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Big drug development expected to bring millions to USF

TAMPA — A promising anti-depression drug created at the University of South Florida stands to become USF's most lucrative patent ever, thanks to a major pharmaceutical deal announced Thursday.

USF expects to reap millions of dollars up front, with revenue growing well into the future if a drug now known as TC-5214 makes it into the $20 billion market for antidepressants.

The drug evolved from USF research into using a nearly forgotten high blood pressure medicine as a treatment for Tourette's syndrome. That didn't pan out, but it led to the discovery of a new drug that appears to relieve depression.

USF administrators described its development as a serendipitous twist that could bring the university a big payoff.

"We all know Gatorade, and we all know some of the big names," said Karen Holbrook, USF's vice president for research and innovation. "One of those is hitting the University of South Florida."

The name is AstraZeneca, one of the world's biggest pharmaceutical companies.

On Thursday, AstraZeneca announced it would make a $200 million payment to a North Carolina company called Targacept, which has a license agreement with USF, in a joint effort to develop the drug, win FDA approval and market it.

USF will get an undisclosed cut of that payment, as well as further payments and royalties if the drug is approved and finds a market.

That will take at least two years, but the long-range potential is big. AstraZeneca will pay Targacept another $540 million if development, regulatory and initial sales milestones are met. And there's another $500 million, plus double-digit royalties, for Targacept if further global sales goals are met.

USF, which holds the patent for TC-5214, has a license agreement with Targacept for a percentage of the milestone payments plus royalties if the FDA approves the drug.

USF patents for genetically engineered mice used to study Alzheimer's disease have brought millions of dollars to the university, according to Valerie L. McDevitt, assistant vice president for research in USF's technology licensing office. Those, however, don't have the cash-generating potential of a therapeutic drug.

Under university policy, 45 percent of the revenue goes to USF to support its research mission. Another 45 percent will go to the four inventors whose names are on the patent:

• Paul R. Sanberg, a distinguished university professor, director of USF's Center for Aging and Brain Repair and associate vice president for innovation.

• Archie Silver, the retired director of child and adolescent psychiatry at USF. Silver, now in his 90s, lives in an assisted living facility.

• R. Douglas Shytle, an associate professor and research scientist in the Center for Aging and Brain Repair and the USF Silver Child Development Center.

• Mary Newman, who started working with white lab rats as a USF undergraduate and ended up helping with the research that led to the development of the new drug. She went on to get a doctoral degree from USF and is now a research scientist and associate professor at Rush University Medical Center in Chicago.

The final 10 percent of the revenue will go into research accounts for the inventors who are still at USF.

The drug grew out of research the scientists were doing in the mid 1990s using nicotine patches as a possible treatment for Tourette's syndrome.

They noticed that the constant exposure to nicotine desensitized the brain receptors that react with nicotine. So they decided to look for another drug that blocked those receptors but without nicotine's side effects, especially in children.

Sanberg sat down with the Physicians' Desk Reference and found mecamylamine, a hypertension drug Merck sold in the 1950s.

Further research with mecamylamine and a variant of that old drug that the USF scientists engineered themselves didn't pan out for treating Tourette's syndrome.

But the scientists noticed something else.

"It was probably after the third or fourth patient Dr. Silver treated," Shytle said. "He came to my office and said, 'I think we've discovered a new antidepressant.' "

So the USF team patented their version of the drug and went looking for partners in the pharmaceutical industry. The first went out of business, so the drug ended up with Targacept.

Under the deal announced Thursday, the companies will explore using TC-5214 to treat major depressive disorder, which afflicts an estimated 42 million people worldwide.

Serotonin reuptake inhibitors (SSRIs) are commonly prescribed for depression, according to Targacept, but many patients do not respond to them.

The USF drug is different than SSRIs because it works on a different set of receptors, those that respond to nicotine.

So far, the USF drug has been studied in a large clinical trial of adults whose major depressive disorder did not respond adequately to the SSRI citalopram, a widely used antidepressant sold under the brand name Celexa.

Targacept said patients who received citalopram and TC-5214 together responded better than those who got the citalopram and a placebo. The most frequent adverse effects were headaches, dizziness and constipation.

The drug faces more clinical testing before it can be approved for sale, but on Thursday, USF administrators were elated that a major player like AstraZeneca had signed on.

"As the drug goes on the market, we will continue getting royalties," Holbrook said. "This is the starting point. This is long-term gain. And that's why I say this is a huge deal."

Richard Danielson can be reached at danielson@sptimes.com or (813) 226-3403.

FAST FACTS

About TC-5214

. Evolved out of research at USF's College of Medicine in the mid 1990s.

. Based on an old drug used for hypertension.

. Works by blocking the brain's receptors for nicotine. SSRIs, a common type of antidepressant, block receptors for serotonin.

. Adverse effects in a recent clinical trial: headaches, dizziness, constipation.

What's next

A larger trial in mid 2010 and the possible filing of a new drug application with the U.S. Food and Drug Administration in 2012.

Big drug development expected to bring millions to USF 12/03/09 [Last modified: Friday, December 4, 2009 1:37am]
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