At least a few people in San Diego are sitting tight today at work, unable to get a jump on the holiday weekend.
That’s the case at San Diego-based Optimer Pharmaceuticals (NASDAQ: OPTR), which is awaiting word from the FDA on whether its first drug can be cleared for sale in the U.S. The agency’s deadline to complete its review of Optimer’s fidaxomicin (Dificid) is Memorial Day, Monday May 30, but since that’s a federal holiday, it’s possible the good folks in Rockville, MD will deliver their verdict before the holiday weekend kicks off today.
This is a big moment for Optimer, although not a very suspenseful one. The company won a 13-0 endorsement from an FDA advisory panel last month, which recommended its new antibiotic be approved for treating C. difficile, a sometimes deadly bacterial infection people get in hospitals. If approved, this will be Optimer’s first approved product after spending 13 years and more than $175 million on R&D.
The company, which has about 100 employees now, plans to double in size this year as it seeks to commercialize a product with potential to generate $158 million in sales in 2015, according to analyst Eun Yang of Jefferies & Co.
“For us, it’s a dream come true. There are hundreds or even thousands of biotech companies that never see their product all the way through to the market,” says Optimer CEO Pedro Lichtinger. “For us to get the product to this stage and carry it to the commercial stage, it’s fantastic.”
C.diff, a hardy bug that lurks in hard-to-reach surfaces at hospitals and nursing homes, is estimated to kill between 15,000 and 30,000 people in the U.S. each year, many of them elderly. The disease, which is hard to diagnose properly, is currently treated with a common generic drug called metronidazole or an oral form of vancomycin (Vancocin) from Exton, PA-based Viropharma (NASDAQ: VPHM).
Optimer’s drug is designed to specifically kill the C.diff bug, while mostly sparing healthy bacteria in the gut. Optimer showed that its antibiotic can cure patients a little more than 90 percent of the time, which was slightly better than the standard vancomycin. The trials, which followed patients for 30 days, showed that about half as many patients on the Optimer drug had a single recurrence, when compared with those who got vancomycin.
If the FDA delivers a positive verdict today, or sometime early next week, the big questions will be about the drug’s label, and its price. The FDA advisory panel last month had some debate about the meaning of the word recurrence, and shortly after the panel, Lichtinger said Optimer would have to work carefully with the FDA on language to describe the drug’s benefit fairly and precisely, based on clinical studies. Optimer is hopeful that the prescribing label, which doctors and insurers depend on for guidance, will say something about how the new drug offers a “superior and sustained clinical response,” Lichtinger says.
Once approved, Optimer plans to announce the price in a conference call with analysts. Lichtinger didn’t offer an expected price range, although he did say that Cubist Pharmaceuticals’ daptomycin (Cubicin) and Pfizer’s linezolid (Zyvox) are a couple of benchmark antibiotics that compete with vancomycin, although they are used for different infections. Lichtinger noted that neither of those products have language in their label that says they are superior to existing antibiotics—language Optimer hopes to get.
“We believe strongly in the cost effectiveness of our drug. We’ll price it accordingly. It will reflect its superiority,” Lichtinger says.
Optimer, and its U.S. partner, Cubist Pharmaceuticals, will have to wait until mid-July to actually start selling the product, Lichtinger says. The sales forces of the two companies are ready, he says, but the product is manufactured in Canada, and needs to pass state-by-state regulations covering importation of drugs, Lichtinger says.
There will be a lot of work to do with insurers, but because Optimer’s drug is the first new treatment for C.difficile in 25 years, it will essentially have the category to itself, and expects “almost universal endorsement” on the preferred drug lists, or formularies, that hospitals use to guide prescribing decisions, Lichtinger says. In terms of restrictions, some insurers may want to ask for a second opinion from an infectious disease specialist before reimbursing for a prescription of the new Optimer drug, Lichtinger says.
Optimer has so far brought on about 20 salespeople and plans to grow its field force to 100, although almost all are queued up and ready to start their jobs once the word arrives from the FDA. That, you can bet, will make this an especially memorable Memorial Day weekend for those folks, and everybody who’s worked at Optimer through its long drug development phase. The company, with R&D and sales together, should have more than 200 employees by year-end, Lichtinger says.
All that expansion means that Optimer is looking for new space to accommodate its growth, Lichtinger says. Right now the company is split between two facilities, which he says, is “not practical.” But finding space to get everybody together is what you call a high-class problem—a good thing to deal with in an industry where so few drugs are fortunate enough to pass the FDA’s scrutiny.
“It’s wonderful to see the fruits of many years of work,” Lichtinger says.
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