Pages

Monday, March 24, 2014

Merck強化主攻(diabetes) ,聯盟Samsung 進入phase III (insulin glargine)

Merck, Samsung Bioepis to develop insulin glargine candidate for diabetes  PBR Staff Writer Published 12 February 2014  Merck and Samsung Bioepis have expanded their collaboration with an agreement to develop, manufacture and commercialize MK-1293, an insulin glargine candidate, to treat patients with type 1 and type 2 diabetes.The company said that Phase III clinical trials in type 1 and type 2 diabetes will commence soon. Merck senior vice president of Diabetes, Global Human Health Matt Strasburger said the company seeks to collaborate with Samsung Bioepis on this insulin glargine candidate, as diabetes is a top priority for the company. "Merck is strengthening its leadership in diabetes through our own work and in collaboration with others, and this agreement will help build our portfolio across the spectrum of the disease," Strasburger said.Samsung Bioepis CEO Christopher Hansung Ko said, "This collaboration will bring better access to patients with diabetes worldwide."As part of the deal, the companies will collaborate on clinical development, regulatory filings and manufacturing. The deal builds on the agreement made by the two companies in February 2013 to develop and commercialize multiple biosimilar candidates. Samsung Bioepis is a joint venture between Samsung Biologics and Biogen, and it aims to develop affordable and high-quality biopharmaceutical and biosimilar products.

 

Biosimilars年成長率近50% 拚產率/臨床/COG/Branding !!!!

Biosimilars Market Worth $1,954 Million by 2018 - New Report by MarketsandMarkets Key Players in the market are Celltrion, Inc., Cipla Ltd. Lg Life Sciences Ltd., Merck Kgaa, Mylan, Inc., Ranbaxy Laboratories LtdStada Arzneimittel Ag, Synthon, Teva Pharmaceutical Industries Ltd. (PRWEB) February 17, 2014The "Biosimilars Market Product [Recombinant Non-Glycosylated Proteins (Insulin, Filgrastim, Somatropin), Glycosylated (Monoclonal Antibodies, Erythropoietin), Peptides (Glucagon, Calcitonin)] & Application (Oncology, Blood Disorders) - Global Forecast to 2018", provides a detailed overview of the major drivers, restraints, challenges, opportunities, current market trends, and strategies impacting the global biosimilars market along with the estimates and forecasts of the revenue and share analysis. The global biosimilars market is segmented on the basis of products, applications, and services. By product, the global biosimilars market is further segmented into recombinant non-glycosylated proteins (insulin, granulocyte colony-stimulating factor (G-CSF), interferon, and human growth hormone), recombinant glycosylated proteins (erythropoietin, monoclonal antibodies, and follitropin), and recombinant peptides (glucagon and calcitonin). The recombinant glycosylated proteins segment is the largest segment and accounts for a share of 40% of the global biosimilars market in 2013 at an estimated $314.2 million and is expected to grow at a CAGR of 17.5% from 2013 to 2018. The biggest factor behind the growth of this segment is the increasing demand for second-wave biosimilar products, such as insulin and interferon, for the treatment of diabetes and infectious disorders. Of all segments under the product category, the monoclonal antibodies segment is the fastest-growing segment at an estimated CAGR of more than 40% from 2013 to 2018. By application, oncology is the largest and fastest-growing segment and accounts for a share of 25%of the global biosimilars market. This is attributed to the increasing prevalence of oncology along with the rise in aging population and the changing lifestyle. Europe dominates the global biosimilars market with around 40% share in 2013. The factors driving the European market are its well-defined regulatory guidelines; presence of various biosimilar drugs such as omnitrope, tevagrastim, and binocrits; numerous pipeline products; and more than 15 biologics going off-patent in the coming years. Although the penetration of biosimilars varies by country, it also depends on various other factors, including local pricing and reimbursement policies, stakeholder influence, and attitudes towards the adoption and use of biosimilars. Currently, Germany commands the highest share in the European market due to the presence of a reference pricing system. The U.S., on the other hand, has a very restricted biosimilars market owing to the stringent regulatory environment in North America. The Asia-Pacific market is estimated to be the fastest-growing market. Asia-Pacific accounts for an overall share of 29% of the global biosimilars market. This large share of the market is mainly due to the semi-regulatory environment of the region that easily approves similar biologics in the market. In addition, low manufacturing costs and the presence of highly skilled expertise at low costs are also factors that make Asia-Pacific a lucrative destination for the biosimilars market. The factors restricting the growth of the market are high manufacturing complexities and costs, stringent regulatory environment in the U.S. and Europe, innovative strategies used by biologic drug manufacturers to protect their intellectual property, costly purification process, arrival of biobetters, and the presence of low-priced biogenerics that compete with biosimilars in the market. The key players in the biosimilars market are Sandoz (Germany), Hospira (U.S.), Teva (Israel), Dr. Reddy's Laboratories (India), Biocon Ltd. (India), Mylan (U.S.), Biopartners (Switzerland), Amgen (U.S.), Intas Biopharmaceultical Ltd. (India), and Innovent Biologics, Inc. (U.S.). In 2013, Sandoz is the highest contributor (50%) to the global biosimilars market.

