Last $20.35 USD
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Volume 160.0
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As of 8:10 PM 12/26/14 All times are local (Market data is delayed by at least 15 minutes).

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h lundbeck a/s (HLUKF) 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.

5,769 Employees
Last Reported Date: 11/5/14
Founded in 1915

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h lundbeck a/s (HLUKF) Key Developments

H. Lundbeck A/S Revised Earnings guidance for the Fiscal Year of 2014

H. Lundbeck A/S revised earnings guidance for the fiscal year of 2014. For the fiscal year 2014, the company is still expecting constant currency revenue to be around DKK 13.5 billion. The company now expects core profit from operations (core EBIT) in constant currency to be in the range DKK 1.1 billion to DKK 1.3 billion against previously DKK 0.9 billion to DKK 1.4 billion for 2014. Expected reported profit from operations (EBIT) in constant currency is now expected at DKK 0 billion to DKK 0.2 billion compared to previously at DKK 0 billion to DKK 0.5 billion for 2014.

Ossianix Expands and Extends its Research Collaboration with Lundbeck on CNS Therapeutics

Ossianix, Inc. announced an expansion and extension of its strategic research collaboration with H. Lundbeck A/S (Lundbeck). This collaboration follows a previous equity investment in 2012 and prior research collaboration in 2013. The collaboration will use Ossianix's innovative single domain antibody platform based on the shark VNAR structure to deliver next generation CNS biotherapeutics. Ossianix will work with Lundbeck on multiple targets aligned with Lundbeck's therapeutic goals. The collaboration will additionally continue to work on the ligand-gated P2X3 ion channel expressed on sensory neurons for the treatment of neuropathic pain. Lundbeck will fund the research plan with development and regulatory milestones and a joint research committee will manage the projects. A third component of the agreement provides an additional equity investment for Ossianix to advance it own therapeutic programs.

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S Present Phase III Study Results Evaluating the Efficacy of Investigational Compound Brexpiprazole

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced the presentation of Phase III study results evaluating the efficacy of investigational compound brexpiprazole as adjunctive treatment to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) at the Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Phoenix, Arizona. The data were shared in a poster presentation, 'Efficacy and Safety of Adjunctive Brexpiprazole (OPC-34712) in Major Depressive Disorder: Results of Two Pivotal Clinical Studies.' The poster featured results of two Phase III clinical studies evaluating the efficacy, safety and tolerability of adjunctive brexpiprazole in patients with MDD and inadequate response to ADT (Study 1: NCT01360645; Study 2: NCT01360632). Patients with MDD who failed to reach adequate response during 1-3 treatment attempts with ADT 0(which is commonly found in current clinical practice) were enrolled and received an additional trial with a (single-blind) ADT for 8 weeks. Those patients who still failed to reach an adequate response throughout this phase were then randomized (double-blind) to ADT and brexpiprazole or ADT and placebo for 6 weeks. The primary endpoint for both studies was change in MADRS. Pre-specified analyses were conducted both on the efficacy population and on the final protocol population (fulfilling amended randomization criteria) for each individual study. In both studies, key findings included: Adjunctive brexpiprazole showed greater improvement than adjunctive placebo in MADRS total score at Week 6 in the efficacy population per final protocol in Study 1 (2mg+ADT [N=175]: -3.21, p=0.0002), and in Study 2 (1mg+ADT [N=211]: -1.30, p=0.0737; 3mg+ADT [N=213]: -1.95, p=0.0079). Similar results were observed for the efficacy population in both studies; The completion rate was high (>90%) and comparable across brexpiprazole and placebo groups. Discontinuations due to adverse events were low across all groups (1mg = 1.3%, 2mg = 3.2%, 3mg = 3.5%, placebo = 0.7%) and only one patient discontinued due to lack of efficacy (in the brexpiprazole 1mg group); All doses of adjunctive brexpiprazole resulted in notably low levels of sedating or activating side effects; and the most frequent adverse events (incidence >5% in any group and more than twice the incidence in the placebo group across the two studies) included akathisia (4.4%, 7.4%, 13.5% vs.1.7%), weight increase (6.6%, 8.0%, 5.7% vs. 1.9%), tremor (4.0%, 2.1%, 5.2% vs. 2.2%) somnolence (4.0%, 4.3%, 5.7% vs. 0.5%) and nasopharyngitis (6.6%, 1.1%. 3.1% vs. 1.7%), in the brexpiprazole 1mg+ADT (N=226), 2mg+ADT (N=188), 3mg+ADT (N=229) versus combined placebo + ADT groups (N=411), respectively.


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Price/Sales 1.7x
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