Handok signs contract with Actelion Pharmaceuticals Korea for the sale of new pulmonary arterial hypertension drug “Opsumit”

– Handok designated to take charge of sales of “Opsumit,” the next generation of the pulmonary arterial hypertension drug “Tracleer.”

– Among oral pulmonary arterial hypertension drugs, Opsumit is the only drug that has been proven to be clinically effective and capable of reducing mortality and hospitalization rates in clinical studies longer than two years.

Handok (Chairman and CEO: Kim Young-jin) signed a contract with Actelion Pharmaceuticals Korea (President: Lee Sang-kyun) for the sale of the new pulmonary arterial hypertension (PAH) drug Opsumit (10-milligram tablets of macitentan) in Korea. In 2005, Handok signed a contract with Actelion Pharmaceuticals for the sale of the PAH drug Tracleer. With the signing of this new agreement, Handok will be in charge of the marketing and sales of the new drug in Korea.

Opsumit is a new PAH drug that is administered once a day. With its effectiveness in the treatment of idiopathic PAH, hereditary PAH, and PAH associated with connective tissue diseases having been proven, the drug was approved by the USFDA in October 2013. In Korea, it was approved for sale by the Ministry of Food and Drug Safety in November 2014, and its launch is currently being prepared.

Among oral PAH drugs, Opsumit is the first to be proven clinically effective in a clinical study longer than two years (SERAPHIN study). It was also proven to reduce mortality and hospitalization rates. The results of the SERAPHIN clinical study, which was conducted on 742 PAH patients, show that, in the group that was administered 10 milligrams of Opsumit, the mortality and morbidity rates were decreased by 45 percent in comparison with the placebo group, and the hospitalization rate was reduced by 50 percent. Moreover, the rate of side effects, such as hepatic toxicity and edema, was comparable to that of the placebo group, thus displaying excellent tolerance.

Handok Chairman Kim Young-jin announced that by adding Opsumit to the PAH drug Tracleer, which is already supplied by Handok, more diverse treatments will become available to PAH patients, saying, “Based on the experience we have gained in the PAH market so far, we will do our best to ensure that Opsumit becomes well-established.”

President of Actelion Pharmaceuticals Korea, Lee Sang-kyun, stated, “Opsumit is now marketed in 27 countries, including countries in America and Europe as well as in Australia and Japan. In collaboration with Handok, our current strategic partner in the distribution and sale of Tracleer, we will do our best to supply this excellent drug to Korean PAH patients.”