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Sunday, September 2, 2012
台灣武田將成立 亞太CMO物流中心/ 引進COPD與cancer 新藥
後発薬こそ生きる道
用地溝油 提煉 cephalosporin ?!!
全球非制药巨头(三星、LG、现代、GE、联想) 佈局醫藥市場
福大、弘裕、聚隆 傳產跨業醫材 !!
日本 救心丸 取經 中國 六神丸 反銷中國
邱議瑩...最難的一戰 !
賴清德…..十全大補丸、轉大人的中藥 !!
生技醫事人員 眼睛超時工作 !!
光化性角化病: ZYCLARA(R) Cream EU approved for actinic keratosis
台韓攜手佈局亞洲國際醫療市場?!
日本武田获得强生7种OTC药的在日独销权
发布时间:2012-8-30 来源:药品资讯网信息中心据日本媒体报道,日本武田药品工业公司(Takeda PHarmaceutical Company Limited.)于2012年8月3日发布消息称,已与强生公司(Johnson & Johnson K.K. Consumer Company)签订了7种强生正在销售的OTC医药品品牌的在日独家销售合同。这7种OTC医药品品牌分别为"Aneton"(止咳化痰药、鼻炎药)、"Tylenol"(解热镇痛药)、"Cor-tyzine"(鼻炎药)、"Visine"(眼药水)、"Terres Hi"(皮肤病治疗药)、"Terra-Cortril"(皮肤病治疗药)、"Terramycin"(皮肤病治疗药)。在此之前,武田药品工业已经获得了强生戒烟辅助剂"Nicorette"在日本的独家销售权。今后,双方将不断推进准备工作,武田药品工业预定于2012年内开始销售及宣传推销活动。 据了解,通过该合同,武田药品工业在日本的产品阵容将得到扩充,这有助于其在前景广阔的OTC医药品市场提高存在感。
韩将严查外企滥用专利权现象
发布时间:2012-8-30 来源:药品资讯网信息中心韩国公正交易委员会29日表示,在信息技术、制药、机械等对跨国企业的专利技术依存度较高的领域,滥用专利权的现象较多,今后会对这种现象进行重点监督。 韩国公正交易委员会表示,那些为了妨碍其他企业的发展而故意进行专利诉讼或是阻碍其他公司进入市场的行为将会被严惩,一旦发现有不公正现象,将会进行严肃调查。该委员会计划在信息技术领域重点监督软件、企业服务器等外国企业掌控的市场是否存在不公正行为,对跨国企业与韩国国内企业签订的知识产权许可协议的情况进行调查。 之所以采取上述措施,主要是因为美国、欧洲的跨国企业以专利权为武器针对韩国国内企业采取不同的专利使用费标准、强迫签署不必要的服务协议或购买其他不必要的产品等。 在制药领域,将重点调查滥用新药专利权的现象。制药产业和信息技术行业一样,跨国企业技术支配能力极强,韩国国内企业处于明显的弱势地位,基本还在生产仿制药的阶段。 在机械和化工领域,将重点调查许可协议的情况,若发现在专利到期后仍征收专利费的现象,将进行严处。 韩国公正交易委员会高层人士说,由于专利使用费金额庞大,对上述现象进行严查是很必要的,另外也会对韩国国内大企业对中小企业滥用专利权的现象进行严肃查处。 据统计,每年韩国国内企业向外国企业支付的专利使用费为10万亿韩元左右(约合人民币559.97亿元)。在2012年上半年的国际收支统计中,韩国国内企业支付的知识产权使用费为43亿美元。
礼来特立帕肽注射液上市一年效果显著
发布时间:2012-8-30 来源:药品资讯网信息中心笔者日前自礼来制药获悉,特立帕肽注射液已经上市10年,全球来自80多个国家的超过100万名严重骨质疏松患者接受了特立帕肽注射液的治疗,去年获批进入我国药物市场。 北京协和医院骨科主治医师盛林表示,除了对骨质疏松性骨折的外科治疗,通过药物对骨质疏松进行全面治疗,已经越来越引起骨科医生的重视。 特立帕肽注射液是促骨形成药,通过增加成骨细胞数量和活性,从而促进新骨生成,相当于在凹陷的路面重新填补新的水泥。促骨形成药是应对骨质疏松性骨折有效手段之一,在重建骨微结构,提高骨强度方面具有较好的研究证据。 礼来中国专科产品组市场总监曹少华透露,"2011年3月,特立帕肽注射液被国家食品药品监督管理局批准在中国用于治疗严重骨质疏松的绝经后女性患者。上市一年来,我们为广大的中国骨质疏松患者提供完整的、从外科手术到后期药物恢复治疗的全套解决方案,提升他们的生活质量,让患者真正从这一创新药物中获益。"
交大生醫電子轉譯研究中心主持人:吳重雨
生醫研究用於治療 長庚交大作伙來【台灣醒報記者郭庚儒台北報導】「這是長庚醫院的第一次!」桃園長庚醫院院長黃美涓與交通大學校長吳妍華今天簽訂學術合作備忘錄,共同推動臨床與基礎生醫電子轉譯領域,將基礎醫學研究,直接運用於臨床治療。黃美涓表示,未來將進行醫學博士培育、爭取國家型研究計畫、舉辦國際級學術研討會,及共享圖書和儀器等,期望透過雙方的交流,不但有卓越的學術研究,也有優秀的產出。出席簽訂備忘錄的交大生醫電子轉譯研究中心教授暨總主持人吳重雨表示,目前研究成果,包括:自我供應植入式人工視網膜、癲癇治療電子系統、骨導式人工電子耳等,應用於神經醫學、神經復健與老人醫學。吳妍華則說,交大目前已與馬偕、奇美、義大、中醫大、新竹、花蓮慈濟等醫院簽訂合作協議,在智慧型仿生系統晶片、遠距醫療服務、居家照護元件等項目有相當研究成果,期望與長庚共同在生醫電子轉譯領域發展新契機,而交大今年也首度招收醫學士博士班學生,培育醫療人才。「這是長庚醫院的第一次,卻是交大的第十次。」黃美涓說,長庚醫院成立36年以來,這是第一次與學術單位合作,期望透過交大在電機、資訊、工程等領域的傑出研究,結合長庚豐富的臨床經驗與醫療設備,讓有需要的病患能有更好的醫療服務。
行政院承諾33項振興生技方案?!!
