Candidates have successfully completed Phase I, and Janssen retains an option to buy them back once PPD finishes Phase II trials.
PPD has in-licensed two compounds from Janssen Pharmaceutica, both of which are ready to begin Phase II trials. One candidate is designed to treat diarrhea-predominant irritable bowel syndrome (IBS-d) and the other for complicated skin and skin structure and respiratory infections.
PPD will be responsible for Phase II development, and once completed Janssen has the option to resume development of each compound. In exchange, PPD will receive up to $330 million in clinical and sales milestones plus royalties. If Janssen does not buy back a program, PPD will have the option to continue developing the compound and will pay $250 million in clinical and sales milestones plus royalties.
“Our agreements with Janssen diversify and strengthen our compound partnering portfolio and may gain us entry into two large markets,” said Fred Eshelman, executive chairman of PPD. “The IBS-d market holds significant drug development potential because of the lack of approved products for this indication, and new antibiotics are needed to address increasing incidences of resistant strain bacterial infections.”
The IBS-d compound is a potential first-in-class locally active mu opioid receptor agonist and delta opioid receptor antagonist. The antibacterial molecule is a broad-spectrum fluoroquinolone with activity against Gram positive and Gram negative bacteria and MRSA. It is being developed as both an oral and intravenous therapy to treat skin and respiratory infections.