Sucampo Pharmaceuticals Inc. (SCMP) and Takeda Pharmaceuticals U.S.A., Inc. announced Thursday that their drug lubiprostone, marketed under the trade name Amitiza, met the primary endpoint in a late-stage clinical trial for opioid-induced bowel dysfunction, or OBD.
Amitiza is already approved by the FDA for the treatment of chronic idiopathic constipation in adults of both genders and irritable bowel syndrome with constipation in women aged 18 years and older.
In the phase III opioid-induced bowel dysfunction trial in patients with chronic, non-cancer pain, excluding those taking methadone, patients were randomized to receive Amitiza 24-mcg capsule or placebo capsule twice daily for 12 weeks. The primary endpoint is overall spontaneous bowel movement response rate.
According to the trial results, the response rate was 26.9% for patients treated with Amitiza compared to 18.6% for placebo-treated patients.
Two other trials - OBD0631 and OBD0632, have already been conducted with Amitiza for opioid-induced bowel dysfunction in patients with chronic non-cancer pain. While one study, OBD0631, met the primary endpoint of a statistically significant change from baseline in the frequency of spontaneous bowel movements, the second study OBD0632 failed to achieve statistical significance for the same primary endpoint.
Sucampo Pharma believes that results from the previous phase III trial of Amitiza together with data from the associated long-term safety trial, will be sufficient to support the submission of a supplemental New Drug Application. The supplemental New Drug Application for Amitiza in the indication of opioid-induced bowel dysfunction is expected to be submitted in the first half of 2012.
It is estimated that 4.5 million patients in the U.S. suffer from opioid-induced bowel dysfunction, or OBD. Relistor, an injectable drug, developed by Progenics Pharmaceuticals Inc. (PGNX) in a collaboration with Wyeth, is the first approved treatment for opioid-induced constipation, or OIC. The drug was given FDA approval for OIC in 2008, and its global sales were $16 million in 2010. Currently, there are no FDA-approved, orally administered products that are indicated for the treatment of OBD.
If approved, Amitiza could be the first orally-administered medicine with the indication for OBD.
Ryuji Ueno, Chairman and CEO of Sucampo Pharma, said, " … we will discuss the potential for priority review, as we believe that physicians and their patients are actively seeking new therapies to address this condition".
Sucampo Pharma has a collaboration and license agreement with Takeda Pharmaceutical Company Ltd. for Amitiza in the United States and Canada that was signed in November 2004. Sucampo also has a license agreement in place for Amitiza in Japan with Abbott Japan Co. Ltd. that was inked in 2009.
Takeda records all sales of Amitiza within the U.S. and pays Sucampo Pharma a tiered royalty based on net sales. Takeda also holds marketing rights to Amitiza in Canada, but has not yet commercialized it there. In 2006, the year in which commercial sales of Amitiza in U.S. were initiated, the net sales of the drug were $31 million. The sales of the drug rose to $155 million in 2007; $193 million in 2008; $209 million in 2009; $220.0 million in 2010 and $169.6 million in the nine months of 2011.
In March 2010, Sucampo Pharma filed for arbitration in a bitter dispute with Takeda claiming that Takeda failed to generate an appropriate level of U.S. sales of Amitiza and that it refuses to collaborate and provide information to which Sucampo Pharma is entitled under the 2004 agreement. The hearing on Sucampo Pharma's claims has concluded and the arbitrators' decision is expected this quarter. (Q1, 2012).
SCMP has thus far hit a 52-week low of $2.75 and a 52-week high of $4.69. The stock lost 1.13% on Wednesday to close the day's trading at $4.39.
by RTT Staff Writer
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