Date: 2014-05-12
Type of information: Company acquisition
Acquired company: Lumena Pharmaceuticals (USA)
Acquiring company: Shire (UK - USA)
Amount: $260 million in cash, plus a payment for net cash at closing, and near-term contingent milestone payments related to ongoing clinical trials
Terms: * On May 12, 2014, Shire and Lumena Pharmaceuticals announced the acquisition of Lumena Pharmaceuticals by Shire. Shire will acquire Lumena Pharmaceuticals for an upfront payment of $260 million in cash, plus a payment for net cash at closing, and near-term contingent milestone payments related to ongoing clinical trials.
Details: The acquisition of Lumena strengthens Shire’s pipeline. It complements Shire’s strategic focus on rare diseases and provides a future growth path for Shire’s gastrointestinal business, which generated revenues of over $800 million in 2013. In acquiring Lumena, Shire is gaining experience in liver disease with the opportunity to leverage its existing GI commercial infrastructure. In addition, there is a good fit with Shire’s recent acquisition of Fibrotech, which has brought pipeline programs to address unmet patient need in other fibrotic conditions including renal impairment. Lumena Pharmaceuticals brings to Shire two new oral therapeutic compounds; LUM001, in Phase 2 with four potential orphan indications and LUM002, ready to enter Phase 2 later in 2014. These candidates are both inhibitors of the apical sodium-dependent bile acid transporter (ASBT), which is primarily responsible for recycling bile acids from the intestine to the liver. Blocking bile acid transport with ASBT inhibitors reduces bile acid absorption and has the potential to improve liver function and relieve disease symptoms (such as extreme itching associated with cholestatic liver diseases), and may slow disease progression. LUM001 is a novel, once-daily, orally-administered, potent and selective ASBT inhibitor that works by preventing recycling of bile acids back to the liver and is thought to reduce bile acid accumulation, improve liver function and potentially relieve the extreme itching associated with cholestatic liver disease. It is currently in Phase 2 clinical development for four rare cholestatic liver disease indications; two pediatric and two adult with a potential 2016 launch. These potential indications are: Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC). The company has just announced that it is now dosing of the first patient in the INDIGO Phase 2 clinical trial of this candidate, LUM001, in children with progressive familial intrahepatic cholestasis. Additionally, the CAMEO Phase 2 clinical trial of LUM001 in adults with primary sclerosing cholangitis (PSC) is open for enrollment. LUM002 is a novel, once daily, orally-administered, highly potent and selective inhibitor of ASBT, in development for the treatment of nonalcoholic steatohepatitis (NASH), a common and often “silent” liver disease characterized by fat deposits in the liver and inflammation which can progress to significant fibrosis. By blocking bile acid reabsorption, LUM002 is thought to modulate colonic bile acid concentrations and receptor signaling on cells in the lower portion of the GI tract. This signaling is believed to result in the secretion of peptides that regulate insulin release from the pancreas, glucose metabolism and the synthesis of cholesterol and fatty acids. Phase 1 safety trials in healthy volunteers and a Phase 1b trial in patients with metabolic disease have been completed. The next step is to initiate a Phase 2 clinical trial in patients with NASH – anticipated to begin in the second half of 2014.
Related: Rare diseases Orphan drugs
