Tibotec and Emcure Collaborate on Access to Darunavir for India
County Cork, Ireland (December 3, 2008) - Tibotec Pharmaceuticals today announced that it has signed a royalty-free, non-exclusive license agreement with Emcure Pharmaceuticals Limited of India to distribute the protease inhibitor darunavir (DRV) in India.
Tibotec is committed to ensuring access to innovative HIV/AIDS therapies and has collaborated with Emcure because of the company’s strong reputation in India and extensive reach through its country-wide distribution network. The agreement will help to build a sustainable effort in India to ensure patients in need have access to darunavir.
Tibotec has been working with regulatory authorities in India to register darunavir. When approved, darunavir, co-administered with ritonavir and with other antiretroviral agents (ARVs), is expected to be indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients.
“Tibotec believes that strong collaborations with companies such as Emcure provide the best options for HIV/AIDS patients by enhancing drug access and maintaining the quality of medicines,“ said Wlodek Kubiak, VP of Worldwide Access Programs. Tibotec works with local companies in resource-poor countries to facilitate access to its antiretrovirals. In 2007 Tibotec provided a royalty-free voluntary license to Aspen Pharmaceutical for darunavir for sub-Saharan Africa and for least developed countries outside that region.
“Emcure seeks to work with leaders in innovative new therapies such as Tibotec to provide important treatments for HIV for the Indian people,” said Mr. Satish Mehta, CEO of Emcure.
Darunavir is currently registered in 79 countries worldwide.
Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need. The Company’s main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA.
Tibotec has developed a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access Program for darunavir includes access pricing, registration, medical education for appropriate use and voluntary licensing.
Tibotec Pharmaceuticals is a member of the Johnson & Johnson family of companies.
For further information on Tibotec, please visit: www.tibotec.com.
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.
Emcure Pharmaceuticals Ltd., based in Pune, India, is a vertically integrated pharmaceutical company focusing on research and development as well as manufacturing of APIs, Formulations, and Biotechnology products. Emcure has emerged as one of the fastest growing pharmaceutical companies in India. The Company has four US-FDA approved plants including one in USA.
Emcure has a strong presence in India, Asia, and sub-Saharan Africa where prevalence of HIV/AIDS is high. As part of its Corporate Social Responsibility, Emcure believes in pursuing the fight against HIV/AIDS in these developing parts of the world. Several of Emcure’s products are regularly supplied to these countries at affordable prices including some that have been approved under the PEPFAR program. Emcure is a preferred partner to many of the large pharmaceutical companies and has similar arrangements in place with Bristol-Myers Squib for atazanavir and Gilead Sciences for tenofovir as part of their Global Access Programs.
For further information about Emcure, please visit www.emcure.co.in.