3TC® is a rare achievement: a breakthrough in scientific research, a drug brought to the world by two innovative companies, a treatment that has changed the lives of a vast number of people living with HIV/AIDS everywhere. “History will likely regard 3TC®, next to insulin, as Canada’s greatest contribution to medical therapies in the twentieth century,” says Dr. Mark Wainberg, President of the International AIDS Society.

The story of how 3TC® came to be goes back to 1986 when three Canadian research scientists joined forces to achieve a long-time dream – the creation of a leading research-based Canadian biopharmaceutical company. The company was to become BioChem Pharma, and the research scientists were Dr. Francesco Bellini, who is now the company’s President and CEO; Dr. Gervais Dionne, BioChem’s Executive Vice-President, Research and Development; and the late Dr. Bernard Belleau, a distinguished organic chemist and professor of chemistry at McGill University.

Early on, BioChem Pharma decided that one of its focus activities would be HIV/AIDS. At the time, Retrovir® (AZT™) was the first and only antiviral production on the market to treat what had become the most notorious virus of the decade. There was an obvious unmet medical need.

In the late eighties, innovative science produced a promising breakthrough. Dr. Belleau and the small team of researchers from McGill University who had joined him at BioChem Pharma discovered a new class of compound for a drug that was to become 3TC®. But the initial discovery was only the beginning.

Based on this new approach, it took a year and a half of intensive work for BioChem to develop a number of compounds for in vitro testing.

Initial compounds that Dr. Wainberg tested at McGill University on behalf of the company were not active against the virus. However, one among the second series, BCH-189, did show promise and Dr. Belleau reported the findings at the fifth International Conference on AIDS held in Montreal in the summer of 1989. Dr. Belleau saw the promise of his discovery confirmed, but, sadly, died suddenly in September 1989.
 

Approved in most major countries, 3TC is commercialized in Canada through a partnership between BioChem Pharma and Glaxo Wellcome, and elsewhere in the world by Glaxo Wellcome. [Photo, courtesy BioChem Pharma]

It was now up to the other members of the BioChem team to move his discovery from the laboratory to persons in need, a task almost as daunting as the discovery itself. In 1990, the company had only 50 employees – neither the people nor the financial resources to single-handedly develop the drug. BioChem needed a strong partner, a large firm with clinical development, manufacturing expertise, and pharmaceutical marketing that could make 3TC® available globally after it was approved.

The ideal candidate turned out to be U.K.-based Glaxo, now Glaxo Wellcome, which eventually would play a vital role in the development of 3TC® for worldwide commercialization. Within Canada, BioChem Pharma and Glaxo Wellcome entered into an agreement to jointly commercialize 3TC®.

A partnership of this kind was unique in the pharmaceutical industry at the time. The two companies combined their efforts to meet the urgent needs of people living with a fatal infection and, in doing so, began an industry trend. Says Dr. Dionne, “We decided that to give people living with HIV/AIDS access to the product as soon as possible, and to minimize risk, it would be much better to partner with a large company.”

The agreement with Glaxo Wellcome was a milestone in the development of 3TC®. Pivotal pre-approval clinical trials ran worldwide from April of 1991 to March of 1995 and it became increasingly clear that the health of people being tested with this new drug had improved remarkably: they were gaining weight, and feeling better, and there were many reports of people who had come back from their sick beds to assume normal activities.

Given the remarkable results of the trials, Glaxo Wellcome wanted to ensure that patients had easy access to this drug while it was still being tested. It therefore created the largest compassionate access program in the history of any medication. 3TC® was made available to more than 45,000 people living with HIV/AIDS worldwide, about 3,000 of whom were in Canada.

Glaxo Wellcome also met regularly with representatives of the HIV/AIDS community. The company wanted to keep them informed of its development plans for 3TC® but also wanted to consult with them on the clinical trial designs and to obtain their feedback.
 

In tribute to the breakthough represented by 3TC, the prestigious Prix Galien (Canada) 1996, in the innovative research category, was awared to the antiviral research team of Bio chem Pharma, including members of Glaxo Wellcome and McGill University, and in 1997, to BioChem Pharma and Glaxo Wellcome in the innovative product category. [Photo, courtesy BioChem Pharma]

“It was a good model and we learned a lot. There’s no reason we shouldn’t be able to do it with other types of diseases,” says Dr. Michael Levy, Senior Vice-President, Medical Sciences, and Chief Medical Officer at Glaxo Wellcome.

Finally, in the autumn of 1995, 3TC® was approved for commercialization in the United States and Canada. “That was the fastest drug approval in the history of Canada as far as I know,” says Dr. Levy. Later on, in 1996, 3TC® was approved in Europe and elsewhere. In that year, it became the most prescribed HIV medication in North America and, today, 3TC® is the cornerstone of HIV/AIDS combination therapy around the world.

In 1996 the researchers who worked on the drug from BioChem Pharma, Glaxo Wellcome, and McGill University, including the late Dr. Belleau, were awarded the prestigious Prix Galien (Canada) for innovation in research. Then again, in 1997, the Prix Galien was attributed to the two companies for 3TC® in the innovative product category, marking the first time that this award has ever been granted for the same product two years in a row.

And 3TC® for HIV/AIDS has opened other paths as well. It not only represents highly innovative medicine as an antiviral agent but also helped demonstrate the efficacy of combination therapy in this area, a scientific breakthrough in itself.

Both BioChem Pharma and Glaxo Wellcome continue their commitment to research and their focus on HIV/AIDS. Their success with 3TC® has radically improved the prospects of thousands of people who are now living longer and better lives.

Staff