Samjin Pharmaceutical Aims for 'First Generic' in Pulmonary Artery Treatment... Secures Distribution Rights

Published 26 Apr.2023 14:15(KST)

Samjin Pharmaceutical announced on the 26th that its pulmonary arterial hypertension treatment ‘Masiten Tablet (active ingredient Masitentan)’ has recently obtained priority marketing approval from the Ministry of Food and Drug Safety following a patent avoidance decision by the Patent Trial and Appeal Board in response to a passive scope of rights confirmation trial. Through this, Samjin Pharmaceutical will be able to conduct exclusive sales and marketing of Masiten Tablet for nine months until January next year and plans to proceed with the launch process to quickly capture the generic market.

Samjin Pharmaceutical's pulmonary arterial hypertension treatment 'Masiten Tablets' <br>[Photo by Samjin Pharmaceutical]

Samjin Pharmaceutical's pulmonary arterial hypertension treatment 'Masiten Tablets'
[Photo by Samjin Pharmaceutical]

Pulmonary arterial hypertension is an intractable disease caused by increased blood pressure in the pulmonary artery that supplies blood from the heart to the lungs. It can cause right heart failure, sudden cardiac death, and is known to have an average survival period of only three years. In particular, in Korea, due to low awareness and treatment rates of the disease, it is estimated that about 6,000 people suffer from the disease, including those not yet diagnosed.

Among pulmonary arterial hypertension treatments, Masitentan, classified as an endothelin receptor antagonist, is widely used both as monotherapy and combination therapy, and its efficacy has been verified. The original Masitentan treatment was developed by Swiss company Actelion under the brand name ‘Opsumit Tablet’. In Korea, it is sold by Janssen Korea.

Opsumit Tablet was protected by a substance patent that expired in March last year and a composition patent (formulation patent) that was originally scheduled to expire in October 2027. Samjin Pharmaceutical plans to launch Masiten Tablet on the market immediately after completing related administrative procedures, having successfully avoided the formulation patent following the expiration of the substance patent.

According to IQVIA, a pharmaceutical market research firm, the Masitentan formulation accounted for about 17 billion KRW in sales in the domestic pulmonary arterial hypertension treatment market as of last year. Although awareness of pulmonary arterial hypertension in Korea was low in the past, recent advances in diagnostic testing have increased the number of patients, and the related treatment market is expected to gradually expand.

Yoo Jung-min, PM of Masiten Tablet at Samjin Pharmaceutical, said, “The lower price of Masiten Tablet compared to the original will be a new alternative that reduces the economic burden on patients,” adding, “We will make every effort to prepare for the launch as the first generic with good quality and economical pricing.”