Aurinia Announces PTAB Has Terminated Inter Partes Review

Rhea-AI Summary

Aurinia Pharmaceuticals (NASDAQ: AUPH) announced that the Patent Trial and Appeal Board (PTAB) has terminated the Inter Partes Review (IPR) related to its U.S. Patent No. 10,286,036. This patent is associated with LUPKYNIS, the first FDA-approved oral therapy for lupus nephritis (LN), a serious condition affecting many patients with systemic lupus erythematosus (SLE). With approximately 200,000-300,000 individuals in the U.S. diagnosed with SLE, around 50% may develop LN, emphasizing the therapeutic importance of LUPKYNIS for these patients.

Positive

• Termination of IPR strengthens Aurinia's patent position for LUPKYNIS.
• LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis.

Negative

• None.

VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia) announces that the Patent Trial and Appeal Board (PTAB) of the United States’ Patent and Trademark Office has terminated the Inter Partes Review (IPR) it had instituted with respect to Aurinia’s U.S. Patent No. 10,286,036.

About LUPKYNIS
LUPKYNIS is the first FDA-approved oral therapy for LN. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is in the United States (U.S.) and across the European Union (E.U).

About Lupus Nephritis
LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. In January 2021, the Company introduced LUPKYNIS^® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis (LN). The Company’s head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230125005640/en/

Investor/Media:

Aurinia@westwicke.com

Source: Aurinia Pharmaceuticals Inc.

FAQ

What is the significance of the PTAB's decision for AUPH?

The termination of the IPR strengthens Aurinia's patent protection for LUPKYNIS.

What is LUPKYNIS and what condition does it treat?

LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis, a serious kidney condition associated with systemic lupus erythematosus.

How many people are affected by lupus nephritis in the U.S.?

Approximately 200,000 to 300,000 people live with systemic lupus erythematosus in the U.S., and around 50% may develop lupus nephritis.

When was LUPKYNIS approved by the FDA?

LUPKYNIS was introduced in January 2021 as the first FDA-approved oral therapy for active lupus nephritis.

What is the stock symbol for Aurinia Pharmaceuticals?

The stock symbol for Aurinia Pharmaceuticals is AUPH.