Navigation Links
Vanda Pharmaceuticals Reports First Quarter 2012 Results
Date:5/8/2012

24.  The tasimelteon Non-24 program continues to advance towards the goal of a projected mid-2013 NDA filing with the FDA.  Vanda is in continuing discussions with the FDA to confirm the path and requirements for this regulatory submission.  Vanda expects to complete the two Phase III efficacy studies, SET and RESET, by the end of 2012.

The tasimelteon MAGELLAN efficacy study for MDD is ongoing and Vanda expects to report top-line results in the first half of 2013.  This Phase IIb/III study in MDD is expected to enroll 500 patients across approximately 40 sites in the U.S.

On April 16, 2012, Vanda announced that it had obtained exclusive world-wide rights from Eli Lilly and Company to develop and commercialize VLY-686, a small molecule neurokinin 1 receptor (NK-1R) antagonist for all human indications.  In 2012, Vanda intends to initiate and complete the technology transfer activities and further examine the clinical and commercial profile of VLY-686.  This strategic evaluation will further inform potential indications for an early clinical development program.  VLY-686 is a Phase II ready program.

First quarter 2012 sales of Fanapt® were reported by Novartis to be $15.4 million.  Fanapt® prescriptions, as reported by IMS, reached 35,000 for the first quarter of 2012.  This represents a 39% increase over first quarter 2011 prescriptions.

The review of Vanda's Marketing Authorization Application (MAA) for oral iloperidone tablets in the European Union is ongoing.  The European Medicines Agency (EMA) has provided its standard 120-day list of questions and has granted Vanda a 3-month extension, through mid-May 2012.  Vanda expects to respond to the EMA questions by such time.  Regulatory filings for market approval of Fanapt® by Vanda's commercial partners are under review in Israel, Mexico and Argentina. 

2012 FINANCIAL GUIDANCE

  • General
    '/>"/>

    • SOURCE Vanda Pharmaceuticals Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    0

    GOOD

    Page: 1 2 3 4 5 6 7 8 9

    Related medicine technology :

