It is more than thirty years since Prostones, a class of compounds derived from functional fatty acids, were discovered. These naturally occurring compounds in the human body are the mainstay of research for Sucampo Pharmaceuticals Inc. (SCMP).
For readers who are new to this Bethesda, Maryland-based biopharmaceutical company, here's a brief overview of its pipeline and what to expect in the coming months...
Sucampo has two FDA-approved drugs and a couple of drug candidates covering a variety of therapeutic areas namely, gastrointestinal, respiratory, vascular and central nervous system diseases and disorders.
The two FDA-approved drugs of Sucampo are:
* Amitiza (lubiprostone), a treatment for chronic idiopathic constipation in adults of both genders and for irritable bowel syndrome with constipation in women aged 18 years and older.
* Rescula (unoprostone isopropyl) for the lowering of intra-ocular pressure, or IOP, in open-angle glaucoma and ocular hypertension in patients who are intolerant of or insufficiently responsive to other IOP lowering medications.
Sucampo is also working towards expanding label indications of its marketed drugs - Amitiza and Rescula.
Amitiza 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 in patients with chronic non-cancer pain and opioid-induced bowel dysfunction in cancer patients.
Rescula is being tested as a potential treatment for dry age-related macular degeneration. An exploratory clinical study of Rescula for the ophthalmic indication of dry AMD was initiated in the second quarter of 2011 and results from this study are anticipated in December of this year.
If this study is successful, the company plans to initiate a dose-ranging phase II trial in a significantly larger number of patients to evaluate the effectiveness of Rescula to prevent the progression of dry AMD to wet AMD in the first half of 2012.
Sucampo is scheduled to report top-line results of third phase III efficacy trial of Amitiza for opioid-induced bowel dysfunction in patients with chronic non-cancer pain by the end of this year. This study, which was initiated in December 2010, has enrolled a total of 447 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.
The company intends filing a supplemental New Drug Application for Amitiza for opioid-induced bowel dysfunction next year if the results from the third phase III efficacy trial are positive. 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.
Sucampo has sought approval for Amitiza in the U.K. to treat chronic idiopathic constipation, and a decision by the Medicines and Healthcare products Regulatory Agency is expected by the third quarter of 2012.
The company has also filed a New Drug Application for Amitiza for chronic idiopathic constipation in Japan with the Pharmaceuticals and Medical Devices Agency. A decision on the NDA is expected in early 2012.
Amitiza was approved in Switzerland for the long-term treatment of adult patients with chronic idiopathic constipation in November 2009. The company is in discussions with the Swiss Federal Office of Public Health for pricing approval. The drug is expected to be made available in Switzerland starting in 2012.
Sucampo signed a collaboration and license agreement with Takeda Pharmaceutical Company Ltd. for Amitiza in the United States and Canada 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. 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.
Last March, 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 is currently scheduled to conclude by the end of December 2011.
Sucampo's other drug candidates are in preclinical testing and they include, Cobiprostone, SPI-3608 and SPI-017. Cobiprostone is being tested for oral mucositis, chronic obstructive pulmonary disease and wound healing. SPI-3608 and SPI-017 are being evaluated for the management of pain caused by spinal stenosis.
SPI-017 has completed a phase I trial for peripheral arterial disease in Japan while Cobiprostone has been tested in a phase II trial as a potential treatment for the prevention of gastric ulcers and other gastrointestinal injuries in patients treated with non-steroidal anti-inflammatory drugs. The results of the Cobiprostone trial presented in 2009 demonstrated that use of high-dose Cobiprostone was associated with a 50.0% reduction in gastroduodenal ulcers when compared to placebo.
A quick look at the balance sheet...
In the third quarter ended September 30, 2011, Sucampo incurred a net loss of $4.1 million or $0.10 per share on revenue of $14.4 million. This compares with net income of $1.9 million or $0.05 per share on revenue of $20.9 million in the third quarter of 2010.
Sucampo went public in August 2007, pricing its shares at $11.50 each. Over the past 1 year, the stock has traded in a range of $2.75 to $4.75. SCMP closed Wednesday's trading at $3.72, down 1.33%.
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