Kye Pharmaceuticals Secures Exclusive Canadian License, Supply and Commercialization Agreement for a novel proton pump inhibitor (PPI) treatment option for gastroesophageal reflux disease (GERD) in infants, children and adults
• Gastroesophageal reflux disease (GERD) is a common condition in young children and can lead to gastrointestinal symptoms, pain and discomfort, respiratory symptoms, sleep disturbances, among others.1-4
• It is estimated that out of 380 000 newborns in Canada in 2024, approximately 100 000 were suffering from GERD within their first 12 months of life.5-13
MISSISSAUGA, ON, May 1, 2025 – Kye Pharmaceuticals, Inc. ("Kye"), a commercial-stage biopharmaceutical company focused on identifying, licensing, and commercializing novel medicines for patients in Canada, today announced that it has entered into an exclusive license, supply and commercialization agreement with a European-based novel specialty pharmaceutical company. This agreement will bring a novel oral proton pump inhibitor (PPI) treatment option for gastroesophageal reflux disease (GERD) in infants, children, and adults to the Canadian market.
GERD is a common condition in young children that can lead to gastrointestinal symptoms, pain and discomfort, respiratory symptoms, sleep disturbances, among others.1-4 Kye is well positioned to partner on this novel treatment option, providing physicians and parents with an effective and convenient solution to alleviate this painful and uncomfortable condition in these very young patients.
Already marketed in many other countries, this medication has established itself as an important treatment option for pediatric GERD.
“This new partnership will add to Kye’s existing portfolio of pediatric medicines for Canadian patients,” said John McKendry, President of Kye Pharmaceuticals. “We are committed to delivering innovative solutions that improve the health and well-being of children across Canada.”
Under the terms of the agreement, Kye will have the exclusive Canadian rights and will be responsible for supporting all regulatory, marketing, and commercialization activities in Canada.
Kye plans to announce additional details about the partnership and the specific medication closer to Health Canada approval, anticipated in 2026. With this agreement, Kye Pharmaceuticals continues its mission of expanding access to essential novel treatments in Canada, further strengthening its pediatric portfolio and commitment to patient care.
About GERD
GERD, or Gastroesophageal Reflux Disease, is a chronic digestive condition where stomach acid or bile irritates the lining of the esophagus. It happens when the lower esophageal sphincter (LES), which is a muscle at the bottom of the esophagus, weakens or relaxes inappropriately, allowing stomach contents to flow back up into the esophagus. This is called acid reflux. Common symptoms of GERD include Heartburn (a burning sensation in the chest or throat), regurgitation of food or sour liquid, difficulty swallowing, chronic cough, sore throat and hoarseness, among others.1-4
There is a high GERD prevalence in Canada with between 5.54 to 7.34 million total estimated cases in 2024 [between 1.1 to 26.5% prevalence rate in different age groups]. The highest prevalence rates [25.5 to 26.5%] are seen in newborns between the age of 0-1 years of age. In 2024, over 380,000 newborns were reported in Canada and out of these approximately 100,000 are estimated to be suffering from GERD within their first 12 months of life.5-13
About Kye Pharmaceuticals Inc.
Kye Pharmaceuticals is a growth-stage Canadian specialty pharmaceutical company committed to bringing value to Canadians by identifying, licensing, and commercializing novel prescription medicines that are not otherwise available to patients across Canada. With a growing pipeline of novel medicines, Kye's portfolio spans a range of therapeutic areas, including cardiology, psychiatry, pediatrics, rare diseases, hematology, and neurology. Kye is committed to licensing and launching medicines that matter for Canadians by delivering better outcomes to our partners, healthcare professionals, and, most importantly, patients across Canada. For more information, please visit www.kyepharma.com.
References
[1] Reflux in Infants [Accessed on March 21st 2025] - https://medlineplus.gov/refluxininfants.html
[2] Nationwide Children’s - Gastroesophageal Reflux Disease (GERD) in Infants [Accessed on March 21st 2025] - https://www.nationwidechildrens.org/conditions/gastroesophageal-reflux-disease-gerd-in-infants
[3] Mayo Clinic – Infant reflux [Accessed on March 21st 2025] - https://www.mayoclinic.org/diseases-conditions/infant-acid-reflux/symptoms-causes/syc-20351408
[4] Boston Children’s Hospital - Gastroesophageal Reflux Disease (GERD) [Accessed on March 21st 2025] - https://www.childrenshospital.org/conditions/gerd
[5] Age (in single years), average age and median age and gender: Canada, provinces and territories, census metropolitan areas and census agglomerations with parts. Table: 98-10-0020-01. Release date: 2022-04-27. https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=9810002001
[6] Canada's population clock (real-time model). [Assessed on April 8th 2024]. https://www150.statcan.gc.ca/n1/pub/71-607-x/71-607-x2018005-eng.htm
[7] Fedorak et al., 2010 – Canadian Digestive Health Foundation Public Impact Series: Gastroesophageal reflux disease in Canada: Incidence, prevalence, and direct and indirect economic impact. [Link] Available from: https://www.researchgate.net/publication/45283122_Canadian_Digestive_Health_Foundation_Public_Impact_Series_Gastroesophageal_Reflux_Disease_in_Canada_Incidence_Prevalence_and_Direct_and_Indirect_Economic_Impact [accessed Apr 04 2024].
[8] Ruigomez et al., Comparison of gastro-oesophageal reflux disease and heartburn diagnoses in UK primary care. Curr Med Res Opin2006;22:1661-8. https://pubmed.ncbi.nlm.nih.gov/16968569/
[9] Kotzan et al., Assessing NSAID prescription use as a predisposing factor for gastroesophageal reflux disease in a Medicaid population. Pharm Res 2001;18:1367-72. https://pubmed.ncbi.nlm.nih.gov/11683254/
[10] Nelson et al., Pediatric gastroesophageal reflux disease and acid-related conditions: Trends in incidence of diagnosis and acid suppression therapy. J Med Econ 2009;12:348-55. https://reference.medscape.com/medline/abstract/19827992
[11] Eusebi LH et al. Global prevalence of, and risk factors for, gastro-oesophageal reflux symptoms: a meta-analysis. Gut. 2018 Mar;67(3):430-40. In North America, it is estimated that the prevalence of GERD is 15%. (Eusebi et al. 2018). https://pubmed.ncbi.nlm.nih.gov/28232473/
[12] Singendonk et al., Prevalence of Gastroesophageal Reflux Disease Symptoms in Infants and Children: A Systematic Review. J Pediatr Gastroenterol Nutr. 2019 Jun;68(6):811-817. doi: 10.1097/MPG.0000000000002280. https://pubmed.ncbi.nlm.nih.gov/31124988/
[13] Sintusek P et al., Gastroesophageal reflux disease in children: What’s new right now? World J Gastrointest Endosc. 2023 Mar 16; 15(3): 84–102. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10080553/
For more information, please contact:
Media and Investor Contact: John McKendry, Kye Pharmaceuticals Inc, 1-888-822-7126,
Email: johnm@kyepharma.com
Website: https://www.kyepharma.com/
