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As of 2:16 AM 07/22/14 All times are local (Market data is delayed by at least 15 minutes).

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h lundbeck a/s (LDB) Details

H. Lundbeck A/S, a specialty pharmaceutical company, engages in the research, development, production, marketing, and sale of pharmaceuticals for the treatment of brain disorders in Europe, the United States, and internationally. The company’s principal products include Cipralex and Lexapro to treat depression, Ebixa for Alzheimer’s disease, Azilect to treat Parkinson’s disease, Xenazine for chorea associated with Huntington's disease, Sabril to treat epilepsy, Sycrest for bipolar disorder, and Onfi to treat Lennox-Gastaut syndrome. Its compounds in registration application include aripiprazole IM depot for the treatment of schizophrenia; Selincro for alcohol dependence; and Brintellix for the treatment of depression and anxiety. The company’s products in Phase III trials comprise IV carbamazepine for epilepsy; Brexpiprazole for psychiatric disorders; Desmoteplase for stroke; and Zicronapine for psychosis. Its products in Phase II trials include Tedatioxetine for depression and Lu AE58054 for Alzheimer's disease. H. Lundbeck A/S has strategic research collaboration with Ossianix, Inc. The company was founded in 1915 and is based in Valby, Denmark.

5,557 Employees
Last Reported Date: 05/8/14
Founded in 1915

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h lundbeck a/s (LDB) Key Developments

Otsuka and Lundbeck Submit New Drug Application for Brexpiprazole for Treatment of Schizophrenia and as Adjunctive Therapy for Treatment of Major Depression

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for brexpiprazole for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD). The clinical development program included data from more than 6,500 participants of whom more than 5,300 received brexpiprazole. Following the submission the FDA will determine if the NDA is sufficiently complete to allow for a substantive review of the data; a decision from the FDA on initiation of the substantive review is expected in September 2014. Brexpiprazole is a novel investigational psychotropic compound discovered by Otsuka and under co-development with Lundbeck. Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.

H. Lundbeck A/S Revised Earnings Guidance for the Year 2014; Provides Earnings Guidance for the Year 2015

H. Lundbeck A/S revised earnings guidance for the year 2014. For the year, the company expected revenue of DKK 13.5 billion, EBIT in the range of DKK 0.0 billion to DKK 0.5 billion and core EBIT of DKK 0.9 billion to DKK 1.4 billion against previous guidance for the revenue of DKK 13.5 billion, EBIT in the range of DKK 0.5 billion to DKK 1.0 billion and core EBIT of DKK 1.2 billion to DKK 1.7 billion a year ago. The expected impact on its profitability in 2014 will to some extent depend on the timing of the launch of NORTHERA due in the second half of 2014. The company provided earnings guidance for the year 2015. The company announced the completion of the tender offer by its wholly owned indirect subsidiary, Charlie Acquisition Corp., to purchase all of the outstanding shares of Chelsea Therapeutics International Ltd. and it is expected to be dilutive to both cash flow and EBIT for the year, and cash flow accretive in 2015.

Takeda Pharmaceutical Company Limited and H. Lundbeck A/S Presents Results on Sexual Functioning in Well Treated MDD Patients Experiencing Treatment-Emergent Sexual Dysfunction

Takeda Pharmaceutical Company Limited and H. Lundbeck A/S (Lundbeck) announced that the companies presented results about sexual functioning from a head-to-head study of Brintellix® (vortioxetine) vs. escitalopram in patients with well treated major depressive disorder (MDD) experiencing treatment-emergent sexual dysfunction (TESD). The data, accepted as a late-breaker, was shared in a poster presentation #41. In the study, 447 patients with recent major depressive episodes who had responded to SSRI monotherapy but were experiencing TESD were discontinued on their initial treatment and then randomized to Brintellix 10 mg/day or escitalopram 10 mg/day (10 mg for week one and 20 mg for week two of treatment) for eight weeks. The dose of Brintellix or escitalopram could be adjusted after week two, four, or six, as judged by the investigator. The primary endpoint was change from baseline to week 8 in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) total score using mixed-effects model repeated measures approach (MMRM). The results demonstrated that patients treated with Brintellix (n=169) experienced a statistically significant improvement, with a mean treatment difference of 2.2 points (95% CI: 0.48-4.02) in the CSFQ-14 total score after eight weeks of treatment (P=0.013; MMRM) compared to escitalopram (n=179). The CSFQ-14 is a clinical and research instrument identifying five scales of sexual functioning and yields scores for three scales corresponding to the phases of the sexual response cycle.1 Numerically more Brintellix-treated patients were responders (change from baseline in CSFQ-14 total score >3; OR=1.51; P=0.06), as compared with escitalopram. Numerically similar responses on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score were observed between the two groups at the end of week eight. In this study, common adverse events for Brintellix were nausea, headache, and dizziness. These findings build on the global clinical trial program for Brintellix. The comprehensive clinical trial program evaluating the safety and efficacy of Brintellix was comprised of seven positive pivotal studies, including six 6-8 week short-term studies and one 24-64 week long-term maintenance study that demonstrated statistically significant improvements in overall symptoms of depression in adults with MDD.


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