| Mon 25 Apr 2005, 14:58 | | Aspen and US-based Gilead |
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Aspen Pharmacare Holdings Limited - Aspen and US-based Gilead enter into ARV
deal
Aspen Pharmacare Holdings Limited
(Incorporated in the Republic of South Africa)
(Registration number 1985/002935/06)
Share code: APN ISIN: ZAE000023586
Press Release
Monday, April 25, 2005
Aspen and US-based Gilead enter into ARV deal
Foster City, CA, and Johannesburg, South Africa. Leading research based
pharmaceutical company, Gilead Sciences, Inc. (Nasdaq: GILD) and JSE Securities
Exchange listed Aspen (APN) today announced that the companies have signed a
letter of intent to enter into a non-exclusive licensing and distribution
agreement for Gilead`s anti-retroviral (ARV) products TruvadaRegistered
(emtricitabine and tenofovir disoproxil fumarate) and VireadRegistered
(tenofovir disoproxil fumarate). Aspen will manufacture finished product for
the 95 resource-limited countries included in Gilead`s global Access Program and
will distribute the products in Africa.
Stephen Saad, Aspen Pharmacare Group CEO, said `this initiative between Aspen
and Gilead further lightens the burden on ARV global capacities and enables both
companies to expand access and affordability of key Aids medication to some of
the world`s most resource constrained countries, who also happen to be the ones
hit hardest by the HIV/Aids pandemic. This collaboration with Gilead, who are
one of the world` leading anti-viral research and scientific based company`s
further underscores the manufacturing, quality and technical capabilities of
Aspen and displays how north-south collaboration can be used to provide
solutions to some of the world`s biggest socio-economic challenges.`
`Gilead has continually explored ways to broaden and expedite access to our
antiretrovirals in resource-limited parts of the world where HIV is impacting
the lives of so many individuals,` said John C. Martin, PhD, President and Chief
Executive Officer, Gilead Sciences. `We share this goal with Aspen Pharmacare,
and this collaboration allows us to ensure safe and effective HIV therapy
reaches as many people as possible.`
Under the terms of the proposed collaborative agreement, Aspen will manufacture
Truvada and Viread, according to U.S. standards for Good Manufacturing Practices
(GMP), and distribute the products under their global trade names in specified
countries. Gilead will provide active pharmaceutical ingredient (APIs) for its
products to Aspen and will transfer the necessary technology for tableting of
the products in Aspen`s US Food and Drug Administration (FDA) approved
facilities in South Africa. In addition, Aspen will pursue regulatory approval
for the products in the African territories where these two products are
unregistered at this point.
Aspen has agreed to sell the products at the developing market access prices
through Gilead`s global Access Program. The companies anticipate finalizing
this agreement by the latest September 2005.
Viread and Truvada are newer generation ARVs used in combination with other ARVs
and will significantly complement Aspen`s existing ARV range of products. The
importance of an expanded pipeline of ARVs is critical to the future management
of AIDS patients as the potential mutation of the HIV virus and potential
resistance to existing ARV treatments futuristically surfaces. Saad went on to
comment that,`Aspen is highly committed to providing a comprehensive ARV
offering and keeping abreast of the latest pharmaceutical developments in the
evolution of ARVs. This collaboration with Gilead continues to keep Aspen at the
forefront of AIDS treatment and further enhances Aspen`s already comprehensive
ARV pipeline of ARVs.`
Gilead Sciences is a biopharmaceutical company that discovers, develops and
commercializes innovative therapeutics in areas of unmet medical need. The
company`s mission is to advance the care of patients suffering from life-
threatening diseases worldwide. Headquartered in Foster City, California,
Gilead has operations in North America, Europe and Australia.
Aspen is the leading listed pharmaceutical company on the JSE Securities
Exchange and the African continent`s largest pharmaceutical manufacturer. Aspen
is a major supplier of branded pharmaceutical and healthcare products to the
African continent and selected international markets and also the largest
supplier of generics to both the private and public sectors in South Africa.
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 is also acknowledged as the world`s first pharmaceutical
manufacturer to be granted approval by the US Food and Drug Administration (FDA)
to manufacture combination therapy ARVs in a co-packed form.
ends
Issued by: Shauneen Beukes, Shauneen Beukes Communications
Tel: (012) 661-8467
Fax: (088) (012) 6618467
Cell: 082 389 8900
On Behalf Of: Stavros Nicolau, Aspen Senior Executive: Group Strategic Trade
Tel: (011) 239 6798
Fax: (011) 239 6018
Cell: 082 458 3135
