強化藥品行銷通路 !中天&禾利行合作(化療漾) !!!

中天「化療漾」授權禾利行 台灣市場5年銷售目標20億元！ 鉅亨網記者胡薏文 台北　　2012-12-23 15:51:18　中天生技(4128-TW)今天正式宣布，將癌症新藥「化療漾」授權本土最大藥商禾利行，為台灣獨家代，雙方簽署5年合約，預估台灣市場5年銷售目標為25萬瓶、約20億元。另外在化療漾大陸市場部分，也將申請大陸藥證，同時為因應後續國際市場需求，中天也將擴產5倍，設立年產能80-100萬瓶新廠，預定明年第4季完工投產。中天化療漾去年底通過新藥認證，今年3月獲准上市銷售，中天生技集團董事長路孔明表示，這段期間有許多公司來洽談代理，但精挑細選後，決定交由禾利行獨家代理，禾利行原本均代理進口藥品，這也是首度代理本土藥品，而中天與禾利行將是「強強結合」，也證明台灣研發成功的新藥，已獲得市場認同。未來中天集團其他新藥產品，也將優先選擇禾利行。禾利行總經理鄭文同表示，中天「化療漾」經過嚴謹的科學與臨床試驗，證實對於目前癌症病人於治療時經常發生、最痛苦的癌症疲勞與食慾不振，具有極為顯著的改善效果，是一項極為安全且有效的癌症輔助治療新藥，由於這2項癌症病狀目前全世界都沒有安全的藥物可用，未來「化療漾」市場潛力十分龐大。中天指出，台灣每年新增癌症病患達9萬人，加上罹癌者約50萬人，進行化療、癒後保養等，都是化療漾的適用對象。中天與禾利行預估，在台灣市場部分，明年起正式開始銷售，5年將售目標為25萬瓶，銷售目標為20億元。中天化療漾已取得美國、歐洲、大陸、台灣等地區多項專利，下一步將積極開拓國際市場，以全球獨家的臨床療效擴大「化療漾」市場利基。其中大陸部分，可望透過兩岸ECFA機制，申請大陸藥證，中天為因應未來國內外市場需求，並決定在桃園增建年產量80-100萬瓶化療漾的新廠，預定明年底前投產，屆時對中天營收可望產生巨大效益。化療漾是中天生技研發14年，投資逾15億元才研發成功的台灣第一個癌症輔助治療新成藥，臨床試驗證實，「化療漾」可以顯著改善癌症病人化學藥物治療產生的疲勞與食慾不振。為了希望讓這項本自行研發成功的新藥，能夠讓罹患癌症的國人普遍可以負擔得起，中天表示，在定價策略上，以每瓶180cc售價8000元，接受化療時每天服用2次共8cc，每天僅356元，化療後長期保養服用量可酌減為1次，每天僅需178元，在費用方面，低於目前相關藥品。

東洋 國際大廠代工微脂體定案 !!!

製藥績優生 續航力超強 2012-12-23 01:28 工商時報 記者杜蕙蓉／台北報導

製藥業前三季獲利 冬季旺季效應來臨，生技製藥業挾著第4季營收將展現不錯成長力道，吸引投資買盤，近日包括晟德（4123）、健亞（4130）、健喬（4114）、神隆（1789）等股價走勢突出，醫材業中的合世（1781）、?美（4728）表現也相當亮麗；在生技類股漲幅已高下，法人認為，具基本面題材的業績股，將有機會輪棒為多頭主流。法人表示，氣候寒冷的冬季，向來是呼吸道、心血管用藥的旺季，以11月營收來看，包括神隆、旭富（4119）、國光（4142）、南光（1752）、濟生（4111）、健喬、友華（4120）、晟德單月營收年成長率都以2成起跳，由於這波寒流持續，預計各製藥公司的業績成長力道可延續至明年第1季。就初步統計，目前包括南光、杏輝（1734）、健亞第4季都有日本代工訂單挹注業績，而健喬在呼吸道、心血管、荷爾蒙、癌症及泌尿系統等領域發威下，法人預估健喬今年營收年增率約17～18 ％。至於備受矚目的東洋（4105），第3季業外因認列智擎新購入藥品的權利金、部分榮港生技與東曜的研發費用，加上旭東海普延後處分所致，單季EPS僅0.03元，但近期在為國際大廠代工微脂體定案，在可望有授權金和營業額進補下，未來營運看好。

