Optimer Pharmaceuticals won the unanimous support of an FDA panel of experts for its new antibiotic fidaxomicin and can now march into the agency with a solid endorsement on safety and efficacy. But the advisory panel split right down the middle on a key issue: Does fidaxomicin prevent the recurrence of Clostridium difficile infections?
San Diego-based Optimer designed its trials to show just how effective fidaxomicin is at guarding against hospital-acquired C. diff infections, which trigger diarrhea and can be particularly lethal for the elderly. And the FDA has been eager to help accelerate development, offering a priority review designation. The agency is now expected to offer a final decision on the application by May 30.
Buoyed by the advisory vote, Optimer announced this morning that it has inked a two-year co-promotion deal with Cubist on the antibiotic, agreeing to pay $15 million a year to get the maker of Cubicin in its corner ahead of a likely near-term launch. There's another $17.5 million in sales milestones on the table.
"Cubist has a proven track record and well established relations with all stakeholders involved in the antibiotics space. We believe this collaboration will maximize the impact of and de-risk Dificid's U.S. commercial launch, assuming approval," said Pedro Lichtinger, president and CEO of Optimer. "Optimer plans to hire 100 sales representatives to target the 1,100 hospitals, which comprise about 70% of U.S. hospital CDI cases. We also believe this collaboration with Cubist will allow us to accelerate formulary adoption, expand our market reach and penetration to up to 2,000 hospitals, comprising over 90% of U.S. hospital CDI cases, and commit resources to long-term care facilities that comprise approximately one-third of all CDI cases."
To maximize revenue Optimer will push for a label that includes its claim that fidaxomicin prevents the recurrence of infection. But it couldn't completely make its case with the experts, with half voting in favor of the claim and half voting against, with one abstention.
- check out Optimer's release on the panel vote
- here's the release on the deal with Cubist
- read the Reuters story
- here's the report from Bloomberg