Novopharm Ltd.

First Cannabidiol treatment study of its kind to be approved by the FDA BURLINGTON, ON, March 11, 2024 /PRNewswire/ - EmpowerPharm Inc. is delighted to announce that the final participant has completed their treatment in the Phase II clinical trial assessing the efficacy of pharmaceutical-grade Cannabidiol (CBD) for Social Anxiety Disorder. The anticipated release of the top-line results are due next month in April. The trial, sponsored by EmpowerPharm, was a multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of CBD in individuals with Social Anxiety Disorder. It is the first study of its kind to be approved by the FDA. This pivotal Phase II study involved the enrollment of 239 patients from 19 clinical centers across the United States. The research team at EmpowerPharm has developed a novel, patented drug delivery platform using a Self-Nanoemulsifying Drug Delivery System (SNEDDS), which ensures superior bioavailability, consistent potency, extended shelf-life, and stability. This platform has potential applications for enhancing legacy drug molecules. "Coincidentally, the first product developed using the SNEDDS technology is a prescription cannabidiol (CBD) pill, which is poised to become the first pharmaceutical-grade prescription drug of its kind approved for the treatment of anxiety," said Chairman and Co-CEO, Aubrey Dan. "Over the last two decades, there has been a notable lack of innovation in the development of new medications for anxiety. There's an urgent demand for novel drugs that can offer effective relief without the adverse side effects and addictive potential of current prescriptions." After the report of Phase II Clinical Trials is complete and submitted in April, EmpowerPharm will move into Phase III clinical trials which will precede the FDA approvals process, marking anticipated availability to patients by 2028. "Our vision was to develop top-quality prescription pharmaceuticals to meet unmet needs. With over 15 million adults suffering from Social Anxiety Disorder in the United States, our mission is unequivocally clear," said Peter Billiaert, President and Co-CEO. EmpowerPharm is seeking strategeic partners to launch this breakthrough innovation. The market for Social Anxiety Disorder treatments was valued at $11.8 billion in 2022 and is expected to grow to $16 billion by 2030. EmpowerPharm anticipates that the introduction of the world's first CBD-based prescription drug could result in annual sales between $160 million and $320 million USD. This innovation not only has the potential to disrupt the market for Social Anxiety Disorder, but also holds promise for other patient populations. Its impact on conditions such as depression and sleep quality could open up additional market opportunities exceeding $8 billion. EmpowerPharm Inc. is led by Chairman and Co-CEO, Aubrey Dan, a seasoned pharmaceutical executive at Novopharm Limited with more than 20-years of industry experience, and EmpowerPharm President and co-CEO, Peter Billiaert. Billiaert is a veteran in the pharmaceutical industry with more than 40-years experience in R&D program management at Novopharm Limited and Teva Pharmaceuticals. SOURCE EmpowerPharm Inc.

Allan Oberman appointed as CEO to transform Apotex into a Canadian-based global health company. TORONTO, April 3, 2023 /PRNewswire/ - Apotex Pharmaceutical Holdings Inc. ("Apotex" or the "Company") today announced that its acquisition by an affiliate of funds advised by SK Capital Partners, LP ("SK Capital") has closed. The Company also announces that experienced pharmaceutical executive Allan Oberman has been appointed President and CEO and member of the Board of Apotex. Allan brings four decades of experience in corporate leadership to Apotex, including 20 years in the pharmaceutical industry. Most recently, he served as CEO of Concordia International Corp. and CEO of Sagent Pharmaceuticals Inc. Prior to these positions, he served as President and CEO of Teva Canada (formerly Novopharm Limited), COO of Teva International Group, President of Teva EMIA and President and CEO of Teva Americas Generics. Mr. Oberman has almost three decades of corporate governance experience, having served on numerous boards, including as Chairman of the Canadian Generic Pharmaceutical Association, and Vice-Chairman of the U.S. Association for Accessible Medicines. He has an MBA from the Schulich School of Business, York University, and a BA from Western University. "As a competitor to Apotex for many years, I am very familiar with the company and have admired its people, long-term track record of innovation and commitment to making medicines affordable to patients in Canada and worldwide," stated Allan Oberman, President and CEO of Apotex. "I'm excited to join the team and build on that legacy." "We welcome Allan to the Apotex team. His experience leading major Canadian and international pharmaceutical companies and delivering enhanced shareholder value will benefit Apotex as we grow into a Canadian-based global health company," said Aaron Davenport, Chairman of the Board of Apotex and Managing Director at SK Capital. "SK Capital looks forward to working with Apotex as it moves into its next phase of growth, leveraging its iconic brand, broad product portfolio, international presence and skilled team." Jeff Watson, Apotex's CEO since 2018, will join the Apotex Board of Directors. "We thank Jeff for his leadership and welcome him to the Board, where we will continue to benefit from his stewardship and counsel," added Mr. Davenport. About SK Capital SK Capital is a private investment firm with a disciplined focus on sectors that create the building blocks of modern life and a more sustainable future, including specialty materials, ingredients, and life sciences. The firm seeks to build strong and growing businesses that create substantial long-term economic value. SK Capital aims to utilize its industry, operating, and investment experience to identify opportunities to transform businesses into higher-performing organizations with improved strategic positioning, growth, and profitability, as well as lower operating risk. SK Capital's portfolio of businesses generates revenues of approximately USD $16 billion annually, employs more than 20,000 people globally and operates 203 plants in 32 countries. The firm currently has approximately USD $7.2 billion of assets under management. For more information, please visit skcapitalpartners.com. About Apotex Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs nearly 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the United States, Mexico, and India. For more information, visit . SOURCE Apotex Inc.

