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ALK to Present New Phase 3 Data Demonstrating the Efficacy and Safety of RAGWITEK® (short ragweed pollen allergen extract tablet for sublingual use 12 Amb a 1-U) Sublingual Allergy Immunotherapy (SLIT)-Tablets in Pediatric Patients at ACAAI 2019 Annual Scientific Meeting

November 8, 2019

ROUND ROCK, Texas, Nov. 8, 2019 /PRNewswire/ -- ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF), a global, research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies, announced new Phase 3 data today on its sublingual allergy immunotherapy (SLIT) portfolio, including efficacy and safety findings from the largest allergy immunotherapy clinical trial in children with ragweed allergic rhinitis with or without conjunctivitis (AR/C) to be presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2019 Annual Scientific Meeting, held Nov. 7-11 in Houston.

The study, titled “Efficacy and Safety of Ragweed SLIT-Tablet from a Large Trial in Children with Allergic Rhinoconjunctivitis,” (Poster #P450), demonstrated that RAGWITEK® (short ragweed pollen allergen extract tablet for sublingual use 12 Amb a 1-U) significantly improved AR/C symptoms in children age 5-17 and decreased medication use compared to placebo. Overall, treatment was well tolerated and discontinuation rates due to adverse events (AEs) were low. The data will be presented during a poster discussion at the meeting on November 9, 2019 at 11:30 a.m. CDT.

“Allergic rhinitis affects millions of children,1 and those with ragweed allergies plus conjunctivitis may not get complete relief from currently available treatments. Although sublingual tablets for ragweed are available for adults, the treatment had not previously been evaluated in a pediatric population,” said David I. Bernstein, FAAAAI, FACAAI, FACP, MD, University of Cincinnati College of Medicine, Bernstein Clinical Research. “These data reported at this year’s ACAAI Scientific Meeting contribute to greater understanding of allergy immunotherapy and suggest that ragweed SLIT-tablets are a potentially effective and well tolerated treatment option for children.”

RAGWITEK is not approved by the U.S. Food and Drug Administration (FDA) for use in pediatric patients. ALK plans to initiate discussions with relevant regulatory authorities to potentially expand the current product label to include a pediatric indication.

Ragweed is a common cause of seasonal, airborne allergy in North America and in certain parts of Europe as well as international markets. RAGWITEK was first launched for adult use in the U.S. and Canada in 2014 and was approved in nine European countries and Russia in late 2017.

About Efficacy and Safety of Ragweed SLIT-Tablet from a Large Trial in Children with Allergic Rhinoconjunctivitis

More information on the study can be found here on ClinicalTrials.gov.

About Sublingual Allergy Immunotherapy (SLIT)-Tablets

Allergy immunotherapy, or AIT, treats the underlying cause of environmental allergies using a person’s own immune system. Small amounts of allergens are introduced into the body so the immune system can gradually learn to tolerate them better. It targets the specific allergy trigger that causes the immune system to overreact and provides long-lasting improvement for years after treatment. SLIT-Tablets are prescription medication taken once daily at home. Subcutaneous immunotherapy (SCIT), also known as allergy shots, is another form of allergy immunotherapy administered in a doctor’s office.

Important Safety Information for RAGWITEK

RAGWITEK is a prescription medicine used for sublingual (under the tongue) immunotherapy to treat ragweed pollen allergies that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. RAGWITEK may be prescribed for persons 18 through 65 years of age who are allergic to ragweed pollen.

RAGWITEK is taken for about 12 weeks before the ragweed pollen season and throughout ragweed pollen season.

RAGWITEK is NOT a medication that gives immediate relief for symptoms of ragweed allergy.

Important Safety Information about RAGWITEK

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for RAGWITEK, including the information about severe allergic reactions, and discuss it with the doctor. The physician Prescribing Information also is available.

About ALK
ALK is a global specialty pharmaceutical company focused on allergy. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,400 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.

For further information, please contact:

ALK:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: Stuart Loesch, tel. +1 908 842 8363, mobile +1 267 753 5838

1 Centers for Disease Control and Prevention, National Center for Health Statistics. Allergies and Hay Fever. Available at: https://www.cdc.gov/nchs/fastats/allergies.htm. Accessed September 5, 2019.

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SOURCE ALK, INC.