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:)Aus Avalon wird Clinical u.schon gibt,s was positives.

02.06.2009 12:04
Clinical Data, Inc. Announces Positive Results from Second Phase III Trial of Vilazodone for Depression

- On Track to File NDA This Year -

- Conference Call to Discuss Results Today at 8:30 am EST -

Clinical Data, Inc. (NASDAQ: CLDA) today announced positive top-line results from the second of two Phase III trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). In the study, vilazodone achieved statistically significant results on the primary endpoint and secondary efficacy endpoints related to MDD. Study results suggest that vilazodone was generally well-tolerated and the efficacy and safety data were consistent with the findings from the previous Phase III trial. In addition, study findings corroborate that effects of vilazodone on sexual function were comparable to placebo, an important finding since many antidepressants have been associated with causing or exacerbating sexual dysfunction. A statistically significant improvement in the symptoms of anxiety associated with MDD was also observed. Clinical Data intends to file these data as the second of two positive registration studies in support of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for vilazodone for the treatment of MDD by the end of 2009.

”We are delighted with these top-line Phase III results, which provide further evidence of the potential of vilazodone as a first-in-class drug for the treatment of depression,” said Carol R. Reed, MD, Executive Vice President and Chief Medical Officer of Clinical Data. ”Physicians and patients continue to seek new treatment options for MDD. With a new, dual mechanism of action and the potential for a favorable safety profile, we believe that, if approved, vilazodone will have broad clinical utility for the treatment of MDD. The positive results from this study, coupled with the results of the prior Phase III and long-term safety studies, will provide the basis for our NDA filing later this year for vilazodone for the treatment of depression.”

Separately, the Phase III study also sought to replicate a proprietary biomarker that had been identified in the first Phase III trial as potentially associated with response to vilazodone. Although this goal was not met, biomarker analyses remain ongoing. ”While our lead biomarker of response to vilazodone did not replicate in this trial, it is one in a series of candidate biomarkers that we will continue to evaluate,” continued Dr. Reed.

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 MDD with 5-HT1A partial agonism, an accepted adjunctive treatment for MDD and a first-line therapy for anxiety disorders.

This second Phase III study was a randomized, double-blind, placebo-controlled trial of 481 patients with MDD conducted at 12 sites in the United States. The study achieved its primary endpoint of demonstrating a reduction in the symptoms of depression, as measured by a statistical separation from placebo, in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after up to 8 weeks of treatment (p=0.007, ITT/LOCF). Vilazodone also met a key secondary endpoint as demonstrated by a statistically significant reduction in depression symptoms, compared to placebo, as measured by mean change from baseline on the Hamilton Depression Rating Scale (HAMD17, p=0.021). These two rating scales are the most common psychometric measures of response to antidepressants used in clinical trials. There was also a statistically significant improvement in symptoms of anxiety associated with depression, as measured by the Hamilton Anxiety Rating Scale (HAMA, p=0.038). The effects of vilazodone on sexual function were comparable to placebo, as measured by a validated sexual function scale, the Changes in Sexual Function Questionnaire (CSFQ).

Vilazodone was generally well tolerated. The discontinuation rate due to adverse events for patients on vilazodone was 4.3% vs. 1.7% for those treated with placebo. In this study, the most common adverse events associated with vilazodone included diarrhea (31% vilazodone vs. 11% placebo), nausea (26% vs. 6%), and headache (13% vs. 10%). One patient out of 240 patients randomized to the vilazodone group discontinued the trial due to diarrhea and three patients due to nausea.

In September 2007, Clinical Data announced that vilazodone demonstrated both statistical and clinical significance on primary and secondary endpoints for efficacy in its first Phase III trial. The Company has also completed its long-term safety study of vilazodone, exceeding the typical exposure requirements for an NDA filing.

