Ironwood Pharmaceuticals Inc. (IRWD) and
Forest Laboratories Inc. (FRX) won U.S. regulatory approval of their
linaclotide treatment for irritable bowel syndrome with
constipation.
The therapy was also approved for chronic constipation, the
Food and Drug Administration said in a statement on its website
today. As many as 11 million Americans have irritable bowel
syndrome with constipation, a disorder that causes abdominal
pain, according to Cambridge, Massachusetts-based Ironwood.
Linaclotide will compete with Takeda Pharmaceutical Co. (4502)’s
Amitiza, which generated 18.7 billion yen ($237.6 million) for
the Japanese drugmaker in the 12 months ended in March. Peak
sales for linaclotide may reach $1.35 billion, Edward Nash, an
analyst with Cowen & Co., said in an Aug. 28 interview. The drug
may help reduce patients’ pain, an important element in the
treatment of IBS-C, he said.
“That’s the really big differentiator for the drug,” Nash
said by telephone. “At the end of the day, why is a patient
going to even come to the doctor? Yes, it’s because they’re
constipated or have diarrhea, but it’s the pain associated with
that that’s so significant.”
Linaclotide was developed by Ironwood with New York-based
Forest Labs, and the companies will co-promote the drug in the
U.S. Ironwood licensed the drug in Europe to Barcelona, Spain-
based Almirall SA (ALM), and to Tokyo-based Astellas Pharma Inc. (4503) for
several Asian countries.
Forest rose 1.2 percent to $35.06 at 11:54 a.m. New York
time. Ironwood shares were halted before the news.
Linaclotide was shown in studies to help alleviate
abdominal pain and symptoms of constipation. The most common
side effect was diarrhea, which might be expected “as a side
effect for treating constipation; you’re going to overshoot the
mark,” Nash said.
Source: Businessweek
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