Primary liver cancer (hepatocellular carcinoma or HCC) is the fifth most common cancer worldwide. Surgery to remove the tumour remains the principal form of treatment for liver cancer, however recurrence of the disease after surgery is common and survival after recurrence is poor. At the moment there is no recommended standard treatment for HCC immediately after the tumour has been removed surgically. PI-88 is a new experimental drug which blocks the growth of new blood vessels in tumours to stop the tumour growing (starves it of food) and also stops tumour cells spreading. Previous experience with PI-88 has shown it has been well tolerated and has shown some benefit in delaying the time it takes for the hepatocellular carcinoma to reappear after surgery. The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.
基亞肝癌新藥獲美FDA孤兒藥認定,授權金上看4億美元 2012-04-11 10:17 時報資訊 基亞生技(3176)宣布,PI-88肝癌新藥獲美國FDA(食品藥物管理局)通知,正式取得肝癌「孤兒藥」資格認定(Orphan Drug Designation),未來上市將有七年的美國市場專賣獨占權。該公司表示,此將顯著提升PI-88於美國市場之價值,有利與國外大廠的授權談判及未來市場的拓展,法人認為,上半年可望有結果,授權金上看4億美元。PI-88擁有「雙重抗癌效果」,能抑制類肝素及血管生長因子,目前由基亞在台灣、韓國及中國大陸共20個醫學中心執行第三期肝癌臨床試驗,預計102年底完成三期臨床,年中先完成期中分析,如期中分析達預期療效標準,將於102年提前申請藥品上市。基亞表示,將保留亞洲市場,歐美市場將授權國際大廠,目前持續洽談中。經美國FDA認定為「孤兒藥」的藥品,可獲得美國主管機關給予行政協助及市場專賣保護期等優惠措施,並有利申請當地研究經費補助,未來上市將有七年的美國市場專賣獨占權,擁有專利保護以外更具價值的市場專屬保護。基亞表示,拿到美國FDA通知取得肝癌「孤兒藥」資格認定,有利與國外大廠的授權談判及未來市場的拓展,今年應該會有結果。法人表示,上半年可望有結果,授權金約2-4億美元。根據工研院生醫所的估計,亞太華人地區肝癌病患新增人數在台灣、中國、香港、與新加坡分別為8,020位、365,000位、1,600位,為亞洲區重大疾病。PI-88全球上市後,樂觀估計藥品銷售值每年達新台幣738億元,保守估計市場銷售值也可以達到新台幣520億元。如果PI-88能依計畫如期上市,則將有機會成為全球第一個核准做為肝癌術後預防復發的藥物,不僅造福肝癌病患,同時也將帶領台灣生技產業進入另一里程碑。Pages
Thursday, April 12, 2012
加速中國製藥轉型一例: 海正辉瑞制药公司
海正药业:与辉瑞设立合资公司促制剂转型 时间: 2012年04月06 浙江证券网 2011年,公司实现主营业务收入50.69亿元,较去年同期增长13.18%;实现营业利润5.67亿元,同比增长30.98%;扣非后归属于母公司股东净利润4.60亿元,比去年同期增长38.38%。公司全年实现EPS0.98元/股,同比增长28.95%。公司业绩增长较快,符合之前预期。 2011年公司自产产品实现销售收入255,768.38万元,较去年同期增长13.68%,占营业收入的49.55%,其中抗肿瘤药、抗寄生虫药及兽药增长较快,增长率分别为20.43%、26.00%。抗肿瘤药增长较快一方面由于其原料药实施自主营销后,客户维护和新市场开拓力度均得到加强;另一方面得益于国内抗肿瘤制剂销售保持持续增长。抗寄生虫药及兽药增长较快主要是由于公司调整产品结构,新产品销售收入增加。 公司及全资子公司海正药业(杭州)有限公司与辉瑞卢森堡公司于2月18日签订了《合资框架协议》。拟设立合资公司名称为"海正辉瑞制药有限公司",总投资2.95亿美元,注册资本2.5亿美元,其中,海正药业、海正杭州公司、辉瑞卢森堡公司各占合资公司注册资本的5%、46%、49%。合资公司的成立有利于将海正药业在产品研发、生产制造以及国内市场的品牌优势与辉瑞公司在全球认知度和全球制剂产品推广能力的优势结合,进一步开拓国内外品牌仿制药市场,加速公司原料药到制剂一体化转型升级的步伐。
金可 模壓製程 估2013產能突破2億片!!
輝瑞不是武田… 市場不確定因素大增!!
