Treating HIV in the Developing World:

Lamberto Andreotti (center), executive vice president and president, Worldwide Medicines, is shown here with (left) Satish Mehta, chief executive officer, Emcure Pharmaceuticals Ltd., and Stavros Nicolaou, senior executive, Strategic Trade Development, Aspen PharmaCare, at the signing of the technology transfer agreement. Aspen PharmaCare (based in Africa) is the second company Bristol-Myers Squibb selected to participate in the tech transfer agreement. The companies were chosen based on the quality of their operations and their support for HIV access and philanthropy. Under the agreement, in addition to giving the generic companies a voluntary license for its HIV medicine in sub-Saharan Africa and India, Bristol-Myers Squibb staff will teach the companies how to make, package and distribute the product.

There was therefore an urgent need to provide a treatment option which could help address these difficulties. One of Bristol-Myers Squibb’s HIV medicines would help meet these needs, but there were cost and supply issues that would make it difficult for patients to have access to this drug. Knowing that access to this medicine was important for HIV patients in India and Africa, Bristol-Myers Squibb developed an innovative approach to ensure that patients had access to it through local generic companies at an affordable price. Bristol-Myers Squibb began the process of creating a technology transfer agreement.

A few years ago, Bristol-Myers Squibb performed the beginning stages of this important strategy to proactively engage generic partners early on in the manufacture of this drug to ensure that capacity and supply was sufficient and sustainable in the areas hardest hit by the epidemic -- Africa and India. The entire process of technology transfer from Bristol-Myers Squibb to Emcure was extremely successful, and included the transfer of active pharmaceutical ingredient (API), formulation, and regulatory expertise. Technical Operations and Regulatory teams from New Jersey, Connecticut, and Puerto Rico worked together with Emcure teams for weeks at a stretch. Because of this excellent teamwork, the transfer was successfully completed against very aggressive timelines, including the manufacture of API exhibit batches in a record period of five months.

As a result of this tech transfer last year, Emcure was able to make this drug available for the first time in India and plans to make it available in Africa in the near future. The introduction of this generic drug has created tremendous excitement among Indian clinicians, who were finally able for the first time ever to put patients on this drug in India. From the first day of the launch, the availability of this generic drug has renewed the hopes of many who had only limited options available to them.

Thanks to Bristol-Myers Squibb for their humanitarian efforts. It is indeed a remarkable step taken by Bristol-Myers Squibb to make their medicine accessible in India and Africa through tech transfer to Emcure, a company that shares similar beliefs and concerns for patient welfare. This innovative agreement demonstrates that through voluntary licensing and commitment to HIV, Bristol-Myers Squibb was able to bring its drug to the developing world, where it is helping to improve the lives of patients living with HIV. Bristol-Myers Squibb has done the right thing by reaching out to companies like Emcure that can assist in helping to ensure that patients in the developing world who need more treatment options get access to them.

Bristol-Myers Squibb has provided a model and a potential standard. Although HIV continues to devastate the lives of individuals, families, and communities, continued creative approaches to access and care, like tech transfer, represent meaningful steps toward treating this devastating disease.