22 aug: Finanskalender 2019 for GrønlandsBANKEN
23 aug: Nykredit Bank-koncernen Halvårsrapport 2018
22-08-2018 12:17:54

ALK submits registration application for tree SLIT-tablet in Europe

Relateret indhold
12 nov - 
Aktier/tendens: Pilen peger opad for børsdagen
09 nov - 
Fredagens aktier: Klø til Chr. Hansen sendte C25 på wee..
09 nov - 
Aktier/middag: Chr. Hansen trækker C25 i rødt efter sto..
Relateret debat
12 nov - 
Ok, men din måde at formulere det på, lignede et citat ..
12 nov - 
Nej, gittekh. Det var helt bestemt ikke nogen fejl ved ..
12 nov - 
Søren Hansen, Sydbank var meget positiv på..

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the European regulatory filing for its investigational tree pollen sublingual allergy immunotherapy (SLIT) tablet has been accepted for review by the relevant health authorities via the decentralised procedure, with Germany as the reference member state.

The European regulatory review process is anticipated to take approximately 12 months so that, subject to approval, the first market introductions could take place from late 2019.

“With SLIT-tablets for house dust mite, grass, ragweed and Japanese cedar allergies already marketed, this filing represents an important step forward for ALK in completing its tablet portfolio. With these five tablets, we will be able to effectively cover more than 80% of global respiratory allergies," says Carsten Hellmann, President and CEO of ALK.

The data used in the filing include results from the Phase III clinical trial initiated in 2016 to evaluate the efficacy and safety of ALK's tree pollen SLIT-tablet compared with placebo in adult and adolescent patients with birch pollen induced allergic rhinitis and/or conjunctivitis. The trial was a randomised, placebo-controlled, double-blind, multi-centre trial including 634 patients aged 12-65 years in eight European countries. A preceding Phase II trial in an environmental exposure chamber showed that the tree pollen SLIT-tablet significantly reduced allergic symptoms in response to both birch and oak pollen compared with placebo.

The primary endpoint of the trial was the average daily rhinoconjunctivitis total combined score, which is the sum of the allergic symptom score and the use of symptom-relieving medication, measured during the birch pollen season. Treatment with the tree SLIT-tablet reduced the total combined score (primary endpoint) by 39.6% compared to placebo. The results were highly statistically significant (p < 0.0001).="" the="" effect="" was="" shown="" to="" be="" comparable="" across="" the="" entire="" birch,="" alder="" and="" hazel="" pollen="" season.="" the="" trial="" also="" showed="" that="" the="" treatment="" was="" well-tolerated="" by="" patients,="" with="" no="" new="" or="" unexpected="" adverse="" events="" reported="" compared="" to="" previous="" clinical="" trials="" with="">

Allergic rhinitis (with or without conjunctivitis) represents a global health problem affecting 10 to 25% of the population. The prevalence in the general population in Europe and North America is ~20%. In Northern and Central Europe, USA and Canada, respiratory allergies are commonly caused by allergens from the birch homologous group of trees, which also includes alder, beech, hazel and oak. ALK estimates that around 15 million Europeans have tree pollen allergies of which ~10% are believed to have symptoms that are not well controlled by conventional symptom-relieving medications. If approved, ALK’s tree tablet may become a relevant treatment option for some of these patients with uncontrolled allergies to tree pollen.

This announcement does not impact ALK’s financial guidance for 2018.

ALK-Abelló A/S

For further information please contact:

Carsten Hellmann, President & CEO, tel. +45 4574 7576

Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525

Media: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014

This information is information that ALK-Abelló A/S is obliged to make public pursuant to the EU Market Abuse Regulation.

About ALK

ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,300 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net

.

Attachment

Primary Logo

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
12 nov
ALK-B
Nu kan jeg se, at du lægger præcis samme ordlyd på en kommentar til NKT. Jeg håber det er en fejl
1

Schouw/CEO: Arbejder på at imødegå effekten af højere råvarepriser

12-11-2018 15:37:16
Stigende råvarepriser og hård konkurrence har givet indtjeningsmæssig modvind for industrikonglomeratet Schouw & Co. i tredje kvartal, men udviklingen har ifølge selskabets direktør, Jens Bjerg Sørensen, dog været som ventet. Den kommende tid er fokus særligt rettet mod at optimere og effektivisere, efter at selskabet tidligere har gennemført store kapacitetsinvesteringer. - Tredje kvartal er gået..

William Demant fjerner variant af i øret-apparat - citat - NY

12-11-2018 13:59:53
William Demant Holding kan ikke længere tilbyde en variant af selskabets nye ITE-produkter (in the ear, red.) af Oticon Opn, der har både telespole og trådløs 2,4 GHz-teknologi.Kunderne skal nu vælge mellem en ITE-udgave med telespole eller 2,4 GHz-teknologi.Det skriver branchemediet Medwatch.Produktet blev ellers først lanceret for nylig og blev sammen med en stribe andre nye produkter præsentere..

NKT vinder ordre til en værdi af næsten 150 mio. kr.

12-11-2018 09:35:50
Den danske kabelproducent NKT skal udskifte højspændingsforbindelsen mellem Danmark og Sverige.Det bekræfter NKT i en meddelelse mandag morgen, hvor det også fremgår, at ordrens værdi i standard metalpriser lyder på 20 mio. euro, svarende til næsten 150 mio. danske kr.Ordren er vundet i et konsortium med Boskalis, der tidligere gik under navnet VBMS. Den indebærer projektering, produktion og insta..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Danske Bank/Kepler: Anbefaling og kursmål trækkes hver sin vej
2
Aktier/tendens: Pilen peger opad for børsdagen
3
NKT vinder ordre til en værdi af næsten 150 mio. kr.
4
Aktier: Sydbank og Rockwool kan erstatte Nordea og Bavarian i C25
5
Mandagens aktier: Simcorp blev straffet i generelt nervøst marked

Relaterede aktiekurser

ALK-Abelló B A/S 995,00 -6,8% Fald i aktiekurs

Køb- og salgssignaler

  • Trend
  • Pengemaskinen

Copyright Berlingske Media 2018  Handelsbetingelser  |  Cookiedeklaration  |  Cookie- og Privatlivspolitik  |  Ophavsret og vilkår
Aktieinformation leveres af Morningstar.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
13. november 2018 01:24:34
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20181109.5 - EUROWEB3 - 2018-11-13 01:24:34 - 2018-11-13 01:24:34 - 1 - Website: OKAY