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Almirall invests in Ironwood Pharmaceuticals

Funding for European commercialisation boosted by positive phase III results for chronic constipation drug
Spanish-headquartered Almirall has made a $15m equity investment in Ironwood Pharmaceuticals, developers of linaclotide, a novel option for the treatment of irritable bowel syndrome with constipation (IBS-C), as well as for chronic constipation (CC).

The move follows the announcement of positive results for this compound from two pivotal phase III trials in patients with CC.  
 
This investment is part of the exclusive licensing-in agreement for linaclotide that was
announced last May, through which Almirall will market and obtain regulatory approvals for the compound throughout the EU, Russia, former Soviet countries, Switzerland, Norway and Turkey, as well as countries of the former Yugoslavia.

The positive phase III trial results are consistent with those from phase II, and form part of a larger phase III programme investigating the effect of linaclotide in CC and IBS-C.

Almirall's priority in Europe will be the IBS-C indication, for which treatment options are limited for patients.
 
Two phase III trials assessing the safety and efficacy of linaclotide in patients with IBS-C are ongoing, the results of which are expected in the second half of 2010. 
 
“We are very pleased with this investment, which reflects the good progression of
linaclotide, a very significant asset in our pipeline,” said Eduardo Sanchiz, chief
executive for corporate development and finance.
 
Linaclotide is a first-in-class compound in a confirmatory phase III programme for the
treatment of IBS-C and chronic constipation in the US. In a phase IIb study in 419
patients with IBS-C, linaclotide significantly reduced abdominal pain and bloating and
improved bowel function throughout the 12-week treatment period. It is a once daily, orally delivered peptide that acts locally in the gut with no detectable systemic exposure at therapeutic doses.

An estimated nine million patients in Europe suffer from IBS-C.
 

11th November 2009

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