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

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

• The international multicenter (North America and Europe), double-blind placebo-controlled study evaluating the efficacy and safety of ragweed SLIT-tablet (RAGWITEK) in children age 5-17 (mean age=12.1 years) with ragweed allergic rhinitis with or without conjunctivitis and with or without asthma was conducted by MSD (known as Merck in the U.S. and Canada), under the terms of its former partnership agreement with ALK.
• 1,025 children were randomized; 1,022 received treatment; 952 completed the study.
• Study participants were randomized 1:1 to daily RAGWITEK or placebo approximately 12 to 20 weeks prior to the start of ragweed pollen season. Treatment continued throughout the season for approximately eight weeks. Participants were instructed to use study-provided medication as needed to treat rhinoconjunctivitis symptoms.
• The study's primary endpoint was the average total combined score (TCS), a sum of rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS), over the peak ragweed season. Key secondary endpoints included the average TCS during the entire ragweed season, and DSS and DMS during the peak season.
• The study met its primary and key secondary endpoints related to TCS. Relative improvements in TCS with RAGWITEK compared with placebo were −38.3% (95% CI, −46.0%, −29.7%; least square [LS] mean difference=2.73; P<0.001) during peak ragweed season and −32.4% (95% CI, −40.7%, −23.3%; LS mean difference=1.86; P<0.001) during the entire ragweed season.
  
• Both DSS and DMS were improved with RAGWITEK compared with placebo by −35.4% (95% CI, −43.2%, −26.1%; LS mean difference=1.40; P<0.001) and −47.7% (95% CI, −59.8, −32.5%; LS mean difference=1.84; P<0.001), respectively, during peak ragweed season.
• The most common AEs related to RAGWITEK were throat irritation, oral pruritus and ear pruritus. Two systemic allergic reactions related to RAGWITEK were reported (non-serious, mild skin pruritus and redness beginning on day six and serious moderate hypersensitivity [urticaria] on day 26). One additional participant experienced a serious AE related to RAGWITEK (severe laryngitis on day 126 that resolved in two days). No participants treated with RAGWITEK received intramuscular epinephrine.

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 

• RAGWITEK can cause severe allergic reactions that may be life-threatening. Stop taking RAGWITEK and get medical treatment right away if you have any of the following symptoms after taking RAGWITEK:
• Trouble breathing
• Throat tightness or swelling
• Trouble swallowing or speaking
• Dizziness or fainting
• Rapid or weak heartbeat
• Severe stomach cramps or pain, vomiting, or diarrhea
• Severe flushing or itching of the skin
• Do not take RAGWITEK if you have severe, unstable or uncontrolled asthma; had a severe allergic reaction in the past that included trouble breathing, dizziness or fainting, or rapid or weak heartbeat; had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before; have ever been diagnosed with eosinophilic esophagitis; or are allergic to any of the inactive ingredients contained in RAGWITEK.
• For home administration of RAGWITEK, your doctor will prescribe auto-injectable epinephrine, a medicine you can inject if you have a severe allergic reaction after taking RAGWITEK. Talk to your doctor or read the epinephrine patient information if you have any questions about the use of auto-injectable epinephrine.
• The first dose of RAGWITEK must be taken in the doctor's office. After taking the first tablet, you will be watched for at least 30 minutes for symptoms of a serious allergic reaction.
• You should tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of RAGWITEK. Ask your doctor or pharmacist for advice before taking RAGWITEK.
• Stop RAGWITEK and contact your doctor if you have any of the following after taking RAGWITEK: Any type of a serious allergic reaction; throat tightness that worsens or swelling of the tongue or throat that causes trouble speaking, breathing or swallowing; asthma or any other breathing condition that gets worse or heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens. Also stop taking RAGWITEK following mouth surgery procedures (such as tooth removal) or if you develop any mouth infections, ulcers or cuts in the mouth or throat.
• The most commonly reported side effects were itching of the mouth, lips, or tongue, swelling under the tongue, or throat irritation. These side effects, by themselves, were not dangerous or life-threatening.
• Your doctor may decide that RAGWITEK is not the best treatment for you if you have asthma; plan to become pregnant or are breast-feeding; are unable or unwilling to administer epinephrine; or are taking certain medicines, including other allergen immunotherapy.

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.

SOURCE ALK, INC.

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