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to start on the expansion plan. Patients who get these transplants as treatments for blood diseases go through a period when they are quite vulnerable to infections, as they are going through what amounts to a re-boot of their immune systems. As a preventive measure, most of these patients already get an antifungal medication, and a quinolone antibiotic to ward off bacterial invaders, and some even get an antiviral preventive, Lichtinger says. If patients getting bone marrow transplants end up getting infected with C.diff, then the death rate rises to one out of 20 patients, and treatment of the infection ends up costing about $132,000 per patient, according to Optimer’s market research.
So combining the high cost of infection with a physician specialty that’s well-versed in prophylactic therapy makes this the ideal test case for the new strategy, Lichtinger says. His bet is that physicians will also be receptive to this idea because Optimer’s antibiotic is only approved to fight “C.diff” bacteria, and is a so-called “narrow spectrum” antibiotic as opposed to a “broad-spectrum” antibiotic that kills a wide range of good and bad bacteria. Overprescribing of those powerful broad-spectrum antibiotics, like vancomycin, can lead to the development of resistance to the most powerful antibiotics over time, and hospitals don’t want to contribute to that already significant problem, Lichtinger says.
Of course, Optimer will have to gather proof for this concept before physicians start incorporating the new medicine into the standard of care. The company is getting ready to start a 350-patient clinical trial of bone marrow transplant patients, which should start enrolling people by the end of this year. Results should be in from that trial in the first half of 2014, and the new use of the Optimer drug could be approved by the FDA by the first half of 2015, Lichtinger says.
The company has become so committed to the expansion plan for Dificid that it said earlier this month that it is eliminating its tiny basic research function, a move that led the company to cut the jobs of seven workers. Who knows what those people and their collaborators may have come up with to fill Optimer’s pipeline, but Yang, who rates the company a “Buy,” applauded the new plan to make the most of Dificid. “We do not view Optimer’s discontinuing its discovery programs as negative; rather, we view its better alignment of its R&D spend in clinical programs as positive,” Yang wrote in a note to clients Jan. 9.