Chronic Idiopathic Constipation, or CIC, is a very common functional gastrointestinal disorder, and over 30 million Americans are estimated to suffer from this disorder. Sucampo Pharmaceuticals Inc.'s (SCMP: Quote) Amitiza, approved in 2006, is the widely available prescription drug therapy to treat CIC in adults. Working on the development of a new drug for the same indication is Synergy Pharmaceuticals Inc. (SGYP: Quote).
For readers who are new to Synergy Pharma, here's a brief overview of the company's pipeline and the upcoming events...
The company has two compounds in development namely, Plecanatide and SP-333.
Plecanatide is Synergy Pharma's lead investigational drug, and is under phase II/III clinical development for the treatment of chronic idiopathic constipation. Plecanatide is an analogue of Uroguanylin, a natural human hormone that regulates the secretion of fluid into the intestine which is critical for normal digestion.
The phase II/III trial of Plecanatide in chronic idiopathic constipation was initiated in October 2011. The trial, designed to enroll 880 patients, achieved the halfway mark of 440 patients in April of this year.
Synergy Pharma expects completing enrollment of the trial this quarter (3Q) and reporting top line data in the fourth quarter.
Yet another functional gastrointestinal disorder which the company is focusing on is constipation-predominant irritable bowel syndrome, or IBS-C.
A phase II clinical trial evaluating Plecanatide in IBS-C patients is expected to commence in the second half of 2012. This trial will enroll over 300 patients. Note that Sucampo's Amitiza approved for CIC is also approved in the additional indication of IBS-C in women aged 18 years and older. In 2011, Amitiza garnered net sales of $226 million.
Plecanatide belongs to the same class of drugs as that of Linaclotide, referred to as guanylate cyclase C (GC-C) agonists, from Ironwood Pharmaceuticals Inc. (IRWD: Quote) to treat CIC and IBS-C. Linaclotide is under FDA review and the regulatory agency's decision is scheduled for September of this year.
Also in the pipeline of Synergy Pharma is SP-333, which is under preclinical development for ulcerative colitis.
A quick look at the company's balance sheet...
Since inception in 2005, Synergy Pharma has incurred losses and has not generated any revenue till date. As of March 31, 2012, the company had an accumulated deficit of $76.6 million.
In the first quarter ended March 31, 2012, the company's net loss widened to $7.02 million or $0.13 per share from $3.70 million or $0.08 per share in the year-ago quarter. The company ended Q1 2012 with $6.12 million in cash. Synergy Pharma also raised gross proceeds of $51.75 million through a public offering of common stock that was announced in May.
Last month, Synergy Pharma was added to the broad-market Russell 3000 Index, the Russell Global Index and the Russell Microcap Index. Inclusion in the Russell Indexes provides greater visibility and potentially will lead to increased liquidity and a broader stockholder base, says the company.
Synergy Pharma shares have gained more than 30% year-to-date. The stock has thus far recorded a 52-week low of $3.17 and a 52-week high of $8.70. SGYP closed Thursday's trading at $4.68, down 1.47%.
Considering the fact that top-line Plecanatide data are due by year end, it remains to be seen if 2012 will be a transformative year for Synergy Pharma. Stay tuned!
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by RTT Staff Writer
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