BioDelivery Sciences Announces Commercial Launch of ONSOLIS in Canada

Aug. 22, 2011, PRNewswire ONSOLIS is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL) for the management of breakthrough pain in opioid tolerant, adult patients with cancer. ONSOLIS will be marketed in Canada by Meda Valeant Pharma Canada Inc., a joint venture between BDSI's commercial partner for ONSOLIS, Meda, and Valeant Canada Limited. "We are excited about the upcoming commercial launch of ONSOLIS in Canada," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "The achievement of this important milestone provides an opportunity for growth of ONSOLIS outside of the U.S. market, particularly where commercial efforts will not be impacted by a REMS requirement." Dr. Sirgo continued, "The Canadian market is also of particular importance as ONSOLIS will be among the first products available for the management of breakthrough pain in opioid tolerant individuals with cancer in that country. We remain highly confident based on the attributes of ONSOLIS that we can effectively compete in any market and believe that our partner Meda Valeant will leverage these attributes to build an important new market for ONSOLIS in Canada. We also look forward to introducing ONSOLIS into additional markets in the future." Valeant Pharmaceuticals International, Inc. is a multi-national specialty pharmaceutical company that develops and markets prescription and nonprescription pharmaceutical products. In Canada, the Valeant portfolio includes products for the treatment of pain and oncology supportive care, making them an ideal partner for the commercialization of ONSOLIS.

About BioDelivery Sciences International BioDelivery Sciences International /quotes/zigman/86973/quotes/nls/bdsi BDSI +8.71% is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL) for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation for the treatment of opioid dependence. Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting (BEMA Granisetron). BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com . BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.

Cautionary Note on Forward-Looking Statements This press release, the presentation described herein and the statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, those relating to the sales performance of ONSOLIS in Canada) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publically update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned that peak sales and market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such estimates are accurate or that such sales levels will be achieved, if at all.

SOURCE BioDelivery Sciences International, Inc.

(另思維) 台灣生技醫藥”本土”的現實!!

生技產業的希望與問題（許英昌） 2011年 08月22日 在資誠會計師事務所、生策會及玉山協會協助下，首檔台灣生技創投基金（TMF）在全民期盼下終於浮現，雖然由先前聲稱投資600億元縮小到60億元，但政府仍出資20％，帶動生技產業朝往下扎根向上結果的目標前進，政府將以投資醫療儀器為主軸，結合半導體及資訊產業經驗，帶動台灣新一波產業革命。毫無疑問在寧靜的生技製藥產業中，掀起陣陣波瀾。生技製藥產業包括人才、技術、資金、管理及市場整合，過去20年來台灣在肝炎防治、臨床試驗、疫苗製造及人才培育上，皆有傑出成果。新生技製藥公司，如神隆、太景、東洋及基亞等，也在困難重重環境中，如雨後春筍般脫穎而出。TMF的成立，有如一針強心劑；然而回顧過去Biofront、行政院生技產業策略諮議委員會提出「台灣生技起飛鑽石行動方案」等種種國家型計劃的執行結果，僅見樹卻不見林，TMF果真能使台灣生技業脫胎換骨嗎？如何避免曇花一現？ 第一、台灣生技遠景坐落何處？管理大師波特指出，未來人類將面臨人口結構改變、知識經濟時代、全球化經濟、能源缺乏及氣候變遷等問題，而台灣未來生技製藥產業的遠景及藍圖為何？心中要有未來情境及遠見才有策略，方能避開與他國硬碰硬競爭，從差異化中找出台灣生技產業核心競爭力，將其具體務實化，展現核心價值。TMF的決策專注於醫療器材投資與開發，果真能整合台灣生技與資通訊產業，說服產官學界支持嗎？不入虎穴焉得虎子，當年人類基因解碼計劃，洛克斐勒大學巴爾的摩校長（David Baltimore）與史丹福大學柏格（Paul Berg）教授的辯論，不就是最好例子，然而利用台灣低成本優勢，配合新科技製造多劑型多樣性學名藥，又何嘗不是優勢呢？醫療儀器並非唯一選擇。

