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Thursday, 04/17/2014 5:21:53 PM

Thursday, April 17, 2014 5:21:53 PM

Post# of 30990
Roskamp taking over promising drug firm
Article from EIN Newsdesk: Sarasota Herald Tribune article.

Some quotes:
"
The Roskamp Institute, convinced of the value of an anti-inflammation drug that has shown promise, has taken over the beleaguered pharmaceutical company that developed it.
Roskamp managers plan to move Star Scientific to Southwest Florida.
Dr. Michael Mullan, the institute’s president and chief executive, will become CEO of the fledgling company.
Mullan is shutting Star Scientific’s offices in Washington, D.C.; Glen Allen, Va.; and Gloucester, Mass.; as part of the relocation of roughly two dozen company employees, who will be housed at Roskamp’s south Manatee County campus.
In time, Roskamp — recognized as a national leader in the battle against Alzheimer’s disease — and Mullan hope to secure Food and Drug Administration approval for an anti-inflammatory prescription drug that Star Scientific patented."

"Moving to Sarasota is one of the best things that could have ever happened to this company,” said Robert W. Scannell, whose San Francisco-based Tradewinds Investment Management LP owns just under 10 percent of Star Scientific’s 181 million shares.
“Dr. Mullan and his staff are truly world-class researchers,” Scannell said."

"But even Roskamp officials acknowledge that winning FDA approval for prescription status could cost millions and take three to five years to complete — if it can be completed at all.
Still, the payoff could be huge: Prescription arthritis drugs alone represent a $15 billion annual market."

"Star Scientific’s over-the-counter product, Anatabloc, is, for now, sold at GNC outlets and online. It has been sold for more than three years and has attracted a following for its ability to reduce swelling in joints.
“The key developmental question is, can it be developed for a number of inflammatory disorders?” Mullan said. “That is the strategy of the company, to see if we can develop them for a number of inflammatory disorders — arthritis, ulcerative colitis, maybe some immune disorders.”
Roskamp was drawn to Star Scientific primarily because of evidence that Alzheimer’s disease has a strong inflammatory component to it.
One Roskamp peer-reviewed study showed that anatabine can suppress brain inflammation, which affects Alzheimer’s disease sufferers.
“It does have this anti-inflammatory effect,” Mullan said. “It seems to signal to inflammatory cells to calm down.”

"Both Mullan and Roskamp officials have a personal stake in seeing Star Scientific succeed.
Senior housing developer Bob Roskamp, the institute’s founder, bought 1.5 million of Star Scientific’s shares beginning in 2010, said Ted Jenkins, the company’s head of corporate strategy and development.
Mullan owns warrants or stock options on some 6 million shares, Scannell said.
In all, Star Scientific has 181 million shares outstanding, equating to market capitalization of $143 million based on its recent price of 79 cents per share."
The first two of three phases in the agency’s “investigational new drug process” could take two years. But Star Scientific has a headstart, in that its anatabine compound has been in use for years.
Mullan said the company has kept extensive data on consumers’ experiences — including misuse by patients who have increased dosages beyond the recommended amount — that could expedite the FDA research.
“They may say: ‘Look, it is in the food chain, it has been in an awful lot of people. We haven’t had any serious adverse effects directly attributable to it,’ ” Mullan said.
Irv DeGraw, a professor of finance at St. Petersburg College, said that Roskamp’s involvement is encouraging.
“That’s probably their biggest endorsement,” DeGraw said.
The drug — with FDA approval — could become very attractive to a big pharmaceutical company, DeGraw said.
“I am sure they are looking to get somebody else to get involved, one of the big players,” he said. “Think about it. I am making progress with the FDA. Now I go to some of the big guys. If they like the idea, they will take it over. That happens a lot.”
That prospect has also occurred to Scannell, the investor.
“My guess,” Scannell said, “is that there will be conversations with a major pharmaceutical partner going on over the next two years, and that a deal of some sort will be struck.”
The stock, traded via over-the-counter exchange, has been extremely volatile during the past five years. At one point in July 2012, the shares rose to roughly $5 before sinking.
The price could rise dramatically if FDA approvals are obtained.
Mullan hopes to file an application with the agency by the end of June, though the institute has yet to state which medical condition it intends to target."

Entire article at:
http://tobacco.einnews.com/article/199245437/abbuh1QhyQXgoZrE?n=1&code=nijBwKk8HTxXIdEs

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