Novel Partnerships Evolve Drug Development (cont.)
Johnson & Johnson and the Gates Foundation are also collaborating on development of a new HIV-prevention technology. “So far we’ve collaborated on expanding the preclinical work, and we will soon be going into human development,” says Plumley. “We’ll have other partners involved going forward, but the work between Johnson & Johnson and the Gates Foundation is a strong, strategic, comprehensive relationship.”
Another important collaboration is with the Clinton Foundation. “We’re working on a commercial indication in HIV,” says Plumley. “With the help of the Clinton Foundation, we’ll make sure we can get the drug to patients in Africa rapidly after approval in the U.S.”
TOGETHER EVERYONE WINS
“Our work with the TB Alliance has both a social and business motivation,” says Plumley. “TB is a bacterial disease, and the work Tibotec researchers are doing, as well as their learnings from joint oversight of the overall development of TMC207, is applicable to the Company’s antibiotics research for the commercial market.”
That’s not the only potential commercial benefit. The Food and Drug Administration Amendments Act of 2007 awards a transferable priority-review voucher—meaning that the FDA will review a drug application within six months instead of the standard 10 months—to any company that obtains approval for a treatment that addresses a neglected tropical disease. Vouchers of this kind are an incentive to develop new medicines for developing-world diseases such as malaria, TB and African sleeping sickness.
The agreement with the TB Alliance provides that Tibotec will receive the priority-review voucher if it is the first applicant to receive U.S. FDA approval of TMC207 for a TB indication. That could be very beneficial for the Company, since the voucher can be applied to any medicine in the appropriate stage of development.
“Society is moving more and more to an environment where the philanthropic will merge with the business,” says Plumley. “In a sense, that’s as it should be—it’s not a question of doing what you’ve got to do for the business without thinking of the community or, conversely, doing for the community without thinking about the business implications.
“Johnson & Johnson shareholders will benefit from the commercial development of a TB compound, but what’s interesting is that Johnson & Johnson can see benefit defined in a broad way, inclusive of social benefit,” he says. “There is an openness to collaborate in different ways. It’s no surprise that Johnson & Johnson and others at the forefront of developing these kinds of novel collaborations are those rooted in a strong commitment to their communities.”