再鼎医药与美国Paratek Pharma合作，为中国患者开发新型抗生素药物
Paratek Pharmaceuticals, Inc.是一家在纳斯达克上市的美国生物制药公司，股票代码为PRTK，致力于开发基于四环素化学的创新型疗法并将其商业化。波士顿当地时间2017年4月24日，该公司宣布他们与总部位于上海的再鼎医药，一家中国生物制药公司，达成合作协议。再鼎医药将在中国开发销售omadacycline，惠及中国患者。
根据协议，Paratek给予再鼎医药独家授权，再鼎医药将在大中华区开发、生产和销售omadacycline，包括中国大陆、香港、澳门和台湾市场。两家公司将成立一个联合指导委员会来审核和监督所有的开发、制造和商业化计划和进程。Paratek将在签署协议时收到750万美元的签约金，有资格获得额外的开发、注册和商业化相关的里程碑付款。此外，Paratek将有资格获得omadacycline在大中华区销售收入的分成。
“我们开展的针对皮肤感染和肺炎的临床3期有效性研究的成功展示了omadacycline是治疗严重细菌感染的一种有前途的新的治疗方案，” Paratek的董事长兼首席执行官Michael Bigham先生评论道。“与再鼎医药达成的协议进一步验证了这一潜力，代表了将omadacycline带给大中华区众多病患这一努力的令人激动的一步，这里的患者需要一个新的、有效的、耐受性良好、可IV和每日口服的广谱抗生素，尤其是当耐药性是一个问题。”
再鼎医药的董事长兼首席执行官Samantha Du（杜莹博士）补充道，“我们很高兴与Paratek合作将omadacycline引进中国，带给中国患者。据估计，中国的人均抗生素的使用量明显高于美国。抗生素耐药性在中国已日益成为一个严重的问题。基于Paratek目前已经产生的数据，我们相信omadacycline有潜力成为中国医生试图解决日益严重的耐药问题的一个有价值的新工具。”
Omadacycline是一个新的、每日一次、可口服和静脉注射的广谱抗生素，被开发成针对严重的社区获得性细菌感染患者的经验性治疗，如急性细菌性皮肤和皮肤结构感染、社区获得性细菌性肺炎、尿路感染，以及其它社区获得性细菌感染，特别是当抗生素耐药性令医生担忧时。针对这些适应症，ommadacycline被FDA授予合格传染病产品（Qualified Infectious Disease Product）资格和快速通道待遇。
关于Paratek Pharmaceuticals, Inc.
Paratek是一家生物制药公司，致力于开发销售基于其新颖四环素化学专长的创新疗法。领先候选药物ommadacycline是一类新的被称为aminomethylcyclines的四环素药物中的第一个，对Gram阳性、Gram阴性和非典型细菌具有广谱活性。2016年6月份，Paratek宣布了针对急性细菌性皮肤和皮肤结构感染（ABSSSI）的三期注册研究获得积极的有效性数据，与利奈唑胺对照，omadacycline，通过静脉注射和每日一次口服，展示了药效、总体安全性和耐受性。2017年4月，Paratek宣布了针对社区获得性细菌性肺炎（CABP）的三期注册研究获得的积极的有效性数据，与莫西沙星对比，omadacycline，通过静脉注射和每日一次口服，展示了有效性和安全性。一个针对ABSSSI的比较一天一次只口服omadacycline和一天两次只口服利奈唑胺的三期注册研究于2016年8月份启动。Topline data预计2017年6月底可以获得。针对无并发症尿路感染的临床IB研究于2016年5月份启动，2016年11月份积极的topline PK proof-of principle 数据被报道。该公司计划最早在2017年12月份开始招募患者参加复杂性尿路感染2期POC（proof-of-concept）研究。
两个临床3期试验成功完成，Paratek已满足了FDA关于特殊方案评估的注册申报要求。公司计划最早在2018年第一季度在美国递交NDA，2018年晚些时候递交EMA申请。2016年10月份，Paratek宣布与美国陆军传染病医学研究所（USAMRIID）开展新的合作，研究omadacycline对病原体引起的传染病的公共卫生和生物防御的重要性。这些研究的目的是确定给药方案和评估omadacycline对生物防御病原体的疗效，包括Yersinia pestis（瘟疫）和Bacillus anthracis（炭疽）。
公司的第二个临床3期候选药物是sarecycline，一个良好的耐受性、每日口服、由四环素衍生的窄谱抗生素，具有潜在的在社区环境中治疗痤疮和酒渣鼻的强大的抗炎特性。Allergan拥有在美国开发和商业化该药物的权利。Paratek保留所有的美国之外的权利。2017年3月份，两家公司报道sarecycline在两个相同的3期注册研究中治疗重度痤疮的积极结果。Allergan公司已经公开宣布计划在今年下半年向FDA提交新药申请。
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关于再鼎医药
再鼎医药是一家总部在上海的创新型生物制药公司。该公司拥有一支掌握丰富的全球药物开发经验的团队，致力于将变革性药物引进中国，并为全世界的患者发现和开发新的治疗药物。再鼎医药的愿景是在其世界一流的专业知识和见解的基础上建立一家优秀的药物发现、开发、制造和商业化企业，满足中国患者现有的和不断扩大的需求。公司领导团队在业务的各个方面都有扎实的业绩记录，包括在中国进行新药申报方面取得的开创性成功。通过与领先的跨国制药企业和高度创新的生物科技公司合作，公司已组建了颇具潜力成为中国同类最佳和同类第一的处于不同开发阶段的管线。
了解更多信息，请访问 www.zailaboratory.com。
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以上内容由药时代翻译。错误之处难免，欢迎朋友们批评指正！以下是Paratek Pharma公司的新闻稿原文。
Paratek Pharmaceuticals and Zai Lab Announce Collaboration, Development and License Agreement for Omadacycline in China
BOSTON, April 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today announced that it has entered into a collaboration with Zai Lab (Shanghai) Co., Ltd., a biopharmaceutical company based in China, to support the development and commercialization of omadacycline for patients in China.
Under the agreement, Paratek has granted to Zai Lab an exclusive license to develop, manufacture and commercialize omadacycline for the greater China territory, specifically the People’s Republic of China, Hong Kong, Macau, and Taiwan markets. The companies will establish a joint steering committee to review and oversee all development, manufacturing, and commercialization plans. Paratek will receive a $7.5 million upfront payment in connection with the signing of the agreement and is eligible for additional milestone payments related to development, regulatory, and commercial milestones. In addition, Paratek will be eligible to receive royalty payments on sales of omadacycline in the territory.
