Handok launches the new treatment for pulmonary arterial
hypertension ‘Opsumit’

-A long term data confirms 50% reduction in death or
hospitalization

-A convenient ‘one tablet a day’ dosing regimen without
the need for monthly liver function monitoring

Handok launched Actelion’s ‘Opsumit 10mg tablets (active
ingredient Macitentan, hereafter Opsumit)’ for pulmonary arterial hypertension
(PAH) in Korea. After the launching of ‘Traclear’ by an innovative Swiss drug
development pharmaceutical company Actelion in 2006, Handok also became in
charge of sales and marketing of ‘Opsumit’, the succeeding product to follow ‘Traclear’.

Pulmonary arterial hypertension is a rare and intractable
disease where an increase of blood pressure in the pulmonary artery causes
insufficient blood circulation within the lungs. It causes symptoms such as shortness
of breath, dizziness, fainting, oedema, chest pain and decreased exercise
ability. According to a study, the average survival duration after diagnosis
was found out to be 2~3 years.

‘Opsumit’ is an ‘endothelin receptor antagonist’ (ERA)
which acts on two types of receptors that are distributed throughout
endothelial cells and smooth muscle cells of the blood vessels, ET_A and
ET_B. It acts by inhibiting constriction of blood vessels, thereby
inducing reduction in blood pressure. ‘Opsumit’ is the first oral drug for pulmonary
arterial hypertension to have its effect on reducing death or morbidity risk in
pulmonary arterial hypertension patients confirmed through a two year long term
study (SERAPHIN study). This clinical trial, which was conducted on a total of
742 pulmonary arterial hypertension patients, showed that Opsumit 10mg reduced
death or morbidity risk by 45% compared to the placebo group and reduced death
or hospitalization due to pulmonary arterial hypertension by 50%. Also, its
safety was confirmed as the occurrence of adverse events such as change in
liver function or peripheral oedema appeared to be similar to that of the placebo
group.

Patients taking ‘Opsumit’ do not need to have their liver
function tested every month, which is a real advantage compared to other endothelin
receptor antagonists (ERA). Offering convenience of ‘one tablet a day’ dosing
regimen as well as various fundholding schemes conducted under medical
insurance for rare or intractable diseases, ‘Opsumit’ will provide to be a
beneficial novel treatment for patients suffering from pulmonary arterial
hypertension.

Handok, which dedicated itself to producing drugs for
various rare diseases, has and will continue to endeavor to improve the
diagnosis and treatment environment for pulmonary arterial hypertension by
holding events such as Pulmonary arterial hypertension (PAH) forum every year,
in partnership with Actelion Pharmaceuticals Korea.