SAN DIEGO, July 15, 2013 (GLOBE NEWSWIRE) — Ocera Therapeutics, Inc. (“Ocera”), a clinical stage biopharmaceutical company developing novel therapeutics for orphan liver diseases, and Tranzyme, Inc. ( TZYM ) (“Tranzyme”) today announced that, following a special meeting of the shareholders of Tranzyme held on July 15, 2013, the Ocera and Tranzyme merger has closed. The combined company is named Ocera Therapeutics, Inc. and will trade beginning July 16, 2013 on the NASDAQ Global Market under the symbol “OCRX”. The combined company (the “Company”) operates under the leadership of Linda S. Grais, MD, President and Chief Executive Officer, and the board of directors consists of representatives from both the former Ocera and Tranzyme boards.
Prior to the merger, Tranzyme effected a 12-to-1 reverse split of its outstanding common stock. After giving effect to the merger and the reverse stock split, the holder of each share of the common stock of pre-merger Ocera received approximately 0.11969414 shares of the Company’s common stock. All options and warrants of pre-merger Ocera that were outstanding prior to the merger were assumed by Tranzyme in the merger.
Immediately following the closing of the merger, certain of the Ocera investors, including Domain Associates, Thomas McNerney Partners, Sofinnova Ventures, InterWest Partners, Greenspring Associates, Agechem, CDIB and Wasatch Advisors, invested approximately $20 million in the Company through a private placement financing at $6.0264 per share of post-split Company stock. Following the merger, the reverse split and the financing, the Company has approximately 11.3 million shares outstanding.
“The closing of this merger represents an important milestone as Ocera joins forces with Tranzyme to develop OCR-002, a differentiated product candidate for orphan liver diseases,” said Dr. Grais. “We look forward to advancing OCR-002, currently in Phase 2 development, to address a significant unmet need in the treatment of hepatic encephalopathy in patients with decompensated liver cirrhosis.”
OCR-002 has received Orphan Drug designation in the United States and Europe and has been granted fast track status by the U.S. Food and Drug Administration. It is estimated that there are up to one million patients with cirrhosis in the United States, and approximately 150,000 hospitalizations occur annually in the United States due to complications of hepatic encephalopathy, costing the healthcare system approximately $7 billion every year. For more information about clinical trials related to OCR-002, please visit www.clinicaltrials.gov .
OCR-002 (ornithine phenylacetate) is an ammonia scavenger designed to treat hyperammonemia and associated hepatic encephalopathy in patients with liver cirrhosis, acute liver failure and acute liver injury. OCR-002, through its dual mechanism of action, directly lowers circulating blood levels of ammonia. Ammonia accumulation in the blood impairs brain cell function. Hepatic encephalopathy is an often-reversible neuropsychiatric abnormality observed in patients with liver disease; it is marked by a worsening of brain function when the liver is no longer able to remove toxic substances such as ammonia from the blood. Signs of hepatic encephalopathy include impaired cognition, uncontrolled movements and decreased levels of consciousness leading to coma and death due to brain swelling. OCR-002 is being developed as an injectable formulation for hospitalized patients and as an oral formulation to treat and prevent recurrences of hepatic encephalopathy.
Planning is underway to initiate a Company-sponsored Phase 2b, randomized, double-blind, placebo-controlled efficacy study of OCR-002 as an intravenous treatment for acute hepatic encephalopathy in hospitalized patients with liver cirrhosis. Enrollment is expected to begin in late 2013.
OCR-002 also is the subject of two ongoing, externally-sponsored, Phase 2a studies in patients. Data from these studies are expected in 2014.
About Ocera Therapeutics, Inc.
Ocera Therapeutics, based in San Diego, California with an office in Research Triangle Park, North Carolina, is a clinical stage biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat acute and chronic orphan liver diseases. For additional information, please see www.ocerainc.com .
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this communication, including the timing of enrollment initiation of our Phase 2b clinical trial and the availability of additional data from the Phase 2a trials of OCR-002, constitute “forward-looking