Shire adds to rare disease portfolio with acquisition of Lumena Pharmaceuticals, bringing late stage compounds for rare GI/hepatic conditions

Shire adds to rare disease portfolio with acquisition of Lumena Pharmaceuticals, bringing late stage compounds for rare GI/hepatic conditions

  • Acquisition of Lumena Pharmaceuticals, a biopharmaceutical company with late stage rare disease pipeline assets
  • Adds to Shire’s rare diseases portfolio and leverages this expertise, and is a perfect combination with Shire’s already strong Gastrointestinal (GI) presence
  • Adds LUM001 in Phase 2 development for four rare and devastating hepatic diseases, two pediatric and two adult with a potential 2016 approval and LUM002 a Phase 2-ready candidate for the treatment of non-alcoholic steatohepatitis (NASH)
  • Very attractive opportunity to develop treatments for significant unmet need in rare cholestatic liver diseases as well as a treatment for non-alcoholic steatohepatitis (NASH)
  • 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
  • These two compounds, and Shire’s full portfolio, will be discussed in more detail at an Investor Day later in 2014.

Dublin, Ireland and San Diego, U.S. – May 12th, 2014 – Shire plc (LSE: SHP, NASDAQ: SHPG) and Lumena Pharmaceuticals, Inc., a biopharmaceutical company with rare disease pipeline assets, announce the acquisition of Lumena Pharmaceuticals by Shire.

Lumena Pharmaceuticals Now Dosing Patients in the INDIGO Phase 2 Clinical Trial of LUM001 in Pediatric Patients with Progressive Familial Intrahepatic Cholestasis

CAMEO Phase 2 Clinical Trial of LUM001 Now Enrolling Adults with Primary Sclerosing Cholangitis

SAN DIEGO – May 9, 2014 – Lumena Pharmaceuticals (Lumena), a biopharmaceutical company focused on the development and commercialization of novel products for rare cholestatic liver diseases and serious metabolic disorders, today announced the dosing of the first patient in the INDIGO Phase 2 clinical trial of its lead drug candidate, LUM001, in children with progressive familial intrahepatic cholestasis (PFIC). Additionally, the CAMEO Phase 2 clinical trial of LUM001 in adults with primary sclerosing cholangitis (PSC) is open for enrollment.

Lumena Pharmaceuticals Raises $45 Million in Series B Financing

Funding to support clinical development of treatments for rare cholestatic liver diseases and nonalcoholic steatohepatitis

SAN DIEGO – March 11, 2014 – Lumena Pharmaceuticals (Lumena), a biopharmaceutical company focused on the development and commercialization of novel products for rare cholestatic liver diseases and serious metabolic disorders, today announced that it has secured $45 million in Series B financing. New Enterprise Associates (NEA) led the financing, with Adage Capital Management and RA Capital Management participating and joining existing investors Pappas Ventures, RiverVest Venture Partners and Alta Partners. Founded in 2011 by Pappas Ventures, Lumena will use the funding to advance the clinical development of LUM001, its lead product candidate, for the treatment of rare cholestatic liver disease in pediatric and adult patients, as well as LUM002 for the treatment of nonalcoholic steatohepatitis (NASH).

Lumena Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for LUM001 in Four Rare Liver Diseases

Company receives first positive opinion in the European Union for Primary Sclerosing Cholangitis

SAN DIEGO – November 18, 2013 – Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced that it has received positive opinions for four Orphan Drug Designations by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) for LUM001. The company’s lead drug candidate, LUM001, received the first positive opinion granted by the EMA for primary sclerosing cholangitis (PSC). In addition, the company received positive opinions for LUM001 in three other rare cholestatic liver diseases including Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and primary biliary cirrhosis (PBC). This follows the Orphan Drug Designation in September by the U.S. Food & Drug Administration (FDA) Office of Orphan Product Development for LUM001 in the same indications.

Inhibition of ASBT Improves Liver Function in an Animal Model of Cholestatic Liver Disease

Data Presented Today at Annual Meeting of the American Association for the Study of Liver Diseases in Washington DC Provides Additional Preclinical Validation for LUM001 Currently Being Evaluated in Phase II Studies in Multiple Cholestatic Liver Disease Populations

SAN DIEGO – November 5, 2013 – Lumena Pharmaceuticals, a company developing oral therapeutics for cholestatic liver diseases, today announced that inhibition of the apical sodium-dependent bile acid transporter (ASBT) improves liver function in animal models of cholestasis. The data will be presented at 11:15 a.m. EST today in an oral presentation titled “SC-435, an Oral Inhibitor of ASBT, Improves Liver Function in a Rat Partial Bile Duct Ligation Model of Cholestasis,” at the 64th Annual Meeting of the American Association for the Study of Liver Diseases in Washington DC.

