DUBLIN, Ireland—Irish-headquartered Shire plc announced in late May that it had acquired San Diego-based Lumena Pharmaceuticals in a deal involving a $260-million upfront cash payment, an additional payment for net cash at closing and near-term contingent milestone payments related to key ongoing clinical trials being conducted by Lumena.
The acquisition plays into Shire’s strategic focus on rare diseases and further strengthens its robust pipeline, which it also recently bolstered by acquiring Australian biotech company Fibrotech in May 2014, adding programs addressing unmet patient needs in fibrotic conditions such as renal impairment.
Although Shire does not expect the Lumena acquisition to result in a change to its previously stated earnings guidance for 2014, the company’s gastrointestinal (GI) business generated more than $800 million in revenues for it in 2013, and the addition of Lumena’s late-stage clinical trial compounds provides a growth path for this profitable division. Lumena’s staff bring with them experience in liver disease, which will only strengthen Shire’s existing GI infrastructure going forward, the company says.
Central components of the deal are two promising new therapeutic compounds, LUM001 and LUM002, which inhibit the apical sodium-dependent bile acid transporter (ASBT) responsible for recycling bile acids from the intestine to the liver. The compounds are intended to block bile acid transport and reduce bile acid absorption, which has the potential to improve liver function and relieve disease symptoms associated with cholestatic liver diseases such as debilitating pruritus (extreme itching), and may slow disease progression. Both compounds are orally administered, once-daily, potent and selective ASBT inhibitors.
LUM001 is currently in Phase 2 development in four potential rare liver disease indications—two pediatric and two adult—and has received orphan drug designation for all four indications in both the United States and the European Union. LUM001 is on track for possible approval and launch as early as 2016. The LUM002 compound, slated to enter Phase 2 trials later this year, is a candidate for the treatment of non-alcoholic steatohepatitis, a common liver disease characterized by fat deposits in the liver and inflammation that can progress to significant fibrosis.
The acquisition is an attractive outcome for Lumena, which had decided by the end of 2013 to seek additional resources to support its Phase 2 products. The company had taken a parallel track approach, considering simultaneously the possibility of a public offering or a transaction that would bring an infusion of resources to bear. When Lumena filed for public offering in April 2014, it already had discussions under way with several potential partners; the filing for public offering served to further catalyze those discussions.
“Shire was the most attractive option both for financial reasons and for the combination of capabilities it has to make a difference and move our program forward expeditiously,” Lumena President and CEO Mike Grey tells DDNews.
Lumena’s development team will stay in place to conclude the ongoing studies into four liver disease indications, seeing those trials through to conclusion during the course of 2014 and 2015. Otherwise, Shire will absorb Lumena’s staff and facilities, and its programs will reside at Shire’s facility in Lexington, Mass.
Although the acquisition is not expected to change the timeline of drug development for LUM001 and LUM002, Shire’s commercial expertise, infrastructure and resources in Europe and elsewhere internationally will likely help to clear regulatory hurdles and navigate international filings, ultimately aiding in delivering therapies to global patient populations upon approval.
“Shire has the global infrastructure that will allow us to bring these trials to the finish line and take these compounds to the next stage,” says Grey.
“These attractive potential treatments may offer new hope to patients with rare cholestatic liver disease and further contribute to Shire’s future growth,” said Shire CEO Dr. Flemming Ornskov in a media release announcing the acquisition. “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.”
Lumena Pharmaceuticals is a privately held biopharmaceutical company based in San Diego that was founded in 2011 by Pappas Ventures. The company’s focus is on developing oral therapeutics for rare liver diseases to improve liver function, relieve disease symptoms and dramatically impact patient health. Its major investors include Alta Partners, RiverVest Venture Partners, New Enterprise Associates, Adage Capital Management and RA Capital Management.
Shire plc is a global pharmaceutical company headquartered in Dublin that specializes in neuroscience, rare diseases, gastrointestinal and internal medicine. The company posted revenues in 2013 of nearly $5 billion and currently employs about 5,300 people globally.