 

 

生技IPO後 創投辭董事 不要 大驚小怪

大股東出脫持股？台灣浩鼎7天股價重挫逾3成 鉅亨網記者張旭宏 台北　　2012-12-24 09:00:11　興櫃新藥新三雄之一的台灣浩鼎(4174-TW)12月12日以45元登錄興櫃後，登錄第二天最高來到一度來到135元，隨即在持股超過7%的第3大股東合一創新公告請辭董事，市場疑慮將會出脫持股憂慮下，買壓出籠，股價持續下挫，最低來到87元，短短7天跌幅達35%，目前則回到92元附近。台灣浩鼎日前公告法人董事合一創新辭任，加上更換會計師事務所及簽證會計師，由於合一創新持有達7.67%，因此引發市場揣測大股東將要出脫持股，導致市場賣壓出籠，股價持續重挫。根據業內人士透露，合一創新根本沒有出脫持股！由於合一創新是一家創投公司，一般創投公司持股都超過5年以上，因此浩鼎登錄興櫃後，就會循業界做法，辭掉董監事，以取得彈性陸續來處分手中的持股，因此無須「大驚小怪」。台灣浩鼎目前產品有包括已取得美國授權在台銷售的「鼎腹欣(DIFICID)」治療性乳癌疫苗的OBI-822/821、新世代癌症治療性疫苗、醣類生物標的癌症檢測試劑、肉毒桿菌素等。其中最受關注是新藥產品OBI-822/821，為全球第一個乳癌免疫標靶治療藥物，今年8月獲TFDA核准進行第三期臨床試驗，目前已在美國、加拿大、香港、韓國、印度等地進行多國多中心臨床試驗，同時獲選進入首批兩岸藥研合作專案新藥。

 

癌症疫苗L-BLP25 (StimuvaxR) 遇瓶頸 !!

EMD Serono: Phase III Trial of L-BLP25 (Stimuvax) in Patients with Non-Small Cell Lung Cancer Did not Meet Primary Endpoint Notable treatment effects were observed for L-BLP25 in certain subgroups in the START study ROCKLAND, Mass.--(BUSINESS WIRE)--Dec 19, 2012 - EMD Serono, a subsidiary of Merck KGaA, Darmstadt, Germany, announced today that the Phase III STARTa trial of its investigational product L-BLP25 (formerly referred to as StimuvaxR) in patients with unresectable, locally advanced stage IIIA or IIIB non-small cell lung cancer (NSCLC) did not meet its primary endpoint to demonstrate a statistically significant improvement in overall survival (OS). Despite not meeting the primary endpoint, notable treatment effects were seen for L-BLP25 in certain subgroups. Patient safety in the START trial was monitored frequently by an independent data monitoring committee and no new or unexpected safety concerns were noted for the study. In prior clinical studies, the most frequently reported adverse events included injection site reactions, flu-like symptoms, nausea, cough, fatigue, and dyspnea. Further analyses are planned in the coming weeks to explore the potential benefit-risk profile of L-BLP25 in certain populations. This data will be discussed with external experts and regulatory authorities over the coming months. The START study results will be submitted for publication in a peer-reviewed journal and presented at a future international scientific meeting.The ongoing clinical program of L-BLP25 that includes studies in the Asia Pacific region will continue pending discussion with relevant regulatory agencies."It is disappointing that the START trial did not meet its primary endpoint, in particular for patients suffering from NSCLC," said Dr. Frances Shepherd, Scott Taylor Chair in Lung Cancer Research at the Princess Margaret Hospital and Professor of Medicine at the University of Toronto, Canada, and Coordinating Investigator of the START trial. "However, notable treatment effects were observed in certain subgroups of patients and warrant further investigation of L-BLP25.""We believe that the START study will offer important scientific insights to the potential for immunotherapies in the treatment of this devastating disease and we intend to discuss these data with scientific community and regulatory authorities to gain their advice on potential next steps," said Dr. Annalisa Jenkins, Head of Global Drug Development and Medical for Merck Serono, a division of Merck KGaA, Darmstadt, Germany.START was a randomized, multicenter, double-blind, placebo-controlled trial that assessed the efficacy, safety and tolerability of L-BLP25 in more than 1,500 patients with unresectable stage III NSCLC who had achieved response or stable disease after chemoradiotherapy.

