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ASPEN PHARMACARE HOLDINGS LIMITED - ADDRESS BY STEPHEN SAAD, ASPEN PHARMACARE
GROUP CHIEF EXECUTIVE OFFICER AT THE PRESS CONFERENCE TO ANNOUNCE THE
REGISTRATION OF ASPEN ARV"S BY THE US FOOD and DRUG ADMINISTRATION JHB, 25
JANUARY 2005
Aspen Pharmacare Holdings Limited
(Incorporated in the Republic of South Africa)
(Registration number 1985/002935/06)
Share code: APN ISIN: ZAE000023586
ADDRESS BY STEPHEN SAAD, ASPEN PHARMACARE GROUP CHIEF EXECUTIVE OFFICER AT THE
PRESS CONFERENCE TO ANNOUNCE THE REGISTRATION OF ASPEN ARV"S BY THE US FOOD and
DRUG ADMINISTRATION JHB, 25 JANUARY 2005
Good afternoon
Leading public officials of the Departments of Health, Trade and Industry and
Treasury;
The Honorable Health Attache of the US Embassy in Pretoria;
Members of the Media;
Distinguished Guests;
Ladies and Gentlemen
On behalf of Aspen Pharmacare, Africa"s largest Pharmaceutical manufacturer I am
honoured to address you with the announcement of an world first for our
continent, our industry and for Aspen.
Earlier today, Aspen received written notification from the United States Food
and Drug Administration (USFDA), the Medicines Regulator of that country, that
Aspen has received approval by the US FDA for use of certain of our generic
antiretrovirals (ARV"s).
This landmark approval confirms Aspen as the first Pharmaceutical manufacturer
in the world to successfully receive approval for Generic Antiretrovirals by the
US FDA via the expedited review process. The approval is for the co-packed and
most widely used triple cocktail combination of Lamivudine/Zidovudine and
Nevirapine tablets in conventional adult dosages.
Aspen"s pioneering of ARV"s on the African continent and now its world first
Generic ARV recognition by the FDA has been achieved through the conclusion of
voluntary licenses from the original innovator companies, GlaxoSmithKline,
Boehringer Ingelheim and a Territorial Patent use agreement with Bristol-Myers
Squibb.
Aspen"s responsible approach of respecting and upholding policies that do not
undermine the Intellectual Property System, has forced price reductions and made
these essential drugs accessible to the poorest of the poor. To date six adult
dosage form ARV"s (viz Aspen Stavudine, Aspen Didanosine, Aspen Lamivudine,
Aspen Zidovudine, Aspen Nevirapine and Aspen Lamzid (FDC Lamivudine/ Zidovudine)
and two paediatric dosage form ARV"s (viz Aspen Lamivudine and Aspen Zidovudine)
have been formulated, developed and introduced into the SA market.
Although Africa only represents 13% of the World"s population, it harbours up to
70% of its HIV infected population. Aspen, from Africa, responded in the most
resolute way that it could, by developing an African solution to what is a
pressing African problem.
Our approach to the pandemic and today"s FDA announcement is not only a
demonstration of Aspen"s social commitment to the continent, but speaks volumes
for South Africa"s and Aspen"s scientific, formulation, technological and
manufacturing capabilities. In this regard, it should be remembered that part
of the FDA registration entails a manufacturing plant audit by the FDA, which
confirmed Aspen"s quality and Good Manufacturing Practice (GMP) compliance
credentials, a pre-requisite to manufacturing these ARV"s for export markets.
Furthermore, Aspen"s decision to formulate its own ARV formulations and
intellectual data has been vindicated by the ensurance of no bio data integrity
issues when the FDA recently audited Aspen"s contracted bio labs. Unequivocally
confirming that our bio equivalence studies ensure consistency to the innovator
reference products.
After undergoing two vigorous manufacturing plant audits and equally stringent
audits of our contracted bio labs, audits were completed last December with no
unresolved outstanding issues. These audits paved the way for the ultimate
product registration which we have announced today.
We are confident that our significant investment to date and our continued
investment in South Africa, will continue to differentiate Aspen from its
competitors and will provide cost effective pharmaceutical solutions to our
country, our continent and beyond the borders of our continent.
To this extent, we need to pay tribute to both the Department of Health and the
Medicines Control Council for creating the Drug Regulatory, Scientific and
Pharmaceutical Quality environment, from which a South African company was able
to achieve FDA Registration. I am also using this opportunity to commend the
Aspen scientists who worked tirelessly in achieving FDA registration in record
time.
Ladies and Gentlemen, I"ve given you some insight into Aspen"s capabilities, but
the most important reason we are having this announcement today, is about what
this means to the Patient. Particularly the poorest, and the most vulnerable,
who have the least prospect of accessing ARV"s, which have up until now been
entirely out of their reach.
Aspen through its FDA registration has now become the first accredited generic
supplier to have access to the US President"s Emergency Plan for AIDS Relief
(PEPFAR) fund. This is a fund of US$15billion designated by President Bush for
developing countries. It is understood that upwards of 50% - 60% of these funds
will be used to purchase ARV"s and other HIV/AIDS related pharmaceuticals from
accredited suppliers.
Aspen will sell this co-packaged combination to bona fide recipients of PEPFAR
at affordable prices.
Aspen wishes to commend the US Government"s Administration for the positive and
real steps it has taken in ensuring that we implement ARV generic drug usage at
a vast price reduction, whilst ensuring that the products used in PEPFAR
territories are safe, effective and meet the same stringent quality standards
that would be applied to US citizens. The FDA, too, must be commended for not
only creating a framework which enabled Aspen to obtain our expedited review for
Registration of ARV"s for PEPFAR, but for the positive approach they adopted in
interacting with us.
Ladies and Gentlemen, your presence here today has enabled us to reflect on yet
another South African achievement in our new democracy. It is an achievement
that we can all be proud of as South Africans and one which enables us to
further strike a blow at the potentially devastating economic, social and
humanitarian impact of this pandemic.
Although Aspen harbours ambitious offshore plans in both developed and
developing markets, through initiatives such as these, Aspen will continue to
contribute to the growth and transformation of our country and the continent.
We continue to pledge our commitment to the future of South Africa and the
continent, a future inextricably interwoven with our own.
Thanking you for your attention.
Date: 25/01/2005 11:00:08 AM Supplied by www.sharenet.co.za
Produced by the JSE SENS Department