美時、因華搶市 「藥」進海外【經濟日報╱記者黃文奇／台北報導】 2013.03.19 02:45 am 生技股雙傳利多，美時（1795）、因華昨（18）日都公告新合作案，美時宣布與日本、大陸藥廠簽訂新藥合作研發、販賣合約；因華也宣布，簽訂越南區域產品供貨合約，以擴大市場規模。美時昨日股價以45.55元平盤作收；因華興櫃參考價為67元，下跌1.45元。美時表示，和日本藥廠合作的產品為高活性類固醇，在日本之市值約6,700萬美元（約新台幣19.93億元），預計2014年可向日本厚生省送件查登，2015年可進入日本市場；該合約為美時在腸胃道癌藥物後，對日本市場再次搶灘成功。除了日本合作案，美時也表示，公司與大陸知名藥廠浙江海正藥業也簽立合作研發、販賣合約，該產品為肺癌、乳癌用藥，全球口服市值約7,500萬美元（約新台幣22.31億元），且目前無學名藥上市，預計2015年可向全球主要國家送件申請藥證。美時標示，該產品將成為公司首次「兩岸合作研發，進軍全球」的銷售模式。【2013/03/19 經濟日報】
M&A fever retuns to pharma Abhineet Kumar Mumbai March 18, 2013 Last Updated at 23:30 IST With local companies facing stress in domestic operations, valuations are down. Multinationals are attracted by the generic pipeline of Indian companies. The acquisition of Agila Specialties, the injectibles business of Bangalore-based Strides Arcolab by Canonsburg, Pennsylvania-headquartered Mylan for $1.85 billion, could mark the return of big-ticket acquisitions in the Indian pharmaceutical industry. After Daiichi Sankyo of Japan had acquired Ranbaxy Laboratories in 2008 for $4.6 billion and Abbott Laboratories bought the domestic formulations business of Piramal Healthcare in 2010 for $3.7 billion, the sector had gone quiet. But now there are signs of a revival. On February 27, the day Mylan announced the Agila purchase, GlaxoSmithKline Pharmaceutical hinted to analysts at a meeting in Mumbai that the prospects for closing acquisitions in India looked brighter than ever before. The Indian arm of the London-based pharmaceutical giant has about Rs 2,000 crore of cash lying on its books and harbors ambition to grow inorganically in the country. Multinational interest in local pharmaceutical companies is riding high because there has been a correction in the valuations expected by Indian promoters. For instance, Mylan has bought Agila by paying around eight times its last year's revenue to get access to its 61 Abbreviated New Drug Applications (ANDAs) approved by the US Food and Drug Administration (UFDA). In contrast, Abbott paid 8.7 times the turnover for the Piramal Healthcare buyout in 2010.
Lucrative buys The market was abuzz with talk that Strides' promoter, Arun Kumar, was initially looking for a valuation of $2 billion for Agila but finally sold it for $150 million less. (The company was earlier in talks with Pfizer of the US after the two had signed a collaboration agreement in January 2010.) The valuations expected by Indian promoters have softened because of the increasing stress on their balance sheets caused by rising power costs, pricing curbs and other policy uncertainties. So far as price control is concerned, the government wants to increase its ambit from 74 bulk drugs, and all medicines containing one or more of these bulk drugs, to over 640 essential medicines. Pharmaceutical companies have argued that this will curb profits. Also, the companies have said, there is no evidence of super-normal profits in the industry, which could have been a ground for increasing the price controls. Some others see a political stamp on it - price controls fits in well with the United Progressive Alliance's plans for free medicine for the poor. At the same time, there is a strong lobby at work against acquisition of Indian pharmaceutical companies by multinationals. As a result, a few proposals from overseas companies to invest in Indian drug makers are stuck at the government, though 100 per cent foreign direct investment is allowed in the sector under the automatic route. That's because the domestic lobby has argued that multinational pharmaceutical are buying local companies only to stifle competition. The day is not far, they have said, when the Indian market will be controlled by multinationals, and medicine will become prohibitively expensive for the aam admi.