生醫建言 政院3年達陣 2012-08-31 01:29 工商時報 【記者杜蕙蓉/台北報導】生策會提出33項生醫建言,行政院照單全收,業界大利多。生醫產業最大利多今(31)日拍板,由生策中心/生策會擬定生醫政策總體檢33項建言書,行政院已允諾三年內完全執行。其中本土藥廠研發獲認證的新藥將享有高額保健給付;而生技新藥產業發展條例,也由新藥延伸適用至二類高階醫材,並將在立法院本會期修法通過。 據了解,在各國政府都以扶持生技產業振興經濟良方,此次生策會提出的33項建言,行政院將照單全收,預計立即執行的有11項,一年內完成的有8-10項,其餘為三年內結案,其中新藥和二類醫材是最大贏家。 就初步統計,目前生技新藥條例的適用範圍為高風險醫療器材,僅規劃植入性、置入人體內等第三等級的醫療器材可適用,由於國內生產第三級醫療器材僅占全部業者7%,第二等級占比高達49%。 因此,二類高階醫材納入放寬條例後,包括血糖機、骨材、骨填充材料、導管、隱形眼鏡等都有機會納入,預計至少有百家廠商將爭鳴,精華光、金可、明基材、五鼎、華廣、泰博、雃博、太醫、聯合骨、邦特、双美都將雨露均霑。 而最讓新藥產業心跳加快的是已取得台灣食品藥物管理局(TFDA)新藥認證的新藥,將享有高額健保給付。懷特的「懷特血寶」和中天生技的「化療漾」,由於都已取得藥證,因此,是最大受惠者,昨日二股也都拉出慶祝行情。 中天生技集團創辦人路孔明表示,這是生醫產業有史以來的最大利多,讓整個新藥產業「活」起來,實際上,在各國政府都已積極扶持生技產業為振興經濟的良方下,只有政府祭出最佳的產業政策,才能讓產業有和國際接軌的利基。 以生產氣墊床和呼吸治療器為主雃博生技總經理李永川表示,在韓國、中國、日本等國家都培養本土企業下,創造「母國典範」的生技廠商是厚實競爭力的不二法門。 備受矚目的「2012生技醫療產業政策總體檢論壇」,生策中心和生策會結合產、官、學共同探討擬定4篇16條共33項完整建言,今(31)日將邀請行政院院長陳(沖)、立法院院長王金平共同蒞會,而立法委員黃昭順將公布生技新藥產業發展條例放寬至二類高階醫材,將在本會期修法通過。
光惠合併解散案!!
光惠生技(1791) 訂定本公司與景岳生物科技股份有限公司合併解散基準日發言時間 101/08/3015:17:57發言人 謝春成 發言人職稱 總經理 發言人電話 06-5052151主旨 : 訂定本公司與景岳生物科技股份有限公司合併解散基準日符合條款第9款事實發生日101/08/30說明1.事實發生日:101/08/302.發生緣由:本公司與景岳生技合併解散案,經董事會通過訂定101年9月30日為合併解散基準日。3.因應措施:(1)配合合併案進行,本公司將辦理解散並撤銷公開發行。(2)配合合併換股作業進行,公告本公司股票最後過戶日為101年9月25日,自101年9月26日至101年9月30日止停止辦理股票過戶。4.其他應敘明事項:無以上資料均由各公司依發言當時所屬市場別之規定申報後,由本系統對外公佈,資料如有虛偽不實,均由該公司負責.
景岳光惠CFO調動 景岳生技(3164) 公告本公司會計主管變更案發言時間 101/08/3016:00:47發言人 謝春成 發言人職稱 副執行長(副總經理) 發言人電話 06-5052151主旨 : 公告本公司會計主管變更案符合條款第8款事實發生日101/08/30說明1.人員變動別(請輸入發言人、代理發言人、財務主管、會計主管、研發主管、內部稽核主管或訴訟及非訟代理人):會計主管2.發生變動日期:101/08/303.舊任者姓名、級職及簡歷:葉天佑、協理、景岳生物科技財務及會計主管4.新任者姓名、級職及簡歷:吳美瑢、經理、光惠生物科技財務及會計主管5.異動情形(請輸入「辭職」、「職務調整」、「資遣」、「退休」、「死亡」、「新任」或「解任」):職務調整6.異動原因:公司因合併而內部職務調動7.生效日期:101/09/308.新任者聯絡電話:06-50521519.其他應敘明事項:本公司新任會計主管於101/09/30正式上任。以上資料均由各公司依發言當時所屬市場別之規定申報後,由本系統對外公佈,資料如有虛偽不實,均由該公司負責.
