Hikma completes its FDA response in respect of generic Advair®

Hikma和Vectura开发Advair仿制药再次向FDA提交临床终点研究数据

2019-11-29 11:00:03 BioSpace

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Vectura Group plc (LSE: VEC) notes today’s announcement by Hikma Pharmaceuticals PLC ("Hikma"), its partner in the development of an AB rated substitutable US generic version of Advair Diskus® (VR315US), that it has submitted responses to the US Food and Drug Administration (“FDA”) for review, which includes data from a further Clinical Endpoint study requested by the FDA in a Complete Response Letter (“CRL”). Will Downie, Chief Executive Officer of Vectura, commented: “Hikma’s submission is an important milestone in our generic Advair programme. We believe the submission addresses the outstanding questions raised by the FDA in its CRL and remain confident in the prospects for the approval of VR315US. We continue to see a large market opportunity for VR315US and look forward to working with Hikma to bring this product to the market as quickly as possible.” - Ends- For more information, please contact: Vectura Group plc David Ginivan - VP Corporate Communications +44 (0)7471 352 720 Elizabeth Knowles - VP Investor Relations +44 (0)7767 160 565 Consilium Strategic Communications Mary-Jane Elliott / Sue Stuart / David Daley +44 (0)20 3709 5700 About Vectura Vectura is a provider of innovative inhaled drug delivery solutions that enable partners to bring their medicines to patients. With differentiated proprietary technology and pharmaceutical development expertise, Vectura is one of the few companies globally with the device, formulation and development capabilities to deliver a broad range of complex inhaled therapies. Vectura has ten key inhaled and eleven non-inhaled products marketed by partners with global royalty streams, and a diverse partnered portfolio of drugs in clinical development. Our partners include Hikma, Novartis, Sandoz (a division of Novartis AG), Mundipharma, Kyorin, GSK, Bayer, Chiesi, Almirall, and Tianjin KingYork. For further information, please visit Vectura's website at www.vectura.com Forward-looking statements This press release contains forward-looking statements, including statements about the commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward looking statements, including: commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward looking statements, whether as a result of new information, future events or otherwise.
Vectura Group plc ( LSE : VEC )注意到 Hikma Pharmaceuticals PLC (" Hikma ")今天宣布,其开发 AB 级可替代美国仿制药 Advair Diskus ®( VR315US )的合作伙伴 Hikma Pharmaceuticals PLC (" Hikma ")已向美国食品药品监督管理局(Food and Drug Administration)(" FDA ")提交了回复,以供审查。其中包括 FDA 在完整回应函(“ CRL ”)中要求的进一步临床终点研究的数据。 Vectura 首席执行官威尔•唐尼( Will Downie )评论道:“ Hikma 的呈文是我们普通式 Advair 计划中的一个重要里程碑。我们相信,该文件解决了 FDA 在 CRL 中提出的未决问题,并对 VR315US 的批准前景保持信心。我们继续看到 VR315US 的巨大市场机遇,并期待与 Hikma 合作,尽快将该产品推向市场。” -结束- 如需更多信息,请联系: 威图拉集团有限公司 David Ginivan - VP Corporate Communications +44(0)7471352720 Elizabeth Knowles -副总裁投资者关系+44(0)7767160565 包括战略沟通 Mary-Jane Elliott / Sue Stuart / David Daley +44(0)2037095700 关于威图拉 Vectura 是一家创新的吸入给药解决方案提供商,使合作伙伴能够将其药品带给患者。Vectura 拥有独特的专有技术和药物开发专业知识,是全球为数不多的具备设备、配方和开发能力的公司之一,能够提供广泛的复杂吸入疗法。 Vectura 拥有10个关键吸入产品和11个非吸入产品,这些产品由全球版税流合作伙伴销售,并且在临床开发中拥有多样化的合作伙伴药品组合。我们的合作伙伴包括 Hikma 、 Novartis 、 Sandoz (诺华(Novartis) AG 的一个部门)、 Mundipharma 、 Kyorin 、葛兰素史克(GSK)、拜耳(Bayer)、 Chiesi 、 Almira 和天津 KingYork 。 如需进一步资料,请浏览渔护署网页 www.vectura.com 前瞻性陈述 本新闻稿包含前瞻性声明,包括产品商业化声明。各种风险可能导致 Vectura 的实际结果与前瞻性陈述明示或暗示的结果存在重大差异。包括:由第三方拥有或控制的专利施加的商业限制;依赖战略联盟伙伴开发和商业化产品和服务;难以或拖延获得监管 由于发展努力而对产品和服务进行市场营销的批准;开展研究和开发并扩大商业化活动所需的大量资金;竞争对手的产品举措。由于这些因素,提醒潜在投资者不要依赖任何前瞻性陈述。我们不承担任何更新或修订任何前瞻性声明的意图或义务,无论是由于新信息、未来事件或其他原因。

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