Healios KK

Pictured: Man holding a Chapter 11 bankruptcy filing/iStock, designer491 Acorda Therapeutics on Monday announced that it has voluntarily filed for bankruptcy and is seeking Chapter 11 protections to facilitate the orderly transfer of its assets and the winding down of its business operations. The company has also entered into an asset purchase agreement with German biotech Merz Therapeutics, which has agreed to acquire “substantially all” of Acorda’s assets, including its FDA-approved drugs Inbrija (levodopa inhalation powder), Ampyra (dalfampiridine) and Fampyra (fampiridine), for $185 million. The sale will take place through a competitive auction process, with Merz acting as a “stalking horse” bidder. Acorda’s shares tanked 59% in after-hours trading in reaction to the news, according to Seeking Alpha. The decision to Chapter 11 bankruptcy was made “following an exhaustive process” and lengthy strategic review of its options for the business moving forward, CEO Ron Cohen said in a statement. Acorda contends that filing for bankruptcy “is in the best interest” of stakeholders. “One of our top priorities is to ensure an uninterrupted supply of our medications to people with multiple sclerosis and Parkinson’s disease,” Cohen added. “We are confident that Merz Therapeutics, if they are the ultimate acquirer, will be able to seamlessly continue serving these patients’ needs.” Acorda’s Chapter 11 proceedings will take place in the U.S. Bankruptcy Court for the Southern District of New York. If the court approves and grants certain protections, Acorda will be able to continue its normal operations as it works to wind down the company’s business. Court approval will also allow Acorda to “minimize” the effects of its bankruptcy on employees, clients, patients and other stakeholders, according to the company. Monday’s bankruptcy announcement puts an end to Acorda’s years of financial struggles. In 2019, the company launched a restructuring initiative that saw 25% of its employees laid off, in an attempt to save $21 million. In September 2021, Acorda slashed its headcount by another 15%, hoping to cut costs by around $20 million per year, starting in 2022. The company at the time also shuffled its masthead, including a change in its CCO and COO positions. In January 2024, Acorda also lost a high-powered partner when Biogen opted to return the ex-U.S. licensing rights over Fampyra. The termination of the partnership is scheduled to take effect on Jan. 1, 2025. With its bankruptcy announcement on Monday, Acorda joins a growing group of biotech companies that have shuttered their businesses this year. On Monday, Eiger BioPharmaceuticals announced that it also filed for Chapter 11 bankruptcy and would wind down its operations. In January 2024, Athersys revealed that it had gone bankrupt and would divest its assets to its research partner Healios. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

