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Cancer charity is to “borrow” candidate drugs shelved by companies

London Susan Mayor

In a major initiative to develop new cancer drugs Cancer Research UK will “borrow” candidate drugs that have previously been shelved by drug companies so it can further explore their potential, under a special arrangement announced last week.

The initiative, called Clinical Development Partnerships, will mean that Cancer Research UK and Cancer Research Technology, the charity’s development and commercialisation arm, will be able to use drugs that companies have developed but decided not to develop commercially.

The charity will effectively borrow a drug from a company and conduct early clinical trials at no cost to the company. If the drug looks promising the company retains the option to develop and market the drug, but the charity will get a share of any revenue.

Harpal Kumar, chief executive of Cancer Research Technology and chief operating officer of Cancer Research UK, said: “Cancer Research UK has set an ambitious target to double its drug development activity over the next five years, and we are seizing an opportunity to seek out new treatments that otherwise might not be developed.”

Under the new scheme a scientific advisory board at Cancer Research UK will review drugs that companies have developed preclinically but have decided not to take further. He explained, “This may occur when companies merge and end up with several relatively similar agents in their portfolio and have to limit the number taken forward or when agents are likely to be used in only a small group of patients, such as for a rare type of cancer.”

Drug development is time consuming and costly; a new anticancer drug may take longer than 10 years and hundreds of millions of pounds to develop. “So anything that doesn’t look extremely promising is not developed by a pharmaceutical company,” Mr Kumar said.

“Companies have hundreds of molecules that they have decided not to take forward. They choose which ones to develop, based on the information they have available and commercial factors, but history suggests that the ability to pick winners is rather low. So there are lots of drugs not developed that might be effective treatments.”

The scheme will prioritise drugs that act by mechanisms that have been shown to be important in cancer in laboratory and animal models. These are unlikely to be conventional cytotoxic drugs but more likely to be agents targeting specific receptors or proteins, with small molecules and monoclonal antibodies as potential candidates. “Ideally we will be interested in drugs with a complete preclinical package, including laboratory, scientific, and toxicological data,” Mr Kumar said.

Cancer Research UK will test the agents in phase I and early phase II trials. It will then share the results with the drug company that has “loaned” the agent, which then has the option to develop the drug commercially. If the company decides against this the charity can then find another commercial partner to make the drug available to patients.

Richard Tiner, medical director of the Association of the British Pharmaceutical Industry, the organisation representing drug companies in the United Kingdom, said: “This is a simple, rapid, and cost effective way in which pharmaceutical companies can boost their product lines. Companies will retain intellectual property rights to their original molecules and first option to view the trial data so should have no reservations about loaning these compounds to Cancer Research UK for further investigation.”

Mr Kumar considered that loaning undeveloped drugs to Cancer Research UK was an attractive proposition for companies. He explained that companies were reluctant to pass their “de-prioritised” agents directly to other companies for early clinical research in case the drugs they had shelved turned out to be blockbusters. “We are a government funded body not interested in making money—only developing new drugs for patients with cancer—so the risk of commercial embarrassment is removed,” he said.

In the United States a scheme whereby the National Cancer Institute was to borrow agents from drug and biotechnology companies for rare cancers was cancelled before its launch because of funding cuts to the institute, Mr Kumar said.

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Urgent correction

Steve Palmer
bmj.com, 15 May 2006 [Full text]