Barr Laboratories, Inc.

Greg DeFilippis steps into the CBO role after 20 years of diversified business development experience, most recently as CBO of Halozyme Paulette Gangemi brings more than two decades of expertise leading HR teams in the pharmaceutical and biotechnology industries BOSTON, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Elektrofi, a Boston-based biotechnology company focused on drug formulation and delivery innovations, today announced the appointment of pharmaceutical and medical device expert Greg DeFilippis as Chief Business Officer. Mr. DeFilippis previously served as Senior Vice President, CBO of Halozyme and as CBO at Elektrofi will support business development, collaborations and corporate strategy in the company’s new phase of growth. Elektrofi also announced that it has appointed Paulette Gangemi as Chief Human Resources Officer. Ms. Gangemi will leverage her vast knowledge of Human Resources and leading company-wide transformations in her new role. “I am thrilled to welcome two new executives that each bring extensive knowledge and background in the biotech industry to our senior leadership and growing team,” said Chase Coffman, CEO and Co-Founder of Elektrofi. “Greg’s impressive history in drug delivery and forging new strategic partnerships will be instrumental in the growth of Elektrofi as we prepare for clinical trials and potential partnerships, while I am confident that with Paulette on board, our team will be well equipped to double our headcount of team members dedicated to our mission of redefining the delivery of biologics.” Mr. DeFilippis added, “Elektrofi is at a pivotal time in its growth and is preparing to transition from a preclinical company to a clinical stage company. I am excited to build on the remarkable accomplishments the Elektrofi team have achieved and to ensure that Elektrofi’s business moves in stride with its advancing science.” Mr. DeFilippis most recently served as the Senior Vice President, CBO of Halozyme, where he was responsible for business development, alliance management and project management. Prior to Halozyme, he was the Senior Vice President, Device Business and Alliances at Antares Pharma managing combination drug-device business development, alliance management, product development engineering and project management. Over the course of his career, Mr. DeFilippis has held increasing roles of responsibility in business development, technical operations, supply chain and continuous improvement at biotech and pharmaceutical manufacturing companies including Teva Pharmaceuticals, Barr Laboratories, Pliva, Actavis, and Alpharma. He holds a B.S. in Industrial and Systems Engineering from Virginia Tech and an MBA in Finance from Fairleigh Dickinson University. Ms. Gangemi joins Elektrofi with 20 years of experience leading Human Resources teams in the high-science biopharmaceutical and energy industries. Most recently, she led Employee Relations and Employment Practices at Daiichi Sankyo, Inc., during their transformation into a global oncology company. She was previously the regional head of HR for ThermoFisher Scientific’s Pharmaceutical Services division and also served as Head of HR for the Princeton Plasma Physics Laboratory, a Department of Energy National Lab operated by Princeton University. She holds a master’s degree in Labor and Management Relations from Rutgers University and a B.A. from Green Mountain College in Vermont. Ms. Gangemi added, “Elektrofi has built an incredible team of biologics and drug delivery experts. I look forward to applying my experience to support Elektrofi’s mission to transform the drug delivery paradigm and build a strong company culture in which every member of our team has the tools they need