訓練本土人才團隊 第二、決策應透明化，以避免利益衝突。投資國有潛力公司，引進技術以扶植本土產業生根，並非易事。TMF雖提供另一種模式，推動產業升級，然而移植模仿美國生技創投模式，又有哪幾個國家成功呢？又有誰在負責監督管理呢？簽署ECFA加速兩岸生技交流，果真只有好處沒有隱憂嗎？談判首重於蒐集情資，確定目標及決定議題後，方能趨於較佳結果，我們有足夠智慧專業人才主導兩岸醫藥交流談判嗎？第三、培養生技領導團隊，我們無法期待生物科技的李國鼎出現，從過去20年來，政策鬆散，斷斷續續沒有主軸且因人而異，有如瞎子摸象，又如何力挽狂瀾呢？很明顯地，我們缺乏生技領航員，領導人才或許無法訓練，然而從本土人才中訓練出一團隊，乃正本之道，一味強調高薪延攬，試問20年來又改變多少產業生態呢？試問資通訊產業的成功，難道是靠外來和尚打出一片天嗎？總而言之，我們需要一深諳政府生物科技發展藍圖目標及策略，了解國內學者才能，熟悉產業優勢並能說服國內創投，參與正確投資並具誠信的團隊，才能承擔責任，帶動新生技產業革命。生技發展需要熱情、智慧與勇氣，步步為營。TMF提供機會鼓舞產業，令人激賞。哲學大師波普（Karl Popper）有云：「樂觀是我們的道德義務。」 作者為中正大學生命科學系兼任助理教授

長庚養生村 華僑回台養老青睞!

長庚養生村 生活、醫療兼顧2011/08/22  世界新聞網  華僑掀起回台養老潮，台灣養生村的移民入住率逐年攀升。台塑集團位在林口的長庚養生文化村，回台華僑住戶所占比重已從過去的一成多，成長到目前超過三成，而且人數還不斷增加。 林口長庚養生村占地約34公頃，是目前台灣規模最大的養生村。一期園區自2005年開始啟用。林口養生村最知名的住戶，就是台大榮譽教授齊邦媛，她在長庚養生村中，完成巨作「巨流河」；台塑集團已故創辦人王永慶遺孀王月蘭，也住在養生村。 長庚養生村行政組工作人員指出，近期養生村入住比率最高的，當屬歸國華僑銀髮族，目前園區「長住戶」約450戶，其中華僑住戶所占比重，已從一開始只占12%，成長到目前超過三成，已有135戶左右。 華僑銀髮族近年申請入住的比重提高，台塑集團主管對此表示，這些華僑在國外雖然都有退休金，但若要維持理想的退休生活品質，手頭資金還是不太夠；選擇回台灣住進養生村，可以兼顧入住安養及提高醫療品質兩項條件。

衝著健保制度回台 台塑集團主管指出，美國醫療費用昂貴，養生村中有不少美國回來的老移民，在台灣住久了，都對台灣的健保制度讚不絕口。很多老年人回來，其實是衝著台灣的醫療制度；此外，有些華僑年紀大了，不跟子女同住，但也不習慣住在美加地區的安養院，落葉歸根還是選擇回台。長庚養生村訪查也發現，這些回台的華僑在美國退休後，一個月約可領到1000到3000美元（約2萬9000元到8萬7000元新台幣）退休金。但有住戶說，如果在美國一個月只有1000美元，絕對住不起品質好的安養院，就算一個月可領到3000美元，手頭也不是很寬裕。 長庚養生村單人房目前每月收費最低1萬8000元，雙人房每月最低收費2萬3000元，除住宿外，這些費用還涵蓋健康照護、緊急救護、社團活動費用等。長庚養生村人員說，對一個月領3000美元的華僑來說，若選擇雙人房，再加上每月膳食費用，總支出頂多台幣4到5萬元，資金相當夠用。