"Clinical Data has successfully completed two Phase III trials for vilazodone, an extraordinary achievement for our Company which has continued to deliver positive results within aggressive timeframes,” said Drew Fromkin, President and CEO of Clinical Data. ”We will continue to work diligently to complete the NDA process and commercialize vilazodone. Our success with vilazodone provides a strong foundation for our pursuit of first-in-class or best-in-category therapies, including Stedivaze, a vasodilator for cardiac stress imaging, which is expected to begin a Phase III program shortly.”

Conference Call Information:

Date: Tuesday, June 2, 2009

Time: 8:30 a.m. ET

Internet: The live webcast can be accessed at www.clda.com through the Investor Relations tab.

Telephone: Domestic dial 877-340-7912; International dial 719-325-4904

Access code for both domestic and international callers: 2637742

About Depression and the Antidepressant 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. It is believed that some people may be genetically predisposed to depression and that it may be possible to identify certain genetic biomarkers that might help to predict the likelihood of a patient's pharmacological response to a given antidepressant.

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 for cardiac stress imaging, 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, 2008, 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.

Contacts:

Clinical Data, Inc.
Theresa McNeely, 617-527-9933 x3373
Vice President
Corporate Communications
or
General Business Inquiries
617-527-9933 x3388

:)
Antwort auf Beitrag Nr.: 37.301.945 von Bikermichel am 02.06.09 14:08:07Eine Depression hat nichts mit Angst zu tun. Sie Schlaumeier.


Ich wünsche Ihnen, dass Sie nie! am eigenen Leib erleben, was eine richtige Depression ist.
Antwort auf Beitrag Nr.: 37.304.468 von FANNIEMAE am 02.06.09 18:33:41Hallo,na wenn schon Schlaumeier dann aber richtig.

Allgemeiner Eindruck eines depressiven Menschen auf die Umwelt

- depressive Menschen sprechen oft leise und langsam, sie klingen eintönig
- sie haben oft einen ernsten Gesichtsausdruck, wirken erstarrt oder verbissen
- sie bewegen sich oft kraftlos, schleppend oder unmotiviert ( Antriebslosigkeit)
- der Gang ist nach vorn gebeugt, die Schultern hängen
- sie ziehen oft den Kopf ein, sehen jämmerlich aus
- es hat den Anschein, als kann sich der Betroffene über nichts freuen

Stimmungen von depressiven Menschen

- sie sind bedrückt, traurig, verzweifelt
- sie haben ein andauerndes Elendigkeitsgefühl
- Minderwertigkeitskomplexe ( Man denkt, man ist nichts wert)
- ängstlich, Angst vor dem Leben
- hoffnungslos, Gefühl von Hilflosigkeit
- sie wollen sich verkriechen
- lebensmüde Gedanken, nicht mehr aufwachen wollen, alles Sch...
- man sieht alles negativ
- das Leben scheint sinnlos, warum lebt man überhaupt?
- Hemmungen
- Schuldgefühle
- Schwinden des Selbstwertgefühls
- Interessenverlust
- Unruhe
- Gefühlslosigkeit


Die Hauptsymptome einer Depression sind:

- eine andauernd gedrückte Stimmung
- eine andauernde Freudlosigkeit
- ein Verlust von Interesse an Dingen, die den Erkrankten vorher interessiert haben
- eine grundsätzliche Antriebslosigkeit

Oft autretende körperliche Symptome

Appetitverlust
- es kann eine Appetitlosigkeit mit starkem Gewichtsverlust auftreten
- gelegentliche zunahme desAppetits (Heißhunger vor allem auf Kohlehydrate, Schokolade)
- starkes Bedürfnis nach sehr salzigen oder süßen Lebensmitteln, da der Geschmackssinn durch die Krankheit beeinträchtigt ist
Appetitlosigkeit


Atmung
- der Betroffene spürt eine Enge im Brustkorb
- der Betroffene verspürt einen Druck auf der Brust
- er atmet schwer, keucht oder auch flach und kaum merklich


Augen
- der Erkrankte klagt über schlechte Augen, kann aber keine passende Sehhilfe finden
- Entzündete Augen können auftreten
- schlechtes Sehen (ohne nachweislicher Ursache)
- Lichtüberempfindlichkeit


