PPD, a global CRO, has entered an agreement with Janssen Pharmaceutica N.V. to develop and commercialize two phase II-ready therapeutic compounds, one to treat diarrhea-predominant irritable bowel syndrome (IBS-d) and the other to treat complicated skin, skin structure and respiratory infections.
Under two agreements, PPD in-licensed the two assets and will advance the compounds through phase II development. At the completion of phase II, Janssen will have the option to resume development and commercialization of each compound.
In exchange, PPD will receive up to $330 million in clinical and sales milestones. PPD will also get royalties on sales of the compounds if they are approved for marketing. If Janssen does not buy back a program, PPD will have the option to continue developing and commercializing the compound for that program and Janssen will receive up to $250 million in clinical and sales milestones and royalties on sales of the compounds if approved for marketing.
“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.”