| Wed 4 Apr 2007, 12:00 | | APN - Aspen - Tibotec and Aspen Collaborate on Pre |
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APN
APN
APN - Aspen - Tibotec and Aspen Collaborate on Prezista Access Plan for Africa
Aspen Pharmacare Holdings Limited
(Incorporated in the Republic of South Africa)
(Registration number 1985/002935/06)
Share code: APN & ISIN: ZAE000066692
TIBOTEC AND ASPEN COLLABORATE ON PREZISTA ACCESS PLAN FOR AFRICA
Co Cork, Ireland (April 4th, 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 a 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.
Aspen has five pharmaceutical manufacturing sites. Four are located in South
Africa and one in India. These sites provide for eight manufacturing facilities
with a ninth becoming operational in South Africa in the near future. The Aspen
Group produces a vast range of products including tablets, capsules, liquids,
creams and others.
For further information about Aspen, please visit www.aspenpharma.com
Contacts:
Tibotec : Karen Manson, +32 479 89 47 99 (mobile)
Aspen: Stavros Nicolaou, +27 11 239 6734 (office)
Sponsor: Investec Bank Limited
Date: 04/04/2007 12:00:03 Produced by the JSE SENS Department.
