The US contract research organisation (CRO) will take the two products, for diarrhoea-predominant irritable bowel syndrome (IBS-d) and skin and lung infections, respectively, through to the end of Phase II clinical trials in return for milestone payments and royalties on sales.
Post Phase II, Jannsen has the option to bring development and commercialisation activities in-house. However, if Janssen decides against this PPD can buy the two products for $250m and associated royalties.
PPD chairman Fred Eshelman said the deal "with Janssen diversifies and strengthens our compound partnering portfolio and may gain us entry into two large markets.”
Quite how the Janssen deal fits with PPD’s plans to spin-off its compound partnering operations, announced in late October, is unclear although it may indicate that the US firm thinks a broader portfolio is likely to attractive more potential investors.
Market demand
PPD went on to describe the, as yet unnamed IBS-d drug, as a potential first in class combined mu and delta opiod receptor agonist.
Eshelman explained that: “The [irritable bowel syndrome] 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.”
PPD’s contention about likely demand for the IBS-d product is supported by data published in Nature Reviews Drug Discovery, which estimated that the condition affects 29m US citizens.
And, while details of the candidate antibiotic have not yet been released, the rising rates of hospitalisation and growing numbers of drug resistant bacteria certainly support the idea that demand for new anti-infectives is likely to grow.
According to recent figures in the Journal of the American Medical Association, more than 14m physician visits each year are related to skin and soft-tissue infections, with approximately 94,000 of those treated found to have serious MRSA infections.