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Ocera Therapeutics, Inc. Receives CE Mark for Zysa™ for the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-d)



5/18/2012 7:48:14 AM

SAN DIEGO, May 18, 2012 /PRNewswire/ -- Ocera Therapeutics Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary agents to treat gastrointestinal and liver diseases, announced today that it has received a CE Mark for Zysa (spherical carbon adsorbent, formerly AST-120) for the treatment of diarrhea predominant IBS (IBS-d), a condition affecting 10-15% of the Western world. Zysa is now ready for clinical use in the EU and countries that recognize the CE Mark. Ocera is in active discussions with potential partners for European sales and marketing.

"IBS-d is a condition affecting millions of people for which no new treatment has been approved in decades," stated Dr. Laurent Fischer, President and CEO of Ocera Therapeutics. "By securing a CE Marking for Zysa, we will, with the right partner, be able to offer a new option for the treatment of this disorder that adversely affects the lives of millions of people."

Zysa is an oral adsorbent that removes substances that may potentiate gut secretion and contraction, thereby triggering symptoms of IBS. These include abdominal pain, diarrhea and bloating. Zysa is also marketed as Kremezin in Asia to treat chronic kidney disease.

IBS can be extremely debilitating and is associated with economic burden in both direct medical costs and indirect social costs such as absenteeism and lost productivity, along with decreased quality of life. It represents the most common diagnosis made by gastroenterologists.

In a phase 2 clinical study of patients fulfilling the Rome III criteria for IBS, 26.8% of patients treated with Zysa reported a 50% or more reduction in the number of days with abdominal pain from baseline, compared to only 10.2% of patients treated with placebo (p=0.029) at Week 4. At Week 8, response rates were 32.1 and 25.4% respectively (not statistically significant). Patients treated with Zysa experienced improvement in bloating and stool consistency. These improvements were lost when Zysa was replaced with placebo and regained when Zysa was reinstituted.

"Zysa is a locally acting, novel treatment for IBS that has been proven safe and well-tolerated. It has been shown to reduce pain and bloating for the short-term symptomatic treatment of IBS-d," stated Professor Jan Tack, Head of Clinic, Department of Gastroenterology in Leuven, Belgium and the lead investigator of the Zysa clinical trial. "Given the paucity of proven treatments for IBS-d, Zysa has the potential to become an important new tool for gastroenterologists working with patients to combat this very common disorder."

Ocera Therapeutics has received Fast Track status from the U.S. Food and Drug Administration (FDA) for Zysa for IBS-d and is planning to initiate further studies based on recent guidance and interactions with the FDA. Zysa is protected by patents for the short-term symptomatic relief of IBS-d until 2027. Currently, the only approved treatment in the U.S. for IBS-d is alosetron, which carries significant safety concerns that necessitate a risk minimization program. As such, most patients with nonconstipating IBS are treated with drugs that are either not indicated for IBS and are of unproven or limited efficacy in this population, including antispasmodic agents, antidepressants and probiotics [Brandt 2009; Hammerle 2008].

The CE Marking is a legally required mark for a product that is intended for sale in the European Market and declares the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation. CE Marking certification was conducted by TUV SUD, a globally recognized testing, inspection and certification organization.

About Zysa (spherical carbon adsorbent, AST-120)
Zysa is a novel proprietary spherical carbon adsorbent with a selective adsorption profile for a variety of substances linked to IBS-d. Zysa also adsorbs other substances including ammonia, indoles (serotonin), histamine, bile acids, advanced glycation endproducts (AGE), and certain bacterial toxins. Ocera licensed the compound from Kureha Corporation (Japan). Zysa has been used chronically by over 360,000 patients and studied in over 3,000 patients worldwide. It is marketed as Kremezin in Asia.

About Ocera Therapeutics, Inc.
Ocera Therapeutics, based in San Diego, California, USA, is a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat liver diseases and gastrointestinal disorders. In addition to Zysa (spherical carbon adsorbent), Ocera is developing OCR-002, an ammonia detoxification agent, for the treatment of patients with hepatic encephalopathy and acute liver failure. Ocera has raised over $60 million in financing from Domain Associates, Sofinnova Ventures, Thomas, McNerney & Partners, Greenspring Global Partners and InterWest Partners. Additional information on the company can be found at www.oceratherapeutics.com.

SOURCE Ocera Therapeutics, Inc.


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