創源:生命資訊銀行/ 訊聯:幹細胞銀行
創源9/17以33元上櫃 【記者柯安聰台北報導】由訊聯生技(1784)轉投資創源生技(4160),28日召開法說會,公佈企業營運展望,該公司預計於9月17日掛牌上櫃,掛牌價33元,成為國內首家基因應用上櫃掛牌公司。創源於國內基因檢測領域位居龍頭領先地位,2012年上半年全台有高達5成以上新生兒皆為創源客戶,根據此高滲透率利基,創源趁勝追擊持續推出業界領先服務,28日正式宣告將推展『個人健康雲』計畫,並開展全球首創的「生技雙軌銀行」,正式宣告個人終生健康守護的時代來臨。創源指出,每一個新生命的開始,由受精卵、胚胎,一直經過懷孕發展,成長為一個完整的個體,這就是過去大家所熟悉的「實體生命」,然而,在現今資訊與生醫科技發達的時代,人類才逐漸理解到,伴隨著實體生命的成長,其實有另一個重要的生命也同時成形,稱之為「資訊生命」。資訊生命最重要的起始點就是每個生命體與生俱來的基因密碼,而接下來所有相關的檢測、醫療、用藥,乃至於家族病史等資訊,都會隨著實體生命的成長,而逐漸累積豐富此一「資訊生命」。這些資訊的一旦獲得妥善保存、加值及運用,不僅與個人一生的健康息息相關,更可助益全家族的健康管理。訊聯集團於13年前在台灣領先推動針對「實體生命」的『幹細胞銀行』 ,而今在創源即將成功上櫃之際,再度引領業界新趨勢,開始為每個客戶的「資訊生命」打造一個『生命資訊銀行』。從生命的最起點即開始對生命資訊的三大領域—基因資訊、健康資訊、醫療資訊—以雲端科技做最完整的儲存,以基因醫學新知持續不斷地加值,再以行動通訊科技作最有效的利用,不僅個人健康可以終生受惠,必要時也可對其所指定授權之親族或醫護人員,透過這片雲,即時且正確地提供必需的健康資訊。創源的『生命資訊銀行』與訊聯的『幹細胞銀行』共同構築為個人終生健康守護概念的『生技雙軌銀行』,再次掀起全球的健康概念新革命。此外,創源更率先把經營觸角由基因產業延伸至藥品產業,除了引進世界前20大藥廠所使用之多種先進專業軟體與資料庫,更迎向全球最新『伴隨式診斷』(Companion Diagnostics)趨勢,以基因檢測協助藥商開發個人化藥物市場,成為藥品產業鏈中不可或缺的成員之一,也形成創源另一重要的成長動能。創源100年營收成長率達118%,101年第1季營收較去年同期成長177%,創源目前新生兒市場滲透率高達5成,如以新生兒、新生兒父母、祖父母、外祖父母等直系親屬等資料也加入估算,此一龐大的「生命資訊資料庫」,後續可提供個人一生乃至其家族成員終其一生的加值服務,產生極大經濟價值。創源也將善用此市場利基,計畫在明年推出新生兒用藥過敏性基因篩檢、流產物質晶片篩檢,並於年底完成新生兒全基因定序,整合基因科技、資訊科技與健康照護,建立跨領域的創新營運模式。(自立電子報2012/08/28)
創源 推生技雙軌銀行【經濟日報╱記者周義朗/台北報導】 2012.08.29 03:04 am訊聯生技(1784)轉投資創源生技(4160),昨(28)日召開法說會,該公司預計於9月17日掛牌上櫃,暫定承銷價33元,執行長蔡政憲並宣告將推展個人健康雲計畫,並將開展全球首創的生技雙軌銀行。創源成立於2008年,目前資本額2億元,是訊聯與美國遺傳基因診斷權威美國GGI合作共同創立。該公司的產品包括孕前階段的胚胎著床前基因檢測/胚胎著床前晶片篩檢;產前階段的羊水染色體晶片篩檢/脊髓性肌肉萎縮症基因檢測;分子診斷的核酸檢測。另有發展個人化醫療相關的單一核甘酸多型性分析、全基因體定序資料分析、自體顯性多囊性腎臟疾病基因檢測等。目前該公司除檢測部門外,還設有生物資訊及健康照護部門,以因應個人化醫療時代來臨。昨日興櫃股價收44.28元,下跌0.94元。蔡政憲表示,創源100年營收成長率達118%,101年第1季營收更較去年同期成長177%,創源目前新生兒市場滲透率高達5成,如以新生兒、新生兒父母、祖父母、外祖父母等直系親屬等資料也加入估算,此一龐大的「生命資訊資料庫」,後續可提供個人一生乃至其家族成員終其一生的加值服務,產生極大經濟價值。後續創源也將善用此市場利基,計畫在明年推出新生兒用藥過敏性基因篩檢、流產物質晶片篩檢,並於年底完成新生兒全基因定序,整合基因科技、資訊科技與健康照護,建立跨領域的創新營運模式。【2012/08/29 經濟日報】
健喬 處分健、中化短期持股 虧損2800萬元
健喬Q2因業外轉虧;癌症藥Q4動能轉強 2012/08/30 12:43 精實新聞 2012-08-30 12:43:25 記者 蕭燕翔 報導 帳上持股處分損失,製劑廠健喬(4114)第二季稅後轉虧,上半年稅後盈餘降至6,745.2萬元,每股稅後盈餘0.82元。該公司指出,干擾上季財報的持股都已處分完畢,看好癌症用藥9月以後動能轉強,全年營收成長兩成目標應可達陣,法人也估計,該公司今年每股稅後盈餘仍有機會拼1元以上,創10年新高。 健喬上半年稅後盈餘6,745.2萬元,換算第二季稅後淨損2,782.8萬元,惟來自本業部分仍呈穩定,毛利率維持在44%以上,只是業外因持有健亞(4130)、中化(1701)等短期持股處分,產生近2,800萬元的損失,拖累單季轉虧。不過,健喬指出,該等持股已全數處分完畢,第三季起來自業外的干擾將不會存在。本業部分,該公司近年起主攻的癌症用藥,因解決了前期治療藥品短缺及其他用藥問題,9月起動能可望逐步轉強,今年營收成長兩成的目標應可順利達陣。法人也估計,健喬近幾季本業都能穩定獲利,在業外干擾降低下,今年每股稅後盈餘仍有機會力拼1元以上,創10年新高,而轉投資新藥廠因華即將於9月登錄興櫃,市場估計成交價格可望高於30元,帳上持股的潛在獲利可期。
India: A Powerhouse of Innovation for Neglected Diseases?
