Abbott Laboratories (ABT) along with partner Sucampo Pharmaceuticals Inc. (SCMP) recently reported positive top-line data from a late-stage trial of lubiprostone in Japanese patients with chronic idiopathic constipation (CIC). Lubiprostone demonstrated safety and efficacy in the 48-week trial.
The 209 Japanese patients with CIC, who were enrolled in the phase III trial, were given 24-mcg lubiprostone capsule twice daily for up to 48 weeks. All the enrolled patients had a history of fewer than three spontaneous bowel movements (SBMs) per week for at least six months. Of the 209 patients enrolled, 173 and 163 patients completed 24 weeks and 48 weeks of treatment, respectively.
Sucampo Pharma, responsible for developing lubiprostone in Japan as a potential treatment for patients with CIC, has filed an application with the Japanese Pharmaceuticals and Medical Devices Agency for the approval of lubiprostone 24 mcg for the said indication. An update to that application is expected to be submitted in early 2011.
Sucampo Pharma and Abbott Labs have a license, commercialization, and supply agreement for lubiprostone. Per the terms of the deal Abbott Labs has the Japanese commercialization rights to lubiprostone for the treatment of CIC. Abbott Labs also has the right of first refusal for additional indications of lubiprostone in Japan.
Neutral on Abbott Labs
We currently have a Neutral recommendation on Abbott Labs, which is supported by a Zacks #3 Rank (short-term Hold rating). Despite lingering challenges like the impact of US healthcare reform, product recalls, foreign exchange headwinds and EU pricing austerity, we believe Abbott Labs’ strong business segments, contributions from recent acquisitions and impressive late-stage pipeline should help the company deliver strong earnings growth.
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