升級版 壯陽藥 (Stendra)!!

快偉哥一倍美新壯陽藥上市2012-04-29【明報專訊】過去十多年來，壯陽藥「威而鋼」（Viagra，俗稱「偉哥」）一直佔據主要市場，但此局面或將打破。維福斯公司（VivusInc）生產的新藥「Stendra」，聲稱只需要在性事30分鐘前服用即可，藥力發揮功效較威而鋼快一倍，副作用亦較小。該藥已獲美國食品和藥物管理局（FDA）正式核准上市。
Stendra港未有售據《路透社》報道，美國食品和藥物管理局已核准維福斯的新壯陽藥Stendra的50毫克、100毫克及200毫克上市，當局表示，批准申請可讓患有勃起功能障礙者有更多治療選擇。Stendra現正等候歐洲有關部門審核。香港衛生署表示，該藥現時未有在港註冊，不能在香港售賣。現時的勃起功能障礙藥物市場，主要由美國藥廠輝瑞（Pfizer）生產的「威而鋼」主導，另有EliLily藥廠的犀利士（Cialis）。據報道，Stendra的效用較威而鋼更快，勃起功能障礙者只需在性行為前30分鐘服用即可發揮效力，而臨牀實驗顯示，該藥發揮功效時間實際只需15分鐘，而「威而鋼」則需於性事1小時前服用。Stendra屬於磷酸二酯酶鍵入5（PDE5）抑制劑，用以增加陰莖血液流量。研究人員指出，服用Stendra的副作用較其他壯陽藥小。不過，醫生亦提醒，服用壯陽藥會帶來頭痛、背痛、面部充血、鼻塞等類似感冒的症狀。另外，若陰莖持續勃起逾4小時，應向醫生求助。

首季生技醫材廠獲利出爐 精華光仍居冠 五鼎成長最高

【2012/4/2817:15】〔記者陳永吉/台北報導〕生技醫材股陸續公告首季獲利情況，隱型眼鏡大廠—精華光學(1565)每股獲利超過5元，仍居第一，至於成長性則以血糖儀暨血糖試片廠—五鼎(1733)首季獲利較去年同期成長5成以上最高。精華光首季營收較去年同期小幅成長，但毛利率從去年的49%降至45%，只是營業費用也同步減少下，首季本業的營業利益仍去年同期成長一成，但因去年首季有匯兌收益3千餘萬元，而今年首季卻出現匯損1,725萬元，導致今年首季稅後淨利為2.53億元，較去年同期的2.7億元呈現衰退，每股獲利5.02元，也較去年同期的5.36元減少。至於五鼎則因首季訂單出貨順暢，營收較去年同期成長將近5成，加上毛利率也從39%提高至43%，因此本業營業利益大幅成長將近8成，不過因為首季仍產生匯損1,826萬元，因此首季稅後盈餘為1.45億元，較去年同期成長超過5成，每股稅後盈餘為1.53元。而主攻健身器材的喬山(1736)，首季營收19.4億元，較去年同期成長3成以上，本業營業利益達1.28億元，不過因為認列的轉投資收益較去年同期的1.1億元，大幅縮水剩下2,613萬元，加上去年首季匯兌收益5千多萬元，而今年首季卻出現3千多萬元，來回相差9千多萬元，使得喬山今年首季稅後盈餘僅1.03億元，較去年同期衰退4成，每股獲利僅0.52元，不如市場預期。另外國內生產氣墊床的雃博(4106)，去年底因為關閉中國廠，導致首季營收衰退將近2成，本業營業淨利則衰退4成以上，此外去年同期有匯兌收益，本期卻產生匯損，因此首季的稅後盈餘為5,586萬元，較去年同期衰退18%，每股稅後盈餘為0.67元。

Do we need to assess genomic stability on culture expanded cells for therapy?

 by Alexey Bersenev   on April 27, 2012  I came across of very interesting opinion piece, written by Darwin Prockop in Stem Cells journal. He comments on the study about genomic instability of human adult stem cells, published last year and discussed here.   

