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EVA Pharma signs a voluntary licensing agreement with
Gilead to increase access to
Lenacapavir in countries
with high HIV incidence and
limited resources
(Cairo, Egypt) - EVA Pharma
announces that it has signed a
non-exclusive, royalty-free
voluntary licensing
agreement with
Gilead
Sciences, Inc.,
allowing EVA Pharma to
manufacture and supply
generic lenacapavir in the
form of active
pharmaceutical ingredients
(APIs)
and finished pharmaceutical
products. This agreement
includes the technology
transfer of know-how to make
and use lenacapavir allowing
for sustainable
accessibility to lenacapavir
in 120 high-incidence,
resource-limited countries
through EVA Pharma’s local
manufacturing capabilities
and strong foothold in
Africa. The agreement covers
lenacapavir for HIV
treatment in heavily
treatment-experienced (HTE)
adults with
multi-drug-resistant HIV, as
well as lenacapavir for HIV
prevention (pending
approval).
Gilead is
also exploring frameworks such as
the European Medicines
Agency’s EU Medicines for
All to expedite U.S. FDA
procedures and attain WHO
prequalification. This will
enable EVA Pharma to submit
its high-quality generic
lenacapavir for multiple
regulatory authorities to
support demand and broaden
accessibility across 120
countries.
“The
urgency of NOW
demands that we go fast and
far to end HIV/AIDS. This
goal is only reached through
collective efforts, from
innovation to sustainable
access to medicines,” said
Riad Armanious, CEO of EVA
Pharma. “To this commitment,
we stand our ground as the
sole licensee in Africa, EVA
Pharma has already rolled
the ball on fast-track
actions towards our joint
mission with Gilead.
Combining Gilead’s expertise
and EVA Pharma’s
capabilities and reach we
ensure that no one is left
behind in the fight against
HIV.”
“EVA Pharma has
been committed to the fight
against HIV since 2003,
consistently empowering
governments and healthcare
systems to support patient
care across Africa,” said
Amgad Talaat, Strategic
Alliances Director at EVA
Pharma. “In our ongoing
effort to ensure sustainable
access, EVA Pharma has
expanded its focus to
localizing drug substance
production. In collaboration
with Gilead, we have been
setting numerous firsts in
the area of generic
voluntary licensing, from
combatting HCV to making
remdesivir available for
COVID-19 patients. And now,
we embark on another
significant milestone by
supplying lenacapavir to
patients across the
continent, including South
Africa for the first time”.
Of the six generic
manufacturers in Gilead’s
voluntary licensing
agreement, EVA Pharma is the
sole local manufacturer in
Africa. Responding to the
urgency of this shared
mission, EVA Pharma expects
to complete lenacapavir API
manufacturing by the end of
2024, following the
completion of the tech
transfer from Gilead, paving
the way for the production
of lenacapavir finished
product. The company expects
to begin supplying the
high-quality, African-made
lenacapavir within 25
months.
Leveraging
its extensive pan-African
reach, EVA Pharma will
supply the medicine to 120
countries, with the first
phase of export including 18
countries representing the
highest incidence rate
(about 70% of the HIV burden
in the countries named in
the license) to receive
lenacapavir as quickly as
possible. These countries
are Botswana, Eswatini,
Ethiopia, Kenya, Lesotho,
Malawi, Mozambique, Namibia,
Nigeria, Philippines,
Rwanda, South Africa,
Tanzania, Thailand, Uganda,
Vietnam, Zambia and
Zimbabwe.
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