Checks and balances So, guidelines are being formed which will enable the Competition Commission to vet all cases of acquisition of an Indian drug maker by an overseas company. And permission will come with stringent riders: the acquired company will have to take the commission's permission before discontinuing production of an essential drug. The sentiment is reflected in the stock markets. Stocks of Cadila Healthcare and Ranbaxy Laboratories are down over 20 per cent since September 2012 (See chart). "The threshold for valuations in the Indian pharmaceutical sector has historically been high," says Siddhart Nahata, executive director with Morgan Stanley who advised Mylan in its acquisition of Agila. This, of course, led to deals falling through. But with expectations cooling off now, more mergers and acquisitions could happen. In the past, acquisitions in the Indian pharmaceutical market were driven by different reasons. In Ranbaxy's case, the star attraction was the rights it had bagged from USFDA to launch the generic version of Lipitor, the world's largest-selling medicine, in the US ahead of others with six months of exclusivity thrown in. And Abbott bought the Piramal unit for access to the local market. But that's hardly a factor now. That's because the domestic market is extremely fragmented and competitive. Every medicine has hundreds of brands, and gaining market share is not easy.
Formidable line-up Instead, multinational interest this time is meant to gain access to the pipeline of generic drugs being developed by small and mid-sized Indian companies for the US market. "The trend would broadly be to leverage cost-effective R&D and low-cost manufacturing in India through collaborations, with acquisitions taking place when valuation expectations match," Nahata says in a telephonic interview from London. Thus, Mylan, the world's third largest generic drug maker, had acquired Mumbai-based Unichem Laboratories' export-oriented plant in February for $30 million and the manufacturing unit of Hyderabad based SMS Pharmaceuticals for about $33 million in October. The company had also announced strategic collaboration with Bangalore-based insulin maker Biocon for global development and commercialisation of its three products.
Generic market According to various estimates, nearly a quarter of the $230-billion patented drug market in the US (it is the world's largest market for pharmaceuticals) is going off patent in the next two to three years. This has made multinationals look at Indian generic companies. "Increased focus on generics adoption globally, the rising number of blockbuster drugs going off-patent, R&D pipelines drying up for innovators and constant demand for reduction in manufacturing costs are some of the driving forces that are attracting multinational players to the Indian market," says Ramesh Swaminathan, chief finance officer, Lupin. This has seen a spurt of inbound acquisition for India generic drug makers who have a robust pipeline for these drugs with pending approvals from the USFDA. Lupin, for instance, has 99 ANDAs pending for approval with the USFDA. This follows the highest 142 from Sun Pharmaceuticals. Aurobindo and Torrent have 91 and 24 ANDAs, respectively, pending for approval. "Pharmaceuticals will remain one of the active sectors for inbound M&A activities, driven by the global majors and others looking to acquire prospective API (Active Pharma Ingredient) pipeline as well as domestic formulations market share," says Anjani Kumar, managing director and India investment banking head of South East Asia-based CIMB. "Club that with activities in biotech and increasingly in healthcare services, and you will find that for most global investment banks India remains a key coverage market," he adds. In India, the manufacturing cost is about 30 per cent cheaper than that in the US and it has the largest number of USFDA-approved manufacturing facilities outside the US. Besides, the cost of developing a generic drug in India is about half of that in the US. For Indian companies too, collaborations are important. "Capabilities, in terms of developing and manufacturing the product, are there with all Indian pharmaceutical companies, the lacking part is the marketing setup in local geographies," says Hemant Bakhru, analyst with global brokerage firm CLSA. "They obviously have expertise in India but to develop expertise outside India is difficult." This is where tie-ups with multinationals come in handy. Large Indian pharmaceutical companies such as Sun Pharmaceutical and Dr Reddy's Laboratories have their infrastructure in place in the US because they have got critical mass- each of them is now reaching $1 billion in sales there. They can do pretty much most of the market development on their own as they have tie ups with distributors and retail chains for the sale of generic products. But small and mid-sized companies such as Lupin, Aurbindo Pharma and Torrent Pharma face a challenge in commercialising the product in the US; as a result, their names as potential acquisitions targets have been doing the rounds. Lupin in fact had about $500 million sales in the US last financial year; despite that it is seen as a potential target. Another acquisition target is Ahmedabad-based injectable drug producer Claris Lifesciences. Many companies, including Teva Pharmaceutical and Pfizer Inc, have evinced interest in the company, according to Mumbai-based brokerage India Infoline.
