One of the buzzwords I keep hearing is that biotech investors want companies that are “de-risked.” This is kind of amusing, because the complex nature of biology makes biotech drug development one of the riskiest investments of all. But this craving for security is positive, at least for a while, if you are San Diego-based Optimer Pharmaceuticals.
Optimer (NASDAQ:[[ticker:OPTR]]) removed a lot (if not all) of the risk from its profile Thursday when its lead drug candidate passed a second pivotal clinical trial. The company showed its antibiotic for “C.difficile” bacterial infections, in 535 patients, was roughly equal to the gold standard antibiotic at curing people, and twice as good at preventing dangerous recurrences. That finding was consistent with another study of 629 patients reported in November 2008.
Not surprisingly, Optimer’s stock climbed as much as 15 percent Friday morning , before settling down to a modest 6 percent gain, closing at $12.54 a share.
The success of this pivotal clinical study means that Optimer is racing to send in an application to the FDA for clearance to start selling its first product, fidaxomicin. Optimer plans to file the FDA application by this summer, and it hopes to get a 6-month expedited review, which should make the drug available in early 2011, CEO Michael Chang says. Another application is being prepared for Europe.
If Optimer can get through the regulatory agencies, it will be in a unique position. There is no other antibiotic in development specifically for “C.diff” infections that’s within five years of reaching the market, Chang says, while incidence of this potentially deadly bug is growing. This is sure to spark plenty of speculation about who might form a partnership with Optimer to market this drug overseas, or who might want to buy the company altogether.
“We expect shares likely will continue to move higher ahead of potential lucrative partnership opportunity/take-out possibility,” said Eun Yang, an analyst with Jeffries & Co. in New York, in a note to clients on Friday. “We view regulatory risks as very low.”
When I met Chang a few weeks ago at the JP Morgan Healthcare Conference in San Francisco, he tried to pooh-pooh any speculation of an imminent partnership, or takeover. I asked him why pharma hadn’t yet written a big partnership check already, given that fidaxomicin had passed a major Phase 3 study in November 2008.
“Pharma thinks that small startup companies are desperate. So they are playing