to contribute to that mission.” About Elektrofi Elektrofi is a biotechnology company focused on improving administration for a wide range of medicines including monoclonal antibodies, therapeutic proteins, and other large molecule drugs. Its breakthrough formulation platform enables stabilized, highly concentrated formulations for subcutaneous administration. The company is using this technology to transform therapies that are administered intravenously, and to enhance injectable products by reducing the volume and frequency of dosing. Elektrofi partners with pharmaceutical companies to jointly develop patient-friendly delivery solutions. Headquartered in Boston, the company is shaping the future of biologics delivery. For more information, visit www.elektrofi.com or follow us on Twitter and LinkedIn. Company ContactJason NorrisCo-Founder, Elektrofimedia@elektrofi.com

PARIS — AstraZeneca and Merck arrived at ESMO with long-term data on their blockbuster cancer drug and European confab staple Lynparza, which ushered in the PARP inhibitor market in December 2014. The datasets this time around were a mixed bag — the Big Pharma partners detailed five-year follow-up results to the PAOLA-1 Phase III and seven-year analysis of the SOLO-1 Phase III, two trials that have drummed up plenty of interest at the annual oncology meetup across the pond. PRIMA vs PAOLA: GSK and Merck/AstraZeneca square off in a high-profile PARP showdown at ESMO Looking at the first-line advanced ovarian cancer setting, the trials showed a higher percentage of patients on Lynparza were still alive versus the comparators, but did not clock in with statistical significance among all patients. On the flip side, researchers had yet to reach median overall survival in the SOLO-1 study, despite it being seven years. When taking a bird’s-eye view of the two trials combined, which equates to almost 1,200 patients, the results look pretty good — two out of three patients were still alive, according to AstraZeneca’s oncology leader Susan Galbraith. Historically, only 30-50% of newly diagnosed patients with advanced forms of ovarian cancer will live for five years, she said. Merck CMO Eliav Barr was clinical and concise in his statement, noting Lynparza, as a maintenance therapy, “may provide” very specific patients — HRD-positive and/or BRCA-mutated — “the opportunity to live longer.” Eliav Barr On median OS in the PAOLA-1 study, Lynparza plus cancer drug Avastin was not statistically significant at five years; the combo increased the mark by 56.5 months versus 51.6 months in the Avastin alone arm. When looking specifically at HRD-positive patients, Lynparza plus Avastin showed a “clinically meaningful improvement” on the OS mark with risk of death 38% lower versus Avastin alone, based on a hazard ratio of 0.62, the companies reported Friday. A survival snapshot showed the combo arm had 65.5% of patients still alive at the five-year threshold, versus 48.4% in the comparator group. PFS numbers in the PAOLA-1 study were vastly different. The combo group had an improved median PFS of 46.8 months versus 17.6 months, and the percentage of patients remaining progression-free at half a decade was 46.1% versus 19.2%. The SOLO-1 trial showed that Lynparza was not statistically significant on the OS mark versus placebo in patients harboring BRCA mutation. The risk of death was reduced by 45%, based on a hazard ratio of 0.55, which came in below significance but what the companies touted as “clinically meaningful improvement.” At seven years, 67% of patients on the Big Pharma’s drug were alive, well above the 47% of placebo patients. Of the patients on placebo, 44% wound up receiving a PARP inhibitor later on. Almost half of the Lynparza patients had not received a subsequent treatment for their cancer. That 45% figure was more than double the placebo group, which came in at 21%. For Lynparza patients who did go on another therapy, it was a median time of 64 months before they did so, versus 15.1 months for the placebo group. The companies reported no new safety signals in the long-term follow-ups.

