Ironwood Pharmaceuticals takes an iron fist to gastrointestinal ailments and other medical conditions. The company develops internally discovered gastrointestinal drugs. Its lead candidate Linzess (or linaclotide), a treatment for irritable bowel syndrome (IBS) and chronic constipation, was approved by the FDA in 2012. The product was developed with partner Forest Laboratories, which shares US marketing rights. Outside of the US, Ironwood licensed development and commercialization rights for the drug to Almirall in Europe and Astellas Pharma for certain countries in Asia. The firm also has products in development for other gastrointestinal, central nervous system (CNS), and inflammatory conditions.
Ironwood Pharmaceuticals conducted an IPO in 2010. The company's decision to go public helped it generate additional funds to push the development and commercialization of Linzess forward.
The company is focused on creating first-in-class medicines mainly for gastrointestinal, neurological, and inflammation disorders. Its first FDA-approved drug, Linzess, was approved in August 2012 to treat adult patients with abdominal pain, bloating, and other symptoms associated with IBS, as well as patients with chronic idiopathic constipation. The drug is under review in Europe for the treatment of IBS. Manufacturing of Ironwood Pharmaceuticals' candidates is conducted through third parties and partners.
As a development-stage company, Ironwood Pharmaceuticals has yet to turn a profit and has accumulated a deficit of some $432 million. It has managed to increase revenues in recent years, however, as its collaborative partnerships have matured. In 2011, for instance, the company's revenues increased 50% to about $66 million due to higher development milestone payouts from partners Forest and Almirall. The firm hopes to eventually become profitable after successfully marketing Linzess and gaining approval for other candidates, though it expects to continue to spend most of its income on R&D and commercialization efforts for several years to come.
Following Linzess' FDA approval, Ironwood Pharmaceuticals and Forest are building up their sales and marketing networks to launch the drug in the US market. Though Ironwood Pharmaceuticals will have a direct sales force in the US, it aims to conduct all future international sales through existing and new licensing agreements. The company also intends to explore further gastrointestinal indications for Linzess. In addition, Ironwood Pharmaceuticals has a candidate in clinical development stages for the treatment of small intestine disorders such as dyspepsia and gastroparesis.
Ironwood Pharmaceuticals regularly looks for licensing or acquisition opportunities to expand its development pipeline into existing and new therapeutic fields. For instance in early 2012 it licensed a candidate for anxiety from research firm Bionomics. Ironwood Pharmaceuticals also formed a research partnership with Protagonist Therapeutics in early 2011 in which Protagonist is conducting discovery work on certain targets and Ironwood Pharmaceuticals will take over development and commercialization efforts on any promising candidates. – less