Trius Puts the Brakes on IPO Plan, While It Adjusts to New FDA Clinical Guidelines
[Updated: 4:05 pm Eastern, 3/5/10, with company comment] San Diego will have to wait a while longer for another biotech IPO. Trius Therapeutics, the San Diego-based developer of an antibiotic against dangerous MRSA infections, said this week it has postponed its plan to go public while it adapts to new guidelines from the FDA that will affect its plans for a pivotal clinical trial.
Trius was pretty far along in the IPO process before it hit the brakes. The company filed its prospectus in November, set a price range of $12 to $14 in the last week of February, and was on the calendar to begin trading the week of March 15, according to Renaissance Capital. Credit Suisse, Piper Jaffray, Canaccord Adams and JMP Securities were set to be the lead underwriters on the deal, which was intended to raise as much as $96.6 million for the company.
The company didn’t say how long it expects the delay to last. But it said in a statement on Monday that it believes the FDA’s draft guidance on proper conduct of so-called “non-inferiority” trials—which basically show a new drug is about equally effective as an old one—”will provide greater clarity to the process of finalizing the design of its Phase 3 trials.” That means the IPO will be delayed until the new clinical trial protocol can be modified.
“It’s important to note that the registration statement is still on file, they did not withdraw it,” says Jason Spark, an outside spokesman for the company. “Rather they have only temporarily delayed the process until they get clarity on an acceptable Phase 3 design.”
Trius, founded in 2004, is backed by some big name venture firms, including Sofinnova Ventures, InterWest Partners, Versant Ventures, and Kleiner Perkins Caufield & Byers. It has no marketed products. Its lead drug candidate is torezolid, an antibiotic that’s from the same class as Pfizer’s billion-dollar seller, linezolid (Zyvox). Trius reported some impressive results in June from a mid-stage trial of its drug. The study of 188 patients found the once-daily pill, given for five to seven days, helped 98 percent of patients on the lowest dose achieve what’s considered a clinical cure. There were no clinical relapses at follow-up visits three to four weeks after treatment. CEO Jeff Stein put this result in some more context in an interview with me last June.
Trius is in a position to weather a delay, at least for a while. It has burned through $30 million of investor capital since it was founded, and still had $18.2 in cash and investments heading into this year. Trius has 37 employees.