提專利無效 南光 槓 輝瑞2012-04-13 01:30 工商時報 國際大廠以專利訴訟打壓國內學名藥廠事件再添一樁!繼健亞(4130)告武田製藥勝訴後,南光 (1752)也力搏輝瑞威而鋼專利到期官司,認為該公司研發的「美好挺」並未違反專利,目前產銷正常。 南光總經理王玉杯表示,國際藥廠輝瑞威而鋼活性成分的化合物專利(台灣第80104709號申請案)已於民國100年6月17日到期,雖輝瑞對外宣稱對威而鋼仍擁有「用於治療或預防男性勃起不能或女性性慾官能不良之藥學組成物」的適應症專利。惟該適應症專利欠缺有效性,歐盟已撤銷該適應症專利,歐洲也有四個國家已核准學名藥上市。因此南光已依法提起專利無效舉發。據了解,為了阻止南光的「美好挺」上市,輝瑞之前已發函警告全國四千多家醫療院所與藥局,讓「美好挺」無法上市銷售。王玉杯指出,依據衛生署食品藥物管理局藥物安全監視名單(最後更新日期101/02/20)」,威而鋼藥品(Viagra F.C.T 100mg)並未公告相關任何專利字號,而且,該藥品及包裝也未標示任何專利字號,輝瑞對第三人主張該適應症專利,恐有濫用專利之嫌。 原專利藥廠利用專利訴訟延後學名藥廠上市時間的事件層出不窮,健亞生技就與日商武田製藥纏訟了7年的口服抗糖尿病製劑「Vippar」侵權官司,雖然健亞獲勝訴,武田需賠償5千萬元,但錯失7年學名藥品上市商機,卻一直都是國內學名藥廠心中的痛。
健喬 從健亞&因華獲利可期待!!
今年業績可望創新高 健喬漲停 中央商情網2012-04-12 (中央社)健喬(4114)攝護腺、癌症等新藥效益顯現,以及處分健亞持股挹注,法人估今年EPS可超過2元,創歷年新高;第1季EPS即可達1元左右,激勵股價開盤跳空漲停到33.15元。健喬信元董事長林智暉表示,隨著新藥藥證陸續取得,並逐漸發酵,今年營運將有不同以往的表現,尤其第1季將是分水嶺。他表示,以攝護腺用藥Urief為例,去年營收貢獻僅幾百萬元,今年出貨量將上看1000萬顆,營收貢獻新台幣6、7000萬元。由於國內市場規模達16億元,目標2015至2016年出貨量上看1億顆,營收貢獻將逐年成長。癌症用藥部分,林智暉表示,健喬去年取得的3張藥證,包括「射釔菲爾釔90微球體」、「普癌汰乾粉靜脈注射劑」及「海派栓塞微球體」,因陸續進入教學級醫院,效益逐漸顯現,預估今年來自癌症藥品的營收貢獻將由去年的1000多萬元,跳升至7、8000萬元。其中,「射釔菲爾釔90微球體」從今年7、8月起,就可穩定挹注月營收4、500萬元。此外,健喬代理芬蘭藥廠Orion的強心劑專利新藥Simdax,近日已取得國內藥證。林智暉表示,此藥品在芬蘭已上市10年,並在歐洲11國銷售。以芬蘭900萬人口來說,1年銷量達4000支,每支單價約新台幣5萬元計算,台灣人口有2300萬,需求將更為可觀。林智暉表示,看好Simdax在亞洲的市場,目前已與Orion洽談香港、澳門及中國大陸的銷售權,第2季可望有好消息。除了新藥貢獻,健喬自2006年起布局定量氣霧吸入劑(MDI),今年第3、4季將可取得國內上市許可,未來也計畫在大陸市場銷售。林智暉說,目前正與2家在A股上市的大陸藥廠洽談技術授權,最快今年內可望定案,屆時授權金可望從人民幣1億元起跳。除了本業成長,健喬近來陸續處分健亞(4130)等持股,法人估計,可望挹注健喬第1季稅前盈餘上看新台幣1億元,創單季新高,每股稅前盈餘約1.16元。今年在新藥成長貢獻下,營收年增率將從2成起跳,營收、獲利都創下歷史新高。另外,健喬持有因華生技近1.4萬張,每股持有成本約7元,由於因華生技規劃6、7月登錄興櫃,明年第1季上櫃,健喬潛在收益可期。
美商永生臍帶血 於脊髓損傷、中風治療 品質肯定!