120多年前，以色列的3位药剂师倾尽各自所有积蓄，创办了一家小型药品批发公司，这，就是梯瓦（Teva ）前身。经过几十年的发展、并购扩张，梯瓦逐渐成为全球仿制药巨头。但伴随而来的却是债台高筑、资金链吃紧以及股价暴跌。那么100多年来，在这家“百年老店”身上发生了哪些故事？梯瓦的发展模式中又有哪些精华值得我们学习？发迹于以色列1901年，一家名为“S.L.E”的药品供货商在以色列耶路撒冷成立了。S.L.E取自Chaim Salomon、Moshe Levin和Yitschak Elstein三位耶路撒冷犹太裔药剂师的名字。公司刚起步时，S.L.E因没有生产能力，只从事药品贩卖业务。他们用骆驼、毛驴把药品从耶路撒冷贩运至巴勒斯坦地区销售。这一干就是三十年。尽管此时的S.L.E已成为当地最主要的药品供货商之一，但充其量它也只是一家医药物流企业。二战期间，机会来临。在纳粹残酷的“排犹运动”下，日耳曼地区大量犹太人逃亡至中东地区，此时巴勒斯坦也成为犹太人高密集地区。其中不乏制药行业科学家和商业人才。他们的回归，将欧洲先进的制药技术也带了回来。在这些精英们的帮助下，S.L.E公司在巴勒斯坦建立了一个生产药品的基地，并将其命名为梯瓦制药公司（Teva Pharmaceutical），其中，“Teva”一词是希伯来语，意为“自然”。此时的梯瓦制药已成为一家具有自产自销能力的药厂，他们的服务对象也从巴勒斯坦地区一步一步向外拓展。Teva工厂工作场景1948年，以色列建国以后，其药品市场得到飞速发展。同时，政府还推出了一系列针对国家建设有益的企业，提供税收补贴政策。梯瓦在这一时期，坚定地给自己立下定位：做仿制药，并借助政策红利高速发展。1951年，Teva在以色列第二大城市特拉维夫证券交易所挂牌上市。随后，在上世纪70-80年代，Teva相继建立了原料部门，收购了酒精工厂，吞并了以色列第三大药企Ikapharm，龙头地位得到巩固。此后，整个以色列地区已不能满足Teva的发展。如何出海扩张成为Teva亟需思考的问题。壮大于欧美起初，Teva将出海扩张的目的地瞄准在北非、欧洲等相邻地区。随着1984年美国出台Waxman-Hatch法案（即《药品价格竞争与专利期补偿法》），仿制药研发和申请流程被大大简化，Teva将仿制药市场做到美国。根据Waxman-Hatch法案，仿制药只需要提供简化新药申请，通过生物等效性试验和文献数据即可代替安全有效性试验。同时，美国还鼓励仿制药厂家挑战原研的专利，对首仿药给予6个月的市场独占期，并可以接近原研药的价格销售。Teva抓住了Waxman-Hatch法案带来的发展机遇，其仿制药业务迅速做大。1985年，Teva与美国特种化学品企业W.R.Grace合作，成立TAG Pharma。通过TAG Pharma，他们又低价收购了Lemmon，后成为Teva在美国的仿制药销售部门。Teva也因此在美国打下了基础。上世纪90年代，美国市场为Teva贡献了一半的销售业绩。在1987-1990年的三年间，Teva的销售额从1亿美元增长至3亿美元，并于1987年在纳斯达克成功上市。成也并购，败也并购事实上，Teva的发展史，也是一部并购史。上世纪70年代，Teva以并购中小型仿制药企业为主；90年代后期，Teva已经把目标放在了大中型仿制药企业。至今，Teva已经发起了约30起并购案例。这其中不乏一些大型药企，如秘鲁前十企业Corporacion Infarmasa、日本第三大仿制药公司大洋商品、加拿大第二大仿制药公司Novopharm等。2016年，Teva甚至以超400亿美金的价格，买下了仿制药巨头Actavis Generics。