NS Pharma Receives Innovator Award at the BioNJ 29th Annual Dinner Meeting & Innovation Celebration in Recognition of the FDA’s Accelerated Approval of VILTEPSO® (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy in the U.S.

June 10, 2022

NS Pharma Receives Innovator Award at the BioNJ 29th Annual Dinner Meeting & Innovation Celebration in Recognition of the FDA’s Accelerated Approval of VILTEPSO® (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy in the U.S.

PARAMUS, NJ: June 10, 2022 – NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President, Toru Nakai), was honored with a BioNJ Innovator Award at the BioNJ 29th Annual Dinner Meeting & Innovation Celebration taking place on Thursday, June 9, 2022. The Innovator Award recognizes NS Pharma for their commitment to patients and the launch of VILTEPSO® (viltolarsen) for patients with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping therapy. VILTEPSO® was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on August 12, 2020.

BioNJ is the life sciences trade association for New Jersey, representing nearly 400 research- based life sciences organizations and stakeholders across the healthcare ecosystem. The BioNJ Dinner Meeting & Innovation Celebration brought together hundreds of biotechnology and pharmaceutical professionals, academic leaders, patients, advocates, service providers and government officials to honor the groundbreaking medical innovation driven by companies with a footprint in New Jersey.

“On behalf of NS Pharma, it’s a tremendous honor to receive the BioNJ Innovator Award recognizing our efforts championing for patients with Duchenne muscular dystrophy,” said Tsugio Tanaka, President, NS Pharma, Inc. “We take pride in developing innovative, life- changing medicines for people affected by rare diseases, and this recognition reinforces our commitment to helping patients live healthier, happier lives.”

About Duchenne Muscular Dystrophy (DMD)

DMD is a progressive form of muscular dystrophy that occurs primarily in males. DMD causes progressive weakness and loss of skeletal, cardiac, and pulmonary muscles. Early signs of DMD may include delayed ability to sit, stand or walk. There is a progressive loss of mobility, and by adolescence, patients with DMD may require the use of a wheelchair. Cardiac and respiratory muscle problems begin in the teenage years and lead to serious, life-threatening complications.

About NS Pharma, Inc.

NS Pharma, Inc., is a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. For more information, please visit http://www.nspharma.com. NS Pharma is a registered trademark of the Nippon Shinyaku group of companies.

About VILTEPSO® (viltolarsen) injection

Indication

VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information

In clinical studies, no patients experienced kidney toxicity during treatment with VILTEPSO. However, kidney toxicity from drugs like VILTEPSO may be possible. Your doctor may monitor the health of your kidneys before starting and during treatment with VILTEPSO.

Common side effects include upper respiratory tract infection, injection site reaction, cough, and fever.

For more information about VILTEPSO, see full Prescribing Information.

Contact

U.S. Media Contact:

media@nspharma.com