Nycomed files for EU appro of SBS drug Revestive

Privately-held Swiss drugmaker Nycomed has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for teduglutide (Revestive) as a once-daily subcutaneous treatment for short bowel syndrome (SBS).

Teduglutide is a novel, recombinant analogue of human glucagon-like peptide 2 (GLP-2), a protein involved in the rehabilitation of the intestinal lining. Revestive has received Orphan Drug designation as SBS is a rare disease affecting less than 10,000 patients in Europe, the company noted.

The drug was licensed from USA-based NPS Pharmaceuticals in a deal worth a potential $185 million ($35 million up-front) to the latter, which is developing it under the Gattex trade name and granted rights outside North America (USA, Canada and Mexico) to Nycomed a few years back (The Pharma Letter October 8, 2007). NPS, which saw its share price rise 2.1% to $8.18 in morning trading yesterday, expects to file for US approval in the second half of this year, and will receive a milestone payment from Nycomed as a result the filings.