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Aspen Pharmacare Holdings Limited - Clarification regarding licence for generic

Release Date: 27/07/2005 16:45
Code(s): APN
Wrap Text

Aspen Pharmacare Holdings Limited - Clarification regarding licence for generic version of anti-retroviral efavirenz by msd to aspen Aspen Pharmacare Holdings Limited (Incorporated in the Republic of South Africa) (Registration Number 1985/002935/06) Share code APN ISIN: ZAE000066692 ("Aspen") Press Release CLARIFICATION REGARDING LICENCE FOR GENERIC VERSION OF ANTI-RETROVIRAL EFAVIRENZ BY MSD TO ASPEN MSD and Aspen are pleased to announce that they are engaged in ongoing discussions relating to the formal licence agreement required by the non-binding Letter of Intent for MSD to grant Aspen a licence for efavirenz. It is anticipated that the formal agreement will be signed by 1 August 2005. Aspen intends to commence the testing and development of the product as soon as possible with a view to submitting a dossier for registration by the Medicines Control Council ("MCC") in South Africa during the first quarter of 2006. Because of the nature of the product, Aspen intends to file for fast track approval with the MCC. Aspen has undertaken to contribute a percentage of its sales of efavirenz to the Msizi Trust, to be administered jointly by MSD and Aspen, to provide support to the management, treatment and care of people living with HIV/AIDS in South Africa. ends 26 July 2005 Sponsor: Investec Bank Limited For more information, contact: Mr. Chirfi Guindo, MSD SA CEO Tel: (011) 655 3000 Cell: 082 417 9405 Ms. Seara Macheli, MSD Director, Legal and Corporate Affairs Tell: (011) 655 3000 Cell: 082 886 6565 Stephen Saad, Aspen Pharmacare Group CEO Tel: (031) 268 9506 Cell: 083 303 4833 Gus Attridge, Aspen Pharmacare Deputy Group CEO Tel: (031) 268 9505 Cell: 083 628 8813 Issued by: Lindy Goodfellow (Public Relations Manager) Shauneen Beukes For MSD SA For Aspen Pharmacare Tel: (011) 655 3054 Tel & Fax: (012) 661-8467 Cell: 083 442 5557 Cell: 082 389 8900 About the Aspen Group South African based JSE Securities Exchange (JSE) listed Aspen is Africa"s largest pharmaceutical manufacturer and a major supplier of branded pharmaceutical and healthcare products to southern African and selected international markets. 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 became the world"s first pharmaceutical manufacturer to be granted approval by the US Food and Drug Administration (FDA) to manufacture combination therapy generic anti-retroviral (ARVs) in a co-packed form. This was enabled through voluntary licences from GlaxoSmithKline and Boehringer Ingleheim and underscores Aspen"s scientific and technical capabilities, its manufacturing and quality standards, and GMP compliances. Aspen endorses transformation and broad based black economic empowerment (BEE) as a vehicle to empowering historically disadvantaged South Africans and Aspen"s two strategic BEE partners include CEPPWAWU Investments, the investment arm of the COSATU Affiliated Union CEPPWAWU and Imithi Investments (Pty) Limited, a broad based consortium consisting of parties operational in the Southern African healthcare industry and a number of community advancement organizations. Aspen"s total BEE shareholding exceeds 17%. In 2004 Aspen acquired 100% of the shares of Cape Town based Fine Chemicals Corporation (Pty) Ltd (FCC) which is South Africa"s leading off-patent active pharmaceutical ingredients (API) manufacturer and a significant exporter of API to the USA. As part of a memorandum of understanding, Aspen is currently in negotiation with Indian based Matrix Laboratories Limited (Matrix) in which 50% of Aspen"s current 100% shareholding in FCC will be sold to Matrix. The deal complements Aspen"s efforts to secure a strong supply source for APIs for some of Aspen"s key products. Aspen"s off shore subsidiaries contribute toward the Group"s strategy of establishing a presence in selected geographic areas. Co-Pharma operates in the UK market, while UK based Aspen Resources is an intellectual property owning subsidiary of Aspen Holdings. Aspen Pharmacare Australia continues to complement the Aspen Group"s off shore strategy of increased growth in selected off-shore territories and it is an extension of the Group"s worldwide network of strategic alliances offering a range of products in niche market areas. For more information about Aspen, click on www.aspenpharma.com About Merck Sharp & Dohme Merck Sharp & Dohme (MSD) South Africa is a subsidiary of the global, research- based pharmaceutical company Merck & Co., Inc., Whitehouse Station, NJ USA. MSD discovers, develops and markets a broad range of products designed to save lives, improve human health and enhance patients" quality of life. The company employs 300 people in South Africa, and operates a state-of-the -art manufacturing plant in Midrand, the site of MSD South Africa"s head office. MSD has, since March 2001, made its two HIV products, STOCRIN and CRIXIVAN, available at not - for - profit prices in South Africa and to all sub-Saharan countries. South Africa benefits from the lowest prices offered for these two products, which are lower than or comparable to prices of generic versions of the medicines (for example, the price of Efavirenz 600 mg is R 6, 37 per day (or USD 0, 95 per day). Reference: `Untangling the Web of Price Reductions, June 2005, www.accessmed - msf.org). MSD"s products are novel medicines that represent true advances in patient care. MSD is recognised internationally for its research in many areas, including hypertension, hypercholesterolemia, HIV / AIDS, osteoporosis, asthma, migraine, opthalmics, arthritis, male pattern hair loss, anti-infectives, oncology, diabetes and vaccines. For more information, visit www.merck.com Date: 27/07/2005 04:45:07 PM Supplied by www.sharenet.co.za Produced by the JSE SENS Department

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