Optimer Cruises Into Memorable Memorial Day Weekend, Awaiting FDA Word on Antibiotic

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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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