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`)
ASPEN TO SUPPLY US GOVERNMENT WITH GENERIC ARVs
Aspen Pharmacare, Africa`s largest pharmaceutical manufacturer and JSE
Securities Exchange listed company, is capable of manufacturing generic anti
retroviral (ARV) medicines to meet the needs of the US President`s Emergency
Plan for AIDS Relief (PEPFAR).
PEPFAR has pledged $15bn to assist developing countries as they address the
crisis of HIV/Aids over the next 5 years. Over half of this program will
support effective AIDS treatment to save lives through the provision of ARV
drugs. It is the view of the U.S. Government that Africans with HIV/AIDS should
have medicines available to them that are as safe and effective as those
available to Americans with AIDS. PEPFAR working in partnership with the
public and private sectors is dedicated to achieving this goal.
The US Government recently announced a special PEPFAR initiative through which
ARV manufacturers can obtain an expedited Federal Drug Administration (FDA)
review and certification that their products are safe, effective and meet the
highest standards of quality. Comparable to the South African Medicines
Control Council, FDA is the drug regulatory authority of the United States and
an agency of the US Department of Health and Human Services.
Stephen Saad, Aspen Group CEO said `HIV/Aids is proving to be a major
humanitarian challenge. Aspen`s response has been to formulate and develop
generic ARVs under voluntary licences from the originators. We have six
registered generic ARVs and we are already producing this much needed
medication.`
`As the pioneers of generic ARVs on the African continent, we are working
closely with the US FDA in order to ensure that Aspen ARVs receive FDA
registration promptly. Using the expedited review system, the FDA could grant
Aspen registration for co-packaged ARVs, ARV fixed dose combinations and single
ingredient ARVs. Further, FDA inspections of Aspen`s multi-million rand oral
solid dosage (OSD) facility in Port Elizabeth are expected within the next few
months.
Saad said `this would enhance patient compliance and enable Aspen to be the
first African manufacturer to supply generic ARVs under the PEPFAR program.
Given the commissioning of our new state-of-the-art OSD facility we believe that
we have both the capability and capacity to manufacture these key ARV
formulations in Africa.`
Johannesburg
8 September 2004
Sponsor:
Investec Bank Limited
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