to the rescue. HHS officials and other NIH announce the program to find new uses for old drugs.
HHS
The National Institutes of Health (NIH) today announced a new plan to stimulate drug development: It has an agreement with three large pharmaceutical companies to share abandoned experimental drugs with academic researchers so they can find new uses. NIH puts up $ 20 million for grants to study medicine.
"The goal is simple: to see if we can teach old drugs new tricks," said Health and Human Services Secretary Kathleen Sebelius at a press conference today that included representatives of Pfizer, AstraZeneca and Eli Lilly. These companies will give researchers access to two dozen compounds that have gone through safety studies, but has not done beyond clinical mid-stage trials. They stowed the drugs, either because they do not know enough about the disease for which they worked were developed or because a business decision the sidelined.
Often tens of millions of dollars and years of research have been devoted to these compounds, so they are already well along the drug development pipeline. The government program will allow the university to "Crowdsource" ways to use them, said director Francis Collins NIH. The idea for the refurbishment of the compounds is not new, he noted and others, the drug AZT AIDS, for example, began as a failed treatment of cancer.
NIH first started talking with companies on a drug rescue efforts at a workshop in April 2011. Uses The result Discovering New Therapeutic Molecules for existing program is "the first initiative signature "4-month-old NIH National Center for the advancement of translational sciences (NCATS), Collins said. NCATS plans to put $ 20 million of its $ 575 million budget request for 2013 in the new program.
researchers will be able to browse the basic information about online drugs. If they see one that interests them and successfully apply for a grant, they will have access to compounds and detailed data on safety , pharmacokinetics and administration. If the drug meets milestones in tests on animal models, they can receive funds to take in early clinical trials. NCATS Acting Deputy Director Kathy Hudson said NIH plans to possibly be eight to 10 cooperation agreements which will run up to 3 years.
The pilot program also includes a "model" legal agreement with the companies. The company retains ownership of the compound, but researchers will receive a new intellectual property they discover. The researchers are free to publish their results, although the company gets to review the manuscript to protect confidential information.
If a promising compound, NIH hopes that the original company (which has the first option to license him) or another company will take through clinical trials for advanced stage. Collins said NIH hopes the program will benefit research areas such as neurological diseases that businesses stepped back because of delays and uncertainty of long-term development success.
The new NIH program is similar to an agreement with AstraZeneca in December with the Medical Research Council U.K. share 22 compounds; it has already attracted more than 100 proposals, said Donald Frail, vice president of the unit of innovative medical science and new business opportunities.
Pfizer is interested in the NIH program because it already has a drug repurposing collaboration with Washington University in St. Louis and realized he needed a larger effort, said Rod MacKenzie, senior Vice President group, responsible for research and development pharmatheraupetics. "It gives us a chance to access a large scale ... the wonderful minds that we have in the university community," said McKenzie.
Although 24 compounds in addition to only a small fraction of the medications on shelves-MacKenzie companies said that Pfizer has "dozens" -NIH hope that more companies will participate. "I think people were waiting to see what this [program] like," said Sebelius.
NIH issued a request for information on the program today and expects to issue a request for pre-applications later this month.
* Correction, May 4: An earlier version of this article incorrectly stated that companies can not impose restrictions on the publication of results. The state of research agreements (ie Sec. 11 in agreement Pfizer) that the company has the right to examine and revise manuscripts to protect confidential information. The Company may also request the submission to be delayed for 30 days so that it can apply for a patent.
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