Janssen drops antibiotic program, shifts R&D focus to vaccines

After deciding to drop its work on antibiotics, J&J's Janssen Pharmaceutica is opting out of a development deal with Furiex Pharmaceuticals, a developer which recently spun out of PPD. Furiex ends up with full rights to JNJ-Q2, a broad-spectrum fluoroquinolone antibiotic. Furiex has completed a successful Phase II study for the treatment of acute bacterial skin and skin structure infections and is currently conducting a Phase II study in patients with community acquired bacterial pneumonia.

In its release Furiex noted that "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." Regulators have been lamenting Big Pharma's dwindling appetite for antibiotics as providers face a growing threat of hospital and community-acquired infections. But with slim margins and little financial incentive, bigger companies fail to see why they should invest in the field. And J&J sees a big upside in vaccines, where it is investing heavily. Nevertheless, Furiex sees an opportunity in Janssen's departure as it heads into a late-stage program.

"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."

- here's the Furiex release
- read the story from the News Observer