| Tue 19 Jul 2005, 10:00 | | MSD grants Aspen generic ARV license |
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Aspen - MSD grants Aspen generic ARV license for Efavirenz
Aspen Pharmacare Holdings Limited
(Incorporated in the Republic of South Africa)
(Registration Number 1985/002935/06)
(Share code APN ISIN: number ZAE000066692
(`Aspen`)
MSD grants Aspen generic ARV license for Efavirenz
Merck Sharp & Dohme (MSD) SA (a subsidiary of Merck & Co., Inc.,) has granted a
non-exclusive, royalty-free patent license for the manufacture and supply of a
generic version of efavirenz, (one of MSD`s antiretrovirals (ARV`s), used for
the treatment of HIV/AIDS, to Aspen Pharmacare, Africa`s leading generics
manufacturer.
`We applaud MSD and Aspen`s announcement of their efforts to increase access to
antiretroviral treatment for people living with HIV/AIDS. This announcement is
in line with the government`s commitment to the Comprehensive HIV and AIDS Care,
Management and Treatment Plan for South Africa,` said Dr Humphrey Zokufa,
Registrar of the Medicines Control Council (MCC).
`The announcement of this license is welcomed as it is an indication of MSD and
Aspen`s firm commitment to local investment in South Africa, and to building a
local pharmaceutical industry,` said Lionel October, Deputy Director -General of
Enterprise and Industry Development, Department of Trade and Industry.
`MSD`s decision to grant Aspen a generic license for efavirenz, illustrates our
commitment to fighting HIV/AIDS in South Africa. The terms of this agreement
will ensure the supply of efavirenz to South Africa. MSD will continue to supply
STOCRIN (efavirenz) to Southern Africa at not-for-profit prices. The granting of
this license is an important element of MSD`s continuing efforts to accelerate
access to AIDS medicines and to help patients living with HIV in South Africa.
This decision follows our recent announcement of the second phase of the upgrade
of our local manufacturing facility in Midrand for the manufacture of STOCRIN,`
said Chirfi Guindo, local CEO of MSD SA.`
Stephen Saad, Aspen Group CEO said `this agreement amplifies Aspen`s continued
commitment to fighting the HIV/Aids pandemic and we view our relationship with
MSD as a valuable contributor toward this effort. Efavirenz is a welcome
addition to our existing ARV basket which is presently comprised of Aspen
Stavudine, Aspen Didanosine, Aspen Nevirapine, Aspen Lamivudine (Tablets and
Solution), Aspen Zidovudine (Tablets and Solution) and Aspen Lamzid (combination
Lamivudine/Zidovudine). Aspen was recently awarded the lion`s share of the SA
Government`s multi-million rand ARV tender, which acknowledges the Group`s
commitment to local manufacture, pioneering the formulation and development of
generic ARVs under voluntary licences from the originators and launching
Africa`s first generic ARV.`
The announcement is in keeping with MSD SA and Aspen`s commitment to improved
access to HIV/AIDS care and treatment. In 2004 MSD established the MSD Msizi
Trust aimed at fighting HIV/Aids in South Africa.
ends
For more information, contact:
Mr. Chirfi Guindo, MSD SA CEO
Tel: (011) 655 3000
Cell: 082 417 9405
Ms. Seara Macheli, MSD Director, Legal and Corporate Affairs
Tell: (011) 655 3000
Cell: 082 886 6565
Stephen Saad, Aspen Pharmacare Group CEO
Tel: (031) 268 9506
Cell: 083 303 4833
Gus Attridge, Aspen Pharmacare Deputy Group CEO
Tel: (031) 268 9505
Cell: 083 628 8813
Issued by:
Lindy Goodfellow (Public Relations Manager) Shauneen Beukes
For MSD SA For Aspen Pharmacare
Tel: (011) 655 3054 Tel & Fax: (012) 661-8467
Cell: 083 442 5557 Cell: 082 389 8900
About the Aspen Group
South African based JSE Securities Exchange (JSE) listed Aspen is Africa`s
largest pharmaceutical manufacturer and a major supplier of branded
pharmaceutical and healthcare products to southern African and selected
international markets.
Aspen has an extensive basket of quality, effective and affordable products in
the branded, generic, over-the-counter (OTC), personal care, fast moving
consumer goods (FMCG), nutriceutical and infant nutritional formulations (INFs)
categories.
Aspen became the world`s first pharmaceutical manufacturer to be granted
approval by the US Food and Drug Administration (FDA) to manufacture combination
therapy generic anti-retroviral (ARVs) in a co-packed form. This was enabled
through voluntary licences from GlaxoSmithKline and Boehringer Ingleheim and
underscores Aspen`s scientific and technical capabilities, its manufacturing and
quality standards, and GMP compliances.
Aspen endorses transformation and broad based black economic empowerment (BEE)
as a vehicle to empowering historically disadvantaged South Africans and Aspen`s
two strategic BEE partners include CEPPWAWU Investments, the investment arm of
the COSATU Affiliated Union CEPPWAWU and Imithi Investments (Pty) Limited, a
broad based consortium consisting of parties operational in the Southern African
healthcare industry and a number of community advancement organizations.
Aspen`s total BEE shareholding exceeds 17%.
In 2004 Aspen acquired 100% of the shares of Cape Town based Fine Chemicals
Corporation (Pty) Ltd (FCC) which is South Africa`s leading off-patent active
pharmaceutical ingredients (API) manufacturer and a significant exporter of API
to the USA. As part of a memorandum of understanding, Aspen is currently in
negotiation with Indian based Matrix Laboratories Limited (Matrix) in which 50%
of Aspen`s current 100% shareholding in FCC will be sold to Matrix. The deal
complements Aspen`s efforts to secure a strong supply source for APIs for some
of Aspen`s key products.
Aspen`s off shore subsidiaries contribute toward the Group`s strategy of
establishing a presence in selected geographic areas. Co-Pharma operates in the
UK market, while UK based Aspen Resources is an intellectual property owning
subsidiary of Aspen Holdings. Aspen Pharmacare Australia continues to complement
the Aspen Group`s off shore strategy of increased growth in selected off-shore
territories and it is an extension of the Group`s worldwide network of strategic
alliances offering a range of products in niche market areas.
For more information about Aspen, click on www.aspenpharma.com
About Merck Sharp & Dohme
Merck Sharp & Dohme (MSD) South Africa is a subsidiary of the global, research-
based pharmaceutical company Merck & Co., Inc., Whitehouse Station, NJ USA. MSD
discovers, develops and markets a broad range of products designed to save
lives, improve human health and enhance patients` quality of life.
The company employs 300 people in South Africa, and operates a state-of-the -art
manufacturing plant in Midrand, the site of MSD South Africa`s head office.
MSD has, since March 2001, made its two HIV products, STOCRIN and CRIXIVAN,
available at not - for - profit prices in South Africa and to all sub-Saharan
countries. South Africa benefits from the lowest prices offered for these two
products, which are lower than or comparable to prices of generic versions of
the medicines (for example, the price of Efavirenz 600 mg is R 6, 37 per day (or
USD 0, 95 per day). Reference: `Untangling the Web of Price Reductions, June
2005, www.accessmed - msf.org).
MSD`s products are novel medicines that represent true advances in patient care.
MSD is recognised internationally for its research in many areas, including
hypertension, hypercholesterolemia, HIV / AIDS, osteoporosis, asthma, migraine,
opthalmics, arthritis, male pattern hair loss, anti-infectives, oncology,
diabetes and vaccines.
For more information, visit www.merck.com
