Roche Pharma AG

BioMarin 继续在 CEO Alexander Hardy 设计的新公司战略下进行人员调整，这次将裁员 225 人，占其全球劳动力的大约 7%，这家加州生物技术公司在周三的一份证券文件（PDF）中表示。 BioMarin 证实，这次裁员与 5 月份宣布的另一轮裁员不同，那次裁员影响了大约 170 名员工。受这次裁员影响的员工已在周三得到通知，公司预计这两轮裁员将在今年年底前“基本完成”。 BioMarin 将在之前一轮影响约 170 名员工的裁员基础上再削减约 225 个工作岗位。（iStock / Getty Images Plus） BioMarin 将新裁员归因于“组织重新设计努力”，以及公司对血友病 A 基因疗法 Roctavian 的专注范围缩小，以及决定停止开发 BMN 293，这是一种针对遗传性肥厚型心肌病亚型的临床前基因疗法。后两项举措是在 8 月 5 日 BioMarin 发布第二季度报告时宣布的。 公司发言人在一份声明中表示：“BioMarin 正在制定一项新的公司战略，实现这一战略的关键组成部分是确保 BioMarin 的结构能够为公司未来的持续成功定位。作为新战略的一部分，并且由于我们的产品线和业务优先事项发生了变化，我们的劳动力受到了影响。” 战略重新思考始于 2023 年底，当时 BioMarin 聘请了前 Genentech CEO Hardy 担任掌舵人。公司尚未系统地分享新的蓝图，分析师们期待在 9 月 4 日安排的投资者活动中获得更多清晰度。 BioMarin 的几项产品已经感受到了这次重组的影响。上一轮裁员针对 170 个职位，与 BioMarin 终止四个临床候选药物有关。BioMarin 决定将 Roctavian 集中在其基因疗法已经获得报销政策的三个现有地区——美国、德国和意大利，而不是全球推出。 在战略审查和产品线改革的同时，BioMarin 还调整了其高管团队。公司聘请了 Amgen 的资深人士 Greg Friberg 博士，接替即将退休的 Hank Fuchs 博士，成为新的 R&D 负责人。Hardy 在 Roche 的前同事、交易专家 James Sabry 博士也将加入，担任首席商务官。曾在 Roche Pharma 担任全球产品战略负责人的 Cristin Hubbard，已于 5 月担任 BioMarin 的首席商务官。 BioMarin 发言人没有具体说明 225 人裁员是否涉及任何管理职位。公司预计这一轮员工遣散将花费约 3000 万至 3500 万美元，其中大部分可能在今年发生。 BioMarin 的裁员增加了基因疗法开发者更广泛的挑战。对于 Roctavian，BioMarin 必须解决报销障碍和患者的犹豫，特别是当存在其他有效疗法时。建立额外基础设施以管理一次性药物的要求也是一个障碍。 CSL 最近承认，其血友病 B 基因疗法 Hemgenix 的接受度慢于预期，公司将其归咎于美国医疗保健系统的分散性。 Pfizer 在其杜氏肌营养不良症候选药物失败后，决定停止开发，并在北卡罗来纳州的专门基因疗法设施中裁员 210 人。 上个月早些时候，bluebird bio 将其 2024 年对镰状细胞病基因疗法 Lyfgenia 的预期降至之前预测范围的低端，原因是患者入组速度慢于预期。作为最早的基因疗法参与者之一，bluebird 之前在欧洲做出了一些艰难的决定，并一直依赖外部贷款来维持运营。 7 月份，基因编辑公司 Tome Biosciences 宣布将解散其几乎所有员工，尽管该公司在 A 轮和 B 轮融资中总共筹集了 2.13 亿美元。在解释这一决定时，这家马萨诸塞州的初创公司提到了基因编辑领域投资者情绪的戏剧性转变，特别是对临床前公司。 参考资料：https://www.fiercepharma.com/pharma/biomarin-cuts-deeper-225-layoffs-under-ceos-new-corporate-strategy 识别微信二维码，添加生物制品圈小编，符合条件者即可加入 生物制品微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

