美国干细胞公司BioTime宣布完成对新加坡的胚胎干细胞国际公司(ES Cell International Pte Ltd,ESI)的收购
- BioTime2010年5月5日 16:18 点击:4638
加利福尼亚州Alameda--(美国商业资讯)--从事人类干细胞和再生药物领域产品的研发和销售的生物技术公司BioTime公司(全美证券交易所代码:BTIM)今天宣布,该公司已经完成了对新加坡的胚胎干细胞国际公司(ES Cell International Pte Ltd,ESI)的收购。成立于2000年的ESI一直是人类胚胎干细胞(hES)技术开发领域的全球领导者,该公司是首批向科研领域销售人类胚胎干细胞系的公司之一,已经提交了众多的早期干细胞专利申请,并且与全球干细胞研究团体建立了重要关系。ESI的其它资产包括:一个由依照现行良好操作规范(cGMP)原则生产出的6种新型临床级人类胚胎干细胞系组成的细胞库,以及在以色列干细胞治疗公司Cell Cure Neurosciences, Ltd.中所持的权益。BioTime预计,ESI的资产和科学团队的加入将可以使其更快地开发研究产品和潜在治疗产品,以及建立新的商业关系。
ESI位于新加坡的地标性建筑Biopolis中,Biopolis是亚洲的一个世界级生物医学科学研发中心。Biopolis吸引了来自全球的领先研究人员和制药公司,这不仅因为它具有先进的实验设施和技能熟练的工作人员,而且还因为它毗邻中国、印度和其它快速发展的市场。新加坡作为亚洲的区域性产品分销中心已有很长时间。除了研究和生产活动外,ESI设施还将作为BioTime在亚洲销售产品的装运点。
通过与ESI的前股东和债务持有人进行交易,BioTime已经收购了ESI的所有已发行股票和债务证券。ESI如今已成为了BioTime.的全资子公司。ESI没有重大的第三方负债,此次收购也没有为BioTime自身带来新的债务。为了兑换ESI的所有股票和债务,BioTime已经向ESI 的前股东和债务持有人发行了1,383,400股BioTime普通股以及可以购买另外30万股普通股的认股权证,这批认股权证能够以每股10美元的行权价购买BioTime普通股。此次收购中发行的这批BioTime认股权证的有效期为自发行日起的四年。
BioTime公司总裁兼首席执行官Michael D. West(药理学博士)说:"ESI一直致力于再生药物领域的重大进步。我们非常欢迎ESI的科学团队加入BioTime。ESI的临床级细胞库将可以为 BioTime提供一个领先的生产平台,用于生产广泛的潜在人类治疗产品,并且还将能够加快我们研究产品的开发。与我们的子公司BioTime Asia, Limited一起,ESI还将可以增强我们在亚洲市场的业务。我们还期待与Cell Cure Neurosciences一起推动其视网膜和神经系统产品的开发。"
EDB Investments是一家总部位于新加坡的领先投资公司,对全球的生物医学科学领域进行投资。该公司首席执行官Swee-Yeok Chu女士说:"ESI一直是新加坡干细胞研发领域的领先公司,其技术和资产与BioTime先进的ACTCellerateTM和ReCyteTM技术可产生巨大协同优势。通过此次交易,ESI的知识产权和技术将可以促进BioTime.现有的新型再生和细胞疗法产品的开发。我们很高兴BioTime已经认可了新加坡在基础设施和商业环境方面的优势,并且选择新加坡作为亚洲的产品生产和分销中心。我们期待实现卓有成效的合作,加快向研究人员和患者销售这些重要的新型医疗产品。"
临床级人类胚胎干细胞主细胞库
临床级人类治疗产品的开发需要高标准的质量控制。生产各方面的具体程序以及这类产品的测试(可能对产品的安全性和质量产生影响)一般被称为"现行良好操作规范"(cGMP)。美国食品及药物管理局(FDA)执行的cGMP规则与用于美国的人类疗法的生产相关,并且全球几乎所有国家在人类治疗产品的生产方面都维持着一些类似的质量控制标准。
2007年,ESI推出了全球首个遵照cGMP规则的hES细胞系。ESI和来自Sydney IVF(澳大利亚领先的不孕症和体外受精治疗中心)的科学家还出版了一篇题为"一代6种临床级人类胚胎干细胞系"的科学报告。该报告描述了用于记录临床级 hES细胞系生产的程序,这些细胞系源自人类饲养细胞(通过一个经FDA批准的来源获得),在一个获得许可的cGMP设施中生产,经过了捐赠者同意,并且对捐赠者进行了医疗筛选检查。BioTime的ACTCellerateTM技术可使人类胚胎祖克隆细胞系的衍生具有高水平的纯度和可扩展性,BioTime认为,通过结合这一技术, ESI的临床级主细胞库可用来培养具有业界无与伦比的纯度和质量水平的临床级克隆胚胎祖细胞系。BioTime预计,对ESI的临床级hES细胞库的收购将可以节省公司数年的开发时间,从而加快具有用于研究产品和治疗产品潜力的临床级祖细胞的开发。BioTime的研究产品由Millipore Corporation在全球联合销售。
知识产权
ESI的专利组合包含20个专利族,涉及hES细胞识别、繁殖、遗传操纵、存储和hES细胞定向分化为其它细胞类型(例如,细胞分化为神经元祖、胰腺祖或心肌细胞)的各方面。ESI目前在多个国家--包括美国、英国、澳大利亚、以色列和新加坡--持有或者通过其它公司的授权而获得了50多项已发行专利。与BioTime原有的知识产权组合一起,这些专利如今使BioTime拥有了全球领先的干细胞专利组合之一。BioTime预计,随着干细胞领域的拓展,其知识产权组合的价值将会继续提高,从而创造重要的许可营收机会。
Cell Cure Neurosciences, Ltd.