a. START: Stimulating Targeted Antigenic Responses To NSCLC

About L-BLP25 (StimuvaxR) L-BLP25 is an investigational MUC1 antigen-specific cancer immunotherapy that is designed to stimulate the body's immune system to identify and target cells expressing the cell surface glycoprotein MUC1. MUC1 is expressed in many cancers, such as non-small cell lung cancer (NSCLC), and has multiple roles in promoting tumor growth and survival. L-BLP25 was being investigated in the Phase III START trial and is currently being investigated in the INSPIRE trial, both for the treatment of unresectable stage III NSCLC. Merck KGaA obtained the exclusive worldwide rights for development and commercialization of L-BLP25 from Oncothyreon Inc., Seattle, Washington, USA, in 2007, in an agreement replacing prior collaboration and supply agreements originally entered in 2001. In Japan, Merck KGaA entered into a co-development and co-marketing agreement for L-BLP25 with Ono Pharmaceutical Co., Ltd., Osaka, Japan. The START study was a Phase III, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of L-BLP25 in patients suffering from unresectable, stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemoradiotherapy. The study involves more than 1,500 patients in 33 countries. The primary endpoint of the START study is overall survival (OS).The INSPIRE study is a Phase III, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of L-BLP25 in patients of Asian heritage suffering from unresectable, stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemoradiotherapy. The design of the INSPIRE study is almost identical to the START study. INSPIRE will enroll approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.

浩鼎興櫃成交近10億!!

生技大爆發　浩鼎興櫃首日成交近10億 今富族網記者李珞／報導2012-12-23美國寬鬆政策欲罷不能，QE4呼之欲出的帶動下，大批資金湧向新興市場，台股也乘著這波浪潮，獲得激勵。12月共計將有逾20家企業登錄興櫃，加上兩岸醫藥合作以及國際大藥廠來台挑選合作夥伴的議題，讓掛牌與生技題材持續延燒。浩鼎（4174）於12日登錄興櫃，爆出近10億元大量，帶動生技族群上漲，也讓興櫃市場成交金額突破23億元，創5年以來新高紀錄，並連續占據興櫃成交值榜首。該公司由潤泰（9945）集團持股近5成，其研發的抗乳癌疫苗已進入臨床三期，兩年後有望上市，近日並成為跨國藥廠來台選秀的重點公司。生技類股中，醣聯（4168）、台微體（4152）、中裕（4147）、安成（4180）等個股，也因準上櫃以及大廠選秀加持等因素，持續獲得投資人青睞。本周漲勢較明顯個股有：杰力（5299）、旭晶（3647）、辛耘（3583）及遠業（3307）等。 杰力於7日登錄興櫃，該公司主要從事功率元件、電源管理積體電路開發，今年前10月自結EPS 1.62元。本周股價自27元來到34元。太陽能廠旭晶看好日本市場，與日本西控集團合作，於廣島設太陽能電廠，預計明年第一季並聯售電。一周來股價自2.8元達到3.6元附近。辛耘上月底通過股票申請上市。今年前3季EPS 1.35元。本周股價自30.8元來到36元附近。遠業為全球著名安全監控系統產業專業製造廠商，專業聚焦於CCD攝影機等設備；去年EPS 1.16元，今年前2季為0.53元。遠業曾在今年7月送件申請上市，但由於景氣不明等因素，又在10月撤回申請。本周股價自11.7元漲至15.3元附近。