The Crohn’s disease therapeutics pipeline is expected to witness extensive growth in the coming year due to emerging biosimilars and novel treatments. In addition, increasing number of pipeline drugs, rising demand for better medications, high prevalence of Crohn’s disease, involvement of the regulatory bodies for funding and designation and increase in the government agencies for the healthcare expenditure act as the major drivers for the Crohn’s disease therapeutics.
According to the Centre for Digestive Diseases, an Australian medical institution that collaborates with pharmaceutical companies to provide excellence in gastroenterology, Crohn’s disease is an inflammatory disease of the bowel that most commonly affects the lower small intestine and the large intestine, but can involve other parts of the digestive tract as well, from the mouth to the anus. Crohn’s disease causes inflammation of the entire thickness of the bowel wall that leads to the abdominal pain, diarrhea and a range of other symptoms such as fever and weight loss. The chances of its occurrence are equal for men and women and usually appears for the first time in patients above the age of 30 years with peak incidence in those aged 14-24 years. The etiology of Crohn’s disease is unknown. About 20% of people with Crohn’s Disease have a blood relative with some form of inflammatory bowel disease, most often a sibling and sometimes a parent or child. Smoking has also been observed as a factor contributing towards the development and exacerbation of Crohn’s Disease.
The pipeline of the Crohn’s disease therapeutics is very rich with 40+ drug candidates. Among them, Galapagos NV is developing filgotinib in collaboration with Gilead Sciences, Inc. for Crohn’s disease. Filgotinib is an orally administered, small molecule drug candidate that targets Janus kinase 1 and inhibits its action. A Phase III clinical development is going on in the U.S. and Belgium for the treatment of Crohn’s disease.
The pharmaceutical companies are collaborating for the development of drug candidate for Crohn’s disease. In December 2015, Galapagos NV and Gilead Sciences, Inc. entered into a global partnership for the development and commercialization of the Janus kinase inhibitors filgotinib for inflammatory disease indications including Crohn’s disease. Galapagos received an upfront payment of $725 million consisting of a license fee of $300 million and a $425 million equity investment in Galapagos. In addition, Galapagos is eligible for payments up to $1.35 billion in milestones, with tiered royalties starting at 20% and a profit split in co-promotion territories. The increasing awareness regarding the treatment has been driving the pipeline growth.
However, complex mechanism of action of the disease, less awareness among people about the disease in the developing countries, high cost of treatment and side effects of the medications are impeding the growth of the pipeline.
Some of the companies having a pipeline of Crohn’s disease therapeutics include Gilead Sciences, Inc., Galapagos NV, Astellas Pharma, Abbvie, Inc., Amgen, Inc., Pfizer, Inc., Tillotts Pharma AG, Johnson & Johnson, Takeda Pharmaceutical Company Ltd. and Boehringer Ingelheim GmbH.