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

ALKb.CO on Copenhagen Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Alk Abello A/S and bioCSL enter into a partnership for allergy
Monday, 9 Feb 2015 03:00am EST 

Alk Abello A/S:ALK and bioCSL enter into a partnership for allergy.ALK and bioCSL announce a partnership in Australia and New Zealand which grants bioCSL exclusive rights to promote and sell ALK's slit-tablets.Says this announcement does not impact ALK's financial guidance for FY 2015.Says the deal grants bioCSL exclusive rights to promote and sell ALK's slit-tablets against house dust mite and grass pollen allergy, and ALK's Jext adrenaline auto-injector.  Full Article

Alk Abello A/S proposes dividend
Monday, 9 Feb 2015 02:04am EST 

Alk Abello A/S:Says its board of directors proposes a dividend of 5 Danish crowns per share to the annual general meeting.  Full Article

Alk Abello A/S gives FY 2015 guidance
Monday, 9 Feb 2015 02:00am EST 

Alk Abello A/S:Expects to grow FY 2015 revenue in the base business by 0-5 pct to 2.2 billion - 2.3 billion Danish crowns.FY 2015 EBITDA before special items excluding revenues from sales royalties and milestone payments is expected to be in the range of 225 million - 300 million crowns.FY 2015 revenue of 2.42 billion crowns - Thomson Reuters I/B/E/S.  Full Article

Alk Abello A/S partner submits NDA application for HDM slit-tablet in Japan
Monday, 26 Jan 2015 03:02am EST 

Alk Abello A/S:Says the company's partner for Japan, Torii Pharmaceutical Co. Ltd, submits registration application for house dust mite (HDM) sublingual allergy immunotherapy tablet (SLIT) in Japan * Torii has submitted the new drug application (NDA) to Japanese Ministry of Health, Labour and Welfare (MHLW).Intends to conduct further clinical trials with HDM SLIT-tablet to allow access to China and other emerging markets.  Full Article

Alk Abello A/S submits registration application for house dust mite slit-tablet
Thursday, 20 Nov 2014 05:55am EST 

Alk Abello A/S:Submits registration application for house dust mite SLIT-tablet in Europe.Regulatory review process is expected to take around 12 months, which means that, subject to approval, first launches could possibly take place in FY 2016.  Full Article

Alk Abello A/S reaffirms FY 2014 guidance
Friday, 14 Nov 2014 01:45am EST 

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.  Full Article

Alk Abello A/S's partner Torii initiates final stage of clinical development of Japanese cedar SLIT-tablet
Monday, 1 Sep 2014 09:06pm EDT 

Alk Abello A/S:Says that Torii Pharmaceuticals has initiated a Phase II/III clinical development programme in Japan with the new allergy immunotherapy tablet for the treatment of Japanese cedar tree pollen allergy.The trial is expected to include about 1,000 subjects and will investigate safety and efficacy of the SLIT-tablet in the treatment of Japanese cedar tree pollen-induced allergic rhinitis.Says in addition, Torii is currently finalising the development of ALK's house dust mite SLIT-tablet and is expected to submit a registration application to the Japanese authorities within six months.  Full Article

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

BRIEF-ALK-Abelló and bioCSL enter into a partnership for allergy

* Announce a partnership in Australia and New Zealand which grants bioCSL exclusive rights to promote and sell ALK's slit-tablets

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