Based: Louisville, CO
Founded: 2002
www.replidyne.com
Why It's Fierce: Replidyne hit an important milestone when the company filed an NDA for its new antibiotic last December. The FDA accepted it in February. Replidyne is looking for FDA approval for faropenem medoxomil as a therapy for acute bacterial sinusitis, community-acquired pneumonia, chronic bronchitis and adult skin infections. Researchers went to the NDA with data from 11 Phase III trials involving 5,000 patients.
One of the key advantages of the antibiotic, researchers say, is that it offers high systemic concentrations of the drug. Replidyne believes that there are other indications it can win approval for as well. Their work is based on the groundwork laid by Dr. Charles McHenry while he was at the University of Colorado Health Sciences Center.
Replidyne signed a licensing deal with Forest Labs in February and gained a $50 million up-front payment for the pact, a significant advance that clearly signals Forest's belief in Replidyne's work. Additional milestone paydays are also scheduled. The money should help Replidyne build out its own marketing efforts. The biotech retained commercialization rights on the antibiotic to infectious disease specialists and otolaryngologists.
Replidyne has also established itself with a group of top venture capitalists, raising $62.5 million in Series D funding last September that positioned the company for an IPO. Replidyne is also reserving some of its new-found wealth to advance REP8839 into the clinic for antibiotic resistant bacteria such as the lethal MRSA.
What to look for: A pediatric formulation is in the works, and Replidyne gave credence to rumors of an IPO by filing to go public just days ago.
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