AbbVie and Galapagos extend deal
pharmafile | May 21, 2013 | News story | Sales and Marketing | AbbVie, Crohn's, Galapagos
AbbVie and Belgian biotech Galapagos have bolted on a development programme for Crohn’s disease to the selective JAK1 inhibitor they are currently exploring in rheumatoid arthritis (RA).
GLPG0634 is about to move into Phase IIb in RA – after which AbbVie will be responsible for commercialisation and development in that therapy area.
The extension of this agreement will see Galapagos fund and complete a Phase II programme for it in Crohn’s, running in parallel to the RA study, with a view to moving the investigational drug swiftly into Phase III.
AbbVie will pay Galapagos $50 million when the inflammatory bowel disease study is successfully completed, which is expected to happen before the end of June 2015.
Crohn’s disease affects millions worldwide, including more than one million people in Europe and 500,000 in the US.
It is welcome news for Galapagos, which in March saw the end of its three-year deal with Roche due to a ‘strategic change’ by the Swiss firm.
Galapagos will start the 20-week study with GLPG0634 in 180 Crohn’s patients by the early part of next year, measuring both induction of disease remission and early maintenance of beneficial effects.
JAK enzymes have a key role in the signalling of a number of cytokines which are involved in autoimmune diseases.
The companies have high hopes that their drug may offer real safety benefits because it avoids inhibition of JAK2 – something that has led to anaemia and reduced formation of blood cells in previous studies: patients with Crohn’s already often suffer anaemia due to blood loss via gastrointestinal bleeding.
“Our experience within gastroenterology, combined with a novel alternative treatment for this disease may provide a greater benefit to patients in the future,” said Scott Brun, AbbVie’s vice president, pharmaceutical development.
“Galapagos is in a strong financial position to fund the Crohn’s programme, in addition to the Phase IIb program with GLPG0634 in RA and our other proprietary clinical and pre-clinical programmes,” said the company’s chief executive Onno van de Stolpe.
The compound will be the first selective JAK1 inhibitor to enter Phase II in Crohn’s, and is part of a pipeline that includes another candidate in the same class – licensed to GlaxoSmithKline, GSK2586184 is in Phase II in lupus and psoriasis.
Others include GLPG0187, a novel integrin receptor antagonist currently in a Phase Ib patient study in metastasis, and GLPG0974, which Galapagos is looking at in irritable bowel disease.
Adam Hill
Related Content
Genmab to submit FDA application for lymphoma therapy
Global biotechnology company Genmab plans to submit a supplemental Biologics License Application (sBLA) to the …
The National Institute for Health and Care Excellence announce technology appraisal guidance recommending risankizumab for adult patients with moderate to severe ulcerative colitis
The National Institute for Health and Care Excellence (NICE) have recommended adult patients in England …
Abbvie acquires Cerevel Therapeutics
Abbvie has announced the acquisition of Cerevel Therapeutics, strengthening its neuroscience pipeline. Cerevel has multiple …