幹細胞治療心肌梗塞 積極效果不顯…
東生華 自許為Specialty Pharma(心血管和自體免疫)
東洋小金雞東生華 4/30上櫃 掛牌價85元鉅亨網台北 2012-04-12 東生華董事長林榮錦表示,東生華未來搶攻的市場將鎖定心血管和自體免疫,其中的自體免疫是生技學名藥,將有機會於2014年上市。由元富證券主辦的東洋(4105-TW)旗下小金雞東生華製藥(8432-TW)敲定4月30日上櫃掛牌,掛牌價暫訂85元。東生華去年營收獲利同創新高,EPS達6.02元,隨著年底前僅新增1個降血脂新藥證到手,法人估今年營收及獲利將與去年相當,以上櫃後股本估算,EPS5.5元。東生華去年在藥品銷售大幅攀高帶動下,表現攀頂,營收達6.59億元,年增204.1%,稅後淨利1.68億元,暴增290.86%,EPS 6.02元; 東生華產品領域包含心血管用藥(CV)、腸胃科用藥(GI)、自體免疫疾病用藥(Auto Immune Disease )及中樞神經用藥(CNS)等。2010年9月自母公司台灣東洋分割成立,致力於慢性疾病領域, 提供高經濟效應產品的專家。公司策略已Specialty Drug為研發方向,包含劑型、配方改良,故於國內市場享有五年的行政保護期,可減輕健保調價及學名藥價格競爭的影響。 目前東生華以內銷市場為主,主要通路即為各大醫學中心及教學醫院,目前東生華在國內19家醫學中心及79家區域醫院的覆蓋率達100%,另於近300家地區醫院自營部份達到約50%的覆蓋率,通路佈局完整 慢性病是已開發國家人口老化最常見的疾病,亦為醫療健保資源最大的耗用者。以台灣為例,65歲以上老年人口已超過11%,而慢性病每年耗用36%以上的健保資源;在中國大陸也因先前的 一胎化政策,導致現有老年人口急速攀升,如高血壓患者就超過1.5億人。在兩岸有限健保醫療體系下,提供慢性病具有高經濟價值的藥品就成為當務之急,而東生華正是著力於慢性病領域及 提供高經濟效應產品的專家。 東生華2011年營收約為6.6億元,年增5%,近年來公司營收維持穩定成長,成長幅度5-10%,毛利率持穩在7成左右,業利益成長幅度則達2成以上,目前東生華已處於新藥收成階段,獲利成長明顯。公司未來搶攻的市場將鎖定心血管和自體免疫,其中的自體免疫是生技學名藥,將有機會於2014年上市,屆時將帶動東生華營運翻揚。
東生華: 從Me too到Me better !!
東生華總座陳俊良:年底取得降血脂藥證 搶食50億元商機2012/4/12 鉅亨網 東生華(8432)今(12)日召開上櫃前法人說明會,總經理陳俊良表示,今年年底將取得降血脂組合藥物藥證,搶攻國內降血脂藥物約有50億台幣的市場商機,同時維持維持每兩年1個新產品上市的速度,預計民國105年新成分、複方、劑型藥比重提高至8成,強化獲利動能。 陳俊良進一步指出,公司未來發展將走向「微笑曲線」,創造研發及行銷的差異化,持續專精於差異化慢性病(CV、GI、Auto Immune Disease)藥物及Specialty Drug(劑型、配方改良、me- better)開發,研發以組合劑型、長效劑型為主,未來搶攻的市場將鎖定心血管疾病和自體免疫疾病,目前手邊已有多款研發中新藥,每2年都會有一個新藥上市。目前進度較快為1個降血脂組 合藥物,包含降低低密度膽固醇同時提高高密度膽固醇,有機會今年年底前取得藥證。目前國內降血脂藥物約有40-50億台幣的市場規模,預期未來藥品上市後將有機會帶動東生華營運明顯成 長,挹注新成長動能。 陳俊良表示,國內去年健保給付藥品規模約1,270億元,近年平均複合成長3.8%,而其中醫療院所占比80%,該公司的策略是透過劑型及設計改良,切入新劑型/新複方/特殊藥等利基領域,也 就是從「Me too」到「Me better」,公司核心能力除疾病類別管理外,特別鑽研長效劑型及組合劑型,以降低健保局及病人自付成本。 陳俊良強調,公司10年來逐步聚焦慢性疾病,發展心血管、腸胃道及自體免疫等三大領域,目前在醫療院所通路中,19家醫學中心都已涵蓋,300多家地區型醫院占有也近半,而從醫療院所發 展核心通路對於次級的開業診所及藥局也會有「蝴蝶效應」,幫助公司藥品向下普及。同時在藥品發展定位在二、三棒,也就是從人體臨床試驗開始承接,再到推動藥品上市,因選擇 領域多屬新成分、新複方及新劑型新藥,受健保調整的衝擊較少,使得營收維持5-10%左右成長的。去年來自新成分比重37%、新複方22%及新劑型藥5%,2016年新藥比例將提高至82%。 陳俊良樂觀表示,年底將有一個降血脂的藥品N11上市,去年底也與永昕(4726)合作,發展類風溼性關節炎的蛋白質藥,預計民國107年新成分新藥及生物製劑上市。另外,中國也有1張藥證申請及2張專利等待獲准,其中1張藥證為高血管領域,2張專利則可望在年底獲准後啟動臨床,估計2年後中國將有明顯營收挹注。
醫療人員 恢復正常工時 真能來臨嗎?