Posted: 08/28/2012 4:11 pm The BRIC countries -- Brazil, Russia, India, and China -- are playing an increasingly important role in innovation. Their growing domestic markets demand goods that meet their specific needs, and their dynamic export industries are moving beyond simple imitation. This change is true in health technologies, such as vaccines, drugs and diagnostics, as well as in IT and other areas.As innovation capabilities in emerging economies grow, many are looking to these countries to correct the global health research and development (R&D) imbalance that leaves the poor without needed products such as an improved tuberculosis (TB) vaccine or tests to help diagnose patients in remote rural settings.India, which has already played such an important role in manufacturing affordable antiretroviral drugs, vaccines, and other essential health commodities for developing countries, has been a focus of these hopes. But is India ready to play a leading role in health R&D? Are Indian companies interested in new products for the poor, or are they focused, like their more established Western competitors, on more lucrative opportunities serving patients who can pay more for medicines? Over the past year, the Results for Development Institute (R4D) has taken a close look at the potential of Indian innovators to create life-saving technologies for diseases of the poor.R4D's study concludes that India has much to contribute to global health R&D, but Indian innovators cannot meet this challenge alone, and important obstacles still have to be addressed. Furthermore, India's potential over the next few years is different across different classes of products, with the country better poised to contribute in vaccines and diagnostic tests than in traditional drug development.Until India's formal compliance with the Agreement on Trade Related Aspects of International Property (TRIPS) in 2005, Indian firms didn't have to come up with brand new products to stay in business. Instead, flexibilities in the country's intellectual property rules allowed firms to build business models around efficient, low-cost production of existing health technologies, helping them to provide vital medicines to millions of patients around the world. Indian pharmaceutical and biotechnology companies spent little on R&D, and didn't have an incentive to build strong links with scientists, in India or abroad.Since the implementation of TRIPS seven years ago, firms have had to adjust their business strategies, and many have started to invest in new product development. But different sectors have approached this shift in different ways, with important implications for global health:The Indian vaccine industry has been gradually building its R&D capacity for at least a decade. Spurred by the prospect of sales to the Global Alliance for Vaccines and Immunizations (GAVI), firms have strengthened their capabilities in biotechnology, built collaborations with international partners, and moved from basic vaccines to more sophisticated technologies. They have retained a focus on markets in low- and middle-income countries and an interest in neglected diseases. In 2010, Serum Institute of India launched a new meningitis vaccine for Africa's Meningitis Belt, developed with help from the Gates Foundation, the Program for Appropriate Technology in Health, and the CDC. In the next year or two, Bharat Biotech is hoping to start selling a new $1 rotavirus vaccine developed by India scientists in collaboration with international partners and with financial support from India's Department of Biotechnology, the US National Institutes of Health, and Gates. Rotavirus is responsible for hundreds of thousands of child deaths around the world, and a new low-cost vaccine could give a big boost to prevention strategies in developing countries. The Indian drug industry, on the other hand, has shown less interest in new products for neglected diseases. Although India's drug firms have done a remarkable job in improving access to important generic medicines, especially antiretroviral drugs for HIV, their R&D programs today focus largely on non-communicable diseases affecting mostly wealthy populations. And although some drug firms are investing in new drug development, drug discovery in India is still in its infancy. India's diagnostics industry may be one to watch in coming years, as new diagnostic tests are generally cheaper and quicker to develop than drugs and vaccines, and India's own market may be large enough to support the necessary R&D. Until recently, Indian diagnostic companies have concentrated mostly on copycat or follow-on tests. More recently, though, some new innovation-driven firms have started up. For example, Achira Labs, a start-up company in Bangalore, has developed a fabric-based diagnostic platform that allows field staff to perform medical tests on a small square of silk that costs just a few cents to manufacture. Another new company, Bigtec, has partnered with one of India's most established diagnostic companies, the Tulip Group, to develop a portable PCR machine that holds promise for diagnosing infectious diseases in non-clinical settings. Complementing industry efforts, many public-sector laboratories are also working on new tests. If these efforts succeed, India's test developers could make an important contribution to public health in India and elsewhere, as more accurate, cheaper, and easier-to-use tests could greatly facilitate control of many important infectious diseases, including TB. Indian firms may also have a role to play in producing tests for non-communicable diseases, such as heart disease, that could be used by poor patients in areas that have little or no laboratory infrastructure. Although the different sectors of India's biomedical industry will likely follow distinct trajectories, R4D's study found that they share a series of common challenges, including shortages of qualified R&D managers, weak venture capital markets, and out-of-date and overwhelmed regulatory systems. The Indian government is beginning to address these issues through significant investments in education, financing, regulatory reform and infrastructure, but there is a way to go before these systemic challenges will be overcome.One of the study's key findings is that strengthening innovation in general will not be enough: specific measures will be necessary to harness India's growing technological prowess for public health purposes.In most cases, markets for neglected disease products are too small to cover the costs of R&D, and Indian firms face the same incentives as today's multinational firms to innovative for wealthy populations. Stronger and more predictable demand from India's own government health services for needed vaccines, drugs, and tests would help, but programs to support R&D in key areas should be expanded as well.Those initiatives must be driven by the Indian government, but donor agencies and international partners should continue to lend a hand by creating funding programs that complement government initiatives and focus on diseases of the poor, promoting technology transfer and clarifying the patent landscape for needed products, and articulating their top international procurement priorities.These are just a few of the steps that international partners can take to help India fulfill its promise as a developer of new global health technologies.
