Author: bpc

Aspen (APN), South Africa’s largest listed pharmaceutical company, today announced that it has reached an agreement with Roche to produce a generic version of oseltamivir for Africa. This complements Roche’s continued efforts to increase and speed up availability of the medicine for world wide influenza pandemic planning. The agreement focuses on providing oseltamivir for pandemic use to further help to address the needs of governments and other not for profit organisations in the African sub – continent. Roche will provide technical know how (technical, pre-clinical and clinical data) to assist Aspen to help them expedite their production and the registration. The agreement also allows the supply of Active Pharmaceutical Ingredient (API) from Roche to Aspen. Stephen Saad, Aspen Group CEO said “This agreement complement’s Aspen’s continued commitment to turning the tide against infectious diseases in Africa. The confidence placed in Aspen by Roche, a leading multinational pharmaceutical manufacturer, further endorses the international approval of Aspen’s quality manufacturing and it’s ability to provide solutions for the African continent. This product will be manufactured in Aspen’s Port Elizabeth-based Oral Solid Dose (OSD) facility which was approved by the US Food and Drug Administration in 2004.” David Reddy, Roche’s Pandemic Taskforce Leader, commented: “We are pleased to announce the partnership with Aspen as the latest step in our scale-up efforts to meet the needs of governments in preparing for the potential public health threat posed by avian influenza. This is another demonstration of Roche’s commitment to working as a collaborative and responsible partner with governments and the World Health Organization (WHO) to assist in pandemic planning”. Whilst Roche remains on schedule to meet all orders from African governments by early 2007, the collaboration with Aspen will further enhance the supply of oseltamivir for Africa. The agreement is non-exclusive and will mean that Roche and other sub-licensees will be able to work on pandemic orders within Africa. About Aspen: Aspen is Africa’s largest pharmaceutical manufacturer and a major supplier of branded pharmaceutical, healthcare and nutritional products to the southern African and selected international markets. Aspen is one of the largest generics manufacturers in the southern hemisphere. Aspen is a leading global player in generic ARVs. Aspen is one of the top 20 generic manufacturers worldwide and South Africa’s number one generic brand. Aspen has pharmaceutical manufacturing facilities located at three sites in South Africa. The Group produces a vast range of products including tablets, capsules, liquids, creams and others. Aspen is listed on JSE Limited (JSE) and has a current market cap in excess of R15 billion.

Johannesburg – JSE listed Aspen (APN) and Indian based Lupin Limited have entered into a Memorandum of Understanding for the establishment of a 50:50 joint venture for the development, manufacture and global marketing of selected anti-tuberculosis (TB) products. The JV will also investigate opportunities to enter the Malaria market. Stephen Saad, Aspen Group Chief Executive said “Aspen has long been committed to sourcing and providing solutions to infectious diseases encompassing HIV/Aids, TB and Malaria. Our efforts are underpinned by strategic agreements entered into with leading multinationals for the manufacture and supply of multi-drug resistant tuberculosis (MDR-TB) products and generic anti-retrovirals (ARVs). This agreement further emphasises our resolve to be an active participant in fighting these diseases which are such a scourge on our continent.” Dr. D. B. Gupta, Chairman, Lupin Limited said, “We believe that this is a very important step in providing comprehensive therapeutic care in the areas of conventional TB, MDR-TB and Malaria, which are pandemic in nature and a concerted effort is required to provide treatment to the infected. Lupin and Aspen together are best suited to address these disease areas.” While Lupin has traditional strengths in anti-TB formulations and active pharmaceutical ingredients (APIs), Aspen will bring a range of MDR-TB products to the venture. The agreement compliments the synergies between Lupin’s traditional strengths and Aspen’s experience in the ARV business and African presence. There is a global trend of bundling the treatments of infectious diseases which include HIV/Aids, TB & Malaria. Statistics indicate that 8.6 million new TB cases are diagnosed annually. It is believed that this only constitutes 70% of infected cases with a greatly reduced percentage being treated. Research conducted through the World Health Organisation in 2001 estimates the market size for first line TB products to be between USD 550 – USD 600 million annually. Of this, 50% of the market is considered to be Institutional and the balance is prescription based. MDR-TB, which is caused by bacteria resistant to established TB treatments, is emerging as a major problem. While the cost of treatment of normal TB with first line drugs is estimated at USD 40 – USD 100 per patient, the MDR-TB treatment cost is substantially higher. The cost of treatment is about USD 800 per patient under the WHO managed program through the Green Light Committee. The MDR-TB market is relatively small and is expected to grow exponentially over the next 4-5 years.