The authors of that study have concluded:    …validating the genomic stability of stem cells of all types in culture is crucial …for their safe implementation in cell therapy.   We highlighted this study and were in favor of development specific assays for genomic stability of cell products.   Prockop argues that there are no surprises here. We been here before and such tests could have very limited value in cell therapy. He gave a historical example, where in the 1960′s vaccine manufacturers were required to test cells for karyotype and tumorigenicity in vivo:    Concern about the chromosomal stability of cells in culture arose over 40 years ago when Wi-38 human fibroblasts were first introduced by Hayflick et al. [2] as substrates for viruses to develop vaccines. Manufacturers of vaccines were required to ensure that the cells were free, not only of any adventitious agents, but also of what were then referred to as "any neoplastic properties".   Interestingly, these requirements caused a lot of confusions, because of inconsistency in results of such tests.    Most importantly, there were no differences in growth characteristics or in tumorigenicity in mice between the cultures that did or did not contain t(7:12).   So, the historical attempts to implement genomic stability and tumorigenicity assays in biotechnology, left us with uncertainty:    Where does this leave us in evaluating the potential dangers of therapies with cells that are expanded in culture?  What are the appropriate tests? Given that most human cancer cells do not produce tumors in immune deficient mice, the assay for tumorigenicity using nude mice has unacceptably low sensitivity.   He proposed that the most simple and reliable test today is a senescence of cultured cells:    Do the cells senesce in culture? If they do, they are unlikely to produce tumors or malignancies in patients. Unlikely in the sense that there is a low probability, but not a certainty, that the expanded cultures do not contain a few cells that have acquired an oncogenic mutation. In contrast, cells that are immortal in culture carry a serious risk. Unfortunately, at present there is no strategy for eliminating this risk.   

Examples:    Embryonic stem cells and induced pluripotent cells do not pass the test of senescence in culture. Therefore the risk/benefit ratio is likely to be high. In contrast, the adult stem cells referred to as mesenchymal stem cells or mesenchymal stromal cells (MSCs) currently in use in a large number of clinical trials reproducibly senesce in culture.   Prockop comments intensively on this issue. His opinion is very interesting and definitely should be taken in consideration. I'd agree, that for routine cell products manufacturing, tumorigenicity in vivo test doesn't hold any future. It should be done in pre-clinical phase, before starting a trial. But for routine cell manufacturing a few assays should be developed. Simple, cheap and reliable assays. For example, a chip for the most nasty mutation, which always gives tumors in mice. Karyotype, senescence – all good. Also, different cell products will require different tests for genomic stability. It will depend on starting cell type – mature versus progenitor versus stem cell, number of passages and population doublings in culture, condition treated and so on. What do you think?

A biosimilar manufacturer: BioXpress Therapeutics SA

  April 27, 2012   Located in Geneva, Switzerland, BioXpress Therapeutics SA is a provider of high-quality biologic APIs (mAb and mAb-like biosimilars) for unmet need indications, such as cancer, inflammation and autoimmunity.   Since Q2 2010, BioXpress Therapeutics has completed the validation of protein sequence, cell line development, analysis of production cell line, and pre-Phase I clinical plans for three BioXpress Therapeutics biosimilar drugs. The cell line development for BioXpress Therapeutic's fourth drug has been initiated by the company.   The mAb-based drug market is one of the fastest growing categories of the biopharmaceuticals industry. These products are of high value for pharmaceutical industry, both in research as well as drug development activities. By 2011, biologics worth $18 billion USD in annual sales are expected to lose patent protection in developed countries and by 2018, over half of the approved mAbs will have lost patent protection, thus increasing the potential market size by a factor of at least 5 fold.   The worldwide market for biosimilar medicines will grow to $3.7 billion by 2015, from just $243 million in 2010, as a raft of branded drugs lose patent cover. Of those, monoclonal antibody therapeutics are forecasted to grow at a CAGR approaching 10% over the next five years, driven largely by positive results in the clinic. Cancers and immune-related inflammatory diseases will continue to be leading markets for monoclonal antibodies during the five-year forecast period.   BioXpress Therapeutics is focused on developing monoclonal antibodies and in addition to the 4 biosimilar monoclonal antibody drugs that are already in development, there are 14 additional mAbs in the pipeline.  The company is trying to develop the highest quality products under strict European Medicines Agency (EMA) guidelines.   The pipeline of the company shows us that, they are also interested in "less famous" biologics. Like all other manufacturers, BioXpress is developing etanercept, infliximab, trastuzumab, rituximab but to see natalizumab, omalizumab or palivizumab in pipelines is not usually possible.   

Here is the full list of biosimilar pipeline of BioXpress:  Abatacept (Orencia), Adalimumab (Humira), Alemtuzumab (Campath, MabCampath), Bevacizumab (Avastin), Cetuximab (Erbitux), Denosumab (Xgeva, Prolia), Etanercept (Enbrel), Golimumab (Simponi), Infliximab (Remicade), Natalizumab (Tysabri), Ofatumumab (Arzerra), Omalizumab (Xolair), Palivizumab (Synagis), Panitumumab (Vectibix), Rituximab (Rituxan, Mabthera), Tocilizumab (Actemra, RoActemra), Trastuzumab (Herceptin) and Ustekinumab (Stelara).   

To develop and launch some of these products will not be possible in the near future due to patent limitations in certain areas like EU and USA but to have 18 biosimilar candidates in the pipeline and to be able to develop them is quite impressive.

兩岸合作開發特有型HPV疫苗(HPV52、58型)!!

2012兩岸生技醫藥合作產業論壇-兩岸合作開發亞洲特有型HPV疫苗的產業契機April26th, 2012  論壇依據第六次江陳會簽署的「海峽兩岸醫藥衛生合作協議」宗旨，為加強兩岸醫藥衛生之交流合作，及提供兩岸醫藥品研發合作交流機會，以促進雙方醫藥品流通及生技產業發展。財團法人生物技術開發中心特別邀請台大醫院鄭文芳醫師、國衛院劉士任副研究員、美國南加大陳小江教授就臨床需求、研發趨勢及兩岸合作的角度，為您剖析兩岸合作開發亞洲特有型HPV疫苗的產業契機。目前HPV疫苗市場已有MSD的Gardasil及GSK的Cervarix兩種上市產品，Gardasil可預防感染HPV6、11、16、18型，Cervarix可預防感染HPV16、18型。但對亞洲市場而言，HPV52及58型佔有20%以上的流行病學比重，因此本研討會將為各位介紹未來亞洲特有型HPV疫苗的技術需求趨勢，包括：(1)運用生產成本較低的E.coli量產系統；(2)獨特原創的L1蛋白五聚體(L1pentamer)專利技術；(3)除市售疫苗的4價抗原之外，再加入亞洲地區發病率較高的58型病毒抗原；(4)未來疫苗價格遠低於已上市產品，適合在中國以及亞洲開發中國家進行銷售。貴公司若有興趣參與這項兩岸醫藥合作專案，請於報名時與我們聯繫，我們將進一步為您安排商務會談事宜。本會歡迎國內生技醫藥產業參與，免費參加，座位有限，請儘早報名！會議日期：2012年5月16日星期三上午9時至12時會議地點：台大醫院國際會議中心203室(台北市中正區徐州路2號)會議查詢：劉先生電話：02-23915598報名方式：一律以線上報名為主，不接受現場報名報名網址：http://www.dcb.org.tw/en_msg.aspx?a=2&i=523

指導單位：經濟部技術處

主辦單位：財團法人生物技術開發中心

會議議程：

 

時 間	主 題	講 者
09:00~09:10	開幕致詞	陳啟祥 主任 生物技術開發中心
09:10~09:50	發展亞洲特有型HPV疫苗的臨床需求	鄭文芳 主治醫師 台大醫院
09:50~10:00	休息
10:00~10:40	開發適合亞洲市場的治療型HPV疫苗	劉士任 副研究員 國家衛生研究院
10:40~11:30	亞洲特有型HPV疫苗的兩岸合作商機	陳小江 教授 美國南加州大學
11:30~12:00	綜合討論	向明 博士 生物技術開發中心