健保給付類風濕性關節炎用藥: Tocilizumab (humanized monoclonal antibody against IL-6R)

類風濕性關節炎藥納健保給付【2012/05/07中央社】類風濕性關節炎屬重大傷病，醫師表示，致病原因不明，可能與基因和環境有關，自本月開始健保局也有條件通過治療的第二線用藥安挺樂（Tocilizumab）給付。中華民國風濕病醫學會理事長蔡嘉哲表示，類風濕性關節炎常發生於手、腕、足等小關節。初期有關節紅腫熱痛症狀；中期開始有輕度的軟骨破壞、肌肉萎縮；晚期關節出現肌肉萎縮，關節嚴重變形，影響生活及工作能力，健保局也將類風濕性關節炎列為重大傷病。蔡嘉哲說，類風濕性關節炎會影響身體及心理健康、降低生活品質、降低生產力、增加死亡率，對個人、家庭、及社會都造成很大的負擔，呼籲國人正視疾病，及早發現、及早接受正規治療。林口長庚醫院風濕過敏免疫科醫師羅淑芬表示，目前用於治療的生物製劑分為第一線藥物抗腫瘤壞死因子製劑，如恩博（Etanercept）、復邁（Adalimumab）、欣普尼（Golimumab）；若無效才使用第二線治療藥物，如莫須瘤（Rituximab）與安挺樂（Tocilizumab）。羅淑芬說，自5月起中央健康保險局通過安挺樂健保給付。臨床研究證實類風濕性關節炎患者體內細胞激素介白素六（IL-6）的濃度較高，與受體結合後會引發關節腫痛與破壞。羅淑芬說，安挺樂可透過阻斷介白素六與受體的結合，達到抑制發炎、消除腫痛及停止關節破壞的治療目標，同時也可改善患者的貧血情況，不過健保給付仍是有條件的，需重度類風濕性關節炎患者才適用。

智擎 申請上櫃案!

「智擎生技製藥」申請上櫃作業  鉅亨網2012-04-30辦理智擎生技製藥股份有限公司申請上櫃案之意見徵詢作業。一、公司名稱：智擎生技製藥股份有限公司二、主要營業項目：新藥開發三、公開說明書與評估報告陳列地點：本中心資料室（地址：台北市羅斯福路二段100號13樓）四、凡社會大眾對該公司申請上櫃案，有任何意見或疑慮者，得依前揭作業要點三規定，於101年5月16日前以書面載明下列事項及檢附相關資料送達本中心（地址：台北市羅斯福路二段100號16樓上櫃審查部收）。(一)意見表達者之姓名、聯絡地址及電話，並檢附身分證正反面之影本乙份（其身分本中心予以保密）。(二)對股票上櫃申請案之意見及相關事證資料。五、凡未具名、冒名或以化名所提出之意見或問題，或所提出之意見或問題無具體事證、事蹟者，本中心得不受理。

Enzon and Hisun Announce Strategic Alliance for Enzon's Customized PEGylation Linker Technology and Licensing Agreement for PEG-SN38 in China

