友霖 注意力缺陷過動症藥Methylphenidate (market 1.3billions) 進行phase I (505b2) !!

友霖今年虧鎖估縮小，下半年可望申請上櫃 精實新聞 2013-01-07 16:36:53 記者 蕭燕翔 報導 友華(4120)子公司友霖(4166)生技經營團隊，該廠今年第一季可望正式取得TFDA全廠區認證的許可，今年底、明年初糖尿病用藥預期將獲美國FDA藥品許可證，搶佔第一個上市學名藥的商機。今年目標將把虧損縮小，未來將在取得工業局科技事業許可後，最快下半年送件申請上櫃。友霖生技目前資本額16.8億元，主要股東包括母公司友華58.9%、創投法人23.86%、集團員工8.98%等；該公司多專注於新劑型新藥開發，開發產品聚焦在中樞神經藥品，並以美國市場為開發導向，現鎖定的四大疾病領域包括抗精神病用藥、阿茲海默症用藥、精神興奮劑及抗帕金森氏症用藥等。而該公司去年前11月營收約1.4億元，年增21.88%，去年上半年稅後淨損9,843.4萬元，每股稅後淨損0.59元。友霖生技營運總經理蔡孟霖(見左圖)表示，全球中樞神精藥物市場額達700億美元，全球約有13%人口受相關疾病所苦，而該公司在中樞神經新藥的研發進度上，帕金森氏症口水過多症的Phase IIa臨床試驗已於去年12月完成，今年2、3月數據報告將出爐，將尋求對外授權機會。 另外，在注意力缺陷過動症方面，目前J&J的Concerta一年銷售額達13.2億美元，排名全球前十大中樞神經用藥。友霖目前投入該適應症的新劑型新藥，目前正進行Phase I試驗中。 而在查廠進度方面，友霖去年12月全廠區已完成TFDA查廠作業，預計1、2個月取得正式核可公文。去年12月美國FDA也完成查廠，並獲告知無重大缺失，現正等待該局發出的正式公文。友霖先前主攻美國市場的糖尿病用藥，也已向FDA送件申請藥品許可，今年底、明年初可望獲准，因該藥屬第一個上市的學名藥，上市商機可期。 蔡孟霖表示，今年將陸續增加產量，並尋求帕金森氏症口水過多證藥品的對外授權機會，全年虧損目標將較去年縮小。目前該公司將待抑制口水過多症的臨床數據出爐後，向經濟部工業局申請科技事業許可，最快下半年可望送件申請上櫃。

Methylphenidate is produced in the United States, Mexico, Spain and Pakistan. Other brands include Concerta, Methylin, and Daytrana, and generic forms, including Methylin, Metadate and Attenta are produced by numerous pharmaceutical companies throughout the world. Ritalin is also sold in Canada, Australia, the United Kingdom, Spain, Germany, Israel and other European countries (although in much lower volumes than in the United States). In Belgium the product is sold under the name Rilatine and in Brazil, Portugal and Argentina as Ritalina. In Thailand, it is found under the name Hynidate. Methylphenidate is a benzylpiperidine derivative. It also shares part of its basic structure with catecholamines and phenethylamines.

Methylphenidate primarily acts as a norepinephrine-dopamine reuptake inhibitor. Methylphenidate is most active at modulating levels of dopamine and to a lesser extent norepinephrine. Similar to cocaine, methylphenidate binds to and blocks dopamine transporters and norepinephrine transporters. Moreover, MPH is thought to act as a releasing agent by increasing the release of dopamine and norepinephrine, though to a much lesser extent than amphetamine. Methylphenidate's mechanism of action at dopamine-norepinephrine release is still debated, but is fundamentally different from phenethylamine derivatives, as methylphenidate is thought to increase general firing rate, whereas amphetamine reverses the flow of the monoamine transporters. While both amphetamine and methylphenidate are dopaminergic, it should be noted that their methods of action are distinct. Specifically, methylphenidate is a dopamine reuptake inhibitor while amphetamine is a dopamine releasing agent. Each of these drugs also has a corresponding and minor effect on norepinephrine. Methylphenidate has both dopamine transporter and norepinephrine transporter binding affinity, with the dextromethylphenidate enantiomers displaying a prominent affinity for the norepinephrine transporter. Both the dextrorotary and levorotary enantiomers displayed receptor affinity for the serotonergic 5HT1A and 5HT2B subtypes, though direct binding to the serotonin transporter was not observed. Methylphenidate may also exert a neuroprotective action.