ESI持有Cell Cure Neurosciences Ltd.的49%以上的股份。Cell Cure Neurosciences Ltd.是一家位于以色列的生物技术公司,致力于开发针对视网膜和神经失调疾病的干细胞疗法,包括开发用于治疗干性年龄相关性黄斑变性的视网膜色素上皮细胞。Cell Cure的其他股东包括Hadasit BioHoldings, Ltd.和Teva Pharmaceutical Industries, Ltd.。
背景信息
再生药物是指研发和利用基于人类胚胎干细胞或诱导多功能干细胞技术的疗法。这些疗法将用于受到退化性疾病摧残的组织的再生。科学界和公众对再生药物的主要兴趣在于是否能使人类胚胎干细胞和诱导多功能干细胞分化为人体内所有类型的细胞。许多科学家因此认为人类胚胎干细胞和诱导多功能干细胞很有潜力催生一批新疗法,用于治疗糖尿病、帕金森症、心力衰竭、关节炎、肌肉萎缩症、脊髓损伤、黄斑退化、听力丧失、肝功能衰竭以及其他多种由于细胞和组织功能失调需要替换而产生的功能紊乱等目前不可治愈的疾病。
由于人类胚胎干细胞取自人工授精过程中丢弃的人类胚胎,因此其科研利用引发了许多争议。但是,诱导多功能干细胞可用无争议的成体细胞--如皮肤细胞 --生成,而不用胚胎细胞。成体细胞的特定基因的改造使它们能够转化为与人类胚胎干细胞极为相似的诱导多功能干细胞。BioTime的干细胞治疗产品研发处于临床前阶段,并且需要进行多年的广泛试验后才能用于人类治疗。
关于BioTime公司
总部位于加利福尼亚州Alameda的BioTime是一家专注于再生药物和血浆容量扩张剂的生物技术公司。BioTime通过其全资子公司 Embryome Sciences, Inc.从事干细胞和再生药物领域的科研产品的研发和销售。BioTime的子公司OncoCyte Corporation专注于干细胞技术在癌症治疗中的应用。BioTime还计划在中国研发用于眼科、皮肤科、肌骨系统和血液疾病的治疗产品,包括通过其子公司BioTime Asia, Limited以基因改良的干细胞靶向肿瘤作为治疗目前不可治愈的癌症种类的新方法。除了干细胞产品以外,BioTime还研发血浆容量扩张剂、低温手术的血液置换解决方案,以及用于外科手术、紧急外伤处理及其他应用的技术。BioTime的主打产品Hextend®是一款血浆容量扩张剂,按照独家授权协议,在美国由Hospira, Inc.生产和销售,在韩国由CJ CheilJedang Corp.生产和销售。如欲了解更多关于BioTime和ESI的信息,请访问网站www.biotimeinc.com。
关于EDB Investments
EDB Investments(简称"EDBI")是总部位于新加坡的领先投资公司,其业务遍及全球。EDBI在全球的创新和充满活力的生物医学科学领域进行投资,并且在清洁技术和数字媒体等其它重要行业进行投资。作为一家增值投资公司,EDBI与其投资组合公司紧密合作,利用其广泛的网络和经验来帮助建立和推动这些公司的亚洲发展战略。
欲了解更多信息,请访问:www.edbi.com。
前瞻性陈述
与公司及其子公司未来财务和/或经营业绩,未来研究、技术、临床研发和潜在机会的增长相关的陈述,以及管理层关于未来期望、信念、目标、计划或展望的其他陈述都构成前瞻性陈述。一切非史实性陈述(包括但不限于包含"将会"、"相信"、"计划"、"期望"、"预期"、"估计"等词语的陈述)都应被视为前瞻性陈述。前瞻性陈述涉及各种风险和不确定性,其中包括但不限于潜在产品的研发和/或商业化所蕴含的风险、临床试验或监管部门审核结果的不确定性、未来获取资本的需求和能力、以及知识产权的维护等。实际结果可能与这些前瞻性陈述中期望的结果产生重大差异,因此需要综合考虑许多影响公司业务的不确定性,特别是公司向美国证券交易委员会提交的文件中的警戒性声明中提及的因素。公司没有任何更新上述前瞻性陈述的意愿或责任。
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免责声明:本公告之原文版本乃官方授权版本。译文仅供方便了解之用,烦请参照原文,原文版本乃唯一具法律效力之版本。
联系方式:
BioTime公司
Judith Segall,510-521-3390转 301
jsegall@biotimemail.com
BioTime新闻稿 |
BioTime, Inc. Announces Completion of ES Cell International Pte Ltd Acquisition |
Acquisition to Accelerate Development of Research and Therapeutic Products BioTime, Inc. (NYSE Amex: BTIM), a biotechnology company that develops and markets products in the field of human stem cells and regenerative medicine, today announced that it has completed its acquisition of the Singapore company ES Cell International Pte Ltd ("ESI"). Established in 2000, ESI has been a worldwide leader in the development of human embryonic stem ("hES") cell technology, being one of the initial providers of human embryonic stem cell lines to the research community, having filed numerous early stem cell patent applications, and having built important relationships within the worldwide stem cell research community. Additional ESI assets include a bank of six new clinical-grade human embryonic stem cell lines produced following the principles of current Good Manufacturing Practice ("cGMP"), and equity in the Israel-based stem cell therapeutics company Cell Cure Neurosciences, Ltd. BioTime expects that the addition of ESI's assets and scientific team will enable it to more quickly develop its research products and potential therapeutic products, and establish new commercial relationships. ESI is based in Singapore's iconic Biopolis, a world-class biomedical science research and development hub for Asia. The Biopolis has attracted leading researchers and pharmaceutical companies from around the world, not only because of its laboratory facilities and skilled workforce but also because of its proximity to China, India, and other rapidly growing markets. Singapore has a long history as a regional center for product distribution throughout Asia. In addition to research and manufacturing activities, the ESI facility will be a shipping point for BioTime's product sales in Asia. Through transactions with ESI's former shareholders and debtholders, BioTime has acquired all of the outstanding shares and debt instruments of ESI, which has now become a wholly-owned subsidiary of BioTime. ESI has no significant liabilities to third parties, and BioTime has no new debt obligations of its own as a result of this acquisition. In exchange for all of ESI's shares and debt, BioTime has issued to ESI's former shareholders and debtholders 1,383,400 BioTime common shares, and warrants to purchase an additional 300,000 common shares at