicay® accessible to Chinese people living with HIV

GSK China recently marked the official launch of Tivicay? (dolutegravir), an innovative HIV drug from ViiV Healthcare1, and will continue to work with relevant Chinese government agencies to make it more accessible to people living with HIV in China by its inclusion in China's free antiretroviral (ARV) programme. On 30 December 2015, Tivicay received approval from the China Food and Drug Administration (CFDA) for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age.

Tivicayhas already been approved in 100 countries and recommended by almost all international treatment guidelines as a preferred first-line combined treatment regimen for treatment-na?ve HIV/AIDS patients. In 2015, the World Health Organization (WHO) recommended Tivicay as an alternative first line treatment for na?ve patients

The clinical development programme for Tivicay was comprehensive in its breadth, including people living with HIV who were new to treatment (treatment-naive), as well as those who had already been treated with other HIV medicines (treatment-experienced) and those who were infected with a virus that had developed resistance to previously available integrase inhibitors. Tivicay inhibits an enzyme used by the HIV virus during its replication cycle, known as integrase. By binding to the site where integrase acts, it blocks the “strand transfer” step of the HIV replication process – stopping the virus from forming new viruses.

Hervé Gisserot, Senior Vice President and General Manager, Pharmaceuticals and Vaccines, GSK China/Hong Kong, said, “We are committed to working with the government to ensure that people living with HIV/AIDS have increased access to medicines, such as Tivicay, given its innovative nature and the benefits it can offer. To achieve this we are ready to consider price-access type arrangements in the same spirit of the recent National Drug Price Negotiation pilot.”

Dr Corklin Steinhart, Head of Global Medical Affairs, ViiV Healthcare, said, “With more advanced treatment, HIV/AIDS patients are now able to live much longer. Treatments with greater tolerability in addition to strong efficacy and safety profile bring great value to patients. In our clinical trials for Tivicay, we have consistently seen that Tivicay has outstanding efficacy, is well tolerated and has a high barrier to resistance. We believe this means Tivicay will be a medicine that patients can start and stay on without needing to change their medicines.”

Our commitment to HIV/AIDS beyond our products

GSK supports the Red Ribbon Health Ambassador Campus Tour campaign which is co-organised by the National Health and Family Planning Commission, the Communist Youth League of China, the HIV/AIDS Prevention and Control Working Committee Office of the State Council and the Chinese Association of STD and AIDS Prevention and Control. With GSK's support of one million yuan, the campaign ran promotional and educational activities at 16 major universities across China with the aim of increasing understanding of HIV/AIDS prevention and control in order to minimise the spread of the condition.

The launch of Tivicay is the latest example of GSK delivering on its publically stated commitment to be “in China, with China, for China”. Previous announcements include:

  • Participated the national price negotiation pilot and announced to reduce our first line chronic hepatitis B treatment by up to 67% in May 2016.
  • Launching a Beijing-based Institute for Public Health and Infectious Disease to conduct local development programmes for pivotal HIV and TB R&D assets in March 2016.
  • Partnering with the National Health and Family Planning Commission on a multi-year programme to fund independent training programmes in Hepatitis and COPD for over 13,000 healthcare professionals from September 2015.
  • Partnering with Shanghai-based Desano Pharmaceuticals to announce the local manufacture of the Active Pharmaceutical Ingredient (API) for Tivicay (dolutegravir), our new HIV medicine and one of our most commercially successful products, in July 2015.
  • Transforming our commercial operating model to actively contribute to improving the quality of scientific exchanges with healthcare professionals for the benefit of patients since May 2015.

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GSK – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.? For further information please visit www.gsk.com.

GSK commitment to China
We are a science-led global healthcare company. We research, develop and manufacture a wide range of medicines, vaccines and consumer healthcare products. People are at the heart of what we do. We strive to bring high quality, high performing products to everyone who needs them. Creating innovative products and improving access to them is critical to our mission, allowing us to help build stronger, healthier communities. In China, and around the world, we are on a mission to help people do more, feel better, live longer. We are in China, with China, for China, and our commitment remains unwavering.

GSK enquiries:
Susan Song????? susan.s.song@gsk.com??????????????????????? (Shanghai)

Reference:
1 ViiV Healthcare, a joint venture in which GSK is the majority shareholder, is a global specialist HIV company.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2014.