Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) announced that its gastrointestinal drug, Linzess, has been granted marketing approval by Chinese regulatory authorities to treat adults with irritable bowel syndrome with constipation (“IBS-C”). Ironwood plans to launch the drug in China along with its partner in the country, AstraZeneca plc (NYSE:AZN) in the second half of 2019.
Linzess is marketed to treat IBS-C as well as chronic idiopathic constipation (“CC”) in the United States and 30 more countries. It is commercialized in collaboration with Allergan (NYSE:AGN) in the United States. Ironwood and Allergan co-develop and co-commercialize Linzess and equally share U.S. collaboration profits or losses as well as development costs.
Linzess is marketed by Allergan for IBS-C in Europe and Canada under the brand name Constella. Ironwood receives royalties on sales of Constella in Europe and Canada from Allergan. In Japan, Ironwood has a partnership with Astellas Pharma for the development and commercialization of Linzess.
The drug witnessed solid sales in the first nine months of 2019, generating over half a billion dollars in revenues. The company is also developing Linzess for label expansion in several IBS indications. Additionally, it is developing MD-7246, a delayed release version of linaclotide, for all subtypes of IBS.
The stock has lost 38.1% in the past six months compared with the industry’s 13.2% decline.
Earlier this month, Ironwood and Allergan announced that they have settled all pending patent litigations with Mylan N.V. (NASDAQ:MYL) related to Linzess. Mylan filed an abbreviated new drug application (“ANDA”) seeking approval to market a generic version of Linzess. However, Mylan is yet to receive approval from the FDA for any generic version of Linzess. This is the third patent settlement agreement entered into by Ironwood and Allergan to protect revenues of Linzess from generic competition. In 2018, the companies made similar settlements with India-based companies Sun Pharmaceuticals and Aurobindo Pharma.
In a bid to achieve increased operational performance and strategic flexibility, Ironwood Pharma remains on track to split into two separate entities. The entity focused on Linzess and gastrointestinal (“GI”) pipeline development will retain the current name of the company. Meanwhile, the other entity will focus on the development of the soluble guanylate cyclase (sGC) pipeline for the treatment of serious and orphan diseases and will be named Cyclerion. The transaction is expected to close in the first half of 2019. The separation of the entities is also being anticipated to be tax free.
Ironwood currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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