ViiV Healthcare extends Medicines Patent Pool licence agreement for dolutegravir to cover all lower middle-income countries

Issued: London UK

Follows announcement by majority shareholder GSK to expand graduated approach to patents and intellectual property (IP) to widen access to medicines in the world’s poorest countries

ViiV Healthcare, a global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced an extension of overall country coverage of its existing licence agreement for adults formulation of dolutegravir to the Medicines Patent Pool (MPP) to cover all lower middle income countries (LMICs).

The existing licence agreement already covers all low income, least developed and all sub-Saharan African countries. This extension to include all remaining LMICs means that more than 94% of adults living with HIV in the developing world are now covered by the licence agreement¹.

This is of particular importance in four countries, Armenia, Moldova, Morocco and Ukraine, where ViiV Healthcare has a registered patent for dolutegravir. The revised agreement means that dolutegravir and dolutegravir-based fixed-dose combinations could now be made available through generic manufacturers subject to the necessary regulatory approval to benefit an additional 270,000 people living with HIV^2,3,4,5.

“Our existing collaboration with the MPP is now strengthened through this expansion of the territory coverage of our licence agreement. This is a good example of how we work with global partners to deliver on our commitments to improving access as we continue making good progress to ensure innovative medicines like dolutegravir can be available to more people living with HIV, in particular in those countries where the need is most pressing,” said Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare.

This announcement is aligned to GSK’s recent commitment to seek to offer and agree licences to allow supplies of generic versions of its current and future portfolio of patented medicines in most LMICs for 10 years.

Sir Andrew Witty, Chief Executive Officer, GSK commented: “This is another very positive step by ViiV Healthcare to help accelerate access to the newest HIV medicines for more people in developing countries. It builds on the recent changes GSK has made to adopt a graduated approach to IP linked to a country’s wealth. IP protection remains vital to provide the necessary incentives for investment in research to create new treatments, such as dolutegravir. However, we believe that the global healthcare challenges we all face require us to be flexible in our approach, where appropriate. The positive progress and experience we have had with the Medicines Patent Pool gives us confidence that increasing access, incentivising innovation and achieving business success can go hand in hand.”

ViiV Healthcare entered in a licence agreement with the Medicines Patent Pool in 2014 to increase access to dolutegravir for children and adults in countries where the need is the greatest.

The collaboration with the MPP in adults includes two distinct approaches:

• a royalty-free voluntary licence in all least-developed, all low-income and all sub-Saharan African countries
• a tiered royalty licence for some middle-income countries, where a small percentage of the net sales value is paid according to the gross national income (GNI) per capita

Notes to editors

About ViiV Healthcare

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. For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.

About GSK

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.

About dolutegravir

Dolutegravir (Tivicay) is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Tivicay is approved in over 90 countries across North America, Europe, Asia, Australia, Africa and Latin America.

Tivicay is a registered trademark of the ViiV Healthcare group of companies.

Important Information about Tivicay® (dolutegravir) FDA Indication and Usage:

Tivicay is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Use of Tivicay in INSTI-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of Tivicay 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R.

Important Safety Information for Tivicay® (dolutegravir) Contraindication: 

Tivicay is contraindicated (1) in patients with previous hypersensitivity reaction to dolutegravir, and (2) in patients receiving dofetilide (antiarrhythmic) due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events.

Hypersensitivity Reactions:

Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in 1% or fewer subjects receiving Tivicay in Phase 3 clinical trials. Discontinue Tivicay and other suspect agents immediately if signs or symptoms of hypersensitivity reaction develop, (including but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, oral blisters or lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing.) Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy. Delay in stopping treatment with Tivicay or other suspect agents after the onset of hypersensitivity may result in a life-threatening reaction. Tivicay is contraindicated in patients who have experienced a hypersensitivity reaction to dolutegravir.

Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Coinfection:

Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of Tivicay. In some cases the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where anti-hepatitis therapy was withdrawn. Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with Tivicay are recommended in patients with underlying hepatic disease such as hepatitis B or C.

Fat Redistribution:

Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy.

Immune Reconstitution Syndrome:

During the initial phase of treatment, immune reconstitution syndrome can occur, which may necessitate further evaluation and treatment. Autoimmune disorders have been reported to occur in the setting of immune reconstitution; the time to onset is more variable and can occur many months after initiation of treatment.

Adverse Reactions:

The most commonly reported (≥2%) adverse reactions of moderate to severe intensity in treatment naïve adult subjects in any one trial receiving Tivicay in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).

Drug Interactions:

Co-administration of Tivicay with drugs that are strong inducers of UGT1A1 and/or CYP3A4 may result in reduced plasma concentrations of dolutegravir and require dose adjustments of Tivicay.

• Tivicay should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral iron supplements, oral calcium supplements, or buffered medications.

• Consult the full Prescribing Information for Tivicay for more information on potentially significant drug interactions, including clinical comments.

Pregnancy:

Pregnancy category B. Tivicay should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.

Breastfeeding:

Breastfeeding is NOT recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.

Paediatric Patients:

Safety and efficacy of Tivicay has not been established in children younger than 12 years old, or weighing <40 kg, or in INSTI-experienced paediatric patients with documented or clinically suspected INSTI resistance.

Please visit the following link for the full US prescribing and patient information: https://www.viivhealthcare.com/media/58599/us_tivicay.pdf.

REFERENCES:
1 UNAIDSinfo. Indicators (Aggregated data). http://aidsinfo.unaids.org/. Last accessed 22.04.2016.
2 UNAIDS. Republic of Moldova: HIV and AIDS estimates. Available at: http://www.unaids.org/en/regionscountries/countries/republicofmoldova. Last accessed 22.04.2016
3 UNAIDS. Armenia: HIV and AIDS estimates. Available at: http://www.unaids.org/en/regionscountries/countries/armenia. Last accessed 22.04.2016
4 UNAIDS. Morocco: HIV and AIDS estimates. Available at: http://www.unaids.org/en/regionscountries/countries/morocco. Last accessed 22.04.2016
5 UNAIDS. Ukraine Narrative Report. Available at: http://www.unaids.org/sites/default/files/country/documents/UKR_narrative_report_2015.pdf. Last accessed 22.04.2016