JSE listed Aspen Pharmacare Holdings Limited, Africa’s largest pharmaceutical manufacturer and the largest generic manufacturer in the southern hemisphere, has signed a non-exclusive license and technology transfer collaboration agreement with New York based Bristol-Myers Squibb (BMS) for the manufacture and distribution of a generic version of Atazanavir, a new generation anti-retroviral (ARV). BMS selected Aspen through a bidding process as one of only two pharmaceutical manufacturers globally. The royalty-free, perpetuity agreement provides for the manufacture and distribution of Aspen Atazanavir, a generic version of Atazanavir, to World Bank Tier 1 designated territories. This country classification is rated according to the human development index and it equates to some 70 countries including a number of countries outside of Africa. Stephen Saad, Aspen Group CEO says “this initiative between a world healthcare leader and a South African based pharmaceutical company further highlights the confidence that global pharmaceutical manufacturers have in Aspen’s capabilities. It is indicative of Aspen’s ability to align itself with one of the world’s leading companies in an attempt to solve what has largely become an African based problem. The deal is evident of Aspen’s positioning at the cutting edge of treatments for the developing world as the group continues to strive to ensure that ARV treatment reaches as many people as possible.” “A further advantage of this agreement is that Aspen has collaborated with Indian-based Asterix Laboratories, of which Aspen owns 50%, for the development of the active pharmaceutical ingredients (APIs) thereby fully integrating the deal from base level chemicals to the finished products.” Saad said “this announcement shortly follows the State of the Union Address of the President of South Africa, in which President Mbeki confirmed that South Africa has one of the largest ARV treatment programmes in the world. This initiative with BMS will assist in broadening access to resource limited communities in the South Africa programme and beyond the boarders of South Africa.” “This agreement builds on Bristol-Myers Squibb’s long-standing commitment to the global fight against AIDS,” said Peter R. Dolan, Chief Executive Officer, Bristol-Myers Squibb. “In Sub-Saharan Africa, where the HIV/AIDS pandemic has been especially devastating, we’ve taken a broad-based approach to addressing the AIDS crisis, including providing our AIDS medicines at no profit prices and committing to ensure our patents do not prevent inexpensive treatment in the region. With this new agreement, we’re taking our commitment to the next level, by expanding access to our newest antiretroviral in sub-Saharan Africa, where HIV/AIDS is a significant and growing public health challenge.” “Aspen has remained committed to expanding access to HIV medicines in sub-Saharan Africa, where millions are suffering with the disease.” said Stephen Saad. “We are pleased to be part of this innovative agreement, and have already begun the steps needed to get Atazanavir to the patients in sub-Saharan Africa who so desperately need it.” Saad says “the addition of Aspen Atazanavir further boosts Aspen’s already significant basket of ARVs. It provides broader global access to ARVs to meet the healthcare needs of some 4 million HIV/Aids positive Africans of which an estimated 10% are presently receiving treatment. Primary advantages of Atazanavir include it being a new generation ARV providing significant improvement over existing therapies, and that it is taken orally once daily. With ARV molecules continually being refined, available data confirms that Atazanavir has an enhanced efficacy and safety profile compared to other ARV molecules. Atazanavir is also a United States Food and Drug Administration dossier which further complements Aspen’s strategy to manufacture ARVs for President Bush’s US$15 billion Emergency Plan for AIDS relief (PEPFAR) programme. The product will be produced at Aspen’s world class oral solid dosage (OSD) facility which has been accredited by the US FDA for the manufacture of co-packed generic ARVs. This deal enables Aspen to access existing data, fulfil the technology transfer, register the product through the South African Medicines Control Council and start manufacturing Aspen Atazanavir locally. Johannesburg : February 15, 2005 Sponsoring Brokers: Investec Bank Limited

