- Shire will buy global rights to an experimental irritable bowel disease (IBD) drug from Pfizer, the company announced on Tuesday without disclosing further financial details.
- The drug, known as PF-00547659, has been tested in about 700 patients through Phase 1 and Phase 2 trials, returning positive data for treatment of ulcerative colitis and Crohn's disease.
- Shire expects the drug will enter Phase 3 trials following consultations with global regulators.
While the announcement was light on details, Shire indicated it saw the deal as adding a complementary product to its existing portfolio.
"This licensing transaction fits with Shire’s commitment to advancing research and development in select specialty areas, including areas of unmet patient need for gastrointestinal conditions such as IBD,” said Howard Mayer, head of Clinical Development at Shire.
PF-00547659 is a monoclonal antibody designed to reduce the inflammation characteristic of IBD by targeting an endothelial adhesion molecule that binds to white blood cells.
In the Phase 2 trial, patients with ulcerative colitis experienced a higher rate of remission, response, and mucosal healing after 12 weeks compared to a placebo, the company said. The drug's safety was also studied in a separate study which showed no change in CSF lymphocyte cell count after treatment with the highest clinical dose.
Shire also noted there was no evidence of increased infection, something that has been a concern for Biogen's Tysabri, another IBD drug with a similar mode of action.
Earlier this week two investigational drugs from Shire for rare gastrointestinal diseases were granted breakthrough designations by the FDA. The designation is given to drugs which may demonstrate a substantial improvement over standard of care, although many drugs don't live up to their initial promise. Designation also entails greater collaboration with the FDA throughout clinical development.