Source: BUSINESS WIRE
Tuesday, June 23, 2009
NEWTON, Mass.--(BUSINESS WIRE)--Clinical
Data, Inc. (NASDAQ: CLDA) announced today that the United States
Adopted Name Council (USAN) has approved the generic name vilazodone
hydrochloride. Vilazodone,
if approved, would represent a first-in-class drug for the treatment of
depression, due to its novel dual mechanism of action as both a potent
and selective serotonin reuptake inhibitor (SSRI) and a partial agonist
of the 5-hydroxytryptamine 1a (5-HT1A) receptor. Thus,
vilazodone combines first-line therapy for depression with 5-HT1A
partial agonism, an accepted adjunctive treatment for depression and a
first-line therapy for anxiety disorders. Clinical Data has recently
completed the second of two positive Phase III registration studies.
Results of these studies will form the basis of a new drug application
(NDA) that the Company intends to submit with the U.S. Food and Drug
Administration (FDA) by the end of 2009.
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The purpose of the USAN Council is to select simple, informative and
unique nonproprietary names for drugs based on pharmacological and/or
chemical relationship. The American Medical Association, the United
States Pharmacopeial Convention and the American Pharmacists Association
sponsor the Council. The Council works closely with the World Health
Organization’s International nonproprietary Name Program.
On June 2, 2009, Clinical Data announced top-line results from its
second Phase III studies for vilazodone, with results confirming its
prior positive Phase III trial. Vilazodone was generally well-tolerated
and met both the primary and secondary endpoints of the study with high
statistical significance. In addition, study findings corroborate that
effects of vilazodone on sexual function were comparable to placebo when
measured by an objective validated scale, an important finding since
many antidepressants have been associated with causing or exacerbating
sexual dysfunction. In this second study, the most frequent side effects
associated with vilazodone were diarrhea, nausea, and headache.
The Company has projected that its current cash will be sufficient to
fund operations through the submission of the NDA for vilazodone this
year, as well as the commencement of its Phase III clinical program for
Stedivaze, a vasodilator used for cardiac stress testing, anticipated in
the next month. Management continues to evaluate additional sources of
financing including partnering opportunities with pharmaceutical or
biotechnology companies for development and marketing of late-stage or
pre-clinical compounds, sale of non-core assets and the sale of equity
or debt securities.
At March 31, 2009, the Company reported cash and marketable securities
totaling $56.4 million. Based on its cash position, Clinical Data
received a going concern explanatory paragraph in the unqualified audit
opinion included in its Annual Report on Form 10-K which was filed with
the Securities and Exchange Commission on Monday, June 15, 2009. This
announcement is required by NASDAQ Marketplace Rule 4350(b)(1)(B), which
requires separate disclosure of receipt of an audit opinion containing a
going concern qualification. This announcement does not represent any
change to the Company's Annual Report on Form 10-K or the financial
statements included therein.
About Depression and the Anti-Depressant Market
According to the National Institute of Mental Health (NIMH), 18.1
million Americans suffered from depression in 2007. In addition, major
depressive disorder is the leading cause of disability in individuals
ages 15–44. IMS Health's National Prescription Audit reported more than
200 million prescriptions for antidepressants in 2008. The Surgeon
General's Office also estimates that 5.3% of American adults,
approximately 17 million people, suffer from depressive illness.
About Clinical Data, Inc.
Clinical Data is a biotechnology company focused on the discovery,
development and commercialization of targeted therapeutics: From
Targeted Science to Better Healthcare®. Clinical Data is
leveraging advances in molecular discovery to provide tangible benefits
for patients, healthcare professionals and payors worldwide. The Company
is advancing its late-stage, first-in-class or potential
best-in-category drug candidates including vilazodone, for the treatment
of depression, and Stedivaze, a vasodilator used for cardiac stress
testing, to be followed by promising drug candidates in other
therapeutic areas such as inflammatory diseases and oncology. Coupled
with its biomarker expertise and portfolio of intellectual property,
Clinical Data plans to develop and commercialize targeted therapeutics,
as well as genetic and pharmacogenomic tests to detect serious diseases
and help predict drug safety, tolerability, and efficacy, thereby
improving patient health while reducing costs. To learn more, please
visit the Company's website at www.clda.com/.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
This press release contains certain forward-looking information and
statements that are intended to be covered by the safe harbor for
forward looking statements provided by the Private Securities Litigation
Reform Act of 1995. Forward-looking statements are statements that are
not historical facts. Words such as "expect(s)", "feel(s)",
"believe(s)", "will", "may", "anticipate(s)" and similar expressions are
intended to identify forward-looking statements. These statements
include, but are not limited to, statements about our ability to obtain
regulatory approval for, and successfully introduce vilazodone; our
ability to expand our long-term business opportunities; and all other
statements regarding future performance. All such information and
statements are subject to certain risks and uncertainties, the effects
of which are difficult to predict and generally beyond the control of
the Company, that could cause actual results to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include, but
are not limited to, whether vilazodone will advance further in the
clinical trials process and whether and when, if at all, vilazodone will
receive final approval from the U.S. Food and Drug Administration and
equivalent foreign regulatory agencies and for which indications;
whether vilazodone will be successfully marketed if approved; the extent
to which genetic markers are predictive of clinical outcomes and drug
efficacy and safety; the strength of our intellectual property rights;
competition from pharmaceutical, biotechnology and diagnostics
companies; the development of and our ability to take advantage of the
market for pharmacogenetic and biomarker products and services; general
economic downturns; and those risks identified and discussed by Clinical
Data in its filings with the U.S. Securities and Exchange Commission.
Readers are cautioned not to place undue reliance on these forward
looking statements that speak only as of the date hereof. Clinical Data
does not undertake any obligation to republish revised forward-looking
statements to reflect events or circumstances after the date hereof or
to reflect the occurrence of unanticipated events. Readers are also
urged to carefully review and consider the various disclosures in
Clinical Data's SEC periodic and interim reports, including but not
limited to its Annual Report on Form 10-K for the fiscal year ended
March 31, 2009, Quarterly Report on Form 10-Q for the fiscal quarter
ended December 31, 2008, and Current Reports on Form 8-K filed from time
to time by the Company.