日本Dainippon Sumitomo Pharma 授權 生達: lurasidone

生達轉型 市場按讚 自由時報-2013年10月29日 上午07:43 國內健保價格不佳，本土藥廠積極轉型，生達（1720）近兩年動作頻頻，從股價來看，半年來漲幅將近9成，顯示轉型成效獲得市場肯定。昨天生達宣布與大日本住友製藥株式會社的第一個合作案，由大日本住友製藥研發的第二代抗精神病藥物lurasidone，生達將向台灣TFDA申請藥證，並獨家取得該產品在台銷售權利。生達指出，大日本住友製藥針對精神分裂症治療所開發的lurasidone是該公司相當重視的抗精神病藥物，視為其全球策略性產品之一。目前該藥已於2011年2月在美國以治療精神分裂的適應症上市，並於隔年9月在加拿大以相同適應症上市。歐洲市場方面，歐洲藥物管理局也已於2012年10月受理此案申請藥證。生達估計，因該藥在精神分裂症的適應症上，已在歐美上市，以過去TFDA審件的慣例，有機會在兩年內取得國內藥證，開始銷售，至於未來與大日本住友製藥的合作會不會擴及其他區域或藥品，生達則表示還在洽商中。日前市場也傳出生達將幫中國雲南白藥集團代工產品，雖生達表示不對個別客戶評論，但這也顯示，生達這個老牌藥廠現在已不再固守國內市場，光是今年前三季外銷佔比約為15-20％；明年端強奶粉登陸、糖尿病用藥取得韓國藥證、降血糖藥證中國也在審批中，預期明年外銷比重將近一步提高。

Application for Marketing Approval Submitted in Taiwan for Atypical Antipsychotic Agent Lurasidone  October 28, 2013 Osaka, Japan, October 28th, 2013 – Dainippon Sumitomo Pharma Co., Ltd. ("DSP") (Head Office: Osaka, Japan; President: Masayo Tada) today announced that an application for marketing approval of lurasidone hydrochloride (generic name, "lurasidone"), an atypical antipsychotic agent created by DSP, was submitted on October 25th, 2013 to the Taiwan Food and Drug Administration (TFDA) for the treatment of adult schizophrenia by DSP's licensee for the product in Taiwan, Standard Chem. & Pharm. Co., Ltd. ("SCP") (Headquarters: Tainan, Taiwan; CEO: Roy Fan). This marks the first application submission for lurasidone in Asia. DSP is working to achieve regional expansion of its sales to promote globalization of its business, with a focus on lurasidone and other globally important strategic products. Business development (regulatory approval and marketing) of lurasidone in East Asia and Southeast Asia is a key element in this global strategy.For Taiwan, a license agreement for the exclusive sales of lurasidone was concluded with SCP in August this year. For the grant of the exclusive license to sell lurasidone in Taiwan, DSP receives an upfront payment from SCP and a milestone fee upon the product approval.DSP looks forward to working closely with SCP to obtain the approval of lurasidone in Taiwan at the earliest opportunity and to make the new treatment option available to as many patients with schizophrenia as possible.

About lurasidone  Lurasidone is an atypical antipsychotic, developed originally by DSP with an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects. In addition, lurasidone is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine or muscarinic receptors. The antipsychotic agent is one of DSP's globally important strategic products. It was launched in the United States for the treatment of schizophrenia in February 2011 under the brand name of LATUDA® through DSP's subsidiary Sunovion Pharmaceuticals Inc., and in Canada for the same indication in September 2012. LATUDA® also received the U.S. Food and Drug Administration (FDA) approval for the treatment of bipolar I disorder (bipolar depression) in June 2013. With respect to Europe, the European Medicines Agency (EMA) accepted in October 2012 the Marketing Authorization Application for lurasidone for the treatment of schizophrenia submitted in the previous month by a European subsidiary of Takeda Pharmaceutical Company, Limited ("Takeda"), DSP's development and commercialization partner for Europe. In Switzerland, Takeda Pharma AG, a wholly owned subsidiary of Takeda, obtained the approval of the Marketing Authorization Application in August 2013. In Japan, Phase III clinical study is underway for the treatment of schizophrenia by DSP. In addition, Phase III clinical studies for the treatment of bipolar I disorder (bipolar depression) and bipolar maintenance were initiated in September 2013. The application has been filed with the Australian authorities for the treatment of schizophrenia, and obtaining approval in the Chinese and Southeast Asian markets is planned.

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as lurasidone have an increased chance of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or ministroke during treatment with antipsychotics. Lurasidone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking lurasidone. For more information visit the FDA website: http://www.fda.gov/Drugs.