ViiV Healthcare announces European regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV

London (ots/PRNewswire) -

ViiV Healthcare today announced the submission of a regulatory
application in Europe for its investigational single-tablet regimen
(STR) combining dolutegravir (DTG), abacavir (ABC) and lamivudine
(3TC) for the treatment of people living with HIV. This Marketing
Authorisation Application (MAA) follows the announcement earlier this
week of a similar regulatory submission in the US[1].

"People living with HIV and their doctors seek to use appropriate
treatment options for the individual, while also trying to minimise
the number of pills required for effective and acceptable
antiretroviral treatment," said Dr John Pottage, Chief Medical
Officer, ViiV Healthcare. "This submission, together with the New
Drug Application submitted recently to the US Food and Drug
Administration, aims to make a complete dolutegravir-based regimen
available for the first time in a single once-daily pill."

Dolutegravir was approved by the US Food and Drug Administration
in August 2013 under the brand name Tivicay(R) for use in combination
with other antiretroviral agents for the treatment of HIV-1 in adults
and children aged 12 years and older weighing at least 40 kg (approx.
88 lbs). The review of the MAA for dolutegravir (DTG), submitted in
Europe in December 2012, is in progress with the European Medicines
Agency (EMA). A fixed-dose combination of ABC/3TC for use in
antiretroviral combination therapy is marketed by ViiV Healthcare in
Europe under the brand name Kivexa(R) as a once-daily tablet. The
investigational STR combining DTG/ABC/3TC has sometimes been referred
to as "Trii".

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in
November 2009 by GlaxoSmithKline and Pfizer 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. For more
information on the company, its management, portfolio, pipeline, and
commitment, please visit http://www.viivhealthcare.com.

References

1) ViiV Healthcare announces US regulatory submission for a single-tablet
regimen combining dolutegravir with abacavir and lamivudine for people living with
HIV. Press Release, 23 October 2013. Available at:
https://www.viivhealthcare.com/media/press-releases/2013/october/viiv-healthcare-announces-us-regulatory-submission-for-a-single-tablet-regimen-combining-dolutegravir-with-abacavir-and-lamivudine-for-people-living-with-hiv.aspx

US Prescribing information for Tivicay is available online at:

https://www.viivhealthcare.com/media/58599/us_tivicay.pdf

Please refer to country-specific Kivexa prescribing information.

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. Factors that may affect GSK' s
operations are described under Item 3.D 'Risk factors' in the
company's Annual Report on Form 20-F for 2012.

ots Originaltext: ViiV Healthcare
Im Internet recherchierbar: http://www.presseportal.de

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Dodwell,
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