德意志證券生技論壇
台灣神隆:公告台灣神隆股份有限公司受邀參加德意志證券主辦生技論壇活動 鉅亨網新聞中心2012-08-30 18:46:20第二條第12款符合條款第二條第XX款:12事實發生日:101/08/311.召開法人說明會之日期:101/08/312.召開法人說明會之時間:09 時 30 分3.召開法人說明會之地點:台北W飯店4.法人說明會擇要訊息:公司受邀參加德意志證券主辦生技論壇活動,分享產業資訊及報告已公開之公司業務狀況5.法人說明會簡報內容:內容檔案於會前非交易時間公告於公開資訊觀測站6.公司網站是否有提供法人說明會內容:有,網址: http://www.scinopharm.com.tw/investor1-2.asp7.其他應敘明事項:無
ArQule says partner halts cancer drug trial, shares slide
12:08 p.m. CDT, August 29, 2012(Reuters) - Biotechnology company ArQule Inc said Japan's Kyowa Hakko Kirin Co, which holds development rights to an ArQule cancer drug in parts of Asia, suspended patient enrollment in a late-stage trial to treat lung cancer. Shares of Woburn, Massachusetts-based ArQule fell 28 percent to a more than 9-month low of $4.81 on the Nasdaq on Wednesday. The stock, which was the biggest percentage loser on the exchange, later recouped some of the losses to trade down at $5.25.Kyowa, which is conducting the trial in Japan, South Korea and Taiwan, followed the recommendation of an independent safety review committee in Japan after suspected cases of interstitial lung disease, which can cause scarring of lung tissue.The safety committee has requested additional information on the cases, ArQule said. Treatment of patients already enrolled would continue during the committee's review.The trial was investigating the use of ArQule's drug, tivantinib, in combination with Roche Holding AG's FDA-approved drug Tarceva, generically known as erlotinib, compared with a combination of erlotinib and placebo, to treat patients with non-squamous non-small cell lung cancer. Analysts expect enrollment to the trial, named ATTENTION, to resume shortly and does not expect it to affect other trials on the drug.ArQule is developing the drug with another Japanese drugmaker Daiichi Sankyo Inc in a late-stage trial named MARQUEE for the same indication with about 1,000 patients in the United States, Europe, South America and other territories not covered by the Kyowa agreement,"The side-effect mentioned is seen with Roche's Tarceva. As long as MARQUEE isn't delayed, the timeline for United States and European Union approvals should be unchanged as well," RBC Capital Markets analyst Adnan Butt said.Results from the MARQUEE trial are expected later in the year."If positive results are reported from MARQUEE, it will completely eclipse the news of the clinical hold on ATTENTION," MLV & Co analyst George Zavoico told Reuters.Non-small cell lung cancer occurs when malignant cells form in the tissues of the lungs. Current treatments do not cure the disease, according to the National Cancer Institute.
Indian Drug Firms Eyeing China Market
2012-08-29 20:41:03XinhuaMany Indian pharmaceutical companies are making a beeline not only to export drugs to China but also to invest in Chinese companies or to establish joint ventures with them and export their products to third countries.Many Indian pharmaceutical companies are making a beeline not only to export drugs to China but also to invest in Chinese companies or to establish joint ventures with them and export their products to third countries.Analysts said China's efficient labor and Indian investments would make an ideal partnership. And with BRIC becoming stronger, Indian drug companies find China a lucrative market.BRIC is a new trade alliance composed of four of the world's fastest growing economies: Brazil, Russia, India and China.Indian drug maker Cipla Ltd has recently withdrawn a significant part of its investments in its Chinese partner Desano Holdings but ploughed back part of the money into the group's units manufacturing biosimilars and active pharmaceutical ingredients (APIs)."We have partially exited Desano Group, where we held 49 per cent. However, Cipla would hold stake in three specific companies of Desano Group," a Cipla executive, who did not want to be named, said.In 2011-12, Cipla's fully-owned subsidiary Meditab Group entered into an agreement to dispose of its investment in Desano Holdings for 3.97 billion rupees (72 million U.S. dollars). The payment for the deal was completed in April 2012, it was learned.According to the company executive, Cipla has redeployed part of its funds from the transaction to grow Biomab Holdings for developing biosimilars with two other Chinese companies -- Jiangsu Cdymax and Shanghai Desano Pharmaceutical Investment.Jiangsu Cdymax makes APIs, mostly anti-cancer and hormone drugs, while Shanghai Desano makes anti-viral and anti-malarial APIs as well as finished antibiotics, anti-retrovirals and cardiovascular drugs.Cipla currently holds 25 per cent in Biomab, 48.2 per cent in Jiangsu Cdymax Pharmaceuticals and 16.6 per cent in Shanghai Desano Pharmaceuticals, the official said.After the liquidation of investment in Desano Holdings, each of these units will see investment of around 20 to 25 million U.S. dollars. The rest of the funds will be used to repay debts.The move is aimed at streamlining investments in Cipla's core business. "Investments in specific verticals make more sense for Cipla. Biomab Holdings is a company focused on biosimilar drugs, and increased investment in the company would help Cipla's goal to develop low-priced biotech drugs," the official said.The company plans to launch a number of new products in the next two to three years.Only last year, Cipla, known for its low- cost antiretroviral medicines, made significant investments to build facilities in India and China to produce biosimilar products."There is certainly a lot of focus in Cipla to launch biosimilar products. However, it has to start from India and other emerging markets. Doing so in the regulated markets may still take some time," Praful Bohra, senior research analyst at Nirmal Bang, said.Bohra said Cipla should invest more in the biotech segment to make a mark.Besides biotherapeutics, investment into the other two companies -- Jiangsu Cdymax and Shanghai Desanoare expected to help Cipla's formulations and API business."Jiangsu Cdymax has factories to manufacture API and intermediates, whereas Shanghai Desano is working on certain new formulation products. So, with investments in these companies, we will get to use their manufacturing capacities and also get participation when they launch these products," the Cipla official said.