    1. Vanda Pharmaceuticals Submits Iloperidone New Drug Application
    2. Vanda Pharmaceuticals Reports Third Quarter 2007 Results
    3. Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application
    4. Vanda Presents Phase III Iloperidone Efficacy Data
    5. Phase III Data Show Vanda Pharmaceuticals Tasimelteon (VEC-162) Significantly Improves Sleep in Patients with Chronic Insomnia
    6. Vanda Pharmaceuticals Provides Update on Iloperidone
    7. Clinical Trial Results on the Sleep-Promoting Effects of Vanda Pharmaceuticals Circadian Regulator Tasimelteon (VEC-162) Published in The Lancet
    8. FDA Approves Vanda Pharmaceuticals Fanapt(TM) for the Treatment of Schizophrenia
    9. Vanda Pharmaceuticals Enters into an Exclusive License Agreement for the Commercialization and Development of Fanapt(TM) in the U.S. and Canada for the Treatment of Schizophrenia
    10. Vanda Pharmaceuticals Announces Expiration of Hart-Scott -Rodino Waiting Period for Exclusive License of Fanapt(TM)
    11. Vanda Pharmaceuticals Announces U.S. Patent Allowance for a Long-Acting Injectable Formulation of Fanapt(TM) (iloperidone) in the U.S.
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:5/17/2013)... 17, 2013 Research explores ... outcomes research also   to   be presented ... SHPG ), the global specialty biopharmaceutical company, announces that ... at the American Psychiatric Association (APA) 166th Annual Meeting ... The data being presented represent Shire,s ongoing commitment to ...
    (Date:5/17/2013)... /PRNewswire-iReach/ -- The escalation of new biological drugs, ... emphasis on alternate delivery technologies. Alternate delivery technologies ... factors are converging to create both risk ... device partners . These include new classes of ... toward self-administration for chronic diseases, shifting patient demographics ...
    (Date:5/17/2013)...  Boehringer Ingelheim will contribute to advancing the ... Thoracic Society International Conference (ATS 2013) in ... 22. Data will highlight research conducted ... chronic obstructive pulmonary disease (COPD) [Spiriva® HandiHaler® (tiotropium ... for asthma, idiopathic pulmonary fibrosis (IPF) and COPD. ...
    Breaking Medicine Technology:Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 2Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 3Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 4Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 5Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 6Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 7Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 8Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 9Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 10Pharmaceutical Makers and Delivery Device Partners Rethink Delivery Technologies - New Report Examines this Evolving Segment 2Pharmaceutical Makers and Delivery Device Partners Rethink Delivery Technologies - New Report Examines this Evolving Segment 3Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 2Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 3Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 4Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 5Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 6Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 7Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference 8
    (Date:5/18/2013)... Orlando, FL (May 18, 2013) The use ... for a colonoscopy, according to new research presented ... process, which begins days in advance of the ... preparation medication to be taken at strict intervals. ... for doctors to see cancer and precancerous polyps ...
    (Date:5/18/2013)... of coffee is associated with a reduced risk ... disease, Mayo Clinic research shows. The findings were ... conference in Orlando, Fla. , PSC is ... results in inflammation and subsequent fibrosis that can ... and biliary cancer. , "While rare, PSC has ...
    (Date:5/18/2013)... Hayden, ID (PRWEB) May 18, 2013 ... needs when it comes to safety and comfort ... these requirements and provides clients with an effective ... System®. This is an integrated, turnkey communications ... of care, while allowing residents independence and privacy. ...
    (Date:5/18/2013)... Utah (PRWEB) May 18, 2013 ... on insurance agents’ role in Marketplaces . ... to traditional employer sponsored health benefits, is the ... and health reimbursement arrangements . , ... Health and Human Services (HHS) recently released a ...
    (Date:5/18/2013)... Springs, FL (PRWEB) May 18, 2013 The ... dedicated to the special places we call home. These are ... on maps. They are the locations where the people are ... first-rate show takes viewers off the highways and shares the ... best of both nations with an American sports and film ...
    Breaking Medicine News(10 mins):Health News:New smartphone application improves colonoscopy preparation 2Health News:VisionLink Nurse Call System's New Features Serve the Unique Needs of Retirement Communities 2Health News:VisionLink Nurse Call System's New Features Serve the Unique Needs of Retirement Communities 3Health News:Zane Benefits Publishes New Information on Insurance Agents’ Role in Marketplaces 2Health News:Zane Benefits Publishes New Information on Insurance Agents’ Role in Marketplaces 3Health News:Zane Benefits Publishes New Information on Insurance Agents’ Role in Marketplaces 4Health News:Communities of Distinction TV Presents "A Place to Call Home" Segment 2
    ... the seat of the Polish government Friday in support of ... of the building in a two-week pay protest. ... Silesian coal belt, brandished banners reading, "We want a decent ... ,Ringed by riot police, the demonstrators mingled with ...
    ... more likely to suffer heart attacks, according to a ... Bhopal and Colin Fischbacher at the University of Edinburgh, however, ... in comparison to their non-Asian countrymen. ,As part ... groups from the 2001 Census to Scottish hospital discharge and ...
    ... Britney Spears has openly confessed that she had sex with former ... until she was married. ,"I've only slept with ... into my relationship with Justin, and I thought he was the ... a magazine The most painful thing I have ever experienced ...
    ... the web are all pass, for the latest way to bag ... ,This new trend is a blessing for many singleton smokers ... a cigarette. ,This blend of smoking and flirting developed ... introduced, reports The Sun. ,The Irish were the first ...
    ... identified one unifying principle that could explain how a range ... for the cause of depression has implicated so many suspects ... condition remains an enigma. ,They found that ... treatment in the end appear to funnel through a single ...
    ... Saturday announced new measures aimed at curbing an epidemic ... prove elusive . ,China plans to set ... by the end of the year and to implement ... was quoted by the official Xinhua news agency as ...
    Cached Medicine News:Health News:Trade Unionists Join Polish Nurses' Protest 2Health News:Brain Pathway for Depression Revealed 2Health News:Brain Pathway for Depression Revealed 3Health News:Top China Official Pessimistic on Fixing Food Safety Woes 2
    A "doughy" type of bone cement intended for manual application....
    ... The Videoscopes provide superior image quality ... to the camera head with a ... ensures more light at the operative ... optimum image clarity and reliability.,The Videoscopes ...
    ... a wide range of innovative features, including ... Control (U.S. Patent #4,684,227). Stereopsis is maximized ... Heine's unique Diffuser aperture absorbs only 30% ... and simplifying difficult examinations. A newly incorporated ...
    ... 3-wire patient cable and 4 ... of the unit. 3-step procedure enabling ... 8 or 12 lead ECG through ... position. Records 2.5 seconds per lead ...
    Medicine Products: