Quimica Articulo

Published online 20 July 2011 | Nature475, 275-276 (2011) | doi:10.1038/475275a
News
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Charities seek cut of drug royalties
Non-profits that support medical research are angling for a share of the proceeds and intellectual-property rights.
Heidi Ledford
Early next year, a drug for cystic fibrosis is expected to come before the US Food and DrugAdministration for approval. It is a moment that the Cystic Fibrosis Foundation (CFF) will have waited 12 years and invested US$75 million to witness. Approval of the drug, VX-770 — developed by Vertex Pharmaceuticals of Cambridge, Massachusetts, with support from the foundation — would provide a new treatment for patients, and a revenue stream for the charity.
The CFF, based in Bethesda,Maryland, has a stake in the intellectual property underlying VX-770, and is entitled to royalties from sales of the drug. Such 'venture philanthropy' is increasing among charities. Like venture capitalists, non-profit groups are managing research projects, making funding dependent on the projects reaching predetermined milestones and potentially reaping a financial return. They are also keeping controlover the fruits of their investment in case the journey from lab to treatment encounters obstacles.
SOURCE: FOUNDATION CENTER
"Philanthropies are looking to have more of a hand in managing intellectual property," says Timothy Coetzee, chief research officer of the National Multiple Sclerosis Society in New York, and former president of Fast Forward, the society's venture-philanthropy arm.Philanthropic donations for medical research are increasing (see 'Growing influence'), even as government granting agencies tighten their purse strings and venture capitalists cut back on biotechnology investments. As a result, non-profits have more bargaining power than ever before — especially for early-stage, high-risk projects that tend to be unattractive to private and federal investors.
"Thecharities are providing funds at the time when the risk is the very highest," says Ken Schaner, an attorney at Schaner & Lubitz — a law firm in Bethesda, Maryland, that specializes in working with non-profit organizations. "But yes, they expect a return." The CFF is not alone: charities including the ALS Association in Washington DC, the Muscular Dystrophy Association in Tucson, Arizona, and theWellcome Trust in London have also demanded royalties from some projects. Schaner says that the value of the return often depends on the size of the investment — for example, a foundation might be entitled to six times its input. In some cases, Schaner estimates that the payout could be as much as $1 billion.
“The charities are providing funds at the time when the risk is the very highest. Butyes, they expect a return.”

But organizations aren't interested only in generating revenue for their charitable work. Their involvement also helps to ensure that therapies reach the people who need them, in case anything happens to the drug companies with which they are collaborating.
In 2000, Schaner worked with the CFF to carve out a deal with Aurora Biosciences in San Diego, California — apharmaceutical company that was later sold to Vertex — to develop the drug that was to become VX-770. The deal was one of the first examples of venture philanthropy.
But Schaner says that he couldn't sleep the night after the deal was signed. "I started thinking about what would happen if Aurora lost interest in the project. It could just sit there on the shelf untouched," he says. So he created an'interruption licence' that is now used widely to give charities the intellectual-property rights behind a project if a company abandons it.
Those rights came in handy in another deal. The CFF had invested about $25 million in a recombinant enzyme that could treat pancreatic deficiencies in people with cystic fibrosis. When the developer, Altus Pharmaceuticals in Waltham, Massachusetts,...