Former President Clinton Announces New Agreements to Lower Prices of HIV/AIDS Rapid Tests and Second-Line Drugs Agreements with Nine Companies Will Lower Prices of HIV Diagnosis and Two HIV/AIDS Medicines by 30-50 Percent for 50 Countries Clinton Also Confirms that Nearly a Quarter-Million People Living with HIV are Benefiting from First-Line HIV/AIDS Drug Agreements his Foundation Announced in 2003   New York, NY – Former President Bill Clinton announced today that his foundation’s HIV/AIDS Initiative has negotiated new pricing agreements to lower the prices of HIV diagnosis and two antiretrovirals (ARVs).   Four companies—Chembio Diagnostics (U.S.), Orgenics (Israel; a subsidiary of Inverness Medical Innovations), Qualpro Diagnostics (India; in partnership with Core Diagnostics), and Shanghai Kehua (China)—will offer rapid tests for $0.49-$0.65 per test. As a result of their agreements with the Clinton Foundation, countries will be able to reduce the cost of HIV diagnosis by 50%.   Cipla (India), Ranbaxy (India), Strides Arcolab (India) and Aspen Pharmacare (South Africa)— relying on supply of active pharmaceutical ingredients from Matrix Laboratories (India)—will offer the ARV efavirenz for $240 per patient per year, and Cipla will offer the ARV abacavir for $447. These prices represent savings of more than 30% from current market rates. (The supply of efavirenz at $240 by Cipla and Ranbaxy is conditional on certain volume thresholds; for smaller orders, a surcharge may apply.)   The products and prices announced today will be available to the Foundation’s Procurement Consortium, which currently includes 50 developing countries around the world.   “ The action of these companies is another important step in the fight against HIV/AIDS,” said President Clinton. “With more than one million people on treatment in developing countries, we face a growing challenge to keep costs affordable as we reach out to millions more in need. For relatively low-cost commodities like rapid tests, the challenge is in the volumes. Widespread testing is essential to make prevention and treatment work, and making diagnosis cheaper will allow us to extend testing services to more people, more quickly.”   Over 90% of the 40 million people living with HIV in the world do not know that they are HIV-infected. Aggressively expanding testing services is critical to both prevention and treatment. In order to reach treatment targets, developing countries need to run at least 200 million HIV tests in the next four years. The rapid test prices announced today will help save tens of millions of dollars in this timeframe. For example, Brazil—which hopes to increase annual testing volume from three to seven million tests—would save more than $10 million in 2006, or 80% from original prices, by buying under these agreements.   Speaking in Harlem today, President Clinton added, “Lowering the price of second-line drugs is a major priority for my foundation in 2006. Treatment, once started, is a lifelong commitment, and over time patients move from low-price first-line drugs to second-line combinations that are at least 10 times more expensive. Keeping the global cost of AIDS treatment sustainable will only be possible if we lower the prices of these medicines.”   First-line treatment of HIV/AIDS in developing countries has relied heavily on four ARVs. These were included in original agreements announced by the Clinton Foundation in 2003, and 240,000 patients across its Procurement Consortium are benefiting today from medicines purchased under these agreements. The annual price paid for the most common first-line therapy is $136.   The drug efavirenz is used in alternative first-line treatments (in cases of toxicity from other drugs, or when use of other drugs is contraindicated), but its use triples the price of treatment. When patients become resistant to first-line treatment, it is necessary to use second-line combinations of ARVs, which, in Africa, cost 10 times or more the price of the most common first-line treatment. Abacavir is one of six ARVs used in second-line combinations recommended by the World Health Organization (WHO).   For middle-income countries, the price of second-line medicines is an additional 4-5 times higher than in Africa, and some of these, like Brazil, already spend the majority of their budgets for ARVs on just a few second-line medicines. In two years, as many as 500,000 patients around the world will be on second-line combinations, making their comparative cost a major challenge facing ongoing HIV/AIDS treatment in Africa and around the world.   