Key Developments: Alk Abello A/S (AKBLF.PK)
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7 May 2013
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Latest Key Developments (Source: Significant Developments)
FDA Accepts Biologics License Application (BLA) for Alk Abello A/S and Merck's Ragweed Allergy Immunotherapy Tablet (AIT) for Review
Alk Abello A/S announced that the Company's partner for North America, Merck (known as MSD outside the United States and Canada) informed that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its ragweed allergy immunotherapy tablet (AIT) for review. Merck submitted the BLA, for a tablet against ragweed allergy, to the FDA in March 2013. The application to the FDA is based on results from a clinical development program. Data from the clinical trials have demonstrated that treatment with ragweed AIT reduces patients’ allergy symptoms and their concomitant use of symptom-relieving medication and that the treatment is well tolerated. Full Article
Alk Abello A/S Maintains FY 2013 Financial Guidance
Alk Abello A/S announced that the Company's fiscal year 2013 financial guidance remains unchanged. The Company continues to expect its fiscal year 2013 revenue to exceed DKK 2.3 billion and fiscal year 2013 EBITDA before special items to be in a range of DKK 200 million and DKK 300 million. The Company added that the guidance is subject to the timing of a significant milestone payment. According to I/B/E/S Estimates analysts on average are expecting Alk Abello to report revenue of DKK 2,310.25 million and EBITDA of DKK 252.25 million for the fiscal year 2013. Full Article
FDA Accepts License Application for Grass Allergy Immunotherapy Tablet by Alk Abello A/S' Partner Merck & Co Inc
Alk Abello A/S announced that the Company's Partner for North America, Merck & Co Inc (known as MSD outside the United States and Canada), has informed that the Biologics License Application (BLA) for its investigational grass allergy immunotherapy tablet (AIT) had been accepted for review by the United States Food and Drug Administration (FDA). The BLA, for a disease-modifying tablet against grass pollen allergy, was first submitted to the FDA in January 2013. The product is marketed as GRAZAX in Europe. Merck’s application is based upon results from a clinical development program which demonstrates that treatment with grass AIT reduces patients’ allergy symptoms and their need for symptom-relieving medication. Full Article
Alk Abello A/S's Partner Merck & Co Inc Submits BLA for Marketing Authorization of Ragweed AIT
Alk Abello A/S announced that its partner Merck & Co Inc has submitted a Biologics License Application (BLA) to the US (United States) Food and Drug Administration (FDA) for a marketing authorization for ragweed allergy immunotherapy tablet (AIT). ALK’s partnership with Merck covers the development, registration and commercialization of a portfolio of AITs in North America. The application to the FDA is based on results from a clinical development program. Data from the clinical trials have demonstrated that treatment with ragweed AIT reduces patients’ allergy symptoms and their concomitant use of symptom-relieving medication and that the treatment is well tolerated. The submission of the BLA entitles ALK to a milestone payment of USD 5 million from Merck. Full Article
Alk Abello A/S Proposes FY 2012 Dividend of DKK 5 per Share; Issues FY 2013 Financial Guidance in Line with Analysts' Estimates-Reuters
Reuters reported that the Board of Directors of Alk Abello A/S proposes to the Annual General Meeting of the Company that a dividend of DKK 5 per share is paid for fiscal year 2012. This is unchanged from fiscal year 2011. The Company also announced that it expects fiscal year 2013 revenue at the same level as in fiscal year 2012 and fiscal year 2013 EBITDA in a range of between DKK 200 million and DKK 300 million. The Company reported fiscal year 2012 revenue of DKK 2,345.00 million. According to I/B/E/S estimates, analysts on average are expecting the Company to report fiscal year 2013 revenue of DKK 2,363.25 million and fiscal year 2013 EBITDA of DKK 292.88 million. Full Article
Alk Abello A/S's Partner Merck & Co Inc Submits BLA for Marketing Authorization of Grass AIT to FDA
Alk Abello A/S announced that its partner Merck & Co Inc has submitted a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for a marketing authorization for grass allergy immunotherapy tablet (AIT) – a disease-modifying AIT against grass pollen allergy. The product is marketed as GRAZAX in Europe. The partnership with Merck covers the development, registration and commercialization of a portfolio of AITs in North America. The application to the FDA is based on results from a clinical development program. Data from the clinical trials have demonstrated that treatment with grass AIT reduces patients’ allergy symptoms and their need for symptom-relieving medication and provides a sustained long-term effect after completion of treatment. Full Article
Alk Abello A/S Simplifies Business Structure and Plans Layoffs; Company Confirms FY 2012 Guidance
