Aurinia Pharmaceuticals (TSX:AUP)(NASDAQ:AUPH) is a biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company has commercially launched voclosporin in the United States (U.S.) for the treatment of adult patients with active Lupus nephritis (LN). It continues to conduct pre-clinical, clinical, and regulatory activities to support the voclosporin development program.
Robust business strategy The company’s business strategy is to optimize the clinical and commercial value of voclosporin and become a commercial biopharmaceutical company with a global product portfolio focused on less common kidney and autoimmune diseases with high unmet medical needs. This includes the potential expansion of the existing label for additional kidney indications, the evaluation of voclosporin in novel formulations for the treatment of other autoimmune related disorders, as well as the addition of new pipeline assets that align with the company’s core expertise.
The company has developed a strategic plan to execute on Aurinia’s commercialization of voclosporin as a treatment of adult patients with active LN and to expand the company’s franchise beyond LN. The company plans on obtaining FDA approval for use of voclosporin for the treatment of active LN.
Strategic supply arrangements Further, the company is conducting post-commercial activities including build out of the organization to efficiently and effectively market voclosporin as a treatment of adult patients with active LN. It has engaged Otsuka as a collaboration partner for development and commercialization of voclosporin in Europe. The company also plans to seek approval with the European Medicines Agency in the first half of 2021, and other territories including the United Kingdom (U.K.), Switzerland, Russia, and Japan.
Aurinia is also working on ensuring adequate supply of voclosporin becomes available and the company has entered into strategic long term supply agreements with several key suppliers. The company is evaluating external assets with the potential to be synergistic and complementary to Aurinia’s clinical, regulatory and therapeutic areas of expertise.
Significant market potential The company has conducted extensive market research and analyses of peer reviewed publications to assess market potential and commercial opportunity. Aurinia’s physician research included more than 1,100 rheumatologists and nephrologists across the U.S., Europe and Japan to assess the potential market for adoption of voclosporin and estimate pricing and treatment possibilities.
The National Institute of Diabetes and Digestive and Kidney Diseases estimates that up to 50% of adults with systemic lupus erythematosus (SLE) are diagnosed with lupus nephritis at some point of the patient’s journey with lupus. Using the research and publication analyses, the company estimates the number of SLE patients diagnosed with LN to be about 80,000 to 120,000 in the U.S. This creates incredible opportunity for the company.
Valuable patent portfolio Aurinia’s policy has been to file patent applications to protect technology, inventions and improvements to the company’s inventions that are considered important to the development of Aurinia’s business. The company has an extensive granted patent portfolio which makes Aurinia’s stock very valuable. Aurinia’s intrinsic value appears to far exceed the stock’s market price.
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Fool contributor Nikhil Kumar has no position in any of the stocks mentioned.
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