An "energized and gratified" SuperGen Inc. received FDA approval for Mitozytrex - its proprietary version of generic mitomycin and the first drug the company has moved from start to FDA finish - thereby demonstrating the company's drug development engine is in fine working order, said its chairman and CEO, Joseph Rubinfeld.
"We have the machinery in place," Rubinfeld told BioWorld Today. "Everything is in place, you know what I mean?"
Rubinfeld said the company had a "small celebration" to mark the event before releasing the news Friday morning. SuperGen's stock (NASDAQ:SUPG) rose 60 cents Friday, or 14.7 percent, to close at $4.69.
Mitozytrex (MitoExtra) is now cleared for marketing in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as a palliative treatment when other modalities have failed. It is the first drug Dublin, Calif.-based SuperGen had approved using its "supergenerics" Extra technology platform, a platform that is designed to churn out generics that stand above the crowd and can carve out their own niches.
In Mitozytrex's case, the drug provides a "shielding benefit," SuperGen said. The toxicity of certain anticancer drugs that are administered intravenously can cause ulceration of the skin if the injection misses the vein, but the Extra technology is designed to shield the drug from the injection site and therefore protect patients.
The market for generic mitomycin is in the range of $10 million to $15 million annually, Rubinfeld said. With aggressive marketing, he hopes Mitozytrex can eat up as much as 30 percent of that market.
So, while Mitozytrex "doesn't cure cancer any better" than other anticancer generics, it has the shielding effect, plus increased solubility, stability and shelf life, Rubinfeld said. It's a product he is proud of and the concept is his baby. He sees a list of cancer drugs that could benefit from the platform.
"This is like a wild card," he said. "This is what I founded the company on. It was my invention and I started the company on it." At first, he said, the company was called SuperGenerics, but he changed the name to SuperGen to reflect more of a biotechnology angle and de-emphasize generics. But times have changed in the drug industry.
"Generics is not a dirty word anymore," he said. "The political atmosphere has it so that generics will take over the marketplace." The generic products SuperGen wants to offer, he said, and now is offering with Mitozytrex, have an extra edge that could bring "a premium price and market share."
SuperGen sells Nipent, a chemotherapy agent approved for hairy-cell leukemia, although it is in trials for other indications. It offers mitomycin, a generic version of Mutamycin. Orathecin and decitabine are in late-stage development. With the approval of the supergeneric Mitozytrex, SuperGen is rounding itself out.
"I feel we have the best portfolio around," Rubinfeld said. "We are in generics, supergenerics and proprietary drugs. I'm quite bullish on the future now."