Constella linaclotide regulatory update

Almirall said it will no longer market Constella linaclotide in Germany after failing to agree on a price with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband). In October, Germany's Federal Joint Committee (G-BA) said the guanylate cyclase C ( GCC; GUCY2C) agonist has "no additional benefit" for irritable bowel syndrome with constipation (IBS-C) vs. a change in diet and symptom-specific treatment (see BioCentury, Oct. 21, 2013).

Almirall has exclusive rights to Constella in Europe and the Commonwealth of Independent States (CIS) from Ironwood. Almirall declined to disclose details of its negotiations with GKV-Spitzenverband, and Ironwood said it respects Almirall's "expertise in managing these local markets." ...