Tibotec Announces
Plan to Distribute New Protease Inhibitor Darunavir in Africa
Tibotec
recently announced a royalty-free agreement with Aspen, Africa’s largest pharmaceutical
manufacturer and the largest generics manufacturer in the southern hemisphere,
to distribute the most recently FDA-approved protease inhibitor (PI) darunavir
(Prezista) in sub-Saharan Africa
at a cost of $3 per patient per day. Darunavir/ritonavir 600/100 mg twice daily
in combination with other antiretroviral
agents is approved in the U.S. for treatment-experienced adults and adolescents.
Under
the terms of the agreement, Aspen will “register, package, distribute, and seek
timely regulatory approval” for darunavir and will establish pre-approval access
for patients in sub-Saharan Africa in urgent need of the drug. Tibotec will seek
pre-qualification from the World Health Organization (WHO) and the approval needed
to facilitate funding of darunavir by international organizations.
Aspen
was selected for the major role in this plan due to the company’s
extensive distribution network and its successful work in helping to secure access
to HIV/AIDS drugs in resource-limited settings.
Following
are selected excerpts from the Tibotec press announcement. The complete text of the press release is available on
the company’s website at www.tibotec.com.
Tibotec and Aspen Collaborate on Prezista
Access Plan for Africa
April 4, 2007 -- Tibotec Pharmaceuticals
Ltd. today announced that it has signed a royalty-free, non-exclusive license
agreement with Aspen of South Africa. Aspen will register, package and distribute
the protease inhibitor Prezista (darunavir, DRV) in sub-Saharan Africa. Tibotec
has selected Aspen because of the company’s extensive African distribution network and
pioneering endeavors in enhancing access to AIDS treatment in resource constrained
settings. Aspen and Tibotec will share the responsibility for ensuring prompt
and affordable access to patients in the Sub-Saharan region.
As a result of the agreement there
will be a single co-branded product, under the brand name Prezista, distributed
by Aspen and sold at an ex-factory price that should not exceed US $3 a day. (The
product will be offered on a FOB basis -- incoterm 2000. Additional costs may
include the logistics fee in South Africa, or the freight, insurance, customs
handling, taxes and duties, and other costs levied at the discretion of national
authorities and other respective entities in the other sub-Saharan countries,
which are beyond the control of Aspen and Tibotec. Local retail prices may therefore
be higher.)
Prezista, co-administered with ritonavir
and with other antiretroviral agents (ARVs), is expected to be indicated for treatment-experienced
patients, especially those failing an earlier regimen that includes a protease
inhibitor. The World Health Organization estimates that approximately 4% of people
receiving antiretroviral treatment in low- and middle-income
countries today need advanced treatment options because of HIV drug resistance.
Aspen will seek timely regulatory approval
for Prezista and manage the mechanism for pre-approval access for patients in
sub-Saharan Africa in urgent need of Prezista where this is permitted by local
health authorities. Tibotec is responsible for seeking pre-qualification from
the World Health Organization and sNDA approval in order to facilitate the funding
of Prezista by international organizations. Tibotec, prior to the signing of this
agreement, has filed the Prezista dossier for regulatory approval in South Africa,
Botswana, and Namibia.
The agreement covers all of sub-Saharan
Africa. Twenty countries, with an estimated 80% of total patient need for Prezista
in sub-Saharan Africa, will be targeted for the first wave of regulatory submissions.
These countries are Botswana, Cameroon, Democratic Rep. Congo, Ethiopia, Ghana,
Ivory Coast, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Rwanda, Senegal,
South Africa, Swaziland, Tanzania, Uganda, Zambia, and Zimbabwe.
The agreement also creates a framework
for the manufacture of Prezista by Aspen for sub-Saharan Africa at a later date
if sustained demand for Prezista increases sufficiently to make it economically
viable for Aspen.
The U.S. Food and Drug Administration
(FDA) granted accelerated approval to Prezista, a protease inhibitor formerly
known as TMC114, in June 2006. The European Commission granted conditional
approval in February 2007.
“More and more patients in Sub-Saharan
Africa are in need of access to new therapies when their existing regimens fail.
Tibotec is pleased to be working with a local partner in sub-Saharan Africa to
expedite pre-approval access, registration and the development of sustainable
supply-chains to meet patient need,” said Julie McHugh, Company Group Chairman,
Virology, Tibotec.
“One of the single biggest challenges
facing the future sustainability of ARV programs in the developing world is the
development of more accessible and affordable second- and third-line antiretrovirals.
This Tibotec initiative provides further evidence of the confidence placed in
the capabilities of Aspen and is yet another important step, in securing certainty
in the supply of critical ARVs to patients living with AIDS in the developing
world,” said Stephen Saad, Aspen Group Chief Executive.
About Tibotec
Tibotec
Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and
development company. Tibotec is dedicated to the discovery and
development of innovative HIV/AIDS drugs and anti-infectives for diseases of high
unmet medical need. The Company’s main research and development facilities
are in Mechelen, Belgium with offices in Yardley, PA.
Tibotec is developing a Global Access
Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS
in developing countries. The Global Access Program for Prezista includes access
pricing, registration, medical education for appropriate use and voluntary licensing.
For further information on Tibotec,
please visit:www.tibotec.com.
About Aspen
Aspen has businesses in Australia,
India, South Africa, the United Kingdom, and the United States of America. Aspen
is Africa’s largest pharmaceutical manufacturer and a major supplier of branded
pharmaceutical, healthcare, and nutritional products to the southern African and
selected international markets. Aspen is the largest generics manufacturers in
the southern hemisphere and one of the top 20 generic manufacturers worldwide.
Aspen is South Africa’s number one generic brand. Aspen is also a leading global
player in generic ARVs.