 

不走健保的思維_醫材/設備/儀器 !!

當生技產業不再唯「新藥」是尊 精實新聞 2014-03-05 19:11:40 記者 蕭燕翔 報導 過去多數人投資生技股,都是唯「新藥」是尊,但隨全球醫材新應用的發展,及創新技術讓新藥與醫材的界線模糊化,業界已興起新一波的醫材潮,卡位新商機。 過去一說到生技股,不免分成藥品及醫材兩大板塊,其中,新藥股因高風險、高報酬的特性,成為族群中的「貴族」,目前上市櫃及興櫃超過120家生技公司中有9家股價超過200元,三分之二都為新藥及特殊學名藥族群,且全數都還沒開始獲利,同時所享有的高本益比(或稱本夢比)也是所有台股產業僅見。 而講到醫材股,傳統印象都是進入門檻較藥品低,回收時間較快,評價模式不脫類電子產業的本益比模式,也因此即使是創新醫材或具侵入式、需人體臨床數據的高端產品,本益比還是難與新藥股相比擬。不過隨終端市場的成長性反轉,加上創新技術讓藥品與醫材的界線模糊化,越來越多的生醫業者這幾年加碼投入的重點,反倒轉向過去大家看作生醫股二線軍的醫材;以終端市場來說,雖全球藥品市場預期今年將突破1兆美元,是約當於3千多億美元醫材市場的三倍以上,但這幾年因全球保險財源緊縮,政策鼓勵學名藥廠加入戰局,享有獨家定價優勢的專利藥廠的成長趨緩,自2010年以後全球藥品市場產值已難有過去的高度成長,年複合成長率約落在3-6% 相較之下,醫材市場雖過去產值還難敵藥品,但主要研究機構預估至少至2015年前的年複合成長都會有5-7%水準;特別是鄰近的中國大陸市場,醫材與藥品成長率同樣也呈黃金交叉,根據官方十二五計畫的版本,2011-2015年境內藥品的年複合成長率為10.03%,醫材同期的年複合成長則為10.73%,不過這只是官方設定值,事實上,2012年中國醫材廠的實質年成長率高達21.4%,早已是這幾年面臨醫保藥價年年下調的藥品產業所望塵莫及的水準。 不只是終端成長性的反轉,如新科技的導入,也讓藥品與醫材的界線模糊化,並挑戰大家所熟悉的「醫材」定義。如幹細胞治療領域,在不同的國家或不同的應用領域,就可能被定義為藥品或醫療器材(device);如智擎(4162)與法國夥伴合作的輔助放射腫瘤治療的產品,使用的是特殊金屬鉿(Hafnium),相同的應用在歐美地區就分別被定義為醫材及藥品,端視各地監理機關認定;以醫材與藥品的界線更趨模糊下,爭取定義為醫材反倒成為廠商節省臨床投入時間與成本的技巧之一,無損於產品真正的市場定位。 而過去市場認為癌症等重大疾病的治療,如果不納入健保給付,一年可能動輒幾萬美元,事實上,近年不少「自發性」的醫材應用,價格及利潤同樣令人咋舌,舉大家熟悉的植牙來說,一顆牙醫的報價可能就要5-10萬台幣,利潤率同樣可觀;且相較於藥品產業,醫材廠對品牌忠誠度似乎有過之而無不及;因此無論是血糖儀、隱形眼鏡乃至放射腫瘤設備、影像儀器等,都是少數大廠的壟斷市場 而現階段的台灣生醫廠商也興起了新一波的醫材投資潮,過去聚焦新藥研發的基亞(3176)也將鎖定睡眠治療等領域,投入醫材研發;中國利基藥品通路的F-康聯(4144)也已喊出未來將增加代理醫材領域,以反映中國市場的成長趨勢;聯電(2303)榮譽副董事長宣明智也將在一年內率領20家醫材為主的生醫廠,登陸打群架。 基亞董事長張世忠在一場研討會上也預期,考量回收期、台灣ICT優勢及政策成效,預期政府未來資源投入可能不在獨鍾新藥,轉向醫材,都顯示此波趨勢轉向。 當然,此不代表醫材股將雨露均霑,不具有競爭力、仍擺脫不了價格取向的代工產品,仍非市場所愛,但是如果能打造出台灣醫材廠的微笑曲線,並利用慣有的產線效率控管優勢,在新興市場發光,或許也是台灣醫材廠另波大成長的開始。