Lumena Pharmaceuticals Initiates the CLARITY Phase II Study of LUM001 in Patients with Primary Biliary Cirrhosis

Novel therapeutic approach to be evaluated for its ability to reduce elevated bile acid levels and associated severe itching

SAN DIEGO – October 29, 2013 – Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced the dosing of the first patient in the CLARITY Phase II study of its drug candidate LUM001 in patients with primary biliary cirrhosis (PBC). LUM001 is being developed as a possible therapy for a number of cholestatic liver diseases including, PBC, Alagille syndrome, progressive familial intrahepatic cholestasis and primary sclerosing cholangitis, that result in impaired bile acid flow and retention of bile acids in the liver, leading to progressive liver damage and, ultimately, liver failure. In the CLARITY Phase II study, LUM001 is being evaluated for its ability to alleviate the symptom of severe itching associated with PBC.

Lumena Pharmaceuticals Receives Orphan Drug Designation from US Food & Drug Administration for LUM001 in Four Rare Liver Diseases

Company Pursuing Orphan Path to Development in Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis, Primary Biliary Cirrhosis and Primary Sclerosing Cholangitis

SAN DIEGO – September 26, 2013 – Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced that it has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) Office of Orphan Product Development for LUM001, the company’s lead drug candidate. LUM001 received Orphan Designation in four rare cholestatic liver diseases including Alagille syndrome (ALGS); progressive familial intrahepatic cholestasis (PFIC); primary biliary cirrhosis (PBC); and primary sclerosing cholangitis (PSC).

Lumena Pharmaceuticals Launches Global Clinical Program to Evaluate Safety and Efficacy of LUM001 in Children with Alagille Syndrome

First patient dosed in U.K. in Phase II IMAGO Study; Phase II ITCH Study to start in U.S.

Cooperative Research and Development Agreement established with the National Institutes of Health and the Childhood Liver Disease Research and Education Network (ChiLDREN)

SAN DIEGO – September 26, 2013 – Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced the initiation of a global clinical program to evaluate its drug candidate LUM001 in children with Alagille syndrome (ALGS). The first patient has been dosed in the IMAGO Phase II study being conducted in the U.K., and enrollment of pediatric patients is expected to begin later this year in the ITCH Phase II study in the U.S.

Diabetes drug developer Lumena raises $2.5M; compound regulates blood sugar

Diabetes treatment developer Lumena Pharmaceuticals has secured the $2 million it needs to start clinical trials and a little bit extra for good measure.

The company’s first round of investment was oversubscribed, leading to a haul of $2.5 million, according to amended filings made with the Securities and Exchange Commission. Lumena’s investors are venture capital firms Pappas Ventures and  RiverVest Venture Partners. The new capital means the company can proceed to human tests for its novel type 2 diabetes treatment, which aims to develop a pill to help patients regulate their blood sugar.

Research Triangle Park, North Carolina-based Lumena was founded last year. The company is developing a new diabetes treatment based on the role bile acids play as signaling agents in the gastrointestinal tract. When Lumena launched its fundraising efforts last year, CEO Michael Grey explained that most gastric bypass surgery patients are type 2 diabetics. In 80 percent of those patients, blood glucose levels normalized within days — a change that’s not attributed to weight loss. What happened was that bile was diverted.

In normal gastrointestinal function, bile is recirculated. But gastric bypass surgery also bypasses that mechanism. The presence of bile in the GI tract triggers receptors that release Glucagon-like peptide 1, or GLP-1, a hormone that helps regulate blood sugar. Lumena’s treatment would work within the GI tract to stimulate the body’s production of GLP-1. Unlike other drugs that circulate through the bloodstream, the targeted action could offer fewer side and effects compared to other diabetes treatments.

Lumena’s technology comes from company co-founder Slava Gedulin, a former scientist at Amylin Pharmaceuticals (NASDAQ: AMLN), a San Diego, California biotechnology company that develops diabetes and obesity treatments. Gedulin’s discovery came after he left Amylin and the company has no claims on Lumena’s technology.