Today’s agreements on efavirenz and abacavir represent a first step in the Foundation’s effort to lower the cost of second-line treatment. The Foundation is working with its current partner suppliers to reduce the costs of additional second-line medicines, and expects to add these to its agreements later in 2006. The Clinton Foundation is grateful to the Open Society Institute for its support of the HIV/AIDS Initiative’s ongoing work to make care and treatment more affordable.   Attending the announcement was Arun Kumar, Group CEO and Managing Director of Strides Arcolab, who stated, “Strides supports the Clinton Foundation’s initiative against HIV/AIDS, and we are committed to supply a comprehensive range of first-line and second-line antiretroviral drugs under our agreement which meet global quality standards at affordable prices.” Following today’s agreement, Strides will also supply first-line ARVs under Clinton Foundation agreements.   Speaking about the rapid test agreements today in New York, Larry Siebert, President and CEO of Chembio Diagnostics, said: “The missions of Chembio and the Clinton Foundation HIV/AIDS Initiative are closely aligned, and we are extremely proud to be part of this initiative.”   The Clinton Foundation is committed to providing high-quality products under its agreements. The rapid tests included in today’s deals have been evaluated by WHO and deemed to meet minimum sensitivity and specificity criteria. The ARVs included in the agreements are being submitted to WHO and/or the U.S. Food and Drug Administration (FDA). Cipla has already submitted efavirenz following bioequivalence testing conducted by a research laboratory that has been successfully audited twice by the FDA. Additional submissions are planned for the first quarter of 2006. Cipla, Ranbaxy, Strides, Aspen and Matrix are manufacturing efavirenz and abacavir at sites… Continue reading Former President Clinton Announces New Agreements to Lower Prices of HIV/AIDS Rapid Tests and Second-Line Drugs

JSE listed Aspen Pharmacare Holdings Limited and Lupin Limited of India have entered into an agreement to collaborate in the tuberculosis (TB) related products market in South Africa. The agreement involves cooperation in the areas of technology, manufacture and marketing. Stephen Saad, Aspen Group Chief Executive said, “the agreement enhances South Africa and Aspen’s ability to respond to the growing TB pandemic that continues to affect all sectors of society. HIV and AIDS have substantially raised TB infection rates in South Africa, thereby placing immense pressure on the country’s healthcare resources. Aspen also previously received licenses for multi-drug resistant TB drugs from Eli Lilly. These combined deals complement Aspen’s strength in the TB environment. Consequently Aspen is the only pharmaceutical manufacturer in the country to offer both first and second line TB treatments and Aspen is the continent’s leader in providing pharmaceutical solutions for poverty-related diseases.” Dr K K Sharma, Managing Director, Lupin Limited said, “this is a great opportunity for Lupin and Aspen to bring cost effective TB medication to the growing South African market. We are enthusiastic about our relationship with Aspen and we would like to see the scope of this expand over time.” The arrangement will leverage the Lupin’s technological expertise relating to cures for TB, as well as Aspen’s extensive marketing and technical capabilities. The current market size for TB medication in South Africa is estimated at approximately USD 15 million per annum. The agreement makes provision for milestone payments of up to USD 2 million from Aspen to Lupin based on achievement of key deliverables and a profit sharing arrangement. The agreement remains subject to the fulfilment of certain conditions precedent. About Lupin Headquartered in Mumbai, Lupin (http://www.lupinworld.com) develops, manufactures and markets generic intermediates, active pharmaceutical ingredients and finished dosages. Its FY 2004-05 revenues were USD 280 million. Eleven of Lupin’s plants have been approved by the US FDA and two facilities have been approved by the UK MHRA. About Aspen Aspen is the southern hemisphere’s largest generic pharmaceutical manufacturer and a global leader in generic ARVs. Aspen is also acknowledged as Africa’s largest pharmaceutical manufacturer and as 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, personal care, fast moving consumer goods, nutriceutical and infant milk formula categories. Aspen became the world’s first pharmaceutical manufacturer to be granted US Food and Drug Administration (FDA) approval to manufacture combination therapy generic anti-retrovirals (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’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.