 

佳醫(醫療控股)佈局中國醫美(上海萬歷、石家莊)/洗腎(上海市東醫院) &牙科 !!

佳醫內外皆美 爆發力大【經濟日報╱記者王皓正、葉家瑋/台北報導】 2014.03.10 02:32 am 醫療控股公司佳醫(4104)本業、業外同步豐收,法人表示,佳醫正加快中國大陸市場布局腳步,轉投資方面也成功孵化金雞,旗下的久裕、科妍相繼掛牌,佳醫今年營運將展現爆發力。美原料藥展(DCAT)將從今(10)日到13日開展,DCAT概念股近期走勢火紅,佳醫上周四已拉出長紅K棒,單周漲幅5.04%,專家說,生技股可望續強。佳醫近年逐步轉型醫療控股公司,並加快大陸布局腳步,未來將持續擴充醫美據點旗下經營藥品推廣及物流的久裕企業,以及轉投資的科妍,佳醫持股分別為49.5%9.9%,帳上持有成本低,潛在利益豐厚。佳醫的大陸醫美通路有上海萬歷、石家莊二個據點,洗腎業務在上海市東醫院試點,目前也評估發展牙科。久裕主要業務為藥品業務推廣及經銷物流,近二年轉型經營專科,鎖定「荷爾蒙」領域,如婦女不孕症、生產、更年期等,推升毛利率表現。 2014/03/09 經濟日報】

化療漾: 中藥新藥(癌症惡病質)

中天雙「新」報喜 營運靚【經濟日報╱記者黃文奇/台北報導】 2014.03.04 04:19 am中天生技(4128)昨(3)日表示,公司旗下中藥新藥「化療漾」,近期已在國內四大醫院完成進藥,包括新光、北醫、雙和、萬芳等醫院,目前正與逾10家醫學中心進行進藥協商,最快上半年完成國內通路布局。法人預期,中天新藥銷售今年打底,明年快攻。中天生技表示,桃園龍潭新廠近期已通過環評,最快本月將領證、動工,為了因應公司新藥化療漾、賀必容生產製造,公司將儘速完成該廠,如果順利查廠完成,將在今年第4季投產,將成為新藥新一代生產基地。中天生技昨日股價收33.1元,上漲0.5元, 中天的中藥新藥「化療漾」,歷經14年研發,2011年底被衛生署(衛福部前身)中醫藥委員會(今為中醫藥司)核准通過,成為全球第一個化療支持性中藥新藥。據悉,由於台灣市場對「本土新藥」了解度不高,一度讓化療漾在醫院端布局受阻,近期由中天自組銷售團隊、重新出發,終於報佳音。中天生技表示,化療漾是針對罹癌病患化療後所產生的「癌症惡病質」,進行支持性治療的藥品,目前以成藥規格上市,近期已經規劃授權大陸藥廠生產,搶進對岸華人市場,兩岸市場潛力估達2,000億元。此外,中天的新藥賀必容(Herbiron)年底也在衛福部核准下,成為國內「口服植物新藥」首例,為台灣生技再創新里程碑;衛福部表示,該產品是「緩解女性缺血性貧血、經期不適」等症狀用藥,由於安全、有效才核予藥證。法人推估,台灣市場規模達200億元,該產品今年對中天每股稅後純益(EPS)貢獻度應在1元以上。為因應上述兩項新藥市場所需,中天生技早已規劃在龍潭擴充第二廠區,公司表示,近期環評一年終於完成,本次擴建龍潭廠總占地約4,000,總投資10餘億。

