Shire Acquires Lumena Pharmaceuticals, Adds To Rare Disease Portfolio
By Cyndi Root
Shire announced in a press release that it has acquired Lumena Pharmaceuticals. The purchase brings Lumena’s portfolio of rare disease agents to Shire as well as its gastrointestinal disease and liver disease assets. Shire states that the acquisition also complements Shire’s recent acquisition of Fibrotech, which bolstered to Shire’s portfolio of fibrotic and renal disease treatments.
Flemming Ornskov, CEO of Shire said, “Our pipeline and strategic focus on rare diseases is even further strengthened with the acquisition of Lumena Pharmaceuticals, which also complements our strong GI presence.” Mike Grey President and CEO of Lumena Pharmaceuticals said, “Shire has deep rare disease experience, a global infrastructure, and the commercial expertise to deliver LUM001 to patients around the world.”
Strategic Acquisition
Shire made an upfront payment of $260 million in cash, and has agreed to an additional cash payment at closing and milestone payments for progress in clinical trials. Shire’s focus is on rare diseases and gastrointestinal diseases (revenues of over $800 million in 2013). Lumena has experience in liver disease and gastrointestinal diseases. The acquisition will bring two of Lumena’s compounds to Shire, LUM001 and LUM002, adding to Shire’s rare disease pipeline.
LUM001 and LUM002
LUM001 and LUM002 are selective inhibitors of the apical sodium-dependent bile acid transporter (ASBT). ASBT inhibitors show promise in slowing the disease progression in liver disease. They can reduce bile acid absorption thereby reducing symptoms and improving liver function.
Clinical and Regulatory Status
LUM001 is a designated Food and Drug Administration (FDA) orphan drug and has received similar status in Europe. It is currently in Phase II trials of cholestatic liver disease. Lumena and Shire will proceed to a Phase II study in the second half of 2014 for LUM002 in adults with nonalchoholic steatohepatitis (NASH). LUM001 and LUM002 are once-daily, orally-administered agents.
Recent Shire Acquisitions
Shire acquired Fibrotech, an Australian company, early in May 2014. Shire made an upfront payment and promised milestone payments for progress in fibrosis agents and Fibrotech’s lead product FT011 for diabetic nephropathy. In January of 2014, Shire acquired ViroPharma in order to extend its product line. ViroPharma's lead drug is Cinryze, a treatment for the 18,000 patients in the U.S. and Europe living with hereditary angioedema.