对于生物技术行业来说，2023年是经济不确定的一年，这导致资金短缺，创下了Biotech破产的纪录。根据美国SEC的数据，2022年曾被称为10年来破产率最高的一年，有8家Biotech申请了破产保护，而2023年则以高达41家Biotech宣布破产抢走了这一名头。在《2024年生命科学交易趋势与展望》报告中，Ropes & Gray律师事务所指出，去年之所以出现如此多的破产案例，部分原因是2021年的债务融资激增，以应对当年的利率下降。虽然2022年开始，利率回升，债务融资率回落，可前一年埋下的风险最终还是爆发了。值得注意的是，Biotech破产的信号延续到2024年。1月，Humanigen、Athersys等Biotech纷纷进入关停阶段，国内行业同样不乏坏消息。尽管今年开局并不乐观，但生物制药行业接下来能否变得乐观？如果可以，那些活下去的Biotech又需要做对什么？激增的裁员与破产低利率时期企业通常会选择债务融资，近年来，该工具也在生命科学领域流行起来。随着利率下降，Biotech纷纷向银行寻求资金，但2022年利率上升，使得该行业又重新收紧债务融资的缰绳。这种融资的高比率导致2023年许多企业陷入困境，例如整个行业的裁员浪潮。许多Biotech大刀阔斧进行裁员，甚至连MNC同样不例外：血液制品巨头Grifols裁员2300人，武田裁员1500多人，渤健、基因泰克和赛默飞的裁员规模也达到1000多人。尽管不幸，如此局面也属意料之中。当投资者为生物技术领域提供资金的意愿降低时，该行业的大多数公司，无论是大型制药公司还是初创企业，都借助裁员来应对通货膨胀，保住资本。像已有近20年历史的Infinity Pharmaceuticals，在与MEI Pharma的合并提案被后者否决后，裁减了78%的员工。卖身本是这家英国公司的最后一根救命稻草，MEI将提供1亿美元资金，可以支持它持续运营到2025年，开发其3种癌症候选药物。但由于未能获得股东批准，MEI取消了该计划。裁员之后，Infinity于去年9月申请破产。2023年申请破产的明星Biotech之一，是Sorrento Therapeutics。一些人业内人士认为，这家Biotech的策略颇为冒进。在艾森医药核心产品第三代EGFR-TKI上市迟迟未果的情况下，2021年4月，Sorrento宣布以4.88亿美元的对价将其收购。可后来，豪森药业、艾力斯等产品上市，Sorrento却始终等不到获批。此外，受一系列的法律纠纷影响，Sorrento本不富裕的资金储备变得更加捉襟见肘。遇上资本寒冬，运营更显艰难。有意思的是，2020年1月，行情尚且较好时，Sorrento曾拒绝了一项最高可达9.33亿美元的收购邀约。整体来说，成立时间较长，并不意味着能免受倒闭危机困扰。不过，去年关停的Biotech中，很多都起步于2010年之后，有的甚至仅有2到3年的历史，包括开发眼科基因疗法的Vedere ll、研究微生物组的Federation Bio，以及专注开发靶向细胞凋亡抗肿瘤产品的BAKX Therapeutics等。缘何落入经营困境？想要回答这股浪潮还会持续多久，就需要厘清导致不幸案例的原因。纵观Biotech的关停声明，大部分将此举归咎为经济环境的惨淡，使得既往的融资市场难以维持。这也是Sarah Stevens的看法，她是Azzur Labs和Azzur Cleanroomson Demand的总裁，Azzur集团主要向制药企业提供从discovery到delivery的服务。Stevens表示，宏观上，后COVID时代的全球经济状况不稳定、供应链逆风和通货膨胀，都导致融资环境更具挑战性。而从科学角度说，生产工艺等方面的创新障碍，制约了Biotech跟上CGT等赛道的机遇。例如，细胞疗法公司Athenex在去年5月宣告结束。FDA在其I期神经母细胞瘤临床试验中发现一名患者死亡后，对其候选药物实施了临床搁置。此前，Athenex还遭遇过一些挫折，口服化疗药物被FDA拒绝批准，公司进行裁员。作为创新驱动的公司，项目的进展往往与Biotech一荣俱荣。而临床失败，也是影响Biotech式微的一大原因。类似的案例可谓比比皆是。2023年1月申请破产清算的Tricida，3个月前曾宣布，其核心管线veverimer的III期临床错过主要终点；同样在1月，Xenikos也透露旗下抗体组合疗法的III期临床终止，原因是达到协议规定的60天死亡率停止边界，随后该公司计划关停。押注热门领域，比方说减重，亦需要面临巨大的失败风险，尤其是在诺和诺德、礼来等巨头抢先一步的时候。9 Meters原打算在去年下半年对一种候选肥胖药物NM-136进行人体测试，该药通过靶向GLP发挥作用。不过很快，它就申请破产保护。这一定程度与项目运营策略、效率有关。实际上，2022年，9 Meters在一项针对乳糜泻患者的III期试验失败。该公司虽然做了方向转型，瞄准几种与COVID病毒相关的疾病，包括儿童多系统炎症综合征和长期COVID，进展却都不及预期。细胞疗法领域，Athersys去年在测试其干细胞平台治疗缺血性中风的中期试验折戟，因为其300名患者的样本量不足以达到主要终点。而后，该Biotech申请破产，并将其资产出售给日本同行Healios。新药研发受挫并不罕见。经济和科学上的许多因素，都会影响成功与失败之间的界限。Stevens说，即使行业近来在生物制药方面取得了令人惊叹的进步，要开发出安全有效的新靶点疗法，仍然具有挑战性。Biotech续命“三板斧”01.采用其他融资方法一些Biotech，正尝试将特许权使用费融资作为逃离破产结局的一种方式。与债务和股权融资不同，特许权使用费融资允许寻求资金的Biotech不受外部干预。换句话说，掌控权还在创始团队手中，他们不受立即还款的约束，甚至不受短期期限的约束。因此，Biotech无需稀释所有权，就能继续开展研发项目。生物制药领域，Royalty Pharma、Blackstone和Healthcare Royalty Partners等投资者，在特许权使用费融资领域处于主导地位，它们占了特许权使用费交易额的71%。但最近，根据研究机构ZS的一份报告，其他参与者已推动近一半的特许权使用费融资市场份额。该报告指出，规模较小的Biotech求助于这类融资，主要是为了推进其后期资产或支持早期商业化。50%以上的特许权使用费融资交易，都是在Biotech候选药物申请获得FDA批准后才完成的。尽管越来越多的Biotech采用这种融资方式来替代传统融资，但它并非没有风险。如果公司没有足够的收入来偿还投资者，最终欠下的钱可能会超过公司的价值。此外，赠款也是生物制药领域获得资金的方式，它最大好处是无需偿还，但寻找赠款却十分困难。还需要考虑到，大多数赠款往往是一次性的，在这个意义上，它也不是很可靠的融资形式。02.寻找合作伙伴Stevens指出，在经济动荡时期，伙伴关系可以帮助Biotech避免破产，加强创新。面对融资更具挑战性的环境，需要更大的创造力。Stevens补充说，伙伴关系和协作的发展，有助于后续的合并或收购。将资产整合，是一种促进发展的方式，否则它们可能会因技术平台和能力而处于废置状态。近期的例子，包括再生元和Intellia关于CRISPR疗法的合作，以及阿斯利康对Cellectis的CGT产品的投资。1月，另一家制药巨头诺华，也在Voyager基因治疗方面花费了大量资金。Voyager与诺华的合作可追溯到2022年3月，当时，诺华向这家AAV载体开发公司支付5400万美元预付款，并设定了高达17亿美元的里程碑付款和特许权使用费。