優質養老不用買房 台塑集團主管表示，美加移民入住者增加，是因為「住戶介紹住戶」，因為很多住戶會將入住經驗和住在美國的親友分享，還有人會寫在部落格上，近期很多美加移民就是透過網路來申請入住。這些人還特別強調，不想要回台後還在台灣買房子增加負擔，所以退休回台住養生村，是不錯選擇。

EMA accepts Merck and ARIAD's MAA for ridaforolimus to treat metastatic bone sarcomas

August 18, 2011 Merck (NYSE:MRK), known outside the United States and Canada as MSD, and ARIAD Pharmaceuticals, Inc., (NASDAQ:ARIA), today announced that the European Medicines Agency (EMA) has completed its administrative validation process for the regulatory application for ridaforolimus, an investigational oral mTOR inhibitor developed for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy. The completion of the marketing authorization application (MAA) validation process and acceptance for review now leads to the formal scientific review process by the EMA's Committee for Medicinal Products for Human Use. In addition to the EMA filing, Merck recently submitted a new drug application (NDA) for ridaforolimus to the U.S. Food and Drug Administration. Within the next 60 days, the FDA will determine whether it will accept Merck's application as submitted. As part of an exclusive license agreement with ARIAD, Merck is responsible for the development and worldwide commercialization of ridaforolimus in oncology. ARIAD intends to co-promote ridaforolimus in the United States. "This acceptance of the EMA filing for review is an important milestone as we seek to bring forward a potential treatment option for patients with metastatic bone and soft tissue sarcomas," said Marty Duvall, senior vice president and general manager, oncology franchise, Merck Global Human Health. "We are pleased with both the acceptance of the MAA in Europe and the timely filing of the NDA for ridaforolimus in the United States," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "These regulatory initiatives underscore the importance of ridaforolimus for both ARIAD and the Merck oncology franchise, and we look forward to successful completion of the review process with both regulatory agencies." Source: Merck

中化生提供API 口服mTOR抑制劑 (Ridaforolimus)

默克新藥報喜 中化生進補2011-08-23 工商時報 中化生（1762）參與美國默克藥廠抗骨癌新藥Ridaforolimus研發，在默克已獲歐盟藥品監督局（EMA）接受該新藥的銷售申請，預計很快可正式上市下，中化生業績將直接受惠，原料藥Rapamycin出貨量可望水漲船高，2018年起有機會年貢獻20億元營收。根據美國Cowen & Co指出，Radaforolimus相當成功的3期臨床數據，足以使該藥快速通過美國食品管理局（FDA）審查，該財務公司並預估其市場銷售值將於2015年時，衝破3.5億美元。法人指出，Ridaforolimus除治療骨癌療效外，目前默克和合作的Ariad藥廠亦陸續進行直腸癌，卵巢癌，乳癌，子宮內膜癌及腎臟癌等療效臨床試驗，由於Ridaforolimus的原料藥Rapamycin是由中化生提供，如果Ridaforolimus在治療其他癌症上進行順利，2018全面上市後後，每年將可為中化生帶來高達20億元的營收。中化生副總經理黃重信表示，該公司已接獲默克通知，抗骨癌新藥Ridaforolimus，19日已獲EMA接受在歐盟國家銷售的申請。另外，默克和Ariad藥廠也在1個月前，向美國FDA提出同一療效的新藥申請，預計未來60天內FDA將確認進行實質審查。黃重信指出，目前中化生除了Rapamycin-Ridaforolimus新藥等待歐美國家核准外，尚有Tacrolimus供貨美國兩家學名藥廠申請ANDA上市，而研發中的學名藥新產品，也陸續獲歐美學名藥廠青睞，如抗癌藥Everolimus、免疫抑制劑Temsirolimus及抗真菌劑之Caspofungin、Micafungin、Anidulafungin等系列產品，規劃將於2014年後歐美客戶陸續取得ANDA上市。