Award for Major AIDS Drug Deal

The staff of the Yale University Office of Cooperative Research, which participated in the AIDS drug deal.

Despite over thirty years of research, HIV/AIDS is still one of the world’s foremost public health issues, especially in developing countries. According to the World Health Organization, an estimated 33.3 million people around the world were living with HIV as of 2009, the most recent year for which data is available. Although no one has developed a cure yet, a licensing agreement between Yale, Japanese biotechnology firm Oncolys BioPharma, and U.S. pharmaceutical giant Bristol-Meyers Squibb (BMS) will enable the promising antiretroviral drug, festinavir, to be developed as a treatment. The deal, valued at $286 million in various payments in addition to royalties on sales, was recently recognized by the Licensing Executives Society (LES). LES granted the Deals of Distinction Award to Yale’s Office of Cooperative Research (OCR), Oncolys, and BMS.

Festinavir (also known as 4’-ethynylthymidine or 4’-Ed4T) is an orally available nucleoside analog reverse-transcriptase inhibitor (NRTI). Ordinarily, HIV converts its RNA-based genome into DNAin a process called reverse transcription. The viral DNA is then inserted into the host cell’s genetic code, causing the cell to produce more copies of the virus. NRTIs inhibit reverse transcription, preventing the infection from taking hold. Festinavir was derived from the older HIV drug, stavudine (d4T), by the addition of an ethynyl group at the 4’ position. Festinavir has shown promising clinical safety and efficacy in a Phase Ib/IIa study.

From the beginning, the development of festinavir was a collaborative effort between Yale and its partners. Research into the compound was led by Yung-Chi “Tommy” Cheng, Henry Bronson Professor of Pharmacology at Yale; Professor Hiromichi Tanaka of Showa University in Japan; and Professor Masanori Baba of Kagoshima University, also in Japan. Oncolys supported work to further understand the biology of the compound, cementing a “particularly strong working relationship” between Oncolys, Yale, and the Japanese universities, according to David Lewin, senior associate director of licensing at OCR.

“The history of close collaboration between Yale and Oncolys helped bring the strengths of both together to advance the development of festinavir,” says Lewin. “The business doesn’t stand in the way of the primary mission of the University, [which is] to generate and disseminate knowledge.” Instead, licensing is a method of disseminating knowledge.

Such collaboration, along with Oncolys’s expertise and significant investment in festinavir, made festinavir appealing to major pharmaceutical companies like BMS. According to a study cited by Lewin, 30% of new drugs fail for economic reasons, and not because of safety or efficacy. The development of festinavir was, therefore, an “exercise in the mitigation of risk” as well as a scientific challenge.

Once the hurdle of getting BMS onboard with the drug was cleared, there was still the challenge of actually negotiating an agreement between the three parties, which proved to be a task so complex that it earned Lewin and his colleagues at OCR, Oncolys, and BMS the Licensing Executives Society award. “There was a need to harmonize different agreements” between Yale, Oncolys, and BMS to close the deal. After numerous rounds of negotiations and proposals, an agreement was reached between Yale, Oncolys, and BMS to continue development while anticipating the need to make festinavir available in developing countries, a shared priority among all three organizations.

The LES Deals of Distinction Award recognizes the hard work of all three parties in reaching such a complex agreement. Finding a cure for AIDS will require more than basic research; it will require the coordination of groups from all levels of academia, industry, and government to, as Lewin says, “advance basic research findings to bring general benefits to patients.”