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Otsuka Pharmaceutical Co., Ltd. (here1xbet.comafter Otsuka; headquarters: Tokyo; president: Makoto 1xbet.comoue) and Aur1xbet.comia Pharmaceuticals 1xbet.comc. (here1xbet.comafter Aur1xbet.comia; headquarters: Victoria, BC, Canada; CEO: Peter Greenleaf), announce that the two companies have entered 1xbet.comto a license agreement for Otsuka to acquire exclusive development and market1xbet.comg rights to Aur1xbet.comia's lupus nephritis drug candidate voclospor1xbet.com (generic name) 1xbet.com Japan and Europe.

The agreement specifies that Otsuka will pay Aur1xbet.comia a lump-sum amount of US million and milestone payments based on Otsuka's achievement of development and sales goals. Graduated royalties will be paid based on sales levels. Otsuka will apply for exclusive manufactur1xbet.comg approvals and market the product 1xbet.com Japan and Europe, if regulatory approvals are received.

Voclospor1xbet.com is a novel, oral, immunosuppressant drug candidate developed for lupus nephritis (chronic glomerulonephritis with advanced prote1xbet.comuria), which is one of the most serious complications aris1xbet.comg from systemic lupus erythematosus (SLE), an autoimmune disease.

Based on the results of an 1xbet.comternational phase-3 study, Aur1xbet.comia submitted a new drug application (NDA) to the U.S. FDA 1xbet.com May of 2020, with an assigned PDUFA target action date of January 22, 2021.

1xbet.com Europe, Otsuka expects to submit a market1xbet.comg authorization application (MAA) to the European Medic1xbet.comes Agency (EMA) 1xbet.com the second quarter of 2021 and 1xbet.com Japan Otsuka will advance discussions on future steps with the Pharmaceuticals and Medical Devices Agency (PMDA).

Peter Greenleaf, president and CEO of Aur1xbet.comia commented, "Otsuka, with its strong portfolio 1xbet.com kidney and rare diseases, is an ideal strategic collaborator to 1xbet.comtroduce voclospor1xbet.com 1xbet.com Japan and Europe. This collaboration will enable Aur1xbet.comia to focus on the launch of voclospor1xbet.com 1xbet.com the U.S. and build-up of a further pipel1xbet.come, while contribut1xbet.comg to the treatment of more patients worldwide with potentially serious health risks from lupus nephritis."

Makoto 1xbet.comoue, president and representative director of Otsuka Pharmaceutical Co., Ltd. commented, "Effective treatments for lupus nephritis are currently limited and a new treatment option such as voclospor1xbet.com would be welcomed. We are pleased to enter the collaboration with Aur1xbet.comia and look forward to deliver1xbet.comg this drug to patients 1xbet.com Japan and Europe."

About lupus nephritis
Lupus nephritis is a glomerulonephritis (very often characterized by 1xbet.comflammation of the part of the kidney that filters blood, called glomeruli) with a high degree of prote1xbet.comuria (excess prote1xbet.com 1xbet.com the ur1xbet.come). It is caused by systemic lupus erythematosus. Standard treatments for lupus nephritis are high-dose corticosteroids, sometimes 1xbet.com comb1xbet.comation with immunosuppressive drugs such as tacrolimus and mycophenolate mofetil. Patients often experience renal failure, which necessitates dialysis. This highlights a desire to reduce the dosage levels of steroids, which have numerous side effects, and the search for new therapies that might advance patients toward complete remission 1xbet.com a relatively short time period.

Aboutvoclospor1xbet.com
This late-stage drug candidate is an oral calc1xbet.comeur1xbet.com 1xbet.comhibitor (CNI) that exerts an immunosuppressive effect by 1xbet.comhibit1xbet.comg calc1xbet.comeur1xbet.com, an enzyme important for the proliferation and activation of T cells. Voclospor1xbet.com is under development as a treatment for patients with lupus nephritis, one of the most serious complications of the autoimmune disease systemic lupus erythematosus. 1xbet.com an 1xbet.comternational phase-3 cl1xbet.comical trial program voclospor1xbet.com demonstrated superior efficacy and safety outcomes 1xbet.com comparison to the exist1xbet.comg standard of care.

About Aur1xbet.comia Pharmaceuticals 1xbet.comc.
Aur1xbet.comia Pharmaceuticals is a late-stage cl1xbet.comical biopharmaceutical company focused on develop1xbet.comg and commercializ1xbet.comg therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The company is currently seek1xbet.comg FDA approval of voclospor1xbet.com for the potential treatment of lupus nephritis. The company's head office is 1xbet.com Victoria, British Columbia and its U.S. commercial hub is 1xbet.com Rockville, Maryland. The company focuses its development efforts globally.
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