Lexicon's LX1032 Receives Designation From EMEA

THE WOODLANDS, Texas -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) has received orphan drug designation from the Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMEA) for LX1032, the company's oral drug candidate for managing gastrointestinal symptoms associated with carcinoid syndrome.

LX1032 is designed to reduce serotonin production in patients with metastatic carcinoid tumors. Elevated levels of serotonin contribute to the gastrointestinal and possibly other symptoms experienced by these patients.

The EMEA is a regulatory agency in the European Union (EU) primarily responsible for the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. EMEA's orphan drug program promotes the development of drugs intended for the prevention or treatment of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the EU. Incentives for developing new drugs under orphan drug designation in the EU include 10 years of marketing exclusivity, regulatory assistance, reduced regulatory fees associated with applying for marketing approval, and assistance with clinical trial design.

LX1032 is the first drug candidate for which Lexicon has obtained orphan drug status.

"Gaining orphan designation in Europe for LX1032 provides important regulatory and commercial advantages in the development of this new drug candidate for symptoms associated with carcinoid syndrome," said Philip Brown, M.D., J.D., senior vice president of clinical development at Lexicon. "We are now well positioned to conduct trials of LX1032 in Europe as part of an integrated global development strategy."

Source: Lexicon Pharmaceuticals, Inc.