一年后，诺华行使选择权，在之前5400万美元预付款的基础上，再额外支付2500万美元预付款，Voyager还有资格获得高达6亿美元的相关潜在开发、监管和商业里程碑付款，以及相关产品的特许权使用费。2024年伊始，Voyager又从诺华获得1亿美元预付款，后续里程碑付款和特许权使用费总额高达12亿美元。03.设定合适的估值无论是传统的风险融资，还是其他募资方式，切合实际的估值都至关重要。在BioSpace的一份报告中，Cassel Salpeter董事长James Cassel解释道，企业的估值直接影响到融资条件，最近很多Biotech都犯了高估自身价值的错误。Biotech可能必须考虑采取盈利、里程碑付款和其他类型的结构，因为它们真正需要的是投资方的进入、向前推动财务运转，而有些公司管理者对此抱有不切实际的想法。Cassel提醒，没有Biotech会因为股权稀释而破产，在很多时候，保留公司的一小部分股份，比拥有100%的公司要更好。投资银行Cassel Salpete医疗保健部门董事总经理Ira Leiderman也认为，虽然很难适应，但行业确实有必要重新评估Biotech以市场价或略低于市场价出售普通股的传统交易。“如果你不这样做，你就会破产。”Leiderman说，“你的钱会花光的。”04.2024年，能否乐观？1月，美国Biotech Humanigen正式提交了破产申请。某种程度上，这可以看作是一个象征，一个因为错失风口、回旋余地而成为过去式的代表。Humanigen试图把握COVID-19治疗药物的机会，但2022年就在临床上以失败告终。去年7月，Humanigen表示，预计将无法继续持续经营，并正在探索所有重组方案，其中可能包括启动破产或其他破产程序。最终，当所有选项被拿掉后，Humanigen不得不走上关停之路。但Humanigen的经历并不意味着今年该行业注定要失败。事实上，行业人士相信，美股IPO有望在今年反弹，随着该行业重新站稳脚跟，人们对其持谨慎乐观态度。Stevens认为，2024年剩余时间和2025年的乐观迹象越来越多。“投资界十分活跃，服务供应商也在不断发展，以满足生物制剂和药品生产的特殊需求。”她补充说。为确保生物技术治疗革命的全部潜力得以实现，合作伙伴关系与合作的重要性，将与日俱增。但回到中国，这个问题似乎还面临许多不确定性。成立7年的国内Biotech博际生物，1月已正式向杭州市余杭区人民法院提交破产清算申请。一个月后，联拓生物发布公告，称将在2024年基本完成全面关闭业务，在2027年上半年完全解散。前者以抗体发现和筛选技术、平台闻名，从成立到首个管线获批临床试验仅用2年时间。不过，自2021年3月到申请破产，博际生物再未披露新一轮融资。联拓生物有些不同。这家Biotech所要讲述到license in模式故事，已越发不受欢迎，一个显著的例子是，科创板等二级市场逐渐加强对Biotech原始创新能力的审查。从去年开始，联拓生物一转作风，频繁出售资产。随后，CEO、CFO接连离任，多少暗示了公司的管理问题。这些本土案例会是生物制药行业“暴雷”开始，还是泡沫出清的结束，想必答案在接下来的几个月就会变得更加明显。参考文献：1.Biotech bankruptcies: what to expect in 2024 following a record year? ；Labiotech2.Biotech Gets Creative to Avoid Bankruptcy in 2024；BioSpace3.COVID-19 treatment developer Humanigen files for Chapter 11 bankruptcy；Reuters4.拒绝卖身的“倒爷”Biotech，转眼进入关停倒计时；同写意封面图来源：123rf版权声明/免责声明本文为授权转载文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn430亿美元收购后，辉瑞重塑抗肿瘤版图BCMA ADC复活！退市后「群狼环伺」，归来前「一团乱麻」全球首款端粒酶抑制剂能否获批？为什么这场ODAC会议值得关注点击这里，欣赏更多精彩内容！

Pfizer's ADC prowl, Astellas' gastric cancer rejection and details of Takeda's 2022 TYK2 buy made our news this week. Pfizer is still hungry for ADC opportunities, including in the Far East. Astellas' impressive phase 3 data for its gastric cancer candidate couldn't garner an approval because of manufacturing issues. Takeda's 2022 TYK2 buy from Nimbus was highly competitive, an exec said. And more.  1.  JPM24: Even after Seagen buyout, Pfizer oncology chief still eyes ADC deals As Pfizer continues its prowl for antibody-drug conjugate (ADCs) deals, the company is keeping an eye on opportunities around the globe. In an interview, Pfizer’s new oncology chief Chris Boshoff, Ph.D., said the company is looking for opportunities in China, which he said "is important in this whole area, especially ADC development." The company is “not currently looking for big acquisitions,” Boshoff added. 2. Astellas' gastric cancer candidate rejected by FDA because of manufacturing issues After running two phase 3 trials, Astellas’ near-term approval ambitions for its zolbetuximab have been dashed because of manufacturing issues. The FDA sent the company a complete response letter after flagging unresolved deficiencies at a third-party manufacturing facility during a prelicense inspection.  