Sucampo Pharmaceuticals Inc. (SCMP) is up more than 115 percent since it was featured on our site five months ago, thanks to positive developments in its bowel drug Amitiza trials. Of course, the story isn't over yet as a couple of Amitiza-related events are coming up.
For readers who are new to this Bethesda, Maryland-based biopharmaceutical company, here's what to expect in the coming months...
Amitiza, whose chemical name is lubiprostone, is an FDA-approved drug for treatment of chronic idiopathic constipation in adults of both genders, and for irritable bowel syndrome with constipation in women aged 18 years and older.
Sucampo has been working towards expanding label indications for Amitiza. Accordingly, the drug is being evaluated as a potential treatment for chronic idiopathic constipation in pediatric, patients with renal impairment and patients with hepatic impairment; inflammatory bowel disease; mixed irritable bowel syndrome; opioid-induced bowel dysfunction, or OBD, in patients with chronic non-cancer pain and opioid-induced bowel dysfunction in cancer patients.
Last month, the company reported positive top-line results from an open-label phase III clinical trial designed to evaluate the long-term safety and efficacy of lubiprostone in OBD patients with chronic, non-cancer-related pain. According to the trial results, treatment with lubiprostone not only demonstrated consistent improvements in bowel frequency rates and other OBD-related symptoms, there were also no drug-related serious adverse events.
The company expects to file a supplemental New Drug Application during mid-2012 seeking priority review of Amitiza for the treatment of opioid-induced bowel dysfunction in patients with chronic non-cancer pain.
Sucampo also plans to file submissions this year with the European Union and Swiss regulatory authorities to seek marketing approvals for lubiprostone (Amitiza) for the treatment of opioid-induced bowel dysfunction in patients with chronic non-cancer pain.
Currently, there are no FDA-approved, orally administered products that are indicated for the treatment of OBD. Relistor, developed by Progenics in collaboration with Wyeth, is an FDA-approved treatment for opioid-induced constipation. However, Relistor is only an injectable drug and is not recommended for patients with known or suspected intestinal obstructions.
The company has also filed a New Drug Application for Amitiza for chronic idiopathic constipation in Japan. A decision on the NDA is expected in the second quarter of 2012. If approved, the company plans to take up a reimbursement negotiation with the Japanese regulatory authorities.
Yet another country in which Amitiza is under review as a potential treatment for chronic idiopathic constipation is the EU. A decision in this regard is expected in the third quarter 2012.
Amitiza was approved in Switzerland for the long-term treatment of adult patients with chronic idiopathic constipation in November 2009. The company hopes to conclude pricing negotiations with the Swiss Federal Office of Public Health for an appropriate reimbursement price this year.
Sucampo 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. The company 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 a tiered royalty based on net sales.
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 $226.4 million in 2011. In the first quarter of 2012, the drug raked in sales of $60.7 million, an increase of 19.8% over the year-ago comparable quarter.
In March of 2010, Sucampo 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 is entitled under the 2004 agreement. The hearing on Sucampo's claims concluded last December, and the anticipated date of the arbitration decision is now scheduled for May 31, 2012.
SCMP has thus far hit a 52-week low of $2.75 and a 52-week high of $8.50. The stock added 5.37% on Thursday to close the day's trading at $8.04.
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