Blasenstörungen
- es treten Schmerzen beim Wasserlassen auf
- häufiger Harndrang
- die Blase ist gereizt


Schlafstörungen
- Störungen beim Einschlafen
- Störungen beim Durchschlafen
- nächtliches Erwachen
- öfters Alpträume
- als Flucht vor dem Leben: gesteigertes Schlafbedürfnis
- früheres Erwachen am Morgen
- Startschwierigkeiten am Morgen

siehe auch Schlaflosigkeit , Das Morgentief


Herzbeschwerden
- Stechen im Herzen, Brennen oder Druck
- Herzklopfen, Herzrasen


Hals-, Nasen-, Ohrenbereich
- man verspürt einen Kloß im Hals
- der Hals ist wie zugeschnürt
- man fühlt einen Druckgefühl auf Ohren
- es können Ohrgeräsuche auftreten (ähnlich Tinitus)
- Schmerzen in den Ohren
- schlechteres Hörvermögens (ohne körperlich nachweisbare Ursache)
- Der Mund brennt und ist trocken


Kreislauf
- Schwindelanfälle
- man hat öfters "weiche Knie"
- ein erhöhter Blutdruck ohne körperlich nachweisbare Ursache

Kopf- und Nackenbereich
- diffuse Schmerzen oder Druck
- Verspannungen im Schulter- oder Nackenbereich

Magen-Darm-Beschwerden
- es können Übelkeit, Brechreiz, Erbrechen auftreten
- verstärkt Blähungen
- es kommt zu Sodbrennen oder Magendruck
- häufig Verstopfung oder Durchfall
Probleme mit dem Magen, Übelkeit, Verdauungsstörungen

Vegetatives Nervensystem
- der Betroffenen verspürt Hitzewallungen oder Kälteschauer
- er zittert ungewöhnlich
- er errötet schnell
- er nekommt oft kalte Hände oder Füße
- er ist sehr Temperatur-Empfindlich, schnell ist es ihm zu kalt oder zu warm
- er hat Blutdruckschwankungen


Zahnbereich
- häufige Schmerzen ohne Grund
- Gefühl eines schlecht sitzenden Gebißes
- "Zähne zusammenbeißen" oder Zähneknirschen

Und
- Selbstschädigung
- Keine Lust auf Sexualität
- Man kann nichts mehr entscheiden
- Verlust des Zeitgefühls
- Die Angst, immer dümmer zu werden
- Man ist wie ausgebrannt
- Die Angst vor einer unheilbaren Krankheit


Wie Sie sehen, gibt es viele verschiedene Symptome. Diese Symptome einer Depression müssen nicht bei allen Erkrankten gleichzeitig auftreten. Auch die Stärke der einzelnen Störungen kann variieren. Die Symptome müssen auch nicht ständig auftreten, sie können zeitweilig da sein und dann wieder verschwinden.

Die Depression ist zwar eine Krankheit der Psyche, sie kann aber auch deutliche körperliche Auswirkungen haben.
Eine Depression ist also eine Erkrankung des gesamten Menschen.


Im überigen leidet mein Sohn an einer Depression,mit der wir schon eine ganze Weile zu tun haben.Bin zwar nicht direkt betoffen,aber als Vater natürlich mitten drin.Vielleicht sollte man die Überschrift doch etwas lockerer sehen. :confused:
Dann sollten wir doch hoffen das dieses Medikament(wenn zugelassen)
diesen Menschen auch hilft!

Mfg.Michel
interessant, wenn auch nicht fuer jeden "Notwendig".
Hoert sich an als wuesstest Du aber genau wovon Du sprichst - keine schoene Sache.

