Submitted by Roche
NUTLEY, NJ - January 9, 2008 "“ Roche today announced that it has entered into four new technology transfers with local manufacturing companies in African and Asian nations where improvements in access to anti-retroviral therapy are needed. These companies are Regal Pharmaceuticals in Kenya, CAPS Holdings in Zimbabwe, Shelys Pharmaceuticals in Tanzania and Beximco Pharmaceuticals Ltd in Bangladesh. As part of Roche's Technology Transfer Initiative, these companies will be provided free of charge with the technical expertise to manufacture generic HIV medicine, based upon the processes to produce saquinavir, Roche's second line1 HIV medicine.
Since the launch two years ago, Roche has signed Technology Transfer agreements with a total of nine companies across sub-Saharan Africa and in Least Developed Countries in other parts of the world. Roche also has received similar requests from a total of 35 manufacturers in 15 eligible countries, including Kenya, Ghana, Zimbabwe and Nigeria. Roche will continue to work with these individual applicants to assess production capabilities.
William M. Burns, CEO Division Roche Pharma, said, "these new agreements highlight the ongoing contribution that our Roche Technology Transfer Initiative is making to help strengthen and expand local manufacturing capabilities for HIV medicines in resource-limited countries. With more local manufacturers now looking to scale-up production of essential medicines, the continued uptake of this initiative highlights Roche as an innovative leader in supporting sustainable solutions to improve HIV healthcare where it is needed most."
In addition to these four new agreements, Roche has expanded the Technology Transfer Initiative with training seminars for local manufacturers across sub-Saharan Africa and the world’s Least Developed Countries. These sessions focus on the development of improved manufacturing processes and provide a forum for Roche to share its knowledge and experience with those who have access to fewer resources. The knowledge gained by local manufacturers enables them to strengthen their manufacturing capability and increase manufacturing knowledge on the production of medicines beyond HIV.
Krishna Karnataki, General Manager GMP & Formulations of Shelys Pharmaceuticals in Tanzania, commented, "the practical support that Roche has provided has been a great learning experience for my team, enabling us to make improvements to our entire technical and quality systems. We have been enthused by this partnership and are eager to work with Roche on this initiative to help meet the needs of our people suffering from HIV infections, and improve availability of these badly needed medications."
Roche's dedicated team will work onsite at manufacturing facilities at all four locations and from its headquarters in Switzerland to undertake the technology transfers. The companies will be able to produce saquinavir for supply throughout countries in sub-Saharan Africa, and to those defined as Least Developed by the United Nations, due to Roche's policy of not filing patents on antiretroviral medicines in these countries.
About Roche’s Technology Transfer Initiative
Announced in January 2006, the Roche Technology Transfer Initiative provides local manufacturers with the technical expertise required to produce generic HIV medicines. Manufacturers in sub-Saharan Africa and the Least Developed Countries wishing to produce generic saquinavir for use in these countries will not be required to apply for a voluntary licence because Roche has committed as part of its global policy not to enforce patents on antiretroviral medicines within these countries. Interested manufacturers should contact the Project Manager for the Technology Transfer Initiative at the Roche Kenya office: firstname.lastname@example.org.
Interested local manufacturers in the following countries are invited to contact Roche to discuss the Technology Transfer Initiative: Afghanistan, Angola, Bangladesh, Benin, Bhutan, Burkina Faso, Botswana, Burundi, Cambodia, Cameroon, Congo, CÃ´te d’Ivoire, Cape Verde, Central African Republic, Chad Comoros, Democratic Republic of Congo, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Ghana, Gambia, Guinea, Guinea-Bissau, Haiti, Kenya, Kiribati, Lao People's Democratic Republic, Lesotho, Liberia, Madagascar, Malawi, Maldives, Mali, Mauritius, Mauritania, Mozambique, Myanmar, Namibia, Nigeria, Nepal, Niger, Rwanda, Samoa, Sao Tome and Principe, Seychelles, Senegal, Sierra Leone, Solomon Islands, Somalia, South Africa, Swaziland, United Republic of Tanzania, Timor-Leste, Togo, Tuvalu, Uganda, Vanuatu, Yemen, Zambia, Zimbabwe.
Roche's patent and pricing policy
In addition to its Technology Transfer Initiative, Roche will maintain its current pricing and patent policy. No patents for any of Roche medicines - across all disease areas - will be filed in the world’s Least Developed Countries (LDCs), as defined by the UN. Roche will not file patents on new antiretroviral medicines in LDCs or sub-Saharan Africa. Roche will not take action in these countries against the sale or manufacture of generic versions of antiretroviral medicines. Generic versions of such HIV medicines can therefore be produced in LDCs and sub-Saharan Africa without the need for a voluntary or compulsory licence. Roche makes its HIV protease inhibitors Invirase and Viracept available at no-profit prices for direct supplies from Roche Basel to LDCs and sub-Saharan Africa.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world’s leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2007 Roche was named Top Company of the Year by Med Ad News and one of the Top 20 Employers (Science magazine). In 2006, Roche was ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine’s Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our websites: www.rocheusa.com or www.roche.us.
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1 WHO treatment guidelines for resource limited settings: http://www.who.int/hiv/pub/guidelines/artadultguidelines.pdf.
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.
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