Key Developments: Alk Abello A/S (ALKb.CO)

ALKb.CO on Copenhagen Stock Exchange

763.00DKK
22 Aug 2014
Price Change (% chg)

kr.3.00 (+0.39%)
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kr.760.00
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kr.762.00
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Latest Key Developments (Source: Significant Developments)

Alk Abello A/S reaffirms FY 2014 Revenue guidance; Raises EBITDA Guidance
Wednesday, 13 Aug 2014 02:13am EDT 

Alk Abello A/S:Expects FY 2014 Revenue to equal 2.4 bln Danish crowns.Expects FY 2014 EBITDA at 450 mln Danish crowns before special items, (previously, EBITDA was expected at 425 mln Danish crowns before special items and future income from product supply and sales royalties in North America).Outlook includes an estimated income from product supply and sales royalties from SLIT-tablets in North America.FY 2014 revenue 2.4 bln Danish crowns - Thomson reuters I/B/E/S Estimates.  Full Article

ALK Abello A/S's partner for Japan announces trial results for House Dust Mite SLIT-Tablet
Monday, 16 Jun 2014 03:09am EDT 

Alk Abello A/S:Says partner for Japan, Torii Pharmaceutical Co., Ltd. has completed its second of two Phase II/III trials into ALK's sublingual allergy immunotherapy tablet (SLIT-tablet) for the treatment of house dust mite (HDM)-induced respiratory diseases.Torii initiated the trial in 2012 as a randomised, multi-centre, placebo-controlled, double-blind comparative trial, looking at both the safety and efficacy of the drug in patients with house dust mite-induced allergic asthma.While trial confirmed that treatment was well tolerated by patients, with no new or unexpected findings reported.Says trial did not meet the primary efficacy endpoint of showing a statistically significantly lower risk of moderate to severe asthma exacerbations when compared with patients who received placebo.A parallel trial, investigating the safety and efficacy in HDM-induced allergic rhinitis was successfully completed in March 2014 and met its primary efficacy endpoint.Says Torii will now seek to discuss the trial results, along with relevant supportive documentation from ALK's European development programme, with the Japanese health authorities. Based on the available data.Torii expects to submit a registration application to the authorities within the next six-to-ten months.Torii's two trials were similar in design to ALK's successfully completed European trials. ALK targets a regulatory filing for the house dust mite SLIT-tablet in H2 2014 in Europe.  Full Article

Alk Abello A/S presents Phase III data on house dust mite SLIT-tablet
Monday, 9 Jun 2014 07:50am EDT 

Alk Abello A/S:Presented key trial results on new sublingual allergy immunotherapy tablet (SLIT-tablet) for house dust mite (HDM) respiratory allergic diseases.ALK HDM SLIT-tablet works by addressing underlying causes of HDM respiratory allergic diseases.Says it is first allergy immunotherapy product with comprehensive clinical development programme aimed at treating both upper and lower airway manifestations of HDM-induced allergic respiratory diseases (namely allergic rhinitis and allergic asthma, respectively).MITRA trial met its primary clinical endpoint.Patients who received the dose of 12 SQ-HDM experienced significant improvement in their asthma control as evident by 34 pct reduction in risk of suffering moderate-to-severe asthma exacerbation during withdrawal of inhaled corticosteroids.Phase 2 and 3 data presented demonstrated an onset of action with the 12 SQ-HDM dose as early as 8 to14 weeks post initiation of treatment.Both the MITRA and MERIT trials also demonstrated that the treatment was well tolerated and had a favourable safety profile.  Full Article

Alk Abello A/S partner for North America, Merck, announces launch of RAGWITEK in Canada
Thursday, 15 May 2014 07:02am EDT 

Alk Abello A/S:Its ragweed sublingual allergy immunotherapy tablet, which is licensed to Merck (known as MSD outside USA and Canada) for North America, has been launched in Canada.Product is known in Canada as RAGWITEK.  Full Article

Alk Abello A/S raises FY 2014 financial guidance
Thursday, 8 May 2014 02:00am EDT 

