Shire Adds to Rare Disease Portfolio with Acquisition of Lumena Pharmaceuticals

Shire plc and Lumena Pharmaceuticals, Inc., a biopharmaceutical company with rare disease pipeline assets, announce the acquisition of Lumena Pharmaceuticals by Shire.

The acquisition of Lumena strengthens Shire’s already valuable and robust 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 II with four potential orphan indications and LUM002, ready to enter Phase II later in 2014.

LUM001 and LUM002 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.

These rare cholestatic liver diseases are primarily treated by hepatologists and gastroenterologists and can be covered by a small, specialty sales force consistent with Shire’s model.

Chief Executive of Shire, Flemming Ornskov, MD comments: “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. These attractive potential treatments may offer new hope to patients with rare cholestatic liver disease and further contribute to Shire’s future growth. We are excited by the possibilities of these new assets in liver disease. We have the resources, the infrastructure and the operating capacity to invest in these new potential growth drivers which add further value to Shire’s innovative pipeline.”

President and CEO of Lumena Pharmaceuticals, Mike Grey comments: “I believe that this transaction is a significant win for all parties involved, especially the patients, and the future of LUM001 as a treatment for rare cholestatic liver diseases looks brighter than ever. Shire has deep rare disease experience, a global infrastructure, and the commercial expertise to deliver LUM001 to patients around the world. The Lumena team will work closely with Shire to finish the ongoing Phase II clinical programs as part of our commitment to the patient populations we have championed since we formed Lumena Pharmaceuticals.”

Shire does not expect the acquisition of Lumena to result in a change to its previously stated earnings guidance for 2014.