"Our successful Phase 3 efficacy studies in both skin infections and pneumonia demonstrate the potential of omadacycline to be a promising new therapeutic option for the treatment of patients with serious bacterial infections," said Michael Bigham, Chairman and CEO of Paratek. "This agreement with Zai Lab further validates that potential, and represents an exciting step toward making omadacycline available to the many patients in the greater China territory where there is a proven need for a new, effective, well-tolerated, IV and once-daily oral, broad-spectrum antibiotic, particularly when resistance is of concern."
Samantha Du, Chairman and CEO of Zai Lab, added, "We are very pleased to partner with Paratek to potentially bring omadacycline to Chinese patients. It is estimated that per capita use of antibiotics in China is significantly higher than that in the United States. Consequently, antibiotic resistance is becoming an increasing and severe problem for China. Based on the data generated by Paratek to date, we believe omadacycline has the potential to be a valuable new tool for physicians in China as they try to combat the growing antibiotic resistance problem."
Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, is the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications.
In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy, general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy, general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. Top-line data from this study are expected as early as the end of June. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018.
In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017.
In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax.
Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017.
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About Zai Lab
Zai Lab is a Shanghai-based innovative biopharmaceutical company. The company’s globally-experienced drug development team is passionate about bringing transformative medicines to China and discovering and developing novel therapeutics for patients worldwide. The vision at Zai Lab is to create a premier drug discovery, development, manufacturing and commercialization organization built on a foundation of world-class expertise and insights into the existing and expanding needs of Chinese patients. Zai Lab has a team of leaders who have a collective track record in all aspects of our business, including pioneering success in the regulatory process in China. The company has assembled a pipeline of potential best-in-class and first-in-class in China biopharmaceuticals at different stages of development by securing partnerships with leading multinational pharmaceutical and highly innovative biotechnology companies.
For more information, please visit .
Forward-Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about development, manufacturing and commercialization of omadacycline for the greater China territory, the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, the timing of NDA and EMA submissions, and our ability to obtain regulatory approval of omadacycline. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "believe," "expect,” "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2016, and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.
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