Key Developments: H Lundbeck A/S (HLUKF.PK)
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13 Jun 2013
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Latest Key Developments (Source: Significant Developments)
H Lundbeck A/S Receives US Patent Grant for Processes for Manufacture of Pharmaceutically Active Agent-US Federal News
US Federal News reported that United States Patent no.8,461,353, issued on June 11, 2013 was assigned to H Lundbeck A/S. The patent was issued for "Processes for the manufacture of a pharmaceutically active agent". Full Article
H Lundbeck A/S Announces Positive Results from Pre-Clinical Studies with Vortioxetine
H Lundbeck A/S announced positive results from four pre-clinical animal studies with (vortioxetine, an investigational agent under review with the United States (US) Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other health agencies for the treatment of major depression. In these studies the objective was to further study the pharmacological profile of vortioxetine and the potential effects in models of depressive disorders assessing a variety of cognitive functions, including attention, memory and executive function. Vortioxetine was demonstrated to modulate GABA-ergic activity in a cellular model, an effect of vortioxetine’s multimodal activity. Vortioxetine also demonstrated improvement in attention, memory and executive function in animal models. The preclinical data presented also show a different profile of vortioxetine compared to fluoxetine and escitalopram (SSRIs) as well as duloxetine (an SNRI), which were not active in these animal models. While animal studies may not be directly applicable to human use, the new preclinical data provide supportive evidence that vortioxetine has the potential to improve cognitive symptoms frequently occurring in depressive disorder, such as impaired attention, memory and executive function. The preclinical data further suggest that the potential cognitive effects of vortioxetine in animals may be related to its activity at specific serotonin receptors. Full Article
H Lundbeck A/S and Takeda Pharmaceutical Company Limited's Vortioxetine Clinical Phase III Data Show Improvement in Symptoms of Major Depression
H Lundbeck A/S and Takeda Pharmaceutical Company Limited announced that Vortioxetine clinical phase III data show improvement in symptoms of major depressive disorder (MDD) - commonly referred to as major depression. The studies demonstrate efficacy at doses of 15 mg and 20 mg per day including an improvement of overall functioning. The phase III data will be presented at the 2013 Annual Meeting of the American Psychiatric Association (APA) in San Francisco, USA. Full Article
H Lundbeck A/S Launches Biotie Therapies Oyj's Selincro in United Kingdom
Biotie Therapies Oyj announced that its partner H Lundbeck A/S (Lundbeck) has launched Selincro in the United Kingdom (UK). According to the terms of the license agreement between Biotie and Lundbeck for Selincro, Biotie is eligible for a milestone payment of EUR 2 million related to the UK launch. Biotie will potentially contribute to Lundbeck towards any required post approval commitment studies. These contributions are not expected to be significant in 2013. Lundbeck will continue the rollout of Selincro in additional European markets through 2013 and into 2014. Full Article
H Lundbeck A/S Reaffirms FY 2013 Guidance
H Lundbeck A/S reaffirmed fiscal 2013 Guidance and expects the guidance provided on March 26, 2013 is maintained as a consequence of the intensified generic competition on Ebixa and increased launch costs in the coming quarters. Full Article
Biotie Therapies Oyj's Partner H Lundbeck A/S Launches Selincro in European Markets
Biotie Therapies Oyj announced that its partner H Lundbeck A/S (Lundbeck) has started launching Selincro in the first European markets, making the new treatment available to alcohol dependent patients in Norway, Finland, Poland and the Baltic countries. Lundbeck will continue the rollout of Selincro in Europe through 2013 and into 2014. According to the terms of the license agreement between Biotie and Lundbeck for Selincro, Biotie is eligible for payments upon commercial launch of Selincro in France, Germany, Italy, Spain, and the United Kingdom, some of which may occur in 2013; royalties on sales in all launched markets, which are not expected to give rise to revenue in 2013; and a potential contribution to Lundbeck towards any required post approval commitments studies, which are not expected to be significant in 2013. Full Article
H Lundbeck A/S Presents New Data on Selincro from Three Phase III Studies