an exercise price of $10 per share. The BioTime warrants issued in the acquisition will expire four years after the date of issue. "ESI has been responsible for important advances in the field of regenerative medicine," said Michael D. West, Ph.D., President and Chief Executive Officer of BioTime, Inc. "We are pleased to welcome ESI's scientific team to BioTime. ESI's clinical-grade cell banks will provide BioTime with a leading manufacturing platform for a wide array of potential human therapeutic products, and will accelerate the development of our research products. Together with our subsidiary BioTime Asia, Limited, ESI will also advance our business in Asian markets. We also look forward to working with Cell Cure Neurosciences to advance their retinal and neuroscience product development." "ESI has been a pioneer in stem cell research and development in Singapore, and its technology and assets provide great synergies with the advanced ACTCellerateTM and ReCyteTM technologies of BioTime," said Ms. Swee-Yeok Chu, CEO of EDB Investments ("EDBI"), a leading investment firm headquartered in Singapore that invests globally in the biomedical sciences sector. "Through this transaction, ESI's intellectual property and technology will enhance the development of exciting new products in regenerative and cell therapy at BioTime. We are pleased that BioTime has recognized Singapore's strengths in infrastructure and business environment and have chosen Singapore as a hub for the manufacture and distribution of products throughout Asia, and we look forward to a productive collaboration in accelerating the marketing of these new and important medical products to researchers and patients." Clinical-Grade Human Embryonic Stem Cell Master Cell Banks The development of clinical-grade human therapeutic products requires high standards of quality control. The detailed procedures for all aspects of production and testing of such products with the potential to impact the safety and quality of a product are commonly called "Current Good Manufacturing Practice" or "cGMP." The U.S. Food and Drug Administration ("FDA") enforces cGMP regulations with respect to the manufacturing of human therapeutics for use in the U.S., and virtually every country across the globe maintains some analogous standards for quality control in the manufacture of human therapeutic products. In 2007, ESI announced the world's first hES cell lines derived according to the principles of cGMP. ESI and scientists from Sydney IVF, Australia's leading center for infertility and in vitro fertilization ("IVF") treatment, also published a scientific report titled, "The Generation of Six Clinical-Grade Human Embryonic Stem Cell Lines." The paper outlined the procedures used to document the production of clinical-grade hES cell lines derived on human feeder cells obtained from an FDA approved source, produced in a licensed cGMP facility, with donor consent and medical screening of donors. Combined with BioTime's ACTCellerateTM technology that allows the derivation of human embryonic progenitor clonal cell lines with high levels of purity and scalability, BioTime believes that ESI's clinical-grade master cell banks may be used to generate clonal clinical-grade embryonic progenitor cell lines with a level of purity and quality unsurpassed in the industry. BioTime expects that the acquisition of ESI's clinical-grade hES cell bank will save the Company years of development time and thereby accelerate the development of clinical-grade progenitor cells for potential use in research products and therapeutic products. BioTime's research products are co-marketed worldwide by Millipore Corporation. Intellectual Property ESI's patent portfolio includes 20 patent families covering various aspects of hES cell identification, propagation, genetic manipulation, storage, and directed differentiation of hES cells into other cell types (for example differentiating cells into neuronal progenitors, pancreatic progenitors, or cardiomyocytes). ESI currently holds or licenses from others more than 50 issued patents in various countries, including the United States, the UK, Australia, Israel, and Singapore. Combined with BioTime's existing intellectual property portfolio, these patents now