NORDIC PHARMA Files Submission to Health Canada for the Marketing Authorization of Methotrexate Autoinjector for Treating Rheumatoid Arthritis in Canada

TORONTO–(BUSINESS WIRE)–#caringaboutunmetmedicalneeds–NORDIC PHARMA, a SEVER Life Sciences company, announced today the submission of a New Drug Submission to Health Canada for its methotrexate auto-injector, Nordimet^® for the treatment of severe disabling active rheumatoid arthritis (RA) and symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy. Methotrexate is considered a cornerstone therapy for patients with rheumatoid arthritis (RA), with well-established safety and efficacy profiles and support in international guidelines.

For over a decade, NORDIC PHARMA has successfully built its therapeutic portfolio in Rheumatology around Europe. Its continuous collaboration with patient and physician associations has enabled it to focus its efforts closely on the expectations of patients and physicians for the past 10 years. A successful submission in Canada would mark the continued commitment of the Nordic group to address unmet medical needs.

Rheumatoid arthritis (RA) is the leading cause of pain and disability in North America.⁴ Its prevalence is estimated at 0.24% of the population globally¹. At present, patients still face unpredictable outcomes for their disease, with a gradual deterioration of their quality of life^1,2.

The past decade has brought about important advances in the understanding of RA, its management, and treatment. Methotrexate (MTX) has been used for RA treatment since the ‘80s. Today, MTX is known to be the anchor drug in RA treatment. MTX is a highly effective agent both as monotherapy and in combination with glucocorticoids, other conventional synthetic DMARDs, biological DMARDs, and targeted synthetic DMARDs.³ The subcutaneous route has been recognized to be the best treatment option from the outset, in terms of risk-benefit ratio, compared with the oral route.³ Subcutaneous administration of MTX is to be considered for optimizing RA treatment.

About Nordic Pharma Inc.

NORDIC PHARMA is a privately-owned pharmaceutical company created in 1995 in Sweden. With its pan-European presence and operations in over 17 countries, the group’s major corporate entity focuses on the development and commercialization of niche hospitals, retail, and orphan products to respond to unmet medical needs. Nordic Pharma Americas, Asia, Pacific (AAP) is the newest affiliate of NORDIC PHARMA and the first outside of Europe. With its establishment in 2020, Nordic Pharma AAP is seeking to establish its strong presence in Canada through the commercialization of its innovative products in rheumatology as well as in gynecology, anesthesia, hematology, and oncology.⁵

REFERENCES

1. Cross M et al. The global burden of rheumatoid arthritis: estimates from the Global Burden of Disease 2010 Study. Ann Rheum Dis. 2014;73:1316-22.; 2. Rheumatoid Arthritis. Arthritis Research UK. www.arthritisresearchuk.org; 3. Smolen JS, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 2017;0:1–18. doi:10.1136/annrheumdis-2016-210715; 4. Canadian Chronic Disease Surveillance System (CCDSS) data, August 2019; 5.www.nordicpharma.ca

Contacts

Corporate Media and Communication, Nordic Pharma

Sophia KAZOGLOU

Email: [email protected]