H Lundbeck A/S announced the results of the revised analysis of the Phase III program that formed the basis for the approval of Selincro (nalmefene) in the European Union on February 25, 2013. Alcohol dependent patients with high risk drinking level (>60g/day for men, >40g/day for women) treated with Selincro showed a reduction in total alcohol consumption after six months of 57% in study 1 (ESENSE 1)1 and 62% in study 2 (ESENSE 2),2 and after 12 months of 67% in study 3 (SENSE).3. The two identical six-month studies showed that patients treated with Selincro on average reduced their total alcohol consumption by more than 40% within the first month and by approximately 60% after 6 months, and this was statistically significant from placebo. In addition, data from the one-year study confirmed that the positive effects of Selincro are maintained and even improved after one year of treatment, leading to a 67% reduction in total alcohol consumption – equivalent to nearly one bottle of wine per day. In all three studies Selincro was generally well tolerated, and adverse events were mostly mild to moderate and transient.1,2,3. Lundbeck expects to launch Selincro in its first markets in Q2 2013. Full Article
H Lundbeck A/S Announces Positive Results for Brintellix in Adult Patients with Major Depression and Inadequate Response to SSRI or SNRI Therapy
H Lundbeck A/S announced positive results for the REVIVE study, a double-blind randomized study of Brintellix (vortioxetine) versus agomelatine in adults with major depression (MDD) who changed antidepressant treatment after an inadequate response to SSRI or SNRI treatment. In this study, the objective was to compare the efficacy and tolerability of flexible dose treatment with Brintellix (10-20 milligrams (mg)/day) versus agomelatine (25-50 mg/day) in this challenging MDD patient population. Agomelatine was chosen as a comparator because of its different mode of action from conventional SSRI/SNRI therapies. Few randomized, double-blind studies have been conducted. In the REVIVE study, the primary efficacy endpoint was change from baseline to week eight in MADRS total score. Secondary endpoints included assessments of anxiety symptoms (HAM-A), global clinical judgment (CGI-S, CGI-I) and overall functioning (SDS). Patients were randomized to Brintellix (10-20 mg/day) or agomelatine (25-50 mg/day) for 12 week of double-blind treatment. On the primary efficacy endpoint, Brintellix (n=252) was statistically significantly superior to agomelatine (n=241) (p<0.05) by 2.2 MADRS points. Significant differences in favor of Brintellix were also found for MADRS, HAM-A, CGI-S, CGI-I and SDS from week 4 onwards (p<0.05). Brintellix was well tolerated, with fewer patient withdrawals in the Brintellix group (5.9%) vs. agomelatine (9.5%). Full Article
H Lundbeck A/S Raises FY 2013 Guidance
H Lundbeck A/S announced that it expects now revenue in the range DKK14.4-DKK15 billion, compared to previous estimate of DKK14.1 billion-DKK14.7 billion and EBIT is now expected to reach DKK1.9 billion-DKK2.4 billion for 2013, compared to previous estimate of DKK1.6 billion-DKK2.1 billion. Full Article
H Lundbeck A/S And Otsuka Pharmaceutical Co., Ltd Announces Collaboration For Development And Commercialization Of Lu AE58054 In Development For Alzheimer's Disease
H Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. announced a license and development agreement for Lu AE58054, a selective 5HT6 receptor antagonist currently in development for the treatment of Alzheimer's disease. Under the terms of the agreement, Lundbeck will grant Otsuka co-development and co-commercialization rights to Lu AE58054 in the U.S., Canada, East Asia including Japan, European countries and Nordic countries. Under the terms of the agreement, Lundbeck will receive from Otsuka an initial payment of USD150 million (approximately DKK855 million) upon signing. Both companies will share the sales, development, and commercialization costs based on the agreement. Lundbeck is also entitled to up to USD675 million (approximately DKK3.9 billion) in regulatory and sales milestones. Additional specific financial terms of the agreement remain undisclosed. Full Article
EU fines Lundbeck, eight others 146 million euros for blocking cheaper drugs
BRUSSELS - EU antitrust regulators fined nine drugmakers a total of 146 million euros ($195.5 million) on Wednesday for blocking the supply of cheaper medicines on the market, with a penalty of 94 million euros imposed on Denmark's Lundbeck.
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