Author: bpc

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.

Aspen Pharmacare Holdings Limited (Aspen) has signed definitive joint venture (JV) agreements with Indian-based Matrix Laboratories Limited (Matrix). The deals strengthen Aspen’s vertical integration into the manufacture of Active Pharmaceutical Ingredients (APIs), the key raw materials required in the manufacture of finished dosage form pharmaceuticals including anti-retrovirals (ARVs), and they unlock additional global supply and manufacturing opportunities.   The basis of the two JVs is: The sale of 50% of Aspen’s 100% ownership of Cape Town based Fine Chemicals Corporation Pty Ltd (FCC) to Matrix for a purchase consideration of US$ 20million. FCC is South Africa’s leading API manufacturer and a major exporter of product to the USA and other territories; Aspen to acquire a 50% stake of a newly incorporated Indian company, Astrix Laboratories (“Astrix”), into which Matrix will transfer an API manufacturing facility, technology and intellectual property (IP) for a consideration of US$36,5 million   Stephen Saad, Aspen’s Group Chief Executive said “the JVs strengthen Aspen’s supply source for APIs to meet the increasing demand for pharmaceutical products, most notably ARVs. The deals also provide for additional global trading opportunities for Aspen. Matrix’s technological expertise complements Aspen’s successful strategy of manufacturing quality, internationally approved medicines, including ARVs. The finished dosage form products for which the APIs are required will be manufactured at Aspen’s US Food and Drug Administration (FDA) and World Health Organisation (WHO) accredited Oral Solid Dose (OSD) facility in Port Elizabeth”.   Saad added that he expected Astrix to record revenue in the order of $40 million in its first full year of operation and that Aspen would be a material customer.   N Prasad, Executive Chairman of Matrix said “the long-term strategic relationship between Matrix and Aspen is a great leap forward. It will result in combining the strengths of both the companies to achieve global leadership positions by meeting the large unfulfilled needs in the treatment of HIV/AIDS. This alliance also gives Matrix a strategic presence in South Africa. Technological expertise provided by Matrix will assist in unlocking additional value in the FCC business.”   The Astrix facility, situated near Hyderabad, will be Aspen’s lead supplier of ARV APIs. Astrix will also continue supplying its existing customer base with ARV APIs. The site offers scope for modular expansion and in terms of the agreement Astrix may also source additional API volumes from other Matrix production facilities on a toll-manufacture basis.   Approvals for the JVs are subject to approvals by, inter alia, the South African Reserve Bank, the Reserve Bank of India and South Africa’s Competition authorities.   JSE listed Aspen is the southern hemisphere’s largest generic pharmaceutical manufacturer and a global leader in generic ARVs. Matrix is a leading international API manufacturer listed on the National and Bombay Stock Exchanges.   The US FDA’s 2004 accreditation of Aspen’s world class OSD facility and registration of its co-pack triple combination generic ARV treatment qualified Aspen as the first generic supplier under President Bush’s Emergency Plan for AIDS relief (PEPFAR) programme to which funding of US$15 billion has been committed.   Aspen has actively pursued a meaningful solution to the provision of high quality, affordable generic ARVs in the fight against HIV/AIDS. Aspen pioneered the conclusion of voluntary licence agreements with leading multinationals for the manufacture of generic ARVs which were developed in Aspen’s own laboratories. This underscores Aspen’s scientific and technical capabilities, its manufacturing and quality standards, and GMP compliances. Aspen was also recently awarded the lion’s share of the South African government’s ARV tender.

East London – Bevan Gogwana, MEC for health in the Eastern Cape officially opened Aspen Pharmacare’s Oral Contraceptive manufacturing facility earlier today. Stephen Saad, Group Chief Executive of Aspen Pharmacare, Southern Africa’s largest JSE-listed pharmaceutical company, said “the world-class oral contraceptive facility has been designed, built and validated to European standards, and has the capacity to produce between 24 and 30 million oral contraceptive packs per year”. Aspen Pharmacare supplies the majority of the state’s requirements for oral contraceptives.  The newly opened facility forms part of the company’s East London operation, which it is estimated would cost over R160 million to replace. Saad said “a number of international pharmaceutical manufacturers have strongly endorsed Aspen Pharmacare’s standards and manufacturing processes. This was demonstrated through Wyeth International licensing Aspen Pharmacare to manufacture, market and distribute their oral contraceptives, among other products, from the East London facility”. “It is also strategic that local businesses assist government in addressing the needs prevalent in the health sector. As such, Aspen Pharmacare introduced training and skills development enrichment programmes, and in association with the Department of Health and the South African Health Services, has trained and improved the skills of more than 120 nurses.” In addition, Aspen Pharmacare has made a contribution to primary health care in this region. Engcobo Clinic, which was officially opened by Nelson Mandela earlier this month, provides the community with a fully functional delivery room for pregnant women, doctors’ consulting rooms, nurses’ training facilities and a medicine dispensary.  The trainee nurses receive on-the-job training and Aspen Pharmacare has provided all computer equipment and infrastructure to support the training. Due to limited facilities in the area, Engcobo Clinic also assists with the overflow of patients who cannot be attended to at the All Saints Hospital. Commenting on the outcome of the recent court case between government and the Pharmaceutical Manufacturers Association, Saad said that Aspen Pharmacare was extremely positive about the result. “We are able to manufacture much needed generic anti-retroviral drugs for HIV/Aids patients, and are presently awaiting government’s decision regarding the process that will be followed in this regard.” Saad confirmed that an announcement was imminent concerning a joint venture agreement with an Indian based company to supply raw materials for the local manufacture of generic antiretroviral drugs, which would enable further cost savings for their products throughout Africa. “The impact of legalised generic substitution of medicines is however the main coup for the broader community as well as for Aspen Pharmacare. Medicines account for approximately 33 percent of medical aid expenditure, and through legislated generic substitution medicines, medical aid allocations could be managed more efficiently through the reduction of the cost of medicines. Currently the market split between generic and ethical medicines is 20 : 80, with changes expected to these statistics as a consequence of the above legislative promulgations. Aspen Pharmacare, although actively involved in the manufacture of ethical, as well as over the counter (OTC) and personal care products, is South Africa’s largest generic producer.