FDA又被药企起诉了，连带一起的还有美国卫生和公众服务部（HHS）以及两个组织机构的领导人——FDA新任局长Robert Califf 博士和HHS部长Xavier Becerra，一共4个被告。这不是FDA第一次被起诉了，此前FDA就因不公开辉瑞疫苗审评资料问题而被起诉，闹得沸沸扬扬；也曾因不公开吉利德丙肝药物数据而被起诉；还因药品上市流程复杂、首仿定义人问题、未发出孤儿药认证、批准了医生不认可的医疗器械、药品等原因被多次起诉。这次被起诉的原因是——延迟审批了一款新药。来源：https://www.docketalarm.com/起诉的是一家美国生物科技公司——Avadel CNS Pharmaceuticals（以下简称：A司），起诉的原因是新药批的慢。当然也不仅仅是这个原因，批的慢的药多了，关键是FDA对其专利提出了质疑，竞争对手Jazz Pharmaceuticals（以下简称：J司）也来神助攻，最终导致公司股价断崖式下跌，受到了重大打击。来源：雪球1药企竞争利器：REMS专利事情的起因源自A司在2020年12月递交的一份NDA申请，产品是Lumryz（代号FT218）。这是一款治疗“发作性睡病”的药物。发作性睡病是个很特别的病，也叫特发性嗜睡症，具体表现是过度嗜睡，过度到什么程度呢？大白天的，这个人可能突然困意袭来，然后就猝睡了，睡几分钟再醒，关键这种猝睡是不可控、不可抗拒的，可能会发生在开车、过马路的时候。患有发作性睡病的人，不能干任何高危的事，聊着聊着天也可能睡着，十分影响工作生活，严重的还有可能产生幻觉。2020年7月，首款被用于治疗发作性睡病的新药Xywav获FDA批准上市，主要活性成分为羟丁酸盐，厂家是J司。而A司递交的上市的这款新药，主要活性成分也是羟丁酸盐。A司的解释是：俩药的活性成分确实是一样的，但又不完全一样，其中有专利重合的部分。具体有多不一样就不知道了，这本身也不是大问题，A司递交的时候走的也是505(b)(2)这条改良新药的申请，按照正常流程走就好。问题出在了产品标签上。这里需要提到一个专属名词：REMS专利认证，即风险评估与减轻策略（Risk Evaluation and Mitigation Strategy）。这是2007年美国食品和药品管理修正法案（FDAAA）专门创建的，为处理有安全隐患药物的工具。被纳入REMS计划的药物，在流通时会受到极大的限制。患者配药时有诸多条件，例如：医生处方、药房认证、注册登记、和医生完成一个电话调查，确定不会增加用药风险等。该条款虽然会增加药品流通的困难，但也被很多药企用来限制仿制药上市。最简单的是用法是，用过该条款限制仿制药企获得参比试剂——你不是患者，不符合用药条件，为了限制药品滥用，我不卖你。没有参比试剂，没法做一致性评价，你怎么证明你的药跟我的药一样？另一个用法是，在仿制药品上市之时，起诉该产品的获批会违反原研产品构建的REMS专利。成功的案例是曾经Celgene为沙利度胺打的官司。沙利度胺的分子是上世纪50年代开发的，基础活性成分的专利早就过期了，按说可以随便仿制。但由于该产品具有极高的使用风险，历史上曾经“臭名昭著”，Celgene为其申请了REMS专利，规定了一系列的限制条件。2007年，仿制药企Barr试图推出沙利度胺仿制品，被Celgene起诉该产品会侵犯Celgene的REMS专利——咱俩的药一样，我限制使用，你也得限制。为此Barr又为自己的仿制品构建了REMS系统，并申请了专利。结果Celgene又提出了公民请愿书，要求美国 FDA 拒绝批准任何沙利度胺仿制药，理由是这将给“沙利度胺相关的风险管理增加更多的混乱和负担，可能使系统遭受损害”。结果，居然真的把Barr打出去了，2010 年 5 月，Barr 撤回其投入市场的沙利度胺仿制药。可见REMS专利的厉害之处。J司就为Xywav申请了REMS专利，这让A司很头痛。2推迟、推迟、再推迟在A司的诉状里，我们看到了一句充满怨气的声明——在递交NDA申请后的第525天，PDUFA日期后的第221天，FDA只给我们回了一条'963号专利的说明（963号专利即REMS专利）。来源：https://www.docketalarm.com/彼时，FDA认为A司新药Lumryz有可能违反了J司构建的REMS专利，要求其提交有关两款产品专利重叠部分的证明。2022年6月6日，A司骂骂咧咧得提交了证明（原文：Avadel filed the FDA-ordered “patent certification” under protest），并获得了初步批准。初步批准的意思是：如果产品没有因侵犯一项或多项专利而被起诉，该批准将于2022年7月22日立即生效。了解了故事背景的我们，看到这则说明，感觉这就像是跟J司说的一样。果不其然，J司立刻发起了诉讼，起诉A司侵犯了其REMS专利。根据相关规定，如果因REMS专利被起诉，将会有30个月的审评遏制期。Lumryz本来就是因为疫情而被FDA延迟审批的药物，现在又获得了30个月的延迟审批，2020年递交NDA的药物，最早上市时间直接被推迟到了2023年。不由得让人想起一句经典台词。来源：电影《无间道》这款药物被A司寄予了厚望，也因此，A司受到了重大打击。5月24日，延迟审批的消息披露，随即公司股价大跌48%，几近腰斩。6月30日，A司开始裁员计划，据报道，此举是为了潜在商业计划启动前减小现金失控情况，预计每季度最多可节省1400万美元。7月21日，A司递交诉状，起诉包括FDA在内的4名被告由于错误使用法案，导致药物延迟审批，给公司造成重大损失。“FDA 错误地根据《行政程序法》要求 Avadel 提交专利证明，并且 FDA 无权对 NDA 申请人关于提交专利证明或声明类型的决定进行二次猜测。要求向 '963 专利提交专利证明是武断的、反复无常的、违反法律的、超出法定管辖权和授权的、缺乏法定权利的行为，因此必须被制止。”Avadel在诉状里这样写道。3结语新药研发风险重重，这个案例又向我们生动得诠释了这个观点。你可以把握产品的质量、疗效与安全性；你可以投入巨量资金完成国际多中心临床试验；你可以对药品上市后的市场前景信心满满。但你不能阻止竞争对手，通过某些藏在犄角旮旯里的条款给你一“闷棍”。药品，终究也是商品的一种，商业战场上的竞争总是十分残酷。参考资料：https://www.docketalarm.com/https://www.fiercebiotech.com/biotech/avadels-shares-crumble-narcolepsy-drug-delayed-yet-again-patent-issuehttps://www.docketalarm.com/百度百科-发作性睡病药物安全工具 REMS 或走入抑制仿制药竞争的歧途其他公开资料版权声明/免责声明本文为原创文章，版权归拥有者。仅供感兴趣的个人谨慎参考，非商用，非医用、非投资用。欢迎朋友们批评指正！衷心感谢！文中图片、视频为授权正版作品，或来自微信公共图片库，或取自公司官网/网络根据CC0协议使用，版权归拥有者。任何问题，请与我们联系（电话：13651980212。微信：27674131。邮箱：contact@drugtimes.cn）。衷心感谢！推荐阅读股价上涨124%！猴痘疫情升为高级，Bavarian Nordic或成最大赢家？FDA、NMPA、EMA都推荐了——真实世界证据，新药「加速审批」的下一站？如果出海是一部热播连续剧，那么新剧情层出不穷，跌宕起伏，惊心动魄，扣人心弦！。。。| 药时代出海系列全程直播！欢迎观看「肝病新药联盟」成立暨NASH新药联盟组委会换届大会！二审败诉！重磅ADC药物Enhertu依旧被判侵权。盘点药企专利之争，厉害的药全被告了...阿尔茨海默病（AD）治疗领域的「徘徊」与「探索」艰难的决定！撤掉「肿瘤部门」，关闭全资子公司，卫材在下一盘大棋？首款国产新冠中和抗体，不仅是抗疫的新助力，更是新药研发成功的经典案例...热烈祝贺「中国肝病新药联盟」成立！新一届组委会诞生！智慧芽创始人、CEO张济徽：生物医药，智慧芽笃定的未来点击这里，欢聚药时代！