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Aspen - Aspen To Supply Us Government With Generic ARVs
Aspen Pharmacare Holdings Limited
(Incorporated in the Republic of South Africa)
(Registration Number 1985/002935/06)
Share code APN
ISIN: ZAE000023586
(`Aspen`)
Embargo / Exclusive: Sunday Times - December 12, 2004
FDA approves Aspen`s quest to manufacture ARVs
Aspen Pharmacare, Africa`s largest generics manufacturer and the largest JSE-
listed pharmaceutical company, has received approval from the US Federal Drug
Administration (FDA) for its multi-million rand oral solid dosage (OSD) facility
in Port Elizabeth which will initially manufacture a combination pack generic
antiretroviral (ARV) as soon as the product receives FDA registration.
Earlier this year the US government announced the establishment of the US
President`s Emergency Plan for AIDS Relief (PEPFAR) initiative. PEPFAR pledged
$15bn to assist developing countries as they address the crisis of HIV/Aids over
the next 5 years. This initiative also made provision for manufacturers to
obtain an expedited FDA review and approval of their products, whilst ensuring
that the products are safe, effective and meet the stringent quality standards
of US FDA.
Stephen Saad, Aspen`s Group Chief Executive Officer said `we have applied to the
FDA for an expedited review and Aspen is subsequently undergoing a rigorous
process to secure FDA registration of Lamivudine 150mg/Zidovudine 300mg and
Nevirapine 200mg Co-Packaged Tablets, a combination pack ARV. The FDA`s findings
on the facility, of no outstanding issues (termed 483s), recognizes Aspen as
being the first African manufacturer and the first developing nation to receive
approval for their facility to supply a combination pack generic ARV to the
PEPFAR program.`
Saad said `HIV/Aids is proving to be a major humanitarian challenge. Aspen
pioneered the formulation and development of generic ARVs under voluntary
licences from the originators and we have six registered generic ARVs, some of
which are being manufactured at our OSD facility. The FDA`s GMP approval of OSD
and its supporting areas underscores Aspen`s quality standards of local
manufacture for international markets.`
Aspen Two
The standard FDA procedure, in this instance for Lamivudine 150mg/Zidovudine
300mg and Nevirapine 200mg Co-Packaged Tablets, involves numerous complicated
steps. Initially a pre-operational review of the facility was conducted by the
FDA in September 2004. Their findings were satisfactory which enabled Aspen to
submit a New Drug Application (NDA) for registration of Lamivudine
150mg/Zidovudine 300mg and Nevirapine 200mg Co-Packaged Tablets. Data and pre-
operational reviews were conducted and inspectors subsequently dispatched for on
site inspections at various facilities. The OSD manufacturing facility and its
supporting areas underwent six days of Good Manufacturing Practice (GMP)
inspections. Analytical bio-study inspections were conducted at Farmovs Parexel
in the Free State and further bio-study inspections took place at Q Dot Pharma
in George. The FDA declared the inspection and all its elements to be
satisfactory with no outstanding issues documented. Although the OSD facility
and its supporting areas have attained GMP compliance status, the NDA process is
ongoing as this applies to each new drug which Aspen (or any pharmaceutical
company) may wish to manufacture for the geographic territories as specified in
the PEPFAR agreement. Aspen hopes to receive final approval for the NDA in early
2005.
The Medicines Control Council of South Africa (MCC) also recently inspected the
OSD facility, and MCC approval has been granted for full scale production at the
OSD plant. Further inspections for accreditation are expected by the World
Health Organisation (WHO), the Medicine and Healthcare Products Regulatory
Authority (MHRA) of the United Kingdom as well as the Therapeutic Goods
Administration (TGA) of Australia.
Aspen`s ARV basket is now 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`s
generic ARVs allow for the supply of a full triple combination therapy and the
generic ARV tablets and capsules are being manufactured at the OSD facility.
The results of the South African government`s first ARV tender are still awaited
and Aspen also expects to further extend its supply of generic ARVs offshore
through inter alia the Clinton Foundation which has selected Aspen as one of
only three manufacturers worldwide and the only southern hemisphere manufacturer
of ARVs for its initiatives.
ends
Issued by: Shauneen Beukes, Shauneen Beukes Communications
Tel & Fax: (012) 661-8467
Cell: 082 389 8900
On Behalf Of: Stephen Saad, Aspen Pharmacare Group Chief Executive
Tel: (031) 580-8604
Fax: (031) 580-8640
Cell: 083 303 4833
13 December 2004
Sponsor:
Investec Bank Limited
Date: 13/12/2004 07:00:08 AM
Produced by the JSE SENS Department
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