Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) has been transforming and it is in the process of delivering the first FDA approved Lupus Nephritis (LN) therapy treatment. LN is a serious kidney inflammation resulting from an autoimmune disorder referred to as systemic lupus erythematous.
Voclosporin holds huge potential for LN patients
Months after the company received positive clinical results for the third phase Aurora study, Aurinia has now completed a New Drug Application (NDA) submission for its drug called voclosporin. The company is expecting the application to be acceleratedthrough priority review and thus support early next year’s launch.
Voclosporin could be a huge opportunity for the company considering it demonstrated promising safety profile that met primary and secondary endpoints. This provides significant promise for LN patients across Europe, Japan, and the US. The patent life of the drug of up to 2027 and the incorporation of a dosing protocol could extend its protection in the US up to 2037.
The market size of SLE by 2026 is estimated to hit $2.7 billion growing at a 7% CAGR. The company estimates that the drug could bring sales of over $1 billion. The drug could have other indications like dye eye syndrome as well as proteinuric kidney disease.
Aurinia preparing for the launch of voclosporin
Aurinia’s experienced commercial and leadership team will be vital in the launch of the drug. The company enhanced its leadership by appointing Max Colao as the chief commercial officer. Colao has led product launches at Amgen Inc. (NASDAQ:AMGN), Alexion Pharmaceuticals (NASDAQ:ALXN), and Abeona Therapeutics (NASDAQ:ABEO). Also, they appointed various vice presidents that will help the company in building its brand and creating awareness ahead of the launch.
In Q1 the company reported $315,000 in revenue and a net loss of $16.5 million or 15 cents per share. It ended the quarter in a strong financial position with cash and cash equivalents of $286.1 million that will support operations up to 2021.