仿制药制造商迈兰16亿并购扩展注射剂业务 发布时间：2013-3-13 来源：药品资讯网信息中心 2月27日，全球第四大仿制药制造商迈兰(Mylan)宣布，同意支付16亿美元现金并购印度StridesArcolab公司的注射剂业务——AgilaSpecialties公司。迈兰公司在一份声明中表示，并购完成后，将增加公司在印度的市场份额，但将立即稀释公司的每股收益。为完成本次交易，迈兰公司将向银行申请总额达10亿美元的无担保贷款，并且根据某些条款，公司可能进一步向StridesArcolab公司支付2.5亿美元。消息公布后，StridesArcolab公司股价暴跌，当天在孟买股票交易所的股价下跌了4.8%，至938卢比，创3周以来最低水平。2月27日，迈兰公司股价上涨2.4%，至29.25美元，在过去12个月累计上涨了23%。本次交易将进一步扩大迈兰公司的非专利注射剂市场份额。美国非专利注射药物短缺，这类产品一直有很高的市场需求。去年11月28日，FDA公布了超过120种药物短缺，其中包括了麻醉药注射用丙泊酚(Propofol)和卵巢癌治疗药阿霉素(Doxil)。迈兰公司首席执行官希瑟·布雷斯(Heather Bresch)表示，在这个快速增长、前景广阔的细分市场，这笔交易将立即创建一个新的、强大的全球注射剂领导者。StridesArcolab公司表示，出售完成后，公司将向股东分红高达8亿美元，同时还清债务。Bloombery数据显示，截至2012年6月30日，Strides Arcolab公司的债务有118.9亿卢比(约2.21亿美元)。
庞大的产品线 去年11月，FDA批准Strides Arcolab公司生产的治疗晚期癌症的奥沙利铂注射剂上市，该药在美国的分销由辉瑞负责。Agila Specialties公司还与葛兰素史克和诺华保持着合作关系。根据该公司网站，Agila Specialties公司在印度拥有8个生产设施。Agila Specialties公司获FDA批准的注射剂仿制药数量最多，从2008年到2010年，共批准了32个。相比之下，在此期间，总部位于伊利诺斯州森林湖的Hospira公司仅被批准了23个注射剂仿制药。本次交易将令迈兰公司的注射剂产品组合从500个增长到700个，同时在全球还有350个产品待批。迈兰公司预计，到2017年，仿制药的年市场增长约13%，同时将进军巴西等新市场。
迈兰的收益 当谈到迈兰公司的未来计划时，西雅图Smead资本管理公司首席执行官比尔·史密德(Bill Smead)表示，迈兰公司将很好地管理其中的风险，创造一个相当强的注射剂产品王国。截至去年12月，史密德的基金持有31.7万股迈兰公司的股票。Strides Arcolab公司创建于1990年，5年后开始生产注射剂药物，2004年进入美国的无菌注射剂市场。2010年，Strides Arcolab公司将旗下的注射剂业务更名为Agila Specialties公司。2012年，Agila Specialties公司的销售额为2.55亿美元，扣除利息、税项、折旧及摊销的收益为8600万美元。Strides Arcolab公司表示，与迈兰公司的这笔交易预计将在今年第四季度完成。
白藜芦醇有助于治疗神经退行性疾病 发布时间：2013-3-18 来源：药品资讯网信息中心 白藜芦醇作为一种天然的酚化合物，有预防心血管疾病和抗肿瘤，以及神经保护作用。胚胎神经干细胞存在于中枢神经系统中，可分化为神经元和胶质细胞。有研究以胚胎神经干细胞移植诱导神经退行性疾病动物模型丢失神经元再生。白藜芦醇是否对胚胎神经干细胞产生影响，从而提高其用于治疗神经退行性疾病的能力呢？发表于2013年2月第6期《中国神经再生研究(英文版)》(Neural Regeneration Research)杂志的一项研究"Effects of resveratrol on hydrogen peroxide-induced oxidative stress in embryonic neural stem cells"表明，白藜芦醇提高抗氧化酶活性的作用可减轻胚胎神经干细胞受到的氧化应激性损害。研究为白藜芦醇对抗氧化损伤，间接提高干细胞移植治疗神经退行性疾病效果提供了实验证据。
