a wait-and-see game. They have become picky. They hold the money. They think small startups are begging them to get taken out,” Chang says. “My answer to that is we have always said to the investment community that we are not eager to be taken out. We want to continue to build value for investors.”
But he noted that the takeover speculation is sure to continue, partly because Optimer actually has another drug besides fidaxomicin that has passed a pivotal trial. The company plans to submit a new drug application to the FDA this year for its second drug, prulifloxacin, for traveler’s diarrhea. “We are one of the very few companies out there that has de-risked two late-stage compounds,” Chang says.
While no one I’ve talked with disputes that Optimer has removed the technology risk from fidaxomicin, there is still business risk to be dealt with. So here are some of the basics on how it plans to market the “C.diff” drug, based on my conversation with Chang and Kevin Poulos, the company’s chief commercial officer.
Optimer will seek to get the drug on hospital formulary lists as a designated treatment for “C.diff,” which can be a time-consuming process. It will sell the compound to major distributors like McKesson, which will then distribute it to hospitals, nursing homes and pharmacies. Optimer, a company with 65 employees now, plans to build a 100-person specialty sales force to concentrate on hospitals and nursing homes in the U.S. Whoever Optimer chooses as its Big Pharma partner, if it chooses a partner, will be responsible for marketing the drug overseas.
A handoff of sorts needs to occur smoothly for the Optimer drug to be commercialized. It’s an oral pill that needs to be taken twice daily for a 10-day course. Patients will typically get it for the first three or four days while they are hospitalized, and then get a prescription to buy more at a pharmacy, which they can take at home, Chang says.
Hard data on how many people really get “C.diff” is hard to come by, because hospitals don’t like to publicize when their patients get this dangerous infection. But about 30 to 40 cases were reported per 100,000 people discharged from hospitals in 2001, and that figure has climbed to about 100 cases per 100,000 discharges in 2005, according to data from the Centers for Disease Control and Prevention.
Based on an assumption that the Optimer drug is priced at $1,000 to $1,200 for a 10-day course, Yang, the Jeffries analyst, estimates worldwide fidaxomicin sales of $250 million in 2014.
To get there, Optimer will have to first convince hospitals they have a serious problem. That might be easier said than done. After all, surgeons don’t often like to admit
