The Medicines Patent Pool and Gilead Sciences Sign Licence for Bictegravir

  The Medicines Patent Pool and Gilead Sciences Sign Licence for Bictegravir

As part of a novel, once-daily, single-tablet HIV treatment, bictegravir could
offer new option for people living with HIV in low- and middle-income

  PR Newswire

  GENEVA, October 4, 2017

GENEVA, October 4, 2017 /PRNewswire/ --

The Medicines Patent Pool (MPP) today announced a licence with Gilead Sciences
for bictegravir (BIC), now under review in the United States and the European
Union as part of a once-daily, single-tablet HIV regimen. The licence allows
manufacturers to develop and sell generic medicines containing BIC, if
approved in the United States, in 116 low- and middle-income countries where
more than 30 million people live with HIV.

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"Bictegravir-containing combinations could offer improved, simplified
treatment options, crucial for people living in resource-limited settings,"
said Greg Perry, Executive Director of the Medicines Patent Pool. "With this
new licence, we look forward to our long-running collaboration with Gilead
Sciences continuing to deliver significant results."

Bictegravir is an integrase inhibitor in the same class as dolutegravir (DTG)
and elvitegravir (EVG), also licensed to the MPP. A once-daily, single-tablet
regimen containing BIC along with emtricitabine (FTC) and tenofovir
alafenamide (TAF), BIC/FTC/TAF is currently under investigation in adults as
well as children. In Phase 3 studies, BIC/FTC/TAF demonstrated high rates of
viral suppression with no treatment-emergent resistance through 48 weeks among
treatment-naïve adults and among adults with undetectable viral loads who
switched regimens.

"The once-daily, single-tablet BIC/FTC/TAF regimen has the potential to
simplify the management of HIV, and we are committed to promoting its access
globally," said Gregg Alton, Executive Vice President at Gilead Sciences. "MPP
licensees with the rights to manufacture certain of Gilead's agents, including
TAF and now BIC, will be able to produce the single tablet for low- and
middle-income countries shortly after its approval in the United States."

The MPP and Gilead are also expanding the geographical scope of licences on
other HIV products, enabling generic medicines to be supplied to additional
countries. Belarus, the Philippines, Malaysia and Ukraine are now added to the
MPP-Gilead HIV collaboration for the first time through the expansion of the
licences on TAF, cobicistat (COBI) and tenofovir disoproxil fumarate (TDF).

"We're tremendously pleased with the MPP and Gilead's collaborative efforts
over the many years to improve health outcomes in low- and middle-income
countries," said Lelio Marmora, Executive Director of Unitaid, MPP's funder.
"Through their joint HIV licensing programme, millions stand to benefit from
quality-assured generics of new optimised treatment regimens."

The two parties signed their first voluntary licence in 2011, which was
amended in 2014 and 2015, and covers five Gilead compounds: TDF, EVG, COBI,
FTC and TAF. The new amendment permits manufacturers located in India, China
and South Africa to manufacture bictegravir in such countries and sell
products containing the compound in 116 countries, including 74 middle-income
nations. It expands the number of countries in which a licensee may sell
products containing TDF or TAF (from 112 to 116), EVG (from 100 to 109) and
COBI (103 to 116).

The Medicines Patent Pool has now signed sublicences with 13 generic companies
to manufacture and sell products containing TDF, EVG, COBI, FTC and TAF. To
date, MPP sublicensees have distributed more than four billion doses of
products containing TDF to 124 low- and middle-income countries.

Gilead Sciences submitted a new drug application for the single-tablet regimen
containing BIC/FTC/TAF to the U.S. Food and Drug Administration on 12 June.
The European Medicines Agency validated a marketing application on 13 July.

About the Medicines Patent Pool 

The Medicines Patent Pool is a United Nations-backed public health
organisation working to increase access to HIV, hepatitis C and tuberculosis
treatments in low- and middle-income countries. Through its innovative
business model, the MPP partners with industry, civil society, international
organisations, patient groups and other stakeholders to prioritise, forecast
and license needed medicines and pool intellectual property to encourage
generic manufacture and the development of new formulations. To date, the MPP
has signed agreements with nine patent holders for thirteen HIV
antiretrovirals, one HIV technology platform, two hepatitis C direct-acting
antivirals and a tuberculosis treatment. The MPP was founded and is funded by

Contact: Media Contact: Katherine Moore, Head of Communications, Medicines
Patent Pool, Tel: +41-22-533-5054, Mobile: +41-79-825-4786,
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