Stockholm, Sweden, March 19, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the Japanese Patent Office (JPO) issued a notification to grant the company’s patent application in Japan, 2014-545410, for a medical device, which is one of the main components in the product candidate SC0806. The product candidate is a combination of a medical device (implant) and a medicinal product (FGF1) for patients with Complete Spinal Cord Injury. The notification states that the Japanese patent (derived from 2014-545410) will enter into force no later than April 13, 2018.
The patent will provide important protection for the medical device for treatment of patients with Complete Spinal Cord Injury. A corresponding patent has previously been granted in China and during 2018 also in Australia and the US.
”The patent protection is in line with the company’s strategy to protect important products through patents. A clinical Phase 1/2 study with the product candidate SC0806 for treatment of complete spinal cord injury is currently ongoing. These patients lack effective treatment today. Our ambition is to develop SC0806 and improve the patients’ quality of life,” said Gunilla Osswald, CEO of BioArctic.
BioArctic has an active patent strategy covering all major geographic markets, including the US, EU, Japan and China.
For more information, please contact:
Gunilla Osswald, PhD, CEO
Telephone: + 46 8 695 69 30
Christina Astrén, IR and Communications Director
Telephone: + 46 70 835 43 36
This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the contact persons above, on March 19, 2018, at 01:00 p.m. CET.
SC0806 is a novel product under development for the treatment for patients with Complete Spinal Cord Injury. The product candidate SC0806 is currently in an ongoing Phase 1/2 clinical trial. The first patient was treated in 2016 at Karolinska University Hospital, Sweden. The product candidate is a combination of a biodegradable medical device and a drug substance (FGF1) designed to support nerve regeneration across the injured area in the spinal cord. The product obtained orphan drug designation in 2010 in EU and in 2011 in the US, which gives the company 10 and 7 years of market exclusivity in Europe and the US, respectively.
BioArctic has received funding from the European Union’s Horizon 2020 Research and Innovation Program under Grant Agreement No. 643853 to perform a clinical study with SC0806.
About Spinal Cord Injury
A Spinal Cord Injury (SCI) occurs when trauma or disease damages the spinal cord and results in partial or complete paralysis. The incidence ranges between 12.7 and 44.3 per million inhabitants depending on country.1 Some 40% of these patients are estimated to have chronic complete spinal cord injury.2 Patients with complete spinal cord injury require life-long therapy and care, which means high costs for the healthcare system. The victims are usually young people. The injury has little effect on life expectancy, but leads to major challenges to maintain an acceptable quality of life. Following complete injury, the patient faces a permanent loss of function below the site of injury, with devastating consequences for the patient’s quality of life. Today there is no effective treatment available for the patients. The estimated lifetime cost is approximately 3 MUSD for one patient.3
1) Datamonitor, Stakeholder Opinions: Spinal Cord Injury, 2010.
2) NSCISC Annual Statistics report 2010.
3) Krueger et al., 2013.
BioArctic AB (publ) is a Swedish research based biopharma company focusing on disease modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease. The company also develops a potential treatment for Complete Spinal Cord Injury. BioArctic focuses on innovative treatments in areas with high unmet medical needs. Collaborations with universities are of great importance to the company together with our strategically important global partners in the Alzheimer (Eisai) and Parkinson (AbbVie) projects. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market and out-licensing potential. BioArctic’s B-share is listed on Nasdaq Stockholm Mid Cap (STO:BIOA B). www.bioarctic.com