Ocera Therapeutics Announces Completion of Merger With Tranzyme
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. (Nasdaq: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
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
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
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
statements" within the meaning of Section 27A of the Securities Act and
Section 21E of the Securities Exchange Act and are usually identified by the
use of words such as "anticipates," "believes," "estimates," "expects,"
"intends," "may," "plans," "projects," "seeks," "should," "will," and
variations of such words or similar expressions. We intend these
forward-looking statements to be covered by the safe harbor provisions for
forward-looking statements contained in Section 27A of the Securities Act and
Section 21E of the Securities Exchange Act and are making this statement for
purposes of complying with those safe harbor provisions. These forward-looking
statements reflect our current views about our plans, intentions,
expectations, strategies and prospects, which are based on the information
currently available to us and on assumptions we have made. Although we believe
that our plans, intentions, expectations, strategies and prospects as
reflected in or suggested by those forward-looking statements are reasonable,
we can give no assurance that the plans, intentions, expectations or
strategies will be attained or achieved. Furthermore, actual results may
differ materially from those described in the forward-looking statements and
will be affected by a variety of risks and factors that are beyond our
Risks and uncertainties of the Company include, but are not limited to:
liquidity and trading market for shares following the merger and financing;
inability or the delay in obtaining required regulatory approvals for product
candidates, and/or which may result in unexpected cost expenditures;
uncertainties in obtaining successful clinical results for product candidates
and unexpected costs that may result therefrom; failure to realize any value
of certain product candidates developed and being developed, including with
respect to OCR-002, in light of inherent risks and difficulties involved in
successfully bringing product candidates to market; inability to develop new
product candidates and support existing products; the approval by the FDA and
EMA and any other similar foreign regulatory authorities of other competing or
superior products brought to market; risks resulting from unforeseen side
effects; risk that the market for the combined company's products may not be
as large as expected; inability to obtain, maintain and enforce patents and
other intellectual property rights or the unexpected costs associated with
such enforcement or litigation; inability to obtain and maintain commercial
manufacturing arrangements with third party manufacturers or establish
commercial scale manufacturing capabilities; loss of or diminished demand from
one or more key customers or distributors; unexpected cost increases and
pricing pressures; continuing or deepening economic recession and its negative
impact on customers, vendors or suppliers; uncertainties of cash flows and
inability to meet working capital needs; cost reductions that may not result
in anticipated level of cost savings or cost reductions after the merger; and
risks associated with the possible failure to realize certain benefits of the,
including future financial, tax, accounting treatment, and operating results.
Many of these factors that will determine actual results are beyond the
Company's ability to control or predict.
Other risks and uncertainties are more fully described in our Annual Report on
Form 10-K for the year ended December 31, 2012 filed with the SEC, and in
other filings that Tranzyme makes and will make with the SEC in connection
with the proposed transactions, including the definitive proxy statement filed
with the SEC on June 10, 2013. Existing and prospective investors are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof. The statements made in this press
release speak only as of the date stated herein, and subsequent events and
developments may cause our expectations and beliefs to change. While we may
elect to update these forward-looking statements publicly at some point in the
future, we specifically disclaim any obligation to do so, whether as a result
of new information, future events or otherwise, except as required by law.
These forward-looking statements should not be relied upon as representing our
views as of any date after the date stated herein.
Director, Corporate Communications
Ocera Therapeutics, Inc.
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