BioMarin will cut about 225 jobs on top of a previous round of layoffs affecting about 170 employees. The rightsizing at BioMarin continues to take its toll as CEO Alexander Hardy devises a new corporate strategy for the rare disease biotech.BioMarin plans to cut about 225 employees, or about 7% of its global workforce, the California biotech said in a securities filing (PDF) Wednesday.The latest reductions are separate from a previous set of layoffs affecting about 170 employees announced in May, a BioMarin spokesperson confirmed to Fierce Pharma. Employees impacted by the latest initiative were notified by Wednesday, and both rounds are expected to be “substantially completed” by the end of this year, according to the company.BioMarin chalked up the new cuts to “organizational redesign efforts” as well as the company’s narrowed focus for the hemophilia A gene therapy Roctavian and its decision to discontinue the development of BMN 293, a preclinical gene therapy for a genetically driven subtype of hypertrophic cardiomyopathy. The latter two moves were previously announced alongside BioMarin’s second-quarter report Aug. 5.“BioMarin is in the process of developing a new corporate strategy and a critical component of delivering on this strategy is to ensure that BioMarin is structured in a way that will position the company for continued success in the future,” the company spokesperson said in a statement. “As part of the new strategy, and because of changes related to our pipeline and business priorities going forward, our workforce was impacted.”The strategic rethink started as BioMarin brought on former Genentech CEO Hardy as its helmsman in late 2023. The company has yet to systematically share the new blueprint, and analysts are looking to an investor event that’s scheduled for Sept. 4 to gain more clarity.  Several products have already felt the impact from the revamp. The previous layoff round targeting 170 positions were associated with BioMarin’s termination of four candidates. Rather than a global launch, BioMarin has decided to focus Roctavian on its three existing territories where the gene therapy has secured reimbursement policies—the U.S., Germany and Italy.Amid the strategic review and pipeline makeover, BioMarin has also shuffled its executive team. The company is bringing on Amgen veteran Greg Friberg, M.D., to replace the retiring Hank Fuchs, M.D., as the new R&D chief. One of Hardy’s former colleagues at Roche, dealmaking expert James Sabry, M.D., Ph.D., will also join as chief business officer. Cristin Hubbard, who was Roche Pharma’s head of global product strategy, took on BioMarin’s chief commercial officer role in May.The BioMarin spokesperson didn’t specify whether the 225 layoffs involve any managerial roles. The company expects employee severance in this round will cost about $30 million to $35 million, of which the majority is likely to be incurred this year. The downsizing at BioMarin adds to a broader struggle among gene therapy developers. For Roctavian, BioMarin has to work through reimbursement hurdles and patients’ hesitance, especially when other effective therapies exist. The requirement to establish additional infrastructure to administer the one-time drug has also been an obstacle.CSL recently admitted that uptake of its hemophilia B gene therapy, Hemgenix, has been slower than expected, which the company blamed on the fragmented U.S. healthcare system.  Earlier this month, bluebird bio narrowed its 2024 expectations for its sickle cell disease gene therapy Lyfgenia to the lower end of its prior projection after slower-than-expected patient onboarding. As one of the earliest gene therapy players, bluebird had previously made some difficult decisions in Europe and has been relying on outside loans to stay afloat.In July, Pfizer unveiled a plan to cut 150 jobs at its dedicated gene therapy facility in North Carolina following the high-profile failure of—and the decision to discontinue—its Duchenne muscular dystrophy candidate.Last week, gene editor Tome Biosciences announced that it will disband nearly its entire workforce despite having raised $213 million in a combined series A and B round. In explaining the decision, the Massachusetts startup cited a dramatic shift in investor sentiment across the gene editing space, especially for preclinical companies. 

GenEdit is part of a wave of biotechs creating non-viral methods of gene therapy delivery. Image credit: Shutterstock/Vink Fan. Roche’s Genentech has partnered with biotech GenEdit to use the latter company’s non-viral delivery platform for gene editing therapies. Genentech will pay GenEdit $15m upfront as part of the multiyear collaboration and licence agreement. GenEdit is also in line for a further $629m if it meets certain milestones, according to a 23 January press release. Genentech has picked out GenEdit’s NanoGalaxy platform to advance its autoimmune pipeline. The platform uses non-viral, non-lipid hydrophilic nanoparticles (HNPs) for targeted in vivo delivery. As per the agreement, the two companies will seek out and develop HNPs that can be used to develop nucleic acid-based medicines for autoimmune indications. GenEdit will be tasked with discovering potential nanoparticle candidates while Genentech will oversee clinical and regulatory development, along with commercialisation duties. Roche Pharma Partnering’s global head James Sabry said: “Our collaboration with GenEdit will use their polymer nanoparticle library and platform with the potential to reshape treatment paradigms to help people with devastating and difficult-to-treat autoimmune diseases.” GenEdit was cofounded by CEO Kunwoo Lee in 2016. Lee previously worked with CRISPR pioneer and Nobel Prize winner Jennifer Doudna during his time at the University of California, Berkeley. Lee said: “This collaboration underscores the promise of GenEdit’s NanoGalaxy platform to deliver nucleic acid-based medicines via our hydrophilic nanoparticle technology.” GenEdit is part of a wave of biotechs creating non-viral methods of gene therapy delivery .  An adeno-associated virus (AAV) vector is one of the leading ways of delivering gene therapies, but with its widening use has come safety and durability concerns. In September 2021, the US Food and Drug Administration (FDA) held an advisory committee meeting to discuss the flagged issues. GenEdit aims to overcome the limitations and safety concerns of current approaches. It says its non-viral polymer nanoparticles offer payload flexibility and tissue selectivity, and the ability to re-dose while maintaining low immunogenicity. Genentech is not the only big pharma that has been attracted by GenEdit. Eli Lilly backed the biotech as part of a $26m Series A financing round in September 2021. In February 2022, Sarepta partnered with GenEdit in a $57m deal. The gene therapy maker combined its know-how with GenEdit’s NanoGalaxy platform for use in up to four neuromuscular indications. Earlier this week, Genentech returned global rights of two Alzheimer’s disease drug candidates to AC Immune following clinical failures. The termination of the agreement brought an 18-year relationship between the two companies to an end. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy