湯竣鈞 的Nephoxil 寶齡富錦生技將有所行動….!!

寶齡富錦 新藥將上市【經濟日報╱記者黃文奇／台北報導】 2012.11.16 03:00 am寶齡富錦生技總經理江宗明（左）與公司主持人湯竣鈞（右）。 記者屠惠剛／攝影本土首宗化學新藥將上市，國產實業轉投資的寶齡富錦生技，所開發的抗腎臟病新藥Nephoxil已完成全球第3期臨床試驗，將於12月向衛生署食品藥物管理局（TFDA）申請上市，這項產品明年初叩關美、日市場，搶攻年12億美元（約新台幣350億元）商機。 寶齡富錦成立於1974年，是國內老牌醫藥及美容生技公司，由總經理江宗明創辦，國產實業為持股近一成的大股東。寶齡富錦研發計畫主持人湯竣鈞昨（15）日表示，Nephoxil是寶齡於2001年自美國密西根大學技轉而來，經過他主持完成臨床2期試驗後，曾自2005年起促成這項研發中新藥授權給美國、日本公司，並繼續在台灣進行第3期臨床試驗。寶齡富錦近期針對歐洲市場，也開始進行授權談判。目前，寶齡富錦擁有Nephoxil全球原料供應權利，及52國、29個專利權，專利期限至2024年。湯竣鈞說，該藥物是針對洗腎病患研發的抗「高血磷症」產品，可透過簡單的化學機轉，有效帶走腎臟病患食物中所釋放出來的磷，通過消化道伴隨糞便排出。由於臨床結果良好，湯竣鈞強調，12月將在台灣申請上市許可的藥證，也將向健保局提出Nephoxil的健保藥價申請。生策會執行長吳明發表示，Nephoxil是小分子（化學）新藥，應有較多國外核價前例可循，將有機會成為首波取得健保藥價的本土新藥，具有指標意義。研發12年 只花2.9億寶齡富錦總經理江宗明和公司新藥研發計畫主持人湯竣鈞聯手，低調耕耘12年，花不到1,000萬美元（約新台幣2.9億元）就開發出台灣第一個化學新藥Nephoxil，並成功授權美、日，背後的大股東除了國產實業外，也有本土中藥廠順天堂身影。寶齡富錦是老牌製藥公司，前身為「班友公司」，班友公司在1974年由江宗明等9位台北醫學院藥學系同班同學共同成立，這些同學除了是寶齡富錦大股東之外，也是順天堂大股東。寶齡富錦於2001年得知，中化技轉自密西根大學的腎臟新藥有意釋出，江明宗因此邀請前美國食品藥物管理局（FDA）學名藥主管陳桂恒幫忙評鑑該藥物，陳桂恒看好這項藥物，推薦自己公司的首席新藥研發主管湯竣鈞，接手藥物後續開發。雖然跨入新藥領域，但所有資金全部來自大股東們募集，沒到資本市場集資，江宗明笑稱，為了開發這個新藥「已經兩隻腳踏進棺材好幾次」。但他也透露，由於臨床2期時順利授權給美、日，在授權金、里程碑金的支援下，讓新藥開發持續有新材火添入。據悉，因台美日的同盟模式，寶齡富錦開發Nephoxil等於不花1毛錢，且上市前就賺數百萬美元。江宗明也透露，Nephoxil開發負責人湯竣鈞，不僅是寶齡新藥的主要推手，另一個身分是「台北美國學校董事長」；他是美籍香港華人卻熱愛台灣，每年和財團法人公益平台文化基金會董事長嚴長壽一起在花東辦教育志工營隊，並引進數十位哈佛、MIT博士人才投入美國學校教育。【2012/11/16 經濟日報】

生技本夢比 靠的是….”大環境”????

新藥股掛牌拚場，掀比價效應 2012-11-16 【時報-台北電】基亞生技（3176）效應，新藥股持續火紅，在互別苗頭味道濃厚下，預計於11月底和12月初轉上櫃的台微體（4152）和醣聯（4168）都已調高掛牌價，也讓預計於12月登錄興櫃的浩鼎（4174）未上市行情也逼近百元價位，成為生醫股的多頭指標。大演本夢比行情的新藥股，儘管目前都還是在燒錢階段，但市場和特定買盤看好產業前景，並認為此6檔新藥公司有機會打進國際市場，多頭力道追價意願積極，也新類股獨領風騷，除了資本額較小的醣聯和台微體外，其餘4家公司的市值都已躋身百億俱樂部。已分別敲定於11月28日、30日舉行上櫃前法說會的台微體和醣聯，由於法人看好2家公司的權利金挹注和未來新藥開發的進度，股價在持續飆漲中，醣聯的上櫃價格已由92元調高至105元，而台微體則由108元提高至128元，由於醣聯和台微體昨(15)日興櫃價分別為173和230元，在價差高達4、5成中，是否還會二度調高掛牌價，備受矚目。台微體由於開發的學名藥已授權全球第一大學名藥廠Teva，在權利金挹注下，今年前3季稅後淨損1,633萬元，相較於去年同期的虧損1.37億元，已大幅改善，該公司前3季每股淨損0.42元，而去年同期是虧損5.11元。由於台微體目前仍有幾項新劑型藥陸續規劃上市，預計未來3年內權利金及產品銷售比重約各達5成。醣聯去年在日本三菱化學委託顧問合約金及大塚製藥授權金挹注下，去年每股稅後純益0.61元，今年前3季儘管每股稅後淨損0.61元，但預計年底將有來自三菱化學的顧問合約收入及授權大塚製藥的階段收益入帳，營運應可見轉機。醣聯主要開發治療癌症的單株抗體蛋白質藥物，並且以醣質為抗原，相較於以蛋白質為抗原的抗體藥物前者的標靶性更高。該公司已有6個全人抗體及3株將進入擬人抗體的老鼠抗體，其中2個全人抗體已成功授權大塚製藥，發展為大腸癌用藥。（新聞來源：工商時報─記者杜蕙蓉／台北報導）

 

 

神隆 Double A策略 納入MSCI指數 !!

神隆出頭！台股生技股首檔獲納入MSCI指數 權重與股后相當 鉅亨網／鉅亨網記者胡薏文 台北-2012年11月15日 下午12:08 MSCI公佈最新半年度調整，台股標準指數成分股中新增5檔，其中包括生技股龍頭神隆(1789-TW)，這也是台股中，第一檔被納入MSCI台股指數成分股者，且神隆在台股指數中，權重達0.014%，與股后漢微科(3658-TW)相當。神隆今天股價受到獲MSCI納入台股指數成分股，早盤漲幅約2%，也帶領生技指數抗跌，早盤均力守紅盤之上。神隆進入傳統製藥旺季，第3季稅後淨利3.25億元，每股稅後盈餘0.5元，創下新高，前3季稅後盈餘7.48億元，年增17%，每股稅後盈餘1.15元。神隆不僅獨家提供美國生技新藥公司VIVUS生產之減重口服新型藥物Qsymia ，通過美國食品藥物管理局(FDA)審查批准，正式取得在美銷售資格，第4季正式在美國上市，明年將在歐洲上市，可望明顯帶動神隆代客製造業務的成長動能，第4季業績看俏，同時神隆在大陸市場佈局，也取原料藥(API)加學名藥藥證(ANDA)並行的「Double A」策略，目標明年取得2張學名藥藥證，目前大陸前20大藥廠，已有6家是神隆客戶，神隆將繼續發揮在抗癌原料藥領域的優勢，分別在台灣、大陸兩地積極擴產。

 

台灣尖端先進生技IPO案 !!

台灣尖端生技送件申請登錄興櫃 精實新聞 2012-11-15 13:35:20 記者 林詩茵 報導 台灣尖端先進生技(4186)今(15)日送件申請登錄興櫃，申請實收資本額5.5億元，該公司董事長暨總經理蘇文龍，該公司持股10%股東包括信標生物科技，持股比17.44%，此外，台灣醣聯生技醫藥持股2.42%。 尖端生技主要產品為研發、生產、銷售藥物殘留檢驗試劑，濫用藥物檢驗，臍帶血幹細胞之研發與儲存及生物技術服務等相關業務。內銷市場佔74.99%、外銷25.01%。 該公司去(2011)年營收1億9257萬元，稅後淨損2980萬元，每股稅後虧損0.64元。

台灣尖端先進生技醫藥股份有限公司是第一家經濟部比照當年輔導台積電、聯電技術移轉模式所成立的第一家生物科技衍生公司，為台灣第一間以市場需求為導向，從研發到生產一貫作業的生技醫藥公司。主要股東為經濟部、財團法人生物技術開發中心技術團隊、信標生物科技股份有限公司、台灣醣聯生技醫藥股份有限公司。在政府打造生物科技島的計劃中，期許台灣尖端先進成為生技業的台積電！台灣尖端先進以檢驗試劑及生技研發起家，累積多年之技術，在藥物濫用檢測服務之市佔率達50％以上、藥物殘留檢測試劑更高達90％以上，目前更跨足國際市場，朝向世界第一目標邁進。2003年更積極地將「為國民健康守護」的理想，提昇至「生命的起點」，將經營觸角延伸到嬰兒臍帶血保存業務，希望藉由「檢驗試劑」的早期診斷、早期治療觀念，以及「臍帶血幹細胞」的再生潛力，徹底落實「預防勝於治療」的理想，是國內唯一多角化經營、以生技研發為背景、擁有官股比例的臍帶血銀行。2005年6月發表重大研發成果，成功研發出『HOXB4蛋白質之增生技術』，可以讓臍帶血幹細胞在體外有效增生8倍，成功突破幹細胞移植的最大醫療瓶頸。此研發技術的創新已居國內領先地位，未來可加速幹細胞植入速率，有效提高移植成功率，減少併發症。這項幹細胞增生技術已取得台灣、大陸與國際之公開商品專利，2008年更將成為全球第一家幹細胞體外增生技術進入人體臨床實驗的臍帶血公司，不但在台灣市場獨佔鰲頭，增生專利技術的潛在市場價值更將高達百億以上。集團關係企業台灣醣聯生技醫藥股份有限公司專精於研發癌症蛋白藥，亦於2005年6月發表重大研發成果『抗癌人類單株抗體蛋白藥之突破性開發』可更精準瞄準癌細胞加以破壞，避免傷及其他正常細胞。此技術由美國華盛頓大學授權給台灣醣聯。另一關係企業和標生醫科技股份有限公司專精基因檢測及研發。台灣醣聯於2009年七月更授權日本大塚製藥，授權金2億美元推動抗癌新藥在日本進行臨床實驗，以及未來製造生產和上市推廣的商業權利協議。未來一旦新藥上市，台灣醣聯將可獲得銷售額5-19%約162億的權利金，連續20年；而台灣尖端先進也將因此每年獲利3億元以上。本公司與集團關係企業之間，人員與技術充分交流，提供員工更多學習及工作轉換機會，公司及個人均能精進成長， 公司福利健全、薪資待遇優於同業，歡迎有志菁英加入我們的行列！

 

WuXi, Regeneron In Buying Range Despite Market's Woes

 By Scott Stoddard, Investor's Business DailyPosted 04:40 PM ET Medical stocks WuXi PharmaTech (WX) and Regeneron Pharmaceuticals (REGN) are in buying range after holding up relatively well amid the market's post-election sell-off.China-based WuXi — an outsourcing company offering pharmaceutical, biotechnology and medical device research — is just above a 15.10 buy point in a long base.The stock has an alternative buy point at 15.70, which WuXi topped Thursday but in light trade. WuXi broke out above the 15.10 buy point Monday following a better-than-expected 16% rise in Q3 profit. Volume was just 28% above normal, but it picked up the next day, rising 126% as the stock hit a new high.The stock is thinly traded and WuXi's profit and sales growth, though slow and steady, is weak compared with typical growth companies.In this regard, WuXi is like many other stocks in the Spotlight screen: The fundamentals are not ideal, but the stock has some relative strength, which aggressive investors might consider for purchase.Another medical-sector stock with a better profile is Regeneron.The stock is just above its 142.06 cup-with-handle buy point. The stock has been trading below the 50-day moving average for nearly three weeks, despite that it soundly beat expectations Oct. 24 with its third-quarter profit.Regeneron posted a profit of 37 cents a share in Q1. Second-quarter profit picked up to 90 cents, following a profit of $1.89 in Q3.After many years of losses, the company is on track for a profit this year.Sales growth has picked up in the past two quarters, from a gain of 107% in Q1 to subsequent rises of 182% and 292%.

 

康聯 的 長效干擾素 (phase II) !!

F-康聯Q4營運衝頂 成長估逾1成 全年估賺半個股本 鉅亨網記者張旭宏 台北　　2012-11-16 12:25:30中國醫藥銷售平台F-康聯(4144-TW)前三季財報，稅後淨利2.52億元，每股盈餘3.6元，隨著第四季年底作帳，加上進入冬季的用藥旺季及認滿同澤藥業7200萬元營收，單季營運將再攀高峰，季增估超過1成，法人估計全年仍賺逾半個股本，在中國18大結束政權底定，新藥招標速度將加快，明年營收2位數以上成長。F-康聯指出，第三季營收為4.38億元，季增7.51%，毛利率58.29%，稅後淨利7,309萬元，每股盈餘1.04元，其中營業費用增加，主要是收購同澤的無形資產攤銷及支付長效干擾素的二期臨床費用所致，公司第四季在集中季底作帳，加上認列完整一季的同澤醫藥營收貢獻及冬季用藥旺季，營收將達全年高峰，毛利將推升至6成，法人估全年將賺半個股本。 隨著中國18大結束，政權交班底定，各級醫院恢復招標下，加快新產品進藥進度，旗下代丁、彼多益、銀丁、力百汀、糠酸莫米松鼻噴劑持續銷售挹注，加上康聯多元佈局，積極與同業策略聯盟及入股，明年康聯營收2位數成長。

New analysis indicates that Novartis drug Gilenya shows significant early effect on reducing brain volume loss at 6 months

 Oct 16 2012New analysis of two large Phase III studies demonstrates a significant early treatment effect of Gilenya on relapses and MRI outcomes, including brain volume loss, in MS patients Data show generally higher adherence rates for once-daily oral Gilenya than injectable DMTs and positive real-world experiencePooled analysis of core and long-term study data from over 3,500 patients reinforce known safety profile; more than 49,000 patients treated as of August 2012 Dubai, United Arab Emirates, October 16, 2012 - New data was presented at the 28th congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) that reinforce the generally early and sustained efficacy benefit and long-term safety profile for Gilenya® (fingolimod), the first once-daily oral therapy approved to treat relapsing forms of multiple sclerosis (MS)1,2. "As the first once-daily oral MS therapy, growing real-world experience reinforces Gilenya's high efficacy and long-term safety profile," said David Epstein, Head of the Pharmaceuticals Division of Novartis Pharma AG. "With data showing an early treatment effect on relapses and brain volume loss, Gilenya continues to show positive outcomes for patients and Novartis remains committed to addressing the significant remaining unmet medical need in the MS community."

Analysis shows significant early treatment effect with Gilenya A new post hoc analysis of two large Phase III studies shows treatment with Gilenya 0.5 mg led to significant benefits on relapse-related outcomes within the first three months and on brain volume loss by six months compared to placebo1. There was a significant (p<0.05) Gilenya treatment effect on time to first confirmed relapse within three months in both the pivotal FREEDOMS study (n=1272), and FREEDOMS II, the second large Phase III placebo-controlled study (n=1083). The differences between Gilenya and placebo became persistently significant by Day 82 in FREEDOMS and Day 64 in FREEDOMS II, respectively1.Furthermore, in the FREEDOMS study, patients-treated with Gilenya 0.5 mg had on average a 35% reduction in brain volume loss compared with placebo at the first MRI evaluation after six months of treatment (mean percent brain volume change of -0.22 for Gilenya vs. -0.34 for placebo; p=0.006). In FREEDOMS II, there was a 39% reduction in brain volume loss (mean percent volume change of - 0.23 for Gilenya vs. - 0.38 for placebo; p=0.012) at six months1. "Understanding the onset of efficacy is an important consideration in the treatment of MS as early effective treatment may improve patient outcomes," said Professor Ludwig Kappos, MD, Chair of Neurology, University Hospital, Basel, Switzerland. "The new analysis of Phase III data shows a significant early effect of Gilenya on relapses and MRI measures, and further supports its role as a valuable treatment option for relapsing-remitting MS."

New data published on real-world experience and patient adherenceFirst results from the PANGAEA observational study in Germany indicate that 90% of investigators and 91% of patients rated Gilenya treatment success, defined as efficacy and tolerability, as "Good" or "Very Good"2. PANGAEA is a German registry study aimed to enroll a total of 4,000 patients with a follow-up of five years designed to investigate the efficacy and safety of Gilenya in everyday clinical practice. As of May 2012, one year after initiation of the registry, more than 1,850 patients were enrolled in 475 participating centers. These results also showed an overall safety profile in line with previously reported data2.In addition, a separate analysis of time to discontinuation of therapy among MS patients receiving Gilenya and other disease modifying treatments (DMTs) using pharmacy claims in the US (n=1891) show Gilenya-treated patients were significantly less likely to discontinue treatment over the 12 month observation period (Gilenya: 27.8%, other DMT cohorts: 42.7-54.5%; p<0.01) and discontinued later than patients using injectable DMTs3.

Results from more than 3,500 patients further characterize long-term safety profileA new integrated analysis of safety data from Phase II, Phase III and study extensions for fingolimod (all doses, n=3553) show a safety profile generally consistent with previous results. The total fingolimod exposure was 9,070 patient years, with 1,510 patients treated for more than three years and some for more than seven years4.As of August 2012, more than 49,000 patients have been treated with fingolimod in clinical trials and in the post-marketing setting, and there is approximately 52,000 patient years of exposure5.

About Gilenya Gilenya, licensed from Mitsubishi Tanabe Pharma Corporation, is the first in a new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators. It has demonstrated superior efficacy compared to Avonex, a commonly prescribed treatment, showing a 52% relative reduction in annualized relapse rate (primary endpoint) and a 40% relative reduction in the rate of brain atrophy (secondary endpoint) at one year in a pivotal head-to-head trial in patients with relapsing-remitting multiple sclerosis6. In a recent post hoc sub-group analysis, Gilenya showed a 61% relative reduction in annualized relapse rate compared to interferon-beta-1a (IM) at one year in subgroups of patients with highly active relapsing-remitting MS not responding to interferon treatment7. Gilenya is a generally highly effective once-daily oral MS treatment. In clinical trials it was generally well tolerated with a manageable safety profile, and there is increasing experience of Gilenya's long-term effectiveness and safety profile, with approximately 49,000 patients having been treated in clinical trials and in a post-marketing setting7. Currently, there is approximately 52,000 patient years of exposure5. In clinical trials, the most common side effects were headache, liver enzyme elevations, influenza, diarrhea, back pain, and cough. Other Gilenya-related side effects included transient, generally asymptomatic, heart rate reduction and atrioventricular block upon treatment initiation, mild blood pressure increase, macular edema, and mild bronchoconstriction 6,8. The rates of infections overall, including serious infections, were comparable among treatment groups, although a slight increase in lower respiratory tract infections (primarily bronchitis) was seen in patients treated with Gilenya. The number of malignancies reported across the clinical trial program was small, with comparable rates between the Gilenya and control groups6,8.

References:

1. Chin P.S. et al. Early effect of fingolimod on clinical and MRI related outcomes in relapsing multiple sclerosis. Abstract Presented at ECTRIMS, Lyon, France, October 2012.

2. Ziemssen T. et al. Study design and first interim results of a registry study to establish long-term safety and pharmaco-economic data on fingolimod (Gilenya®) in multiple sclerosis patients in Germany (PANGAEA). Abstract Presented at ECTRIMS, Lyon, France, October 2012

3. Neetu A. et al. Comparison of Time to Discontinuation Among Multiple Sclerosis Patients Receiving Fingolimod and Other First-Line Disease Modifying Treatments. Abstract Presented at ECTRIMS, Lyon, France, October 2012.

4. Cohen J. et al. Long-term safety of fingolimod in relapsing multiple sclerosis: update to integrated analyses of phase 2 and 3 studies and extension phases. Abstract Presented at ECTRIMS, Lyon, France, October 2012.

5. Novartis data on file.

6. Cohen J. et al. Oral Fingolimod vs. Intramuscular Interferon in Relapsing Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010;362:402-415.

7. Havrdová E. et al. Clinical outcomes in subgroups of patients with highly action relapsing-remitting multiple sclerosis treated with Fingolimod (FTY720): Results from the FREEDOMS and TRANSFORMS phase III studies. Poster presented at ECTRIMS, Amsterdam, October 2011.

8. Kappos L, et al. Placebo-Controlled Study of Oral Fingolimod in Relapsing Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010; 362:387-401.

科頂科技+金屬中心 強化 牙科驅動器

聯合創新醫材產品發表會 金屬中心將於中原大學舉辦(中央社訊息服務20121115 14:05:28)台灣的科技產業發達，順勢的也推展了醫療科技持續進步。為使國內各醫材開發相關單位瞭解計畫開發成果以及擴大國內醫療器材廠商新產品來源，金屬工業研究發展中心17日於桃園中原大學舉辦「聯合創新醫材產品發表會」，邀請各界先進共同交流。近年來政府極力推動發展醫療器材領域以提升台灣生技產業之國際競爭力。在98~100年間執行經濟部技術處之「南科高雄園區醫療器材產業服務平台研發計畫」，以及101年執行「高值牙科植入物創新研發與醫療器材產業服務計畫」等計畫，透過計畫中臨床資訊平台連結第一線臨床需求與工程設計，將醫師創新醫材構想經工程設計後進行構想雛型品開發。醫材創新產品概念主要來自臨床使用狀況與臨床需求，透過研發法人與醫師、產業、學界之交流，鏈結臨床、研發與製造廠商，積極展開醫材於技術、工程及研究面向之發展。在政府資源全力支持下，98~101年產出成果豐碩，牙科領域有牙科手術麻醉器械、鼻竇增高器械、重複式植牙鑽削器械、超音波拔牙鋌、人工牙根表面清創器械、取骨與碎骨二合一雙用鑽等；骨科領域有髖關節微創股骨元件、肩鎖關節脫位/骨折內固定器、新式髖關節螺絲釘等；外科與婦科領域有子宮肌瘤切除裝置、手術擴增實境影像定位裝置、具剛性之前端可控彎曲式輸尿管鏡等。除了投入開發各類創新醫療器材之外，金屬中心也輔導科頂科技公司參與「電動牙科治療器械驅動設備技術開發計畫」，協助科頂公司先期探討牙科手機無刷馬達設計與製作的程序，並逐步建立該公司投入電動驅動設備開發的所需能量。也就是說，除了單點式的醫療器材開發之外，金屬中心亦協助業者培養設備開發之技術能量，有助促進技術本土化、健全國內牙科手機技術能量，取代以往需全數仰賴進口之技術與產品。科頂公司之輔導案及其開發成果將於會中同步介紹。訊息來源：財團法人金屬工業研究發展中心more articles from