Sinus drug looking good for Mayo

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Sinus drug looking good for Mayo

9/6/2007

Post-Bulletin - Rochester,MN,

By Jeff Hansel

http://www.postbulletin.com/newsmanager/templates/localnews_story.asp

?z=7 & a=306561

Mayo Clinic could make millions in royalties if a drug company

continues to see good results.

Mayo licensed its patent for an antifungal treatment for chronic

sinusitis to publicly traded drug-development company Accentia

Biopharmaceuticals.

Mayo got patents in both the United States and European, as required

by the National Institutes of Health. Accentia has since developed a

nasal spray called SinuNase.

The drug, intended as a daily nose spray to keep fungi from

multiplying, is currently in a phase III, placebo-controlled

clinical trial, to see if it works without serious side effects.

Accentia expects SinuNase to be the only drug on the market labeled

to treat chronic rhinosinusitis if final study results flourish and

the Food and Drug Administration gives market approval.

Preliminary results released in August look good.

Mayo might get up to tens of millions of dollars annually to spend

on research if Accentia gets federal approval to take the chronic-

nasal-infection drug to market.

Mayo research showed fungal infections cause the chronic nasal

infections. Antifungal treatments relieved the symptoms.

Accentia sought patients whose surgery failed to relieve symptoms

for a phase III placebo-controlled study. The company now says

nearly half the patients in its study " with objective evidence of

improvement " experienced " complete resolution of the two key

cardinal symptoms. "

That could be surprising for doubters who have long thought bacteria

are the cause of sinusitis.

The company will have to wait until the study's end to show if

results are statistically significant.

Yet the interim results passed a critical test; they showed no

reason to discontinue the trial, said Bonitz, Accentia's

director of program coordination.

Last year, Jefferies & Company, Inc. of New York estimated SinuNase

could produce annual sales in excess of $1 billion for Accentia,

with Mayo getting 16 percent of the company's annual profits from

the drug.

A Mayo official declined to confirm that percentage.

" Market analysts say all kinds of things, " said Kathy ,

spokeswoman for Mayo's Office of Intellectual Property.

But Accentia's Bonitz agreed with the analyst and confirmed, " that

figure is correct. "

The researcher who developed the formula, Dr. Jens Ponikau, no

longer works for Mayo. But Ponikau would still get a cut of any

money Accentia gives Mayo from SinuNase sales.

That means, depending on Accentia's business savvy and profit

margins, Mayo could take in anywhere from a few to tens of millions

of dollars annually, with Ponikau getting a big chunk of the money.

According to Accentia, rhinosinusitis affects 35 million Americans,

and 90 percent of cases are chronic. About a half million people

annually resort to surgery, because there are no Food and Drug

Administration-approved medicines on the market.

Even after surgery, many with the condition continue to suffer

from " nasal congestion, facial pain and pressure, nasal discharge

and headaches. "

Antibiotics can quell flare-ups. But they don't stop the primary

cause -- fungal infection -- according to Mayo Clinic research.

Patients simply spray the SinuNase mixture into their noses daily.

Mayo officials avoid discussing their potential financial windfall,

which would fund additional Mayo research. That, said, is

to prevent the appearance of supporting a drug that has yet to

receive Food and Drug Administration approval.

But Accentia's Bonitz said Mayo's the right place for such money to

go.

" What we believe is that right now it's better for the royalty to

accrue to the benefit of an institution like Mayo, rather than to a

commercial licenser, " she said, " because Mayo can use the money to

benefit it's outstanding programs in clinical research, patient care

and medical education. "

Bonitz said Accentia expects the study to be complete by the end of

the year. If results look good for SinuNase, she said, the company

could expect final FDA approval in 2009. Market launch is expected

in 2009, Bonitz said.