Lyndra Inc. and Global Drug Commercialization Center Announce Joint Venture to Develop Lyndra’s Ultra-long-acting Oral Dosage Form for Chinese Marke
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Company forms joint venture with Global Drug Commercialization Center (GDCC) to commercialize Lyndra’s groundbreaking medicines in China. Announcement comes as Lyndra CEO Amy Schulman’s TEDMED talk is released to the public; Schulman featured as “visionary entrepreneur”.
*WATERTOWN, Mass., April 27, 2018 * – Lyndra Inc., an emerging biopharmaceutical company, today announced the formation of a joint venture with Global Drug Commercialization Center (GDCC) to commercialize Lyndra’s groundbreaking medicines in China. The partners held a public ribbon-cutting ceremony for the new Lyndra (China) Pharmaceuticals Co., Ltd. headquarters in Chengdu, China.
Lyndra is developing ultra-long-acting oral therapies that free patients of the need to take daily medications and drastically improve healthcare outcomes.
“The world has lifesaving and life-changing therapies that, for a host of reasons, people just do not take regularly,” Lyndra Co-founder and CEO Amy Schulman said. “At Lyndra, we are deeply committed to making a difference in how people get well. We want to reduce the struggle patients and caregivers face with daily pills. Our ultra-long-acting medicines can ease the burden of medication compliance and simplify the day-to-day challenges of chronic conditions. We are excited to partner with GDCC to bring these benefits across the globe.”
With the creation of this joint venture, GDCC will invest $80 million for development of products tailored to meet the needs of the rapidly growing Chinese market. China is the world’s second-biggest pharmaceuticals market after the U.S., with more than one billion inhabitants and an aging population. GDCC is the drug development and marketing affiliate in China of Quark Ventures and the Global Health Sciences Fund. The fund made its first Series A investment in Lyndra just over a year ago.
“We are excited to continue to advance our partnership with Lyndra,” said Ms. Karimah Es Sabar, CEO of GDCC. “We have been astounded by the pace at which the company has been able to advance this technology. Through our new joint venture, we will be able to further expedite the development of this platform and bring new solutions to an old problem of patient compliance, significantly improving patient outcomes.”
The Lyndra platform is based on technology developed in the laboratory of Dr. Robert Langer at the Massachusetts Institute of Technology with funding from the Bill and Melinda Gates Foundation.
Dr. Langer, a Lyndra co-founder, said, “Our ambition is to provide new oral medicines that patients take weekly instead of daily, with the expectation of significantly improving adherence and overall outcomes. These benefits can be especially valuable in countries like China with large populations and rising health care needs.”
This joint venture marks the first of the companies founded by Dr. Langer to enter into a partnership with GDCC.
Lyndra Board Chair Catherine Reynolds heralded the deal as an extraordinary step for a company of Lyndra’s size. “We are honored that GDCC believes in our vision and our unique competencies, and we are thrilled to expand our reach across the globe.”
About 50 percent of patients – in some cases more – do not take their medications regularly. Nonadherence is an epidemic that causes at least 10 percent of hospitalizations and 125,000 deaths a year in the U.S. alone. It costs the U.S. health system nearly $300 billion annually, more than any actual disease. And it can be 100 percent preventable. Studies indicate that adherence to weekly or monthly medication schedules is significantly higher than to daily schedules. This increased adherence translates to greatly improved outcomes and better quality of life for patients and caregivers. Longer-acting doses also improve the pharmacokinetic profile, reducing side effects and increasing drug efficacy.
TEDMED Recognizes Lyndra as Visionary Leader
Lyndra CEO Amy Schulman was appointed to the prestigious TEDMED Hive in 2017 and presented as part of a TEDMED series called Audacious: Imagining progress and possibilities for a healthier world. The series features entrepreneurs whose “visionary ideas and boundary-breaking innovations are affecting change in every area of health and medicine.”
In her talk, Ms. Schulman noted the many reasons people fail to take daily medications reliably, and asked, “What if we stopped trying to change the patient, and we changed the pill instead?” Ms. Schulman’s talk was released to the public on April 24 and is available for viewing @www.tedmed.com/talks/show?id=727804.
Feasibility Studies
In January, Lyndra published a feasibility study of an oral, once-weekly drug delivery platform for HIV antiretroviral therapy in the peer-reviewed journal Nature Communications. The study demonstrated proof-of-concept of sustained oral delivery of three key potent anti-HIV therapies in an animal model using a novel drug-delivery system comprised of drug-polymer matrices.
An earlier Lyndra study, published in Science Translational Medicine in 2016, demonstrated the long-acting controlled release of ivermectin, a treatment to interrupt the vector transmission of malaria, for up to 14 days.
Funding
Lyndra’s funding and partners reflect the depth and breadth of excitement for the company’s vision and confidence in the team’s technical expertise. Lyndra is pleased to have financial support from the National Institutes of Health and the Bill and Melinda Gates Foundation. Lyndra also raised $23 million in a Series A financing round led by Polaris Partners, and secured a $105 million partnership with Allergan plc.
About Lyndra
Lyndra aims to transform the way patients take medicines through the development of ultra-long-acting, sustained-release oral therapies that drastically improve health outcomes. Our team is developing pills that last a week or longer, and that provide a wide range of medicines in a familiar capsule form. Once inside the stomach, the capsule dissolves and releases a star-shaped pill that delivers steady amounts of medicine for seven days or more.
Lyndra’s ultra-long-acting pills address the epidemic of non-adherence by removing the burden of daily pills. Benefits include improved health outcomes and quality of life, and reduced health costs. Lyndra’s dosage form also improves the pharmacokinetic profile, which reduces side effects and improves drug efficacy.