3. JPM24: How Takeda beat 'almost every biopharmaceutical company' to win Nimbus’ TYK2 med Takeda scooped up a potential rival to Bristol Myers Squibb’s Sotyktu when it threw down $4 billion for Nimbus Therapeutics’ tyrosine kinase 2 med, now known as TAK-279, in 2022. In an interview on the sidelines of this year’s J.P. Morgan Healthcare Conference, Takeda's head of R&D, Andy Plump, M.D., Ph.D., revealed just how competitive the process was. At some point “almost every biopharmaceutical company” was vying for the asset, Plump said. Takeda won out after interacting with Nimbus for a “couple of years” and Plump says those relationships were one of the reasons it ultimately won out. 4. Next-gen Lilly obesity drug secures phase 3 win as Innovent readies Chinese approval push Innovent is getting ready to heat up China’s obesity market with a phase 3 win for its mazdutide. The Chinese biotech bought the rights to the dual GLP-1/glucagon receptor agonist from Eli Lilly in 2019 for an undisclosed sum. Now, the deal is paying off with new data from a late-stage clinical trial, which hit both of its primary endpoints by week 32. The company is now preparing its first drug new drug application.  5. Bayer heats up hot flash rivalry, hitting phase 3 goals to stay on Astellas’ heels Bayer is hot on Astellas’ tail with its hot flash candidate elinzanetant, which met all four endpoints across two phase 3 studies. Astellas’ rival med Veozah scored approval last year, but Bayer’s could become a worthy competitor. The detailed data from Bayer’s studies will be shared at upcoming scientific congresses, the company said. 6. JPM24: Flagship chief says firm will have to ‘do some work’ before linking with China-based partners With a new Singapore outpost, Flagship is taking its time to understand the “Chinese biotech innovation ecosystem” before making any moves in China, CEO Naubar Afeyan, Ph.D., said in an interview on the sidelines of this year’s J.P. Morgan Healthcare Conference. The firm is active in Japan and South Korea after going global with its London and Singapore offices, and it just inked a deal with Samsung that includes access to clinical samples and investment in Flagship firms.   7. WuXi Biologics, WuXi AppTec plot manufacturing expansions in US, China China’s WuXi AppTec commissioned two peptide manufacturing plants in order to meet high demand for peptide therapeutics. The new digs will make for the company’s third peptide manufacturing plant in Changzhou and its first in Taixing. Together, the facilities will boost WuXi AppTec’s total reactor volume to 32,000 liters. Meanwhile, WuXi Biologics is expanding its new site in Worcester, Massachusetts, to meet growing demand. Other News of Note:  8. Athersys files for bankruptcy, sells assets to Healios in wake of stroke cell therapy’s struggles 9. Boehringer Ingelheim deals thrice, ending week with $449M Kyowa Kirin tie up 10. BioNTech, keeping its powder dry, pays WuXi $20M for 2 preclinical monoclonal antibodies