May 7, 2012, 10:04 a.m. EDT   PISCATAWAY, NJ and ZHEJIANG, CHINA, May 07, 2012 (MARKETWIRE via COMTEX) -- Enzon Pharmaceuticals, Inc. ENZN +3.24% and Zhejiang Hisun Pharmaceuticals Co. Ltd (sse code:600267), a leading Chinese pharmaceutical company, announced today a long-term strategic research, development and licensing collaboration. The agreement provides for the research and development of therapeutics using Enzon's customized PEGylation linker technology. The agreement also includes the license to Hisun of development and commercialization rights for Enzon's PEG-SN38 (EZN-2208), a novel, Phase II PEGylated version of SN38, in the territory of China.   Under the terms of the strategic research, development and licensing collaboration, Hisun will pay Enzon to apply its Customized PEGylation Linker Technology, especially its releasable PEGylation technology, and know-how to the development of next-generation, PEGylated versions of select therapeutic candidates within Hisun's pipeline. Once successfully PEGylated, Hisun will have the option to in-license the product candidates, based upon internal selection criteria, and will be fully responsible for funding development and commercialization of these products in the territory of China. Under this agreement, Enzon is entitled to milestone payments and a high-single-digit royalty on net sales for any product developed and commercialized in China, in addition to retaining rights to all PEGylated compounds outside of China.   Hisun has also acquired exclusive development and commercialization rights to PEG-SN38 in China and will pay Enzon an undisclosed upfront fee, milestone payments and a high-single-digit royalty on net sales. Further financial terms were not disclosed. PEG-SN38 has completed Phase II clinical trials in the United States where it was studied as a treatment for metastatic breast cancer, colorectal cancer and solid tumors in pediatric cancer patients. It is a PEGylated conjugate of SN38, the active metabolite of the widely used anti-cancer drug irinotecan. PEG-SN38 offers therapeutic advantages over unmodified SN38, including increased solubility, higher exposure and tumor accumulation, more profound deoxyribonucleic acid (DNA) damage, inhibition of angiogenesis and longer apparent half-life of SN38 as compared to irinotecan.   "Hisun is a dynamic company with an aggressive strategy for expanding its portfolio of innovative therapeutics. We are very excited about this partnership and we look forward to advancing a variety of next-generation therapeutics with Hisun in China and for Enzon in other territories around the world," said Ana Stancic, Principal Executive Officer of Enzon. "Enzon's broad portfolio of proprietary permanent and releasable PEGylation linker technology and decades of know-how offer unmatched, clinically and commercially validated capabilities for the enhancement of existing therapies to create novel, high-value product candidates, including bio-betters."   Hua Bai, CEO and Chairman of Hisun, added, "Enzon's PEGylation technology is utilized in approved products generating a combined total of over $7 billion in annual sales, making them the partner of choice for validated PEGylation technology. In addition to obtaining rights to PEG-SN38, this partnership provides Hisun access to innovative technology and development capabilities that will allow us to deliver novel therapeutics to the rapidly growing pharmaceutical market in China."   Enzon is actively pursuing strategic partnerships with leading biotechnology and pharmaceutical companies worldwide whose marketed, development, or discovery-stage products may benefit from the enhanced pharmaceutical properties of PEGylation. "Our PEGylation platform, combined with our extensive know-how, continues to be the gold standard for maximizing the therapeutic potential of both small molecules and biologics," says Ms. Stancic.   

About Enzon's Customized PEGylation Linker Technology   PEGylation has successfully been used on various pharmaceutical compounds, including enzymes, peptides and antibodies, to improve their pharmaceutical properties through the chemical attachment of polyethylene glycol (PEG) using our Customized Linker Technology. PEGylation technology employs proprietary chemical linkers designed to either release the native molecule at a controlled rate or provide permanent linkage that will maximize inherent activity of the native molecule. In some cases, PEGylation can render a compound therapeutically effective, whereas the unmodified form had only limited clinical utility.   

About Hisun   Hisun is a leading biopharmaceutical group focused on improving patient wellbeing and quality of life. Headquartered in Taizhou (Zhejiang, China), the company currently employs more than 3,800 people. Hisun's operations strictly follow cGMP and received ISO 14000 certification in 2001. To date, more than 40 of the company's products have passed certification by the FDA (US), EDQM (EU), TGA (Australia), KFDA (Korea), etc., and are sold in more than 30 countries. The company opened its U.S. headquarters in Princeton, N.J., in 2010. For more information, visit www.hisunusa.com .   

