Kiniksa Announces Issuance of U.S. Patent for Treatment of Recurrent Pericarditis

Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) ("Kiniksa"), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, today announced that the U.S Patent and Trademark Office issued a patent covering methods of using ARCALYST® (rilonacept) in the treatment of recurrent pericarditis.

The patent issued as U.S. Patent No. 11,026,997 and will expire on March 11, 2039. Kiniksa has exclusive rights to this patent under the ARCALYST License Agreement.

"We believe this patent continues to strengthen our proprietary position on the FDA-approved use of ARCALYST in recurrent pericarditis and provides protection that extends approximately 11 years beyond orphan drug exclusivity and into 2039," said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. "We continue to execute on our commercial strategy and look forward to providing our first full quarter ARCALYST sales in our second quarter earnings report."

About Kiniksa

Kiniksa is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa's portfolio of assets, ARCALYST, mavrilimumab, vixarelimab and KPL-404, are based on strong biologic rationale or validated mechanisms, target underserved conditions and offer the potential for differentiation. These assets are designed to modulate immunological pathways across a spectrum of diseases. 

About Recurrent Pericarditis

Recurrent pericarditis is a painful and debilitating autoinflammatory cardiovascular disease that typically presents with chest pain and is often associated with changes in electrical conduction and sometimes buildup of fluid around the heart, called pericardial effusion. Patients who have additional pericarditis episodes following a symptom-free period of 4-6 weeks are identified as having recurrent pericarditis. Recurrent pericarditis symptoms have an impact on quality of life, limit physical activities, and lead to frequent emergency department visits and hospitalizations. Data show that approximately 40,000 patients in the U.S. seek and receive treatment for recurrent pericarditis each year. Of that group, approximately 14,000 patients experience a second or subsequent event (recurrence) due to persistent underlying disease or inadequate response to conventional therapies, such as nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine and corticosteroids.

About ARCALYST

ARCALYST is a weekly, subcutaneously-injected recombinant dimeric fusion protein that blocks interleukin-1 alpha and interleukin-1 beta signaling. ARCALYST was discovered by Regeneron and is approved by the FDA for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and deficiency of IL-1 receptor antagonist (DIRA). The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to ARCALYST for the treatment of pericarditis in 2020.

About the ARCALYST License Agreement with Regeneron

In 2017, Regeneron granted Kiniksa an exclusive license to develop and commercialize ARCALYST worldwide, excluding Israel, Egypt, Turkey and select countries in the Middle East and North Africa. In the United States and Japan, Kiniksa's license is for all indications other than those involving oncology and local administration to the eye or ear. Upon the approval of the supplemental Biologics License Application (sBLA) for ARCALYST in recurrent pericarditis, the scope of the license granted to Kiniksa expanded to include DIRA and CAPS in the United States and Japan, and Kiniksa assumed the responsibility for sales and distribution of ARCALYST in these additional indications in the United States. Outside the United States and Japan, Kiniksa's license is for all indications other than CAPS and certain periodic fever syndromes, DIRA, oncology, and local application to the eye or ear. Kiniksa and Regeneron will evenly split profits on sales of ARCALYST after deducting certain commercialization expenses, subject to specified limits.