Alk Abello A/S:Due to better than expected performance in Q1 2014, outlook for FY 2014 is adjusted.Sees FY 2014 revenue, including milestone payments to equal about 2.4 bln Danish crowns before future income streams from product supply and sales royalties from SLIT-tablets in North America.Says previously expected FY 2014 revenue between 2.15 bln crowns and 2.2 bln crowns before milestones and any other contribution from SLIT-tablets in North America.Sees FY 2014 EBITDA at about 425 mln crowns before special items and future income from product supply and sales royalties in North America.Says previously expected FY 2014 EBITDA up to 400 mln crowns.FY 2014 revenue of 2,431.91 mln crowns and FY 2014 EBITDA of 430.38 mln crowns - Thomson Reuters I/B/E/S.  Full Article

Alk enters collaboration to accelerate growth in China
Thursday, 24 Apr 2014 10:00pm EDT 

Alk Abello A/S:Says the company and Eddingpharm have agreed a collaboration that will expand ALK’s presence in China.Eddingpharm will handle the sales and distribution of ALK’s marketed products in China, while ALK will support Eddingpharm with medical and scientific expertise.ALK will maintain a local organisation in China.The agreement covers ALK’s diagnostic skin prick test, Soluprick SQ and the subcutaneous immunotherapy (SCIT) product, Alutard SQ.The collaboration will initially run for seven years, provided certain performance targets are met.Eddingpharm is a China-based specialty pharmaceutical company.  Full Article

Alk Abello announces FDA approval for Merck’s ragweed sublingual allergy immunotherapy tablet RAGWITEK
Thursday, 17 Apr 2014 02:58pm EDT 

Alk Abello A/S:Says US Food and Drug Administration (FDA) has approved the Biologic License Application (BLA) for RAGWITEK.RAGWITEK is licensed to Merck (known as MSD outside the USA and Canada) for North America.RAGWITEK is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen.  Full Article

Alk Abello raises low end of prior FY 2014 EBITDA guidance
Monday, 14 Apr 2014 06:05pm EDT 

Alk Abello A/S:Expects FY 2014 operating profit (EBITDA) to be 375-400 million Danish crowns (previously 300-400 million crowns ) before special items, income from product supply, and potential sales royalties in North America.  Full Article

Alk Abello A/S announces FDA approval for Merck’s grass sublingual allergy immunotherapy tablet GRASTEK (GRAZAX)
Monday, 14 Apr 2014 05:55pm EDT 

Alk Abello A/S:Announces that the US Food and Drug Administration (FDA) has approved the Biologic License Application (BLA) for Merck’s grass sublingual allergy immunotherapy (SLIT) tablet GRASTEK.GRASTEK is the US trade name of the grass SLIT-tablet which is licensed to Merck (known as MSD outside the USA and Canada) for North America by ALK, and marketed in Europe under the brand name GRAZAX.GRASTEK is an allergen extract.In the USA, GRASTEK is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens.GRASTEK is approved for use in persons 5 through 65 years of age.GRASTEK is not indicated for the immediate relief of allergic symptoms.  Full Article

Alk Abello A/S announces Merck initiates Phase III clinical development programme for treatment of house dust mite-induced respiratory diseases
Thursday, 20 Mar 2014 03:09am EDT 

Alk Abello A/S:Strategic partner, Merck (known as MSD outside the USA and Canada), is advancing clinical development programme for house dust mite (HDM) SLIT-tablet by initiating Phase III clinical trial in USA and Canada.HDM SLIT-tablet is ALK's new allergy immunotherapy tablet for treatment of HDM-induced respiratory diseases.Trial is expected to include about 1,500 subjects and will investigate safety and efficacy of the tablet in treatment of HDM-induced allergic rhinitis in North American patients.  Full Article

UPDATE 2-NORDIC STOCKS - Factors to watch on April 15

(Adds Aker Solutions, Alma Media and Norsk Hydro, updates H&M and SKF)

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