南光代工新劑型藥 明年(2013)銷美
南光Q2獲利創高,全年EPS挑戰六年新高 2012/08/29 10:43 精實新聞 2012-08-29 10:42:57 記者 蕭燕翔 報導 製劑廠南光(1752)半年報出爐!第二季在業內、外皆美帶動下,單季稅後盈餘2,822.5萬元,季增四成,也創下上市以來單季新高,上半年稅後盈餘4,833萬元,年增4.79倍,每股稅後盈餘0.77元。 南光第二季營收2.316億元,雖較首季歷史高峰小幅下滑,但因毛利率維持在近36%的高峰,加上業外有匯兌回沖入帳,單季稅後盈餘2,822.5萬元,季增四成,也創下上市以來單季新高,上半年平均毛利率35.94%,年增超過3個百分點,稅後盈餘4,833萬元,年增4.79倍,每股稅後盈餘0.77元。 南光指出,前7月營收及獲利成長多來自外銷,內銷主要則受惠大型注射液的健保價格調整。在外銷方面,前7月占營收比重約18%,其中日本達16%仍為大宗,主要成長品項來自癌症針劑,在全球符合PIC/s GMP針劑的產能大缺,歐美日學名藥廠積極往亞洲尋找代工夥伴下,今年以來營收貢獻來自日本客戶之癌症針劑出貨倍增。南光也表示,7月底起與日本指標大型學名藥廠合作,關節用玻尿酸已小量出貨,因日本也開始導入PIC/s GMP規格,但部分針劑合作客戶不打算將廠房升級,因而訂單轉向委外,未來來自該部分的營收貢獻有機會逐年成長。 除日本外,南光指出,中國部分,前7月營收占比約2%,今年有新增兩個新藥證,包括急救用藥及降腦壓用藥。另在美國部分,今年與美國上市學名藥廠簽訂研發生產神經科疾病及血液系統用藥的銷售合約,首個合作品項年中已向FDA送件,因走新劑型模式,最快明年中可望取得藥證,明年中至明年下半年南光產品也將隨之銷美。 法人預估,南光今年營收將超過10億元,年增25-26%,稅後獲利1.14億元,每股稅後盈餘1.8元,可望創下六年新高。
Life Technologies and Sino Biological Inc. Sign Strategic Partnership Agreement for Global Distribution and Product Development
Published: Thursday, Aug. 30, 2012 - 12:04 am BEIJING, Aug. 30, 2012 -- /PRNewswire/ -- Life Technologies Corporation (NASDAQ:LIFE), a U.S.-based global biotechnology leader, and Sino Biological Inc., a leading Chinese biotech company, today announced a partnership for worldwide product distribution and product development. Life Technologies will distribute Sino Biological's extensive portfolio of recombinant proteins, antibodies and Elisa kits utilizing its global distribution channels. The two companies will also jointly develop new products, leveraging R&D synergies to introduce innovative products more quickly. By partnering with one another, the companies are well positioned to provide proteomics products to a global customer base, and as two of the leading life science brands in China, contribute to accelerating growth of the Chinesebiotech industry.
Global Distribution Channels and Innovative New Product Offerings for Dynamic Proteomics Market" The collaboration presents a tremendous opportunity to offer a robust proteomics portfolio to meet customer needs in this highly dynamic global market," said Gregory T. Lucier, Chairman and CEO of Life Technologies. "Through this collaboration we plan to leverage our strong brands, worldwide commercial reach and technology support withSino Biological's world leading technologies to develop solutions for scientists worldwide who are tackling important healthcare challenges such as cancer, diabetes and heart disease.""Sino Biological's mission is to develop the best quality biological tools to assist scientists," said Dr. Liangzhi Xie, president and CEO of Sino Biological. "Combining our state-of-the-art, disruptive technologies in recombinant protein production and antibody development with Life Technologies' innovative product development and worldwide marketing, will allow us to bring powerful research tools to scientists solving critical puzzles in life science research and drug discovery."