盛弘 新通路(瑪科隆) 仍需時間整合!!
KKR Invests in China Cord Blood
Dangers of Chinese Medicine Brought to Light by DNA Studies
by Kai Kupferschmidt on 12 April 2012 Traditional Chinese Medicine (TCM) is enjoying increasing popularity all over the world. But two molecular genetics studies published this week show that the trendy treatments can be harmful, as well. The papers focus attention on the fact that not all of their ingredients are listed, or even legal, and that some can cause cancer. "These two studies show very clearly how dangerous the products of TCM can be," says Fritz Sörgel, the head of the Institute for Biomedical and Pharmaceutical Research in Nuremberg, Germany, who was not involved in the work. "The public needs to be better informed about these dangers." Hundreds of millions of dollars are spent on TCM products each year—a growing portion of it on the Internet—and some scientists are looking at these preparations hoping to discover new pharmacological substances. Many would like to emulate the success of Tu Youyou, the Chinese scientist who isolated artemisinin, now the world's most important malaria drug, from an ancient Chinese medicine. Tu won a Lasker award last year and is rumored to be a Nobel candidate. But critics have long warned that some mixtures can also contain naturally occurring toxins, contaminants like heavy metals, added substances such as steroids that make them appear more effective, and traces of animals that are endangered and trade-restricted. Now, researchers at Murdoch University in Australia have investigated the problem using modern sequencing technology. The team, based at the university's Australian Wildlife Forensic Services and Ancient DNA Laboratory in Perth, analyzed 15 samples of traditional Chinese medicine seized by Australian border officials. "We took these traditional preparations, smashed them to pieces, and extracted the DNA from the powder", explains molecular geneticist Michael Bunce. The scientists then fished out copies of two specific genes, trnL, a chloroplast gene common to all plants, and 16srRNA, conserved among plants and animals, and multiplied and sequenced them. By comparing the sequences to genetic databases, they could pinpoint the animals and plants used to make the medicine. "Sometimes we really struggled to assign a particular DNA to a particular species," Bunce says. But as genetic databases expand, this should become easier. Some products contained material from animals classified as vulnerable or critically endangered, such as the Asiatic black bear and the Saiga antelope—just as the producers claimed. But often, the medicine also harbored ingredients not mentioned on the packaging, the team reports online today in PLoS Genetics. "For example, a product labeled 100 percent Saiga antelope contained considerable quantities of goat and sheep DNA," Bunce writes. "Using DNA to identify the animal species and thus prove illegal trading is very elegant," says Dietmar Lieckfeldt, who works in molecular forensics at the Leibniz Institute for Zoo and Wildlife Research in Berlin, Germany. Identifying animals by their DNA has been possible for a while, he says, but the next--generation sequencing technology makes it possible to nail different species in a mixture very quickly. In the herbal preparations, Bunce and his colleagues found 68 different plant families, among them plants of the genera Ephedra and Asarum. Both can contain toxic chemicals such as aristolochic acid, a compound banned in many countries because it causes kidney disease and cancer of the upper urinary tract (UUC). While detecting DNA from a certain species does not mean that a toxin produced by that plant is present, chemical analysis of one of the four samples containing Asarum DNA did turn up aristolochic acid. The threat posed by aristolochic acid is also highlighted in a paper published in the Proceedings of the National Academy of Sciences on Monday. The researchers, led by pharmacologist Arthur Grollman of Stony Brook University, focused on Taiwan, the country with the highest rate of UUC in the world. A previous analysis had shown that roughly one-third of the Taiwanese population consumed herbs likely to contain aristolochic acid. The scientists sequenced the tumors of 151 patients with UUC. Among patients with characteristic mutations in the important tumor-suppressor gene TP53—which make people more vulnerable to cancer—84% also showed a known molecular signature of exposure to aristolochic acid, they found. The study provides compelling evidence that aristolochic acid is a primary cause of UUC in Taiwan, the authors argue. Bunce and his colleagues also found DNA from plant families known to contain medicinally important species that could pose risks when used in combination with other drugs, as well as DNA from soybean and plants of the cashew family, which can contain allergens. "This just shows that the ingredients in these preparations aren't accurately declared," Bunce argues. Indeed, says Sörgel, the studies show that partaking in traditional Chinese herbal medicine is a gamble. "We just don't know enough about it."