Alk Abello A/S (ALK) announced that it has finalized the planning of the initiatives to streamline its business structure. The costs are related to a streamlining of the European sales and marketing organization as well as to a simplification of the production, as ALK will gradually phase out and close down three production facilities and consolidate the activities in centers of excellence. Furthermore, the business structure will be streamlined in other areas, including Finance and IT (information technology) functions which will be organized in global functions. These changes imply that 120-130 positions will be made redundant over the next few years. As a result of the above, ALK expects to recognize costs of approximately between DKK 60 million and DKK 70 million in a special items line in its income statement for 2012. EBITDA before special items is still expected to exceed DKK 300 million and total revenue of up to DKK 2.4 billion is still expected for the fiscal year 2012. According to I/B/E/S Estimates, analysts on average are expecting the Company to report EBITDA of DKK 317.25 million and revenue of DKK 2,376.14 million for the fiscal year 2012. The initiatives under the Simplify program will lead to cost savings of approximately DKK 100 million net per year to be seen gradually from 2013 and with full effect from 2016. Full Article
Alk Abello A/S Maintains FY 2012 Financial Guidance
Alk Abello A/S announced that its EBITDA outlook for the fiscal year 2012 remains unchanged. The Company still expects fiscal year 2012 EBITDA to exceed DKK 300 million. Growth in vaccine sales for the fiscal year 2012 is now expected to be slightly positive in the range of between 0% and 2% (previously between 3% and 5%), measured in local currencies. Total revenue of up to DKK 2.4 billion is still expected for the fiscal year 2012 as revenues from partnerships largely will offset the lower than expected vaccine sales. According to I/B/E/S Estimates, analysts on average are expecting the Company to report fiscal year 2012 EBITDA of DKK 327.26 million and fiscal year 2012 revenue of DKK 2,379.34 million. Full Article
Alk Abello A/S's Partner Merck & Co Inc Reaches Primary Endpoint in Phase III Trial with Grass Allergy Immunotherapy Tablet; Alk Abello Confirms FY 2015 Financial Guidance
Alk Abello A/S announced that a Phase III clinical trial of its investigational sublingual grass allergy immunotherapy tablet (AIT), conducted by Alk Abello's strategic partner, Merck & Co Inc, has met primary efficacy endpoint. Known as GRAZAX in Europe, the product has been licensed by ALK to Merck for North America. Merck initiated the trial in 2011 to evaluate the efficacy and safety of grass AIT versus placebo in the treatment of grass pollen induced allergic rhinoconjunctivitis (hay fever). The primary endpoint was the combined rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) during the grass pollen season. The trial included approximately 1,500 patients. The study was designed to form a pivotal part of the submission package for Merck's filing of a registration application for grass AIT with the United States. Food and Drug Administration (FDA). Merck has informed ALK that the new data supports and confirms the planned filing of the registration application with the FDA in 2013. Alk Abello also announced that this not change the Company's fiscal year 2015 financial outlook. The Company still expects to report fiscal year 2015 revenue of DKK 3 billion and fiscal year 2015 operating profit (EBITDA) of 25% of revenue. Full Article
Alk Abello A/S' Partner Merck & Co Inc Plans to Initiate Phase III Clinical Trial with HDM AIT in North America
Alk Abello A/S announced that its strategic partner Merck & Co Inc (knowns as MSD outside the United States and Canada) is planning to advance the clinical development program for the house dust mite allergy immunotherapy tablet (HDM AIT) by initiating a Phase III clinical trial in North America. HDM AIT is ALK's new AIT against HDM-induced hay fever and asthma. The trial is expected to include approximately 1,500 patients and will investigate the safety and efficacy of HDM AIT in the treatment of HDM-induced allergic rhinitis/rhinoconjunctivitis in children and adults. Merck anticipates that the study will initiate patient recruitment in 2013 and it is expected to complete in 2015. In Europe, ALK is conducting two clinical Phase III trials investigating safety and efficacy of HDM AIT (MITIZAX) in the treatment of HDM-induced allergic rhinitis and asthma, respectively. In Japan, HDM AIT has been licensed to Torii and is also in Phase II/III clinical development. Recently, Merck initiated a Phase IIb clinical trial for HDM AIT to evaluate dose-related effectiveness, safety and tolerability of HDM AIT. This trial is expected to enroll 120 patients and to complete in 2013. Initiation of patient dosing in the Phase III trial in North America entitles ALK to an undisclosed payment from Merck. This payment is expected to occur in 2013 at the earliest. Full Article
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