兰德拉公司和GDCC宣布联合开发
针对中国市场的超长效口服药物剂型
兰德拉公司首席执行官Amy Schulman在TED演讲后向公众发布：兰德拉公司（Lyndra）与全球药物商业化中心（GDCC）成立合资企业，将兰德拉公司的开创性药物在中国进行商业化。Amy Schulman被视为“富有远见的企业家”。
新兴生物制药公司兰德拉于2018年4月17日宣布与GDCC组建合资企业，将兰德拉在中国的开创性药物商业化。 合作伙伴们为总部设于中国成都的兰德拉（中国）制药有限公司举行了公开剪彩仪式。
兰德拉正在开发超长效口服药物，使患者不需要日常服用药物并大幅改善医疗保健效果。
兰德拉联合创始人兼首席执行官Amy Schulman说：“世界上有许多拯救生命和改变生活的疗法，但出于许多原因，人们并不会经常使用。” “在兰德拉，我们致力于为人们的健康做出改变。我们希望减少患者和护理人员因每日用药而面临的痛苦。我们的超长效药物可以减轻服药依从性负担，并减少慢性病带来的日常挑战。我们很高兴与GDCC合作，为世界带来这些裨益。”
随着合资企业的成立，GDCC将投资8000万美元用于开发定制产品，以满足快速增长的中国市场需求。中国是仅次于美国的全球第二大药品消费市场，居民超10亿，人口正在老龄化。GDCC是加拿大夸克资本和全球健康科学基金在中国的药物开发和营销子公司。该基金在一年多前对兰德拉进行了A轮投资。
“我们很高兴继续推进与兰德拉的合作关系，”GDCC首席执行官卡瑞玛·沙巴女士说，“我们对该公司推进这项技术的步伐感到震惊。通过新成立的合资企业，我们将进一步加速该平台的发展，并对患者服药依从性的旧问题带来新的解决方案，从而显着改善治疗效果。”
兰德拉平台基于麻省理工学院Robert Langer博士实验室开发的技术，由比尔和梅林达盖茨基金会予以资助。
兰德拉联合创始人Robert Langer博士说：“我们的目标是提供新的口服药物，使患者每周服用一次，而不是每天服用。期望显著改善依从性和总体疗效。在中国等人口众多、医疗保健需求不断增加的国家，这些优势尤有价值。”
合资公司是Robert Langer博士首家与GDCC建立合作关系的企业。
兰德拉董事会主席Catherine Reynolds宣称这笔交易对于兰德拉公司来说是伟大的一步。“我们很荣幸GDCC相信我们的愿景和我们独特的竞争力，我们很高兴能够扩大我们在全球的影响力。”
大约有50％的患者 ，在某些情况下甚至更多 ， 在不定期服用他们的药物。仅在美国，普遍的服药依从性不足就导致每年至少10％的住院和12.5万人死亡。美国医疗系统每年因此花费近3000亿美元，超过了任何疾病导致的实际费用。这是可以完全避免的。研究表明患者遵循每周或每月用药时间表的情况明显好于遵循每日服药要求的情况。依从性的增强可以大大改善疗效并提高患者和护理人员的生活质量。长效剂量还可改善药代动力学特征，减少副作用并提高药物疗效。
TEDMED演讲节目认为
兰德拉是富有远见的领导企业
兰德拉首席执行官Amy Schulman于2017年受委派来到著名的TEDMED Hive视频节目，做了名为“敢于冒险：想象种种进步和可能性将带来的一个更加健康的世界”的系列演讲。该系列演讲的主题是“有远见的想法和突破性的创新正在影响健康和医学各个领域的变化”。
演讲中，Schulman女士指出了人们不能保持每日服药的诸多原因，并问道：“如果我们停止尝试改变患者，而去改变药片，将会怎么样？”
可行性研究
今年1月，兰德拉在采用同行评议制的《自然通讯》（Nature Communications）杂志上发表了一项HIV抗逆转录病毒治疗药物每周口服输送平台的可行性研究。该研究做了使用由药物 - 聚合物基质组成的新型药物递送系统在动物模型中持续口服递送三种关键的有效抗HIV药物的概念验证。
发表在2016年《科学转化医学》（Science Translational Medicine）杂志上的兰德拉早期研究表明，该公司对伊维菌素（一种中断疟疾媒介传播的药物）的长效控释可长达14天。
资助情况
从兰德拉获得的资助和与其达成合作的机构可以看出业内对团队专业技术的远见和信心的兴奋深度和广度。公司很高兴能得到美国国立卫生研究院(NIH)和比尔和梅林达盖茨基金会的资助，还在由Polaris Partners基金领导的A轮融资中筹集了2300万美元，并与艾尔建达成了1.05亿美元的合作。
关于兰德拉
兰德拉旨在通过开发超长效、持续释放的口服药物来改变患者服用药物的方式，这些药物将显着改善健康状况。公司团队正在开发持续一周或更长时间的药品，并以较为熟知的胶囊形式递送各种药物。一旦进入胃中，胶囊就会溶解并释放一颗星形药丸，药效可持续七天或更长时间。
兰德拉的超长效药物通过解除每日服药的负担来解决普遍存在的患者服药依从性不足问题。其好处包括改善健康状况，提高生活质量，并降低医疗成本。兰德拉的剂型还可改善药代动力学特征，减少副作用并提高药物疗效。
兰德拉公司于2015年注册成立，总部位于麻省沃特敦。
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翻译：邹鑫垠
成都天府国际生物城
微博：@成都天府国际生物城
官网：www.cdbiotown.com
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