Dad-daughter pharmaceutical team looks to ease cancer patients' pain
www.miami.com
Posted on Wed, Mar. 19, 2003
BY JOHN DORSCHNER
jdorschner@herald.com
HIGH HOPES: Rosanne Satz, above, and her father, Stanley, run Bio-Nucleonics, which got FDA approval for a proposal for the painkiller strontium chloride
Think of Bio-Nucleonics as the Little Pharma that could.
Big pharmaceutical firms spend hundreds of millions of dollars and have teams of lawyers and scientists to help get drugs approved by the Food and Drug Administration.
Miami's Bio-Nucleonics has Stanley Satz and his daughter, Rosanne.
And they have slogged their way through developing a three-inch-thick FDA proposal for strontium chloride Sr-89, a radioactive isotope with which to reduce cancer pain.
''You can't imagine the work that goes into this,'' Rosanne says with a sigh.
The process took 882 days.
She counted.
''We put our life savings into this,'' she explains.
And while ImClone and many others have seen highly touted products get slammed by the FDA, Bio-Nucleonics received approval for its strontium in January.
The Satzes and their small band of employees celebrated with dinner at a North Beach Italian eatery -- then went right back to work the next morning.
The firm now has a dozen employees working out of a warehouse just north of downtown Miami, manufacturing a product that has yet to meet the scrutiny of not only the FDA but also of the Nuclear Regulatory Commission.
''We have to respond to two gods,'' Stanley says with a sigh almost as big as his daughter's. ``Nuclear is one of the most regulated, if not the most regulated, areas in the country.''
NUCLEAR BACKGROUND
Stanley Satz's background is in the Cold War nuclear field -- he doesn't say any more about it than that -- and he decided in 1996 to start a business in nuclear medicine.
His daughter was just finishing business studies at Florida International University, and she jumped aboard.
He became president and chief technology officer. She was named chief executive officer and chief operating officer ''as well as the person dealing with the media.'' Staffers, she jokes, often refer to her as the ``cheap operating officer.''
While starting to develop drugs, Bio-Nucleonics did a side business exporting radioactive isotopes, mostly to Venezuela, where they were used as markers in oil exploration. This kept the company going for a while, but it ceased the export activities as the pharmaceutical side developed.
It also worked hard on obtaining grants, including one of $200,000 from Enterprise Florida. Altogether, the Satzes say, the firm has received almost $3 million in grant money that is being used to develop drugs that are still a long way from market.
The Satzes say nothing from those grants went into their strontium product, which they developed as something to give them income while their other ideas were in development.
They decided to target Metastron, a strontium isotope manufactured by Amersham, a British company.
As a basic element, strontium can't be patented, of course, but Amersham had shown the FDA that an injection of strontium was effective in treating severe cases of cancer pain.
Because Amersham had gone through the FDA's approval hurdles, the federal agency gave the firm five years of exclusivity for the product. That exclusivity had lapsed when the Satzes began looking at strontium.
But Bio-Nucleonics still had to show the FDA that it could produce the isotope in a safe, pure form. The Satzes hired a consultant to explain the FDA process to them.
''He just consulted,'' Rosanne says. ``He didn't do the application. We did.''
Now, Bio-Nucleonics has contracted with a radio pharmacy distributor -- ''We promised not to say who,'' Rosanne says -- to use its salesmen and system to distribute Sr-89.
Rosanne declined to say what the company is charging, but if it's like other generics, the price is likely 20 to 30 percent under the $3,200 or more that Amersham charges.
A SINGLE SHOT
Strontium is given to a patient in a one-time shot. Rosanne sees the potential market as 200,000 to 300,000 patients with prostate, lung or breast cancer that has spread to other areas.
The shot starts easing pain within two weeks and reaches its peak effect within six weeks. The pain relief lasts three to six months. During that six-month period, the strontium shot costs as much as other severe pain alternatives, such as morphine.
Strontium may increase pain briefly the first two days after its administration, but the Satzes say it has far fewer side effects than morphine, which can cause vomiting, nausea and an inability to function.
They add that Amersham brought in $36 million in 1997 on this pain product and that a similar radioactive isotope is earning about $1 million a month.
Compared to Nexium and Viagra, this is a small market. For a pop-and-daughter operation, it's a major chance.
''We could be profitable with this product,'' Rosanne says, ``but this is just the beginning.''
She declines to talk about what else is in Bio-Nucleonic's pipeline, but trade publications report that the firm received $1.5 million in August 2001 from the U.S. Department of Commerce to develop an alloy for use in a stent to prop open arteries after angioplasties.
THE BIG LEAGUES
Bio-Nucleonics is looking to create an alloy that could kill scar tissue by having a short-lived, low-level beta radiation.
With this, the Satzes are entering a Big Pharma arena. Miami Lakes-based Cordis has spent more than $600 million to develop the drug-eluting Cypher stent, which is expected to get FDA approval within the next few weeks.
Rosanne knows they're going to need more funds.
''Absolutely,'' she says. ``You're always looking for money.''
For now, her father remains unwilling to sell a huge stake in the company to get investors.
''We're not,'' he says, ``selling the sizzle.''