About Enzon, Inc.   Enzon Pharmaceuticals, Inc. is a biotechnology company dedicated to the research and development of innovative therapeutics for patients with high unmet medical need. Enzon's drug-development programs utilize two platforms: Customized PEGylation Linker Technology (Customized Linker Technology(R)) and third-generation mRNA-targeting agents utilizing the Locked Nucleic Acid (LNA) technology. Enzon currently has four compounds in human clinical development and multiple novel mRNA antagonists in preclinical research. Enzon receives royalty revenues from licensing arrangements with other companies related to sales of products developed using its proprietary Customized Linker Technology. Further information about Enzon and this press release can be found on the Company's website at www.enzon.com .   

Forward-Looking Statements   This press release contains, or may contain, forward-looking statements within the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements that are purely historical, are forward-looking statements, which can be identified by the use of forward-looking terminology such as the words "believes," "expects," "may," "will," "should," "potential," "anticipates," "plans," or "intends" and similar expressions.   Such forward-looking statements are based upon management's present expectations, objectives, anticipation, plans, hopes, beliefs, intentions or strategies regarding the future and are subject to known and unknown risks and uncertainties that could cause actual results, events or developments to be materially different from those indicated in such forward-looking statements. A more detailed discussion of these and other factors that could affect results is contained in Enzon's filings with the U.S. Securities and Exchange Commission, including Enzon's Annual Report on Form 10-K for the year ended December 31, 2011. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. No assurance can be given that the future results covered by the forward-looking statements will be achieved. All information in this press release is as of the date of this press release and Enzon does not intend to update this information.

Chiltern Announces New Legal Entity In Taiwan

 April 23, 2012 LONDON, April 23, 2012 /PRNewswire via COMTEX/ -- Chiltern International Limited (Chiltern), a global contract research organization (CRO), announced that the company has established a new legal entity in Taiwan.   Dr. Umakanta Sahoo, Chiltern Executive Director, Asia Pacific and Managing Director, India, commented, "Chiltern has already established a strong presence in this region with its offices in India, Singapore and Australia and hence forming a legal entity in other important countries in the region is a natural progression to enhance our global reach." Dr. Sahoo, who will be leading the effort in Taiwan, continued, "With the regional collaboration between Asian countries for mutual acceptance of Asian data, Japan, USA and European clients have shown increased interest in Taiwan to perform global clinical trials due to supportive regulatory environment, excellent hospital infrastructure and healthcare system."   Aize Smink, Chiltern Sr. Executive VP, Global Clinical Development, stated, "We are very pleased to be able to start offering clinical research services in Taiwan as part of our global clinical development capabilities. Taiwan has an excellent medical infrastructure, high quality investigators and research staff to serve our global client base."    

About Chiltern: Established in 1982, Chiltern is a leading global clinical CRO with extensive experience in the management of Phase I-IV clinical trials across a broad range of therapeutic areas, functional service provision and contract staffing solutions. Chiltern has conducted trials in more than 40 countries, employs nearly 1,300 people globally and offers services in Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions. Chiltern prides itself as a development partner that offers flexibility, responsiveness and quality delivery. Further information is available at: www.chiltern.com .

永信 於湖北合資設立永瑞生技 破局!!

永信：補充公告101/3/23序號9「本公司代重要子公司永信藥品工業股份有限公司公告終止大陸永瑞合資案」 鉅亨網　　2012-05-04   第二條　第49款  1.事實發生日:101/05/04    2.公司名稱:永信藥品工業股份有限公司  3.與公司關係(請輸入本公司或聯屬公司):聯屬公司  4.相互持股比例:本公司百分之百持股子公司  5.發生緣由:  (1)永信藥品工業股份有限公司101/3/23董事會決議終止大陸投資永瑞生技有限公司。  (2)永瑞合資案因三方合資股東對於擴量生產之意見歧異未有共識，為避免影響   永信藥品工業股份有限公司營運，擬予終止合資案。  (3)經英屬維京群島YungRay Investment Co., Ltd. 101/05/04董事會通過三方合資終止   ，永信藥品工業股份有限公司正式與原合資案股東簽署終止合約。  6.因應措施:無  7.其他應敘明事項:補充公告本公司101/3/23序號9之公告。