通过一系列并购，Teva迅速成为仿制药龙头之一，其业务已遍布全世界。2015年，Teva市值一度高达738亿美金。2016年，Teva成为世界第一大仿制药巨头，同时还是世界前十大规模药企中唯一一家仿制药企业。不过在快速获得丰厚回报的同时，Teva无节制地并购也为其带来了债务危机。在2016年并购Actavis Generics后，Teva负债高达578亿美金；至2020年底，公司负债依然近400亿美金。不过这还不是最糟糕的。FDA仿制药新政釜底抽薪创新药面临专利断崖2012年，FDA为了改善仿制药批文积压及审评效率问题，出台了《仿制药费用法案（GDUFA）》。FDA为此成立了仿制药办公室，旨在加快仿制药的审批速度。改革成效显著，至2016年底，之前积压的仿制药申请已处理95%。这也意味着仿制药开始扎堆上市，美国仿制药进入内卷。以Teva美国市场占有率为例，2016年，其在美国市场占有率为16%，2020年，下滑至9.6%。利率方面，2017年，Teva仿制药业务毛利为41.7%，与2016年相比，下降5.8%。Teva除了仿制药业务被人熟知外，它还建立了专利药部门。不巧的是，仿制药业务出现“变故”的同时，Teva的核心专利药Copaxone也遭遇危机。Copaxone是一款治疗多发性硬化症的肽类制剂，其销售额占据Teva专利药收入的50%左右，销售峰值高达42.23亿美金。然而，这么一款重磅炸弹，其专利于2015年到期。随后，Mylan等巨头药企的仿制药上市，迅速瓜分市场，Copaxone销售额断崖式下降。债务危机、仿制药市场格局恶化、专利悬崖……此后，高额减值一直伴随Teva左右。2019年底，BioPharma Dive发布的一项统计显示，31家陷入困境的制药公司被投资者认为，在未来12个月内破产的风险最高，Teva便位列其中。目前，Teva的仿制药和创新药业务仍没有好转迹象，债务虽有所减少，但距离“解脱”还有一段距离。回首Teva的发展历程，是并购让其从以色列走向国际大市场，也是并购让其债务缠身，深陷泥潭。尽管如此，Teva仍有很多我们可以学习的地方，比如它对仿制药做强做精的精神，从而凭借过硬的产品品质立足全球；比如它在新药上市前事无巨细的分析评估；比如在战火纷飞年代依然专注科学研究的毅力……参考来源http://www.tevapharm.com/news/teva_pharmaceutical_industries_ltd_signs_definitive_agreement_to_acquire_novopharm_ltd_02_00.aspx；http://www.company-histories.com/Teva-Pharmaceutical-Industries-Ltd-Company-History.html；https://www.tevapharm.com/news-and-media/latest-news/teva-reports-first-quarter-2021-financial-results/；医药魔方《全球仿制药巨头盘点（一） | Teva：进击的以色列巨人》；新康界《他山之石可以攻玉 看仿制药巨头如何进击与转型》。阅读合集 1.安进：“红白”双药引领开端，披荆斩棘42年踏过时光变迁2. 逃不掉的专利悬崖，接连折戟的临床试验，赛诺菲如何度过“水逆”？3. 从黄金时代到黯然离场再到重新布局，跨国药企在华投资浮沉录4. 武田制药：200多年老药企，也曾陷入成长危机5. IPO上市前夕，突然宣布延期上市，退回认购款，百德医疗这是为何？扫一扫，申请药渡数据免费试用