常喝绿茶和咖啡可降中风风险 发布时间：2013-3-18 来源：药品资讯网信息中心 美国心脏病协会主办的期刊《中风》(Stroke)3月14日刊登论文称，日本研究人员的调查显示常喝绿茶和咖啡的人出现中风的风险更低，如果日常生活中两种饮品都经常饮用，降低中风风险的效果则更佳。日本国立大脑和心血管中心的研究人员对8万多名年龄在45岁至74岁的成年人进行了为期13年的随访，并记录他们的饮食习惯。研究开始时，这些人中没有癌症或心血管病患者。随访期间，研究人员通过分析他们的医疗记录，收集心脏病、中风及死因等方面的数据。分析显示，即使在考虑年龄、性别、生活方式等因素后，常喝绿茶和咖啡也与中风风险下降存在关联。与几乎不喝绿茶或咖啡者相比，每天饮用两到三杯绿茶者出现中风的风险低14%，每天至少喝一杯咖啡者出现中风的风险低20%。此外，后两部分人群出现脑溢血的风险也要低32%。研究人员表示，常饮绿茶或咖啡降低中风风险的原因目前还不清楚，不过绿茶内的成分儿茶素具有抗氧化、消炎等功能，咖啡内的绿原酸具有抗氧化、抗菌等功能，它们可能发挥了作用。研究人员认为，茶和咖啡在世界范围内都是很常见的饮品，这意味着它们在降低中风风险方面的好处容易推广。
宣明智率產學合作成員 今天到郭綜合醫院參訪 中央日報 (2013-03-18 17:16)蔡清欽/報導 聯電榮譽副董事長、也是宣捷生物科技董事長宣明智，今天率校院產學合作成員參訪台南市郭綜合醫院時強調，台灣優秀的人當醫生，且衛生署要求下對醫院系統評鑑，無論醫療設備、服務人員素質優秀，臨床經驗豐富，有這些基本要素，他認為未來生醫科技的發展有很好的未來。宣董事長所領軍的校院產學合作成員，包括宣捷生物科技副總經理宣昶有（宣明智兒子）、馬偕醫學院教授陳持平、晶基執行董事孫熙文、晶基執行董事兼研發總監周江鴻、基龍米克斯生物科技業務部副總劉君豪、業務部經理張佐維、亞洲環宇編譯公司執行長蔡耀銘及商務經理周卓穎，他們抵達郭綜合醫院，受到院長郭宗正及相關人員的熱誠接待，並參觀一樓批掛第一線為病友服務情形及二樓門診、生殖醫學中心等相關設施後，在國欣廳進行意見交流。宣董事長指出，他以往所從事的半導體電子，是台灣發展的前一波，集中在科學園區，但未來朝生醫科技發展，他認為與醫院的產學合作，以醫院的臨床經驗配合很重要，所以在醫院旁設點逐水草而居，和臨床環境的醫院有良好互動，可在標準化、品質效率、時間掌握領先，進而和藥商器材商聯結更有效，使得生醫科技發展更有優勢，他強調，醫療生技交流訊息，可鼓舞做更廣更深的好事，未來生物醫學科技技術結合的特質，可為人類提供有益的好東西，充滿各種機會。而宣昶有認為，所有成員從北到南一路走訪各相關醫院，發現許多醫院優勢，如和生醫科技廠商串連合作，發揮彼此的優點，讓他對未來充滿信心。而和郭宗正院長頗有交情的陳持平教授指出，宣董事長的構想在台南生醫產業的佈局，是準備和特色醫院發展、研究結合，產學發展，郭院長也希望以該院專長，和生物最新科技廠商合作，共同開發的意願。宣昶有表示，生技產業的發展，結合台灣半導體、電子工業、精密機械、製造業等舉世聞名的優勢背景，以及先進的醫院合作下，未來可發展出具台灣價值的特色醫材。 【中央網路報】
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