Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) announced today that it has acquired full exclusive license rights to develop and commercialize the compound JNJ-Q2 under its existing development and license agreement with Janssen Pharmaceutica N.V. (Janssen). Furiex acquired these rights as a result of Janssen's decision not to exercise its option under the agreement that gave Janssen the opportunity to continue development of JNJ-Q2.
“JNJ-Q2 has the potential to be an important treatment for skin infections, which commonly involve methicillin resistant Staphylococcus ("Staph”
JNJ-Q2 is a novel broad-spectrum fluoroquinolone antibiotic. Furiex has completed a successful Phase II study for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is currently conducting a Phase II study in patients with community acquired bacterial pneumonia (CABP). Furiex intends to progress development of JNJ-Q2 based on positive results from the completed Phase II ABSSSI study, which were announced in November 2010. Furiex may owe payments to Janssen based on future regulatory milestones and, if the product is approved, sales milestones and royalties.
A description of Janssen's research and development approach, recently posted on the company's website, indicates that, after a broad strategic review of its portfolio in infectious diseases, Janssen will direct its R&D investments toward antivirals and vaccines, and will not be investing in the development of new antibacterial therapies at this time. "Our work with Janssen has enabled us to position JNJ-Q2 for a successful Phase III development program. We are confident in both the clinical data and the market opportunity for JNJ-Q2 and are energized by the opportunity that has been created by Furiex's acquisition of rights to the product," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "JNJ-Q2 has the potential to be an important treatment for skin infections, which commonly involve methicillin resistant Staphylococcus ("Staph") aureus (MRSA), and for which there are limited treatments with both intravenous and oral formulations. When patients with serious infections present to clinics or hospitals, it generally takes days to identify the causative pathogen. For this reason, we believe JNJ-Q2, which reliably covers a large spectrum of pathogens, including bacteria with emerging resistance, is a very attractive development candidate for the growing skin and pneumonia markets."
"Furiex plans to evaluate strategic partnering and financing options to fund the initiation and completion of Phase III clinical trials for JNJ-Q2," said Fred Eshelman, Pharm.D., chairman of Furiex. "Acquiring rights to JNJ-Q2 allows us to focus on Phase III development for the ABSSSI indication. We plan to move forward with the ABSSSI indication ahead of the CABP indication. We believe that staggering these programs will enable the product to get to market sooner. To this end, Furiex is planning an End of Phase II meeting with the FDA this year to begin the transition process to Phase III development for ABSSSI. We look forward to advancing the development of JNJ-Q2 and providing further details regarding this program as it progresses."
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