Ich wuenschte dieser FANNI wuerde nocheinmal seinen Kommentar abgeben.
Ob er wohl den Mum dazu hat?
Antwort auf Beitrag Nr.: 37.304.886 von Bikermichel am 02.06.09 19:24:12Ok. Einverstanden. Nur der Threadtitel ist ein bißchen unglücklich formuliert. Ernsthaftigkeit wäre besser.
Clinical Data, Inc. to Present at Noble Financial’s Fifth Annual Equity Conference

Clinical Data, Inc. (NASDAQ: CLDA), today announced that Drew Fromkin, President and Chief Executive Officer, will be presenting a corporate overview at the Fifth Annual Noble Financial Equity Conference on Tuesday, June 9, 2009 at the Seminole Hard Rock Hotel, Hollywood, FL. Clinical Data's presentation will take place at 8:05 a.m. EDT.

A live audio and archived webcast of the Company presentation can be accessed through the Company's website at www.clda.com.

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 for cardiac stress imaging, 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.

Contacts:

Clinical Data, Inc.
Theresa McNeely, 617-527-9933, x3373
Vice President
Corporate Communications
linical Data Presented at International Congress Showed Treatment With Neupro(R) (rotigotine) Significantly Improved Early Morning akinesia and was Generally Well Tolerated Over Four Years

BRUSSELS, June 12 /PRNewswire/ --

- For the Attention of European Accredited Medical Writers Only

- Data Presented at the 13th International Congress of Parkinson's Disease and Movement Disorders

- Long-term Treatment With rotigotine was Generally Well Tolerated in Patients With Early Stage Parkinson's Disease (up to Four Years)

- Treatment With rotigotine Improved Early Morning akinesia in Patients With Advanced Parkinson's Disease

Clinical data presented this week at the 13th International Congress of Parkinson's Disease and Movement Disorders in Paris, France showed rotigotine improved early morning akinesia in patients with advanced Parkinson's disease. Data also demonstrated the tolerability of rotigotine over four years of treatment in patients with early stage Parkinson's disease.

Neupro(R) (rotigotine) is approved in Europe for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy or in combination with levodopa over the course of the disease through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur.*

Long-term treatment with rotigotine (up to four years) was generally well-tolerated in patients with early stage Parkinson's disease

An open-label extension study of patients with early-stage Parkinson's disease showed that over a four year maintenance period, rotigotine showed low rates of discontinuations and a low incidence of dyskinesia.

The study comprised 137 patients randomized to rotigotine (2 mg/24 h) and 79 randomised to placebo. The majority (63%) remained in the study over 4 years of open-label maintenance. Discontinuations due to treatment-related adverse events were low (17%). Most withdrawals occurred within the first 12 months with the most common occurrences including application site erythema (14%), pruritus (9%), inflammation (7%) and skin reactions (5%).

The adverse events most frequently reported including somnolence (49%), peripheral edema (34%), fall (28%), nausea (25%) and dizziness (25%).

Thirty four patients (16%) experienced dyskinesias. In 28 of the 34 reported cases, dyskinesia developed after initiation of levodopa.

Adjunctive rotigotine improved early morning akinesia in patients with advanced Parkinson's disease

Analysis of patient diaries from two large 6-month, randomized, double blind, placebo-controlled trials (PREFER and CLEOPATRA-PD) showed adjunctive rotigotine improved early-morning akinesia in patients with advanced Parkinson's disease compared with placebo.

In PREFER, analysis comprised 222 patients randomised to rotigotine and 119 randomised to placebo. The proportion of patients in the rotigotine treated group awakening in an 'off' state was reduced by 28.8% (8 mg/24 h) and 22.6% (12 mg/24 h) compared to 9.1% with placebo.

In CLEOPATRA-PD, 200 rotigotine-treated patients and 100 placebo-treated patients were analysed. The proportion of patients awakening in an 'off' state decreased by 22.6% for the rotigotine-treated group (less than or equal to 16 mg/24 h) versus 10.7% with placebo. In addition, the proportion of patients awakening in an 'on' state without troublesome dyskinesia increased by 23.3% with rotigotine (less than or equal to 16 mg/24 h) versus 11.1% with placebo.

* Notes to Editors

In June 2008 Neupro(R) (rotigotine) supply in Europe was limited to patients already established on the drug after ongoing monitoring of marketed product revealed the appearance of crystals in some patches.