Partnership of Two Leading Life Science Brands Accelerates Growth of Chinese Science and Biotechnology "Life Technologies is committed to supporting growth of China's biotech industry," said Dr. Siddhartha Kadia, Life Technologies President, Greater China. "We are delighted to partner with Sino Biological to distribute more than 6000 human-derived proteins and antibodies.These products provide high quality and exceptional value, complementing the well- recognized Novex® and Gibco® branded reagents from Life Technologies."Proteins and antibodies represent a fundamental tool employed by pharmaceutical researchers and academic scientists to facilitate the discovery of novel therapeutic targets in the process of drug development. Proteins and antibodies are also used to culture cells for basic research, drug discovery and production, and development of novel therapeutics such as stem cells. The agreement calls for joint development of proteomic products for additional applications including flow cytometry and imaging technologies.
About Life Technologies Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology company with customers in more than 160 countries using its innovative solutions to solve some of today's most difficult scientific challenges. Quality and innovation are accessible to every lab with its reliable and easy-to-use solutions spanning the biological spectrum with more than 50,000 products for agricultural biotechnology, translational research, molecular medicine and diagnostics, stem cell-based therapies, forensics, food safety and animal health. Its systems, reagents and consumables represent some of the most cited brands in scientific research including: Ion Torrent™, Applied Biosystems®, Invitrogen™, GIBCO®, Ambion®, Molecular Probes®, Novex®, and TaqMan®. Life Technologies employs approximately 10,400 people and upholds its ongoing commitment to innovation with more than 4,000 patents and exclusive licenses. LIFE had sales of $3.7 billion in 2011. Visit us at our website: www.lifetechnologies.com.Life Technologies operates its Greater China business with 10 sales offices in Beijing, Shanghai, Guangzhou, Chengdu, Xi'an, Shenyang, Jinan, Hong Kong and Taiwan and has approximately 1,000 employees as well as three distribution centers in Shanghai, Beijing, and Guangzhou with local inventories of thousands of products.
About Sino Biological Inc. Sino Biological Inc. is one of the largest cDNA, recombinant protein and antibody product manufacturers and suppliers to biomedical and pharmaceutical research in the world. With cutting-edge protein production and second-generation rabbit monoclonal antibody technologies, Sino Biological has developed capabilities and capacities to produce over 1000 new recombinant protein bulks per year in house. It has now commercialized more than 10,000 products, including 3000 recombinant protein and 3000 antibody products, and is quickly becoming the leading global biological solution specialist, offering a comprehensive set of value-added and cost-effective premium quality solutions (CRO services and reagents) to accelerate life science research and biological product development worldwide. Sino Biological is determined to develop and bring only the best quality research tools to scientists worldwide at affordable cost. To learn more about Sino Biological, please visit our website:http://www.sinobiological.com.
台微體 稅後淨利 虧損4069萬元 !!
授權金入帳!台微體上半年虧損縮小 全年有機會賺錢 2012/8/29鉅亨網提供擁有脂質包覆傳輸領先技術的興櫃新藥廠台灣微脂體(4152),公告半年報,上半年在授權金入帳帶動下,虧損幅度明顯減少,稅後淨利虧損至4069萬元,較去年同期減少42%,每股獲利虧損1.04元,據了解台微體下半年仍有新的授權計畫正在進行中,最快年底前就會有好消息,法人估計今年有機會損益平衡,開始獲利賺錢,並會開始啟動上市櫃計畫。台灣微脂體今年3月宣布與全球學名藥領導廠商TEVA及安成藥業簽署三方合作協議,共同進軍癌症藥市場。 據市場估計,此次授權應為用於治療乳癌/卵巢癌的Doxisome,全球市場銷售值上看6億美元,而台微體也因該授權協議認列一筆前期授權金,在授權金入帳下,該公司上半年虧損縮至4069萬元,較去年同期虧損7000多萬元大減42%,每股稅後淨損也縮小至1.04元。目前台灣微脂體產品可分為專利學名藥的-Doxisome(卵巢癌、乳癌)及AmBiL(全身性黴菌感染);新配方新藥的Lipo-Dox(卵巢癌、乳癌)、ProFlow(周邊動脈疾病及糖尿病神經病變及潰瘍)、ProDex(黃斑部病變);純新藥的Lipotecan(原發性肝癌、攝護腺癌)。其中第一個上市新劑型產品Lipo-Dox已於2002年上市,並授權東洋(4105)成為亞洲區合作夥伴,用於周邊血管疾病的ProFlow也已取得國內藥證,並申請日韓及中國藥證。純新藥Lipotecan用於原發性肝癌已獲歐美孤兒藥許可,並正進行臨床二期試驗中。 另外用於治療黃斑部病變的新劑型新藥ProDex已取得美國FDA快速通道(Fast Track),陸續在台灣及美國同步進行一、二期人體臨床,一年半可望完成,最快2016年完成三期臨床。法人報告指出,台灣微脂體目前獲利來源來自權利金,未來三年將逐步調整權利金及產品銷售比重到一半 ,今年上半年在授權金挹注下虧損較去年明顯縮小,目前公司仍在積極洽談其他授權,最快年底前就會有好消息,因此估計今年有機會損益兩平,開始賺錢,只要公司賺錢,上市櫃計畫就會開始正式啟動。
Top 10 Drug Advertising Spends
-- Q1 2012August 9, 2012 While the grand party in direct-to-consumer (DTC) advertising may have peaked about 5 years ago, it remains an important method of marketing drugs. The industry last year spent $2.4 billion on television ads, according to Nielsen. That is a 23% drop from the $3.1 billion spent in 2007.Still, looking at the quarterly numbers, there are some interesting things to see and perhaps learn from. According to Nielsen, in all categories (but excluding business-to-business and Internet ads) the industry plunked down nearly $900 million for DTC advertising in the first three months of the year, about 14% less than the first quarter of last year. More than 70% of that is for television ads, but it also includes print ads, radio and even some billboard advertising. More than a third