抗憂鬱藥 用於抗提前射精_ (SSRI)

久裕代理男性藥 再下一城【經濟日報╱記者黃文奇/台北報導】 2014.03.05 03:01 am 久裕在男性功能障礙藥物代理市場再下一城,繼威而剛(Viagra)後,在台灣再推「抗男性早洩」新藥「必利勁」(Priligy)。董事長張俊仁表示,該產品已切入國內醫院通路,並正式展開銷售。 醫師指出,男性性功能問題主要有「勃起障礙」(占約20%)、「提前射精」(占約31%)兩者,前者在台灣的主流藥物是威而剛,後者目前除了必利勁外,全球仍無合法用藥,因此該藥物將獨占市場。久裕為國內老牌醫療用品、藥品代理、物流、倉儲公司,創辦人張天德於1980年成立,目前服務的醫療通路包括醫學中心、一般醫院、診所、連鎖藥局等,共超過1.2萬家,為本土最大之醫藥行銷服務體系,以代理輝瑞大藥廠的威而剛(Viagra)而聞名。久裕所代理的必利勁原廠義大利最大藥廠Menarini,近期在台行銷活動展開,配合台北榮總、高雄醫學院附設醫院、彰化基督教醫院等,開始由醫師向大眾說明早洩問題如何得到控制。據悉,必利勁目前已在韓國、馬來西亞、香港等地區上市。未來久裕主要負責診所、藥局等通路銷售,業者認為,必利勁將是繼男性用藥威而剛之後,另一個解決男性功能障礙的熱門藥物,潛力可期。業界指出,勃起障礙用藥台灣市場約16億元,威而剛去年在台灣銷售逾10億元,市占率為該領域用藥的六成,領先樂威壯、犀利士等競爭對手遠甚,而有提早射精問題的治療市場,則超過25億元。

物流管理精準 獲利夠「硬」【記者黃文奇/台北報導】威而剛賣出心得,久裕最了解「男人的痛苦」,不但讓威而剛銷售名列全球第三,更通過精準的物流管理,讓通路商不敢亂殺價,15年來讓威而剛產品保持著穩定的獲利。久裕15年前因緣際會代理輝瑞藥廠的知名產品「威而剛」,一賣就是15年,是全球大藥廠輝瑞可以倚靠的好夥伴。近幾年來,久裕一直讓該產品銷售成績亮眼,比起亞洲各國甚至全球各地,台灣威而剛的銷售排名一直名列前茅。久裕董事長張俊仁透露,把價格管好,利潤就會好。

據了解,威而剛、必利勁等男性用藥,目前在台灣都屬「自費」的處方藥 張俊仁表示,自費的問題在於消費者會儘量尋求「低價品」,而終端銷售商為了生意,就可能削價競爭,這樣最後將導致價格破盤,通路商沒有利潤,銷售系統也會停滯。久裕具備嚴密的物流管控系統,每包產品都有自己的編號、履歷,賣到哪個終端通路一清二楚,只要通路屢次犯規,就會終止銷售合約,價格沒浮動空間。據了解,目前台灣威而剛藥品自費額度,單顆約300400元間,價格在久裕精準的管控下,幾乎讓終端通路不敢削價,這樣不僅讓銷售系統穩定,也讓通路商都有利可圖,願意大力推銷該產品。【2014/03/05 經濟日報】@

As a member of selective serotonin reuptake inhibitor (SSRI) family, dapoxetine was initially created as an antidepressant. However, unlike other SSRIs, dapoxetine is absorbed and eliminated rapidly in the body. Its fast acting property makes it suitable for the treatment of PE but not as an antidepressant