健亞 New formulation Cilostazol phase II data unveiled (2013Q4)

健亞去年獲利續創高，今年營收拼雙位數成長 精實新聞 2013-03-26 10:42:38 記者 蕭燕翔 報導 生產排程不及導致營收規模下滑，健亞(4130)去年第四季小虧，但因有武田訴訟的賠償金入帳，全年稅後盈餘6,062萬元，年增9%，續創下成立以來新高，以目前股本估算，每股稅後盈餘0.62元。健亞指出，今年品牌的利基學名藥及代工營收目標雙雙有兩位數成長，而新藥佈局部分，治療間歇性跛行症的PMR目標年底二期臨床Data出爐，與大陸石藥集團合作的糖尿病新藥則將在今年兩岸同步進入IND(人體臨床試驗)。 健亞去年第四季稅後小虧68.9萬元，是近年轉盈後罕見的單季虧損，但去年全年仍因武田賠償金入帳，全年稅後盈餘6,062萬元，續創成立以來新高，以目前股本估算，每股稅後盈餘0.62元。 健亞指出，第四季小虧主要是因國際大藥廠的訂單生產排程不及，導致營收規模下滑，加上PMR等臨床費用支出等。不過，在生產排程調整後，國際大廠的代工訂單首季都已經陸續出貨。展望今年，健亞表示，盼自有品牌的利基學名藥及代工營收貢獻能雙雙成長。在利基學名藥部分，除既有的品項外，今年上半年降血脂的新產品Rotlip也將上市，該藥品也是國內第一顆學名藥；代工部分，據了解，該公司去年下半年已開始出貨日本大廠第一三共的抗生素針劑訂單，第二季起出貨量逐步放大，除剛開始交貨鎖定國內市場外，未來也希望爭取亞洲的代工訂單。 在新藥佈局方面，健亞指出，PMR二期臨床原規劃在振興醫院及林口長庚兩個醫療院所收案40名，但因先前收案標準過高，導致收案進度較慢，目前已調整標準並新增台北長庚的收案點，目標期望6-8個月完成收案後，年底能有二期臨床的初步Data出爐，並以該Data尋求與外合作的機會。 至於與大陸石藥集團合作糖尿病新藥部分，健亞表示，雙方都在進行申請IND的前置作業，目標今年兩岸同步進入IND，2016年力推新藥上市。

Cilostazol (pron.: /sɨˈlɒstəzɒl/) is a quinolinone-derivative medication used in the alleviation of the symptom of intermittent claudication in individuals with peripheral vascular disease. It is manufactured by Otsuka Pharmaceutical Co. under the trade name Pletal. Although drugs similar to cilostazol have increased the risk of death in patients with congestive heart failure, studies of significant size have not addressed people without the disease. Cilostazol is a phosphodiesterase inhibitor with therapeutic focus on cAMP. It inhibits platelet aggregation and is a direct arterial vasodilator. Its main effects are dilation of the arteries supplying blood to the legs and decreasing platelet coagulation. Cilostazol is a selective inhibitor of 3-type phosphodiesterase (PDE3) with therapeutic focus on increasing cAMP. An increase in cAMP results in an increase in the active form of PKA, which is directly related with an inhibition in platelet aggregation. PKA also prevents the activation of an enzyme (myosin light-chain kinase) that is important in the contraction of smooth muscle cells, thereby exerting its vasodilatory effect. Cilostazol is approved for the treatment of intermittent claudication. The typical dose is 100 mg twice a day. The effects may take as long as 3 months to be evident and has been shown to improve pain-free walking distance by 50%.Cilostazol is also frequently used off-label, at the same dose, for treatment of intracranial atherosclerosis and secondary stroke prevention.