of that, 37%, was devoted to the top 10 advertising buys. And much of that was spent on some of the best-selling drugs, products like Eli Lilly's ($LLY) antidepressant Cymbalta and its erectile dysfunction drug Cialis, as well as Abbott Laboratories' ($ABT) Humira. That rheumatoid arthritis drug is poised to become the best-selling drug in the world. That raises the whole chicken and egg question of whether drug companies play it safe and advertise their best-selling drugs or whether advertising propels them to that stratosphere. Some may also argue that they reached these sales levels because of inappropriate promotions since some of the drugs in the top 10 are among those tied to major marketing settlements between their makers and the government.Not surprisingly, three of the top 10 come from Pfizer ($PFE), the largest drug company in the world, but students of this kind of thing may be intrigued to learn that Lipitor got the biggest push, ahead of painkillers Celebrex and Lyrica. That is interesting because sales of Lipitor, now that it's no longer patent-protected, have fallen so fast and so far in the face of generic competitors. That said, the $44.5 million Pfizer spent in the first quarter of 2012 is roughly 60% of the $71.9 million it laid out for advertising Lipitor a year earlier when it was still safe from copycats.For many of the top 10, in fact, the amounts spent were less than last year, but in a few cases they were much more.While most of the television spots will be familiar to anyone who doesn't TiVo through every ad on TV, we at FiercePharma have included links to one television spot for each drug. This we did with help from AdPharm, which has set itself up to provide to subscribers a comprehensive gallery of pharma advertising. Here is the gallery of all the videos for the drugs in the report or you can link from each section. The importance of this was made apparent when searching video sites for public versions of the ads. It turns out that a favorite pastime of amateur video heads is to create spoofs by overdubbing things like their alma mater admission videos with the voice over from ads of antidepressant drugs or to make videos of friends peeling bananas but using the audio from erectile dysfunction drugs.
慕德生新財務長: 許慶賜
慕德生:公告本公司新任財務主管及會計主管 2012/8/28鉅亨網提供第三十四條第11款1.人員變動別(請輸入發言人、代理發言人、財務主管、會計主管、研發主管或內部稽核主管):財務主管、會計主管2.發生變動日期:101/08/283.舊任者姓名、級職及簡歷:不適用4.新任者姓名、級職及簡歷:許慶賜協理、淡江大學管理科學研究所碩士5.異動情形(請輸入「辭職」、「職務調整」、「資遣」、「退休」、「死亡」或「新任」):新任6.異動原因:新任7.生效日期:101/08/288.新任者聯絡電話:(02)2788-77389.其他應敘明事項:無
國鼎 新財務長 黃仕旗
國鼎生技:公告本公司發言人兼財務、會計主管異動 2012/8/29鉅亨網提供第三十四條第11款1.人員變動別(請輸入發言人、代理發言人、財務主管、會計主管、研發主管或內部稽核主管):發言人兼財務、會計主管2.發生變動日期:101/08/293.舊任者姓名、級職及簡歷:遺缺待補4.新任者姓名、級職及簡歷:黃仕旗財務長/立弘生化科技(股)公司/財務經理5.異動情形(請輸入「辭職」、「職務調整」、「資遣」、「退休」、「死亡」或「新任」):新任6.異動原因:新任7.生效日期:101/08/298.新任者聯絡電話:2808-60069.其他應敘明事項:無
API廠盈餘 中化生超越 台耀 神隆
Taiwan’s Academia Sinica Debuts 1st Yeast Energy Transforming Technology
2012/08/29 Taipei, Aug. 29, 2012 (CENS)--A research group recently developed the world`s first yeast energy transforming technology that effectively turns plant cellulose into bio-energy, according to Academia Sinica of Taiwan.The one-step method can simultaneously introduce multiple genes into a yeast host, with such genome technology being promising for economical production of ethanol from plant cellulose, as well as many other synthetic biological applications.Academia Sinica pointed out that the new technology is expected to mature and transferred in one year to substitute existing bio-fuel productions by triggering the next agricultural revolution.The technology platform PGASO (Promoter-based Gene Assembly and Simultaneous Overexpression) is led by Wen-Hsiung Li, Distinguished Research Fellow and Director of the Biodiversity Research Center. The researchers from Academia Sinica`s Biodiversity Research Center, Genomics Researcher Center and Agricultural Biotechnology Research Center, and National Chung Hsing University recently invented a method by which multiple-genes can be introduced into a host organism genome in a single step.Much interest revolves the production of ethanol from plant cellulose due to abundance of natural plant biomass and promise of reduction of greenhouse gases by using cellulosic ethanol rather than gasoline as fuel. Among the current possibilities for development of methods for cellulosic ethanol production, bio-processing is preferred because of simplicity and potential low cost, Academia Sinica said.As PGASO can in principle be applied to a range of hosts and is not limited to yeast, designer microbes engineered by the PGASO technology may also have the potential to produce bio-fuel, expensive pharmaceuticals, rare natural compounds, and even biodegrade plastic.Wong Chi-huey, Academia Sinica president, pointed out that bio-fuel is one of emerging alternative energies among solar and wind powers etc. Due to technological problems, he added, the conversion efficiency of solar power is still too low to be more popular and affordable, while existing bio-fuel comes mainly from beans and corns, leading to high cost and possible food shortage.(by Quincy Liang)