provide BioTime with one of the leading stem cell patent portfolios in the world. BioTime expects that its intellectual property portfolio's value will continue to grow over time as the stem cell sector expands, creating significant licensing revenue opportunities. Cell Cure Neurosciences, Ltd. ESI holds over 49% of the shares of Cell Cure Neurosciences Ltd., an Israel-based biotechnology company focused on developing stem cell-based therapies for retinal and neurological disorders, including the development of retinal pigment epithelial cells for the treatment of dry age-related macular degeneration. The other shareholders of Cell Cure are Hadasit BioHoldings, Ltd. and Teva Pharmaceutical Industries, Ltd. Background Regenerative medicine refers to the development and use of therapies based on hES cell or induced pluripotent stem ("iPS") cell technology. These therapies will be designed to regenerate tissues afflicted by degenerative diseases. The great scientific and public interest in regenerative medicine lies in the potential of hES and induced pluripotent stem ("iPS") cells to become all of the cell types of the human body. Many scientists therefore believe that hES and iPS cells have considerable potential as sources of new therapies for a host of currently incurable diseases such as diabetes, Parkinson's disease, heart failure, arthritis, muscular dystrophy, spinal cord injury, macular degeneration, hearing loss, liver failure, and many other disorders where cells and tissues become dysfunctional and need to be replaced. Since human embryonic stem cells are derived from discarded human embryos created in the process of in vitro fertilization, their use in research has been controversial. However, iPS cells can be created using noncontroversial adult cells, such as skin cells, rather than embryonic cells. The alteration of specific genes in adult cells allows them to be transformed into iPS cells that are very similar to hES cells. BioTime's stem cell-based therapeutic product development is in the preclinical stages and will require years of extensive testing prior to being used in an effort to treat humans. About BioTime, Inc. BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. BioTime develops and markets research products in the field of stem cells and regenerative medicine through its wholly-owned subsidiary, Embryome Sciences, Inc. BioTime's subsidiary OncoCyte Corporation focuses on the therapeutic applications of stem cell technology in cancer. BioTime also plans to develop therapeutic products in China for the treatment of ophthalmologic, skin, and musculo-skeletal system and hematologic diseases, including the targeting of genetically modified stem cells to tumors as a novel means of treating currently incurable forms of cancer through its subsidiary BioTime Asia, Limited. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low temperature) surgery, and technology for use in surgery, emergency trauma treatment, and other applications. BioTime's lead product, Hextend®, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime and ESI can be found on the web at www.biotimeinc.com. About EDB Investments EDB Investments ("EDBI") is a leading investment firm headquartered in Singapore with worldwide presence. EDBI invests globally in the innovative and dynamic sector of Biomedical Sciences, as well as in other key industries such as Clean Technologies and Digital Media. As a value-adding investor, EDBI works closely with its portfolio companies, leveraging on its extensive networks and experience to help bridge and drive the companies' growth strategies for Asia. For more information please visit www.edbi.com. Forward-Looking Statements Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements.Any statements that are not historical fact (including, but not limited to, statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements.Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights.Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements. To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://www.b2i.us/irpass.asp?BzID=1152&to=ea&s=0.
BioTime, Inc.
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May 03, 2010 |
联系邮箱:kefu@labbase.net
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