UCB has fully implemented a cold-chain storage and distribution system and all stocks of Neupro(R) (rotigotine) have been replaced with product that is refrigerated from manufacturer to patient. On 29th May 2009 the European Medicines Agency recommended that the treatment restrictions for Neupro(R) (rotigotine) in Europe be lifted. This recommendation is now passed to the European Commission for endorsement. Once this recommendation is endorsed by the European Commission, doctors in the European Union will then be able to prescribe Neupro(R) (rotigotine) to patients in accordance with the approved product information.

About Neupro(R) (rotigotine) in Europe

Neupro(R) (1 mg/24 h, 2 mg/24 h and 3 mg/24 h) is approved in Europe for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults**. Neupro(R) (rotigotine) (2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h) is approved in Europe for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease, as monotherapy or in combination with levodopa over the course of the disease through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occurs.

Neupro(R) (rotigotine) Important Safety Information

Adverse drug reactions reported in more than 10% of RLS patients treated with Neupro(R) (rotigotine transdermal patch) are nausea, application site reactions, fatigue and headache. Adverse drug reactions reported in more than 10% of Parkinson's patients treated with Neupro(R) (rotigotine) are nausea, dizziness, somnolence and application site reactions. The incidence of some dopaminergic adverse events, such as hallucinations, dyskinesia, and peripheral oedema generally is higher when given in combination with L-dopa in Parkinson's patients. This should be considered when prescribing rotigotine.

Neupro(R) (rotigotine) is contraindicated in case of hypersensitivity to the active substance or to any of its excipients, and in case of magnetic resonance imaging or cardioversion. The backing layer of Neupro(R) (rotigotine) contains aluminium. To avoid skin burns, Neupro(R) (rotigotine) should be removed if the patient has to undergo MRI or cardioversion. Neupro(R) (rotigotine) has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.

Neupro(R) (rotigotine) has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes. In isolated cases "sudden onset of sleep" occurred while driving and resulted in motor vehicle accidents. Patients treated with dopamine agonists including Neupro(R) (rotigotine), have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.

It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of orthostatic hypotension associated with dopaminergic therapy. Hallucinations have been reported, and patients should be informed that hallucinations can occur.

If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals. Exposure could lead to changes in the skin color.

If a generalised skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or pruritus) associated with the use of Neupro(R) (rotigotine) is observed, Neupro(R) (rotigotine) should be discontinued.

Cases of fibrotic complications: retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents. While these complications may resolve when treatment is discontinued, complete resolution does not always occur.

All Neupro(R) (rotigotine) supply should be stored in a refrigerator. There is no need for patients to transport Neupro(R) (rotigotine) patches in special containers and they must not be stored in a freezer compartment.

**The indication for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults is not available in all countries

About Neupro(R) (rotigotine) in the U.S.

UCB recalled Neupro(R) (rotigotine) from the U.S. market in April 2008 after ongoing monitoring revealed that specific batches of Neupro(R) (rotigotine) had deviated from their approved specification. UCB is working with the U.S. Food and Drug Administration (FDA) so that Neupro(R) (rotigotine) can be available to patients with early-stage Parkinson's disease as soon as possible.

About UCB

UCB, Brussels, Belgium (http://www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing more than 10 000 people in over 40 countries, UCB achieved revenues of 3.6 billion Euro in 2008. UCB is listed on Euronext Brussels (symbol: UCB).

Forward looking statement

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.

UCB

Further information and references, contact: Eimear O'Brien, Associate Director, Global CNS Communications, UCB, T +32-2-559-9271, Eimear.OBrien@ucb.com
Clinical Data, Inc. Announces Approval of Generic Name Vilazodone, First in a New Class of Experimental Treatments for Depression

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.

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.

Contacts:

Clinical Data, Inc.
Theresa McNeely, 617-527-9933 x3373
Vice President
Corporate Communications
or
General Business Inquiries


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