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ASPEN PHARMACARE HOLDINGS LIMITED - ADDRESS BY STEPHEN SAAD, ASPEN PHARMACARE

Release Date: 25/01/2005 11:00
Code(s): APN
Wrap Text

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

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