Nasdaq-listed Gilead Sciences has initiated expansion of its global Access programme to provide medicines for the treatment of HIV/AIDS. Working on the model of innovative partnerships, the company?s Access programme is spread across 130 countries for anti-retroviral (ARV) drugs for HIV treatment with a tiered pricing system and substantial discounts. In 2006, the company expanded this programme by providing non-exclusive licenses to the Indian drug manufacturers. Currently, there are 13 Indian partners to manufacture and sell generic versions of Gilead products in developing countries. Explaining the strategy to FE?s BV Mahalakshmi, Gregg H Alton, executive vice president, corporate and medical affairs, says this approach has translated into large scale patient benefits for anti-retroviral coverage since reducing the cost of treatment was a critical step at this juncture.
What is the strategy involved in signing licensing agreements with Indian companies?
We have signed licensing terms with four India-based drug manufacturers – Hetero Drugs , Matrix Laboratories, Ranbaxy laboratories and Strides Arcolab for three drugs which are currently in late stage clinical development. The licensing will help the Indian companies for future rights of our products – elvitegravir, an investigational integrase inhibitor, cobicistat an investigational anti-retroviral boosting agent and Quad which combines four Gilead HIV medicines. We will provide technology transfer and the partners can manufacture high volumes of product at a low cost of production. We developed this model considering some past experiences and challenges such as regulatory strategies for new drug approval, lack of local expertise and limited funds,
Licensing agreements are a cornerstone of our efforts to increase access in the developing nations. Through licensing partnerships, we have reduced the cost of anti-retroviral drugs from $17 to $6. More than 1.1 million patients in developing countries receive Gilead HIV medication produced by the Indian partners. Besides, we also make branded versions of HIV medicines at discounted prices. Our partnership will help to manage pharmacovigilance, medical education and product registration.
How is the funding managed for the partnership programme and what is the advantage for Indian players in the Medicines Patent Pool Foundation (The Pool ) programme?
The Pool was established in July 2010 and is working with a lot of partners to expand global access to quality, low cost anti-retroviral therapy through the licensing of patients. Under the terms of the agreement, licensees are allowed to establish their own price and will pay a royalty of 3% on sale of finished products which include registration, medical education and training.
Further, we have decided to waive off royalty payments on any pediatric formulations or which are in the pipeline and brought to the market. We are looking at extending this programme for other diseases such as liver diseases, cardiovascular diseases, inflammation, respiratory disorders.
What are the challenges in the distribution of ARV products? What is the need for the Access model?
With the present model, we have increased the competition for branded products by enabling Indian manufacturers to produce generic versions of tenofovir. This may erode the margins and put greater pressure on Gilead?s network of distribution partners who sell branded Viread and Truvad. Also, the current competitive tender process, which is required for the global ARV procurement, can put a strain on forecasting. Besides, there are shrunken international donor budgets which threatens support for international HIV treatment. Both donor commitments for global organisations have been levelled off. Hence we developed this programme.
Is this Access programme more of a CSR activity?
This is not a philanthropic activity. This is a part of our business. The HIV market is estimated to be over $20 billion globally. We are discussing various next generation HIV products. Our R&D spend is about $1 billion which includes this programme. We are creating competition through cooperation where there is no IP impact but creates a responsible user IP model.
Are you looking at any acquisitions in India?
No, we are not looking at acquisitions for manufacturing. However, we will look at partnerships with Indian companies to meet the unmet medical needs in developing countries.