In its attempts to expand its gastrointestinal drug portfolio, Shire PLC (ADR) (NASDAQ:SHPG) confirmed that it has purchased the rights to PF-00547659, the experimental inflammatory bowel disease (IBD) drug from Pfizer, Inc. (NYSE:PFE). According to Howard Mayer, Shire Head of Clinical Development, the licensing deal is consistent with the company’s commitment to designing GI treatments for small patient groups. However, the companies did not disclose further details about the deal.
PF-00547659 is specifically developed to target mucosal addressin cell adhesion molecule 1 (MAdCAM-1), a gastrointestinal endothelial adhesion molecule. It shares a similar mechanism of action with Entyvio and Tysabri, the drugs from Takeda Pharmaceutical Co. Ltd. (ADR) (OTCMKTS:TKPYY) and Biogen, Inc. (NASDAQ:BIIB) respectively.
The drug has already undergone Phase I and Phase II trials and has shown positive results for treating Crohn’s disease and ulcerative colitis in a trial of nearly 700 patients.
Crohn’s and ulcerative colitis are two of the most life-threatening IBD conditions that are characterized by fatigue, weight loss, inflamed intestines, severe stomach pains, rectal bleeding, and other related symptoms.
Those who received the IBD drug in the trial had higher mucosal healing, remission, and response rates by the 12th week than those who received a placebo.
Meanwhile, in the study involving CD patients, the subjects did not show any evidence of infection. In 2015, Pfizer clarified that the drug has no effect on the central nervous system’s immune surveillance like that of Tysabri.
A Phase III trial is expected to begin following consultation with global regulators.
This week, Shire has also received a breakthrough designation from the US Food and Drug Administration for its GI drugs SHP621 and SHP625. The pharmaceutical giant has Vyvanse, a binge-eating disorder drug on the market already, and Gattex, a short bowel syndrome treatment.
Numerous IBD treatments are already available in the market today. However, the patents of many of these IBD drugs are expected to expire in the next few years.
Pfizer, on the other hand, is maintaining its focus on Xeljanz, a new rheumatoid arthritis drug, and on PF-04236921, another CD drug currently in the works.