Coherus Acquires Commercial Rights for Leading Lucentis Biosimilar in the United StatesCompany’s First Ophthalmology Franchise Launch Pulled Forward by Two Years


2019-11-07 18:30:09 BioSpace


Coherus BioSciences Inc. , today announced the Company has acquired exclusive rights from Bioeq IP AG, a Swiss biopharmaceutical joint venture, to commercialize Bioeq’s biosimilar candidate to Lucentis® in the United States. Bioeq plans to file a Biologics License Application with the U.S. Food and Drug Administration in the fourth quarter of 2019 and Coherus plans to launch the product in 2021. “This is the leading Lucentis® biosimilar product candidate, and this license pulls forward our previously anticipated Lucentis biosimilar launch in the U.S. by approximately two years,” said Denny Lanfear, President and CEO of Coherus. “We are extremely impressed with Bioeq’s development of this molecule, which included a successful Phase 3 study in wet age-related macular degeneration and robust molecular similarity data. On the commercial side, we see significant similarities in the oncology and ophthalmology therapeutic environments, and believe that our demonstrated proficiencies and infrastructure can be directly and successfully applied to this new area. In oncology, we have seen the broad adoption of UDENYCA®, and we look forward to repeating that in ophthalmology as we continue our mission to expand choice, improve access and lower healthcare costs. ” According to the terms of the agreement, Coherus will make a mid-single digit million-dollar upfront payment as well as other regulatory and launch milestone payments. The companies will share profits approximately equally. Lucentis® is a registered trademark of Genentech, Inc. About Coherus BioSciences, Inc. Coherus is a leading biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales and marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus commercializes UDENYCA® (pegfilgrastim-cbqv) in the U.S. and has received regulatory approval for UDENYCA® in the European Union. Coherus is advancing a late-stage clinical product CHS-1420 (adalimumab biosimilar) and Bioeq’s Lucentis® (ranibizumab biosimilar) towards commercialization, and early-stage clinical products, CHS-2020, an Eylea® (aflibercept biosimilar), and CHS-131, a small molecule for nonalcoholic steatohepatitis (NASH) and multiple sclerosis. For additional information, please visit Forward-Looking Statements Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ ability to facilitate the Bioeq filing of a BLA with the FDA for their biosimilar candidate to Lucentis in the fourth quarter of 2019; Coherus’ ability to launch the Bioeq biosimilar candidate to Lucentis® (ranibizumab) in the United States in 2021; Coherus’ ability to pull forward its previously anticipated Lucentis biosimilar launch in the United States by approximately two years; Coherus’ ability to successfully apply its proficiencies and infrastructure developed for the oncology environment to the ophthalmology environment and repeat a broad commercial launch in ophthalmology that expands choice, improves access and lowers healthcare costs. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus’ or Bioeq’s regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ biosimilar drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the three and six months ended June 30, 2019, filed with the Securities and Exchange Commission on August 1, 2019 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended June 30, 2019 are not necessarily indicative of our operating results for any future periods.
BioSciences Inc .今日宣布,本公司已从瑞士生物制药合资企业 Bioeq IP AG 获得独家权利,将 Bioeq 的生物生物仿制药物候选人商业化至美国的 Lucentis ®公司。Bioeq 计划于2019年第四季度向美国食品药品监督管理局提交《 Biologics License Application 》, Coherus 计划于2021年推出该产品。 “这是 Lucentis ®生物类似产品的领先候选者,这一许可将推动我们先前预期的 Lucentis 生物生物仿制药产品在美国上市大约两年,” Coherus 总裁兼首席执行官 Denny Lan恐惧表示。“我们对 Bioeq 分子的发展印象深刻,该分子包括湿性年龄相关性黄斑变性的第3阶段研究和强大的分子相似性数据。在商业方面,我们在肿瘤和眼科治疗环境中看到了显著的相似之处,并相信我们已经证明的熟练程度和基础设施可以直接和成功地应用到这个新领域。在肿瘤学方面,我们看到了 UDENYCA ®的广泛采用,我们期待着在眼科领域重复这一点,因为我们将继续致力于扩大选择、改善获取渠道和降低医疗成本。“这是一个很好的选择。” 根据协议条款, Coherus 将支付中个位数的百万美元预付款以及其他监管和启动里程碑付款。这些公司将平均分享利润。 Lucentis ®是基因泰克(Genentech), Inc .的注册商标。 关于 Coherus BioSciences , Inc . 科赫公司是一家领先的生物仿制药公司,为主要受监管市场开发和商业化高质量的治疗药物。生物仿制药旨在取代现有的、有品牌的生物制剂,用于治疗一系列慢性病和往往危及生命的疾病,具有降低成本和扩大患者准入的潜力。科赫公司由一批经验丰富、在工艺科学、分析表征、蛋白质生产、销售和营销以及临床监管开发方面拥有世界一流专业知识的行业资深人士组成,在全球生物仿制药市场处于领先地位。Coherus 将 UDENYCA ®( pefilgrastim-cbqv )在美国商业化,并已在欧盟获得 UDENYCA ®的监管批准。Coherus 正在推进后期临床产品 CHS-1420(阿达木单抗生物类似药)和 Bioeq 的 Lucentis ®(雷尼布单抗生物类似药)的商业化,以及早期临床产品 CHS-2020、 Eyla ®(阿达木单抗生物生物仿制药药)和 CHS-131,这是一种用于非酒精性脂肪性肝炎( NASH )和多发性硬化症的小分子。有关详细信息,请访问 。 前瞻性陈述 除包含历史信息外,本新闻稿中所述事项均为1995年《私人证券诉讼改革法案》中“安全港”条款含义内的前瞻性陈述,包括但不限于:Coherus 在2019年第四季度向 Lucentis 公司提交 BLA 申请生物仿制药的能力; Coherus 在2021年向 Lucentis ®( ranibizumab )公司推出 Bioeq 生物仿制药的能力; Coherus 在美国推进先前预期的 Lucentis 生物仿制药上市的能力大约两年; Coherus 成功将其为肿瘤环境开发的熟练程度和基础设施应用到眼科环境中的能力,并重复广泛的眼科商业推出,扩大选择,改善获取和降低医疗成本。这种前瞻性陈述涉及实质性风险和不确定性,可能导致 Coherus 的实际结果、业绩或成就与前瞻性陈述所表达或暗示的任何未来结果、业绩或成就存在重大差异。此类风险和不确定性包括临床药物研发过程中固有的风险和不确定性、监管审批过程中的风险和不确定性;包括 Coherus 或 Bioeq 监管申报的时间安排、 Coherus 无法完成商业交易的风险以及其他可能影响 Coherus 生物生物仿制药药候选人的可用性或商业潜力的事项,以及可能的专利诉讼的风险和不确定性。本新闻稿中所载的所有前瞻性声明仅在作出声明的日期发表。Coherus 不承担更新或修改任何前瞻性陈述的义务。有关可能导致实际结果与这些前瞻性声明中表达的结果不同的风险和不确定性的进一步描述,以及与 Coherus 一般业务相关的风险,请参见 Coherus 截止2019年6月30日的三个月和六个月的10-Q 季报。于2019年8月1日向证券交易委员会备案,其未来定期报告将向证券交易委员会备案。截至2019年6月30日止季度的业绩未必反映我们于任何未来期间的经营业绩。