In 1995, our Chemicals Division received a phone inquiry from a biopharmaceutical company that was developing drugs for a relatively new class of therapeutic agents — antiretroviral drugs — to treat HIV/AIDS and liver disease. The query was in reference to an advanced intermediate (building block chemical) that goes in to the synthesis of an active pharmaceutical ingredient.
At the onset of this project, it became clear that the intermediate chemical needed was not commercially available. Therefore, it would have to be custom manufactured to specification. We considered the chemistry involved, and reached out to our vast network of suppliers, which includes companies with varying manufacturing capabilities. We soon realized that aside from having the manufacturing capabilities to make this advanced intermediate chemical, our supplier needed to be vertically integrated with the starting materials for the project to succeed.
Within a reasonable time, we identified the appropriate partner to help develop this advanced intermediate for our biopharma customer. Through close collaboration among all three parties, we assisted our customer advance through the various stages of clinical trials with the US Food & Drug Administration (FDA). By 2001, our customer received FDA approval to market the antiretroviral drug for the treatment of HIV infection in patients 2 years of age and older, in combination with other antiretroviral drugs. The product’s instant commercial success made it a target for other biopharma companies that manufacture complementary antiretroviral agents to team up together in order to offer combination therapy products, further enhancing the effectiveness of this category. Within a year, the antiretroviral drug also received approval in Europe.
The effectiveness and safety profile of this product were so strong, the FDA and European authorities also approved it for chronic hepatitis B virus in patients 12 years of age and older in 2008.
The importance of this product (and its effect on so many lives) even garnered the attention of former US President Bill Clinton who, through the Clinton Foundation, teamed with biopharmaceutical companies that market these medicines to deliver them to patients in Africa at little to no cost. This remarkable challenge was met through the cooperation of many agencies — public and private.
The success of this new class of HIV medicines, its positive impact on the lives of millions, how it all got started, and knowing we had a small hand in the story, makes us feel really good about ourselves. This is one of many success stories CellMark’s Chemicals Division has produced over its long, rich history (which dates back more than 120 years). Contact our Chemicals teams to see how we can help you build your next success story.