says Jim O’Mara, Ironwood’s vice president of business development. The Spanish company won out, even though it offered less in upfront payments than others, because it offered the greatest percentage royalty on sales over the long-term, O’Mara says. He wouldn’t disclose those terms, but said the deal enables Ironwood to say it may capture half of the value of the program in Europe. Almirall has experience with mass marketing of big drugs for asthma, allergies, and cardiovascular diseaes. Its biggest product sales come through a license of Pfizer’s atorvastatin (Lipitor), the cholesterol-lowering medication that is the biggest selling drug in the world.
Pharmaceutical companies haven’t had much success with irritable bowel syndrome. Switzerland-based Novartis developed tegaserod maleate (Zelnorm), which reached $561 million in peak sales for treating the condition in 2006, despite “modest efficacy,” Hecht told me last November. That drug was yanked from the market in March 2007 after the FDA found it raised cardiovascular risks. Some analysts are predicting the Ironwood drug will exceed $1 billion in sales, although the company isn’t disclosing projections, O’Mara says.
Ironwood has come up with a different approach, an engineered protein fragment or peptide, designed in such a way that it can be packaged in an oral pill that pulls off a tricky balancing act. It has been made to withstand the harsh acids of the stomach, navigate its way into the gut, and act exclusively in that environment, without being absorbed throughout the body, where it can cause side effects, Hecht says. The drug is thought to act by stimulating secretions of fluids into the intestines, which softens stool, and helps people have easier bowel movements, Hecht says.
Last fall, Ironwood and Forest released results of a study of 420 patients which showed the drug significantly improved constipation symptoms and reduced abdominal pain. Researchers reported no serious side effects related to the drug, although 1 percent to 7 percent of patients on the medicine dropped out of the study because of diarrhea, according to a presentation at the American Society of Gastroenterology. The findings have prompted Ironwood and Forest to run four final-stage clinical trials, enrolling as many as 2,500 patients, to confirm whether the drug works well enough to deserve a spot on the market.
Two trials of linaclotide have begun for patients with chronic constipation, and two more for irritable bowel syndrome are expected to start soon, O’Mara says.
