Almirall has filed for approval in Europe of its irritable bowel syndrome drug Constella and signed up Nycomed as a licensing partner for its antihistamine Kestine.
First up, the Spanish drugmaker has submitted a marketing authorisation application to the European Medicines Agency for Constella (linaclotide), an investigational guanylate cyclase-C receptor agonist for the treatment of irritable bowel syndrome with constipation (IBS-C). The submission is based on trials involving more than 1,600 subjects received an once_daily dose of either linaclotide or placebo. Full results will be presented at the European Gastroenterology congress in Stockholm in October.
The MAA follows the submission of linaclotide to the US Food and Drug Administration in August by Ironwood Pharmaceuticals and its US partner, Forest Laboratories. Almirall licensed the rights to the drug in Europe in May 2009.
Bertil Lindmark, Almirall's chief scientific officer, says IBS is associated with "significant reduction in quality of life and intensive consumption of healthcare resources" and people suffering from IBS-C "currently have very limited treatment option". He added that the results of clinical trials "are extremely encouraging and, with this regulatory submission of linaclotide in IBS-C, we look forward to bringing this novel first-in-class medicine to patients in Europe".
Nycomed bags China rights to antihistamine
The Barcelona-based firm also revealed that it has licensed Asian rights to Nycomed for Kestine (ebastine). The drug, which is already available in over 30 countries, is indicated for allergic rhinitis and chronic idiopathic urticaria.
Under the terms of the agreement, Nycomed will have exclusive commercialisation rights for the existing Kestine product in China and will launch it in Malaysia, the Philippines, Singapore, Thailand and Indonesia. Financial details were not disclosed.
Guido Oelkers, head of commercial operations at Nycomed, said Kestine is "a high quality antihistamine which brings existing sales and potential for growth in China and further expansion in other key regional markets". The Swiss firm, which is in the process of being taken over by Japan's Takeda, has recently opened offices in China, South Korea, Indonesia, Malaysia and the Philippines.