Depression drug TC-5214 earns USF its most lucrative patent royalties to date

A depression drug created and patented by a team of University of South Florida researchers is at the center of major deal between global pharmaceutical company AstraZeneca PLC and Targacept, Inc., earning the university its potentially most lucrative patent royalties to date.

The drug, TC-5214, is the invention of USF researchers Paul Sanberg and Douglas Shytle, retired USF psychiatry professor Archie Silver and former student Mary Newman.

On Dec. 3, AstraZeneca and Targacept announced a collaboration and license agreement for the global development and commercialization of TC-5214 as it enters its final stages of testing.

TC-5214 is viewed as a promising alternative to antidepressants currently on the market, about half of which do not work for people who suffer from depressions. Earlier studies have found TC-5214 more effective for those who have not been helped by commonly used drugs, and with fewer side effects.

"This is what everybody waits for when a university is engaged in technology transfer, to get something that really makes a difference to society," said Karen Holbrook, USF's Vice President for Research & Innovation. "It isn't just about doing research because it's exciting, but it's because it makes a difference to the people. Particularly in a public institution, everything we do is for some purpose. This is just dynamite."

Major depressive disorder affects about 42 million people worldwide. The global antidepressant market is valued at more than $20 billion.

Under the agreement, AstraZeneca will make an upfront payment to Targacept of $200 million upon effectiveness and up to an additional $540 million if specified development, regulatory and first commercial sale milestones are achieved. Targacept will also be eligible to receive up to $500 million if specified sales related milestones are achieved.

USF's will be paid a portion of royalties through its agreement with Targacept as the drug moves to market, said Valerie McDevitt, USF's Assistant Vice President for Research who oversees patents and licensing.

Details on the amount of USF's royalties are confidential under its agreement with Targacept, but McDevitt said TC-5214 will generate substantial revenue in the range of millions of dollars for the university and be its most lucrative patent to date.

"The reason this is exciting is that most treatments for depression only work in half of the patients," Shytle said. "This drug works with those who are treatment-resistant."

For USF researchers Sanberg and Shytle, last week's announcement caps a decade long journey in developing the drug which began in the search for an effective treatment for children with Tourette syndrome. The project led the researchers to discover a decades-old blood pressure medicine mecamylamine helped the children with their tic symptoms. It didn't, but it did help the children whose Tourette syndrome also included depression.

The researchers continued to study the drug, eventually creating a unique version of the medicine which was patented in the United States and abroad.

Their research was eventually supported by the Florida High Tech Corridor and through a series of events, ended up in a licensing agreement with Targacept, a North Carolina company which is a spinoff of tobacco giant R.J. Reynolds Tobacco Co.

"This has been a long and sometimes difficult journey, but this is a significant achievement that speaks to the value of investing time and resources into drug development and entrepreneurial research," Sanberg said. "This drug has the potential to positively impact millions of lives. This is an exciting day for us all."

If clinical trials of TC-5214 progress as planned, the drug could be ready for final approval in 2013, the researchers said.