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.
蘭德拉公司和GDCC宣佈聯合開發
針對中國市場的超長效口服藥物劑型
蘭德拉公司首席執行官Amy Schulman在TED演講後向公眾發佈：蘭德拉公司（Lyndra）與全球藥物商業化中心（GDCC）成立合資企業，將蘭德拉公司的開創性藥物在中國進行商業化。Amy Schulman被視為“富有遠見的企業家”。
新興生物製藥公司蘭德拉於2018年4月17日宣佈與GDCC組建合資企業，將蘭德拉在中國的開創性藥物商業化。 合作伙伴們為總部設於中國成都的蘭德拉（中國）製藥有限公司舉行了公開剪彩儀式。
蘭德拉正在開發超長效口服藥物，使患者不需要日常服用藥物並大幅改善醫療保健效果。
蘭德拉聯合創始人兼首席執行官Amy Schulman說：“世界上有許多拯救生命和改變生活的療法，但出於許多原因，人們並不會經常使用。” “在蘭德拉，我們致力於為人們的健康做出改變。我們希望減少患者和護理人員因每日用藥而面臨的痛苦。我們的超長效藥物可以減輕服藥依從性負擔，並減少慢性病帶來的日常挑戰。我們很高興與GDCC合作，為世界帶來這些裨益。”
隨著合資企業的成立，GDCC將投資8000萬美元用於開發定製產品，以滿足快速增長的中國市場需求。中國是僅次於美國的全球第二大藥品消費市場，居民超10億，人口正在老齡化。GDCC是加拿大誇克資本和全球健康科學基金在中國的藥物開發和營銷子公司。該基金在一年多前對蘭德拉進行了A輪投資。
“我們很高興繼續推進與蘭德拉的合作關係，”GDCC首席執行官卡瑞瑪·沙巴女士說，“我們對該公司推進這項技術的步伐感到震驚。通過新成立的合資企業，我們將進一步加速該平臺的發展，並對患者服藥依從性的舊問題帶來新的解決方案，從而顯著改善治療效果。”
蘭德拉平臺基於麻省理工學院Robert Langer博士實驗室開發的技術，由比爾和梅林達蓋茨基金會予以資助。
蘭德拉聯合創始人Robert Langer博士說：“我們的目標是提供新的口服藥物，使患者每週服用一次，而不是每天服用。期望顯著改善依從性和總體療效。在中國等人口眾多、醫療保健需求不斷增加的國家，這些優勢尤有價值。”
合資公司是Robert Langer博士首家與GDCC建立合作關係的企業。
蘭德拉董事會主席Catherine Reynolds宣稱這筆交易對於蘭德拉公司來說是偉大的一步。“我們很榮幸GDCC相信我們的願景和我們獨特的競爭力，我們很高興能夠擴大我們在全球的影響力。”
大約有50％的患者 ，在某些情況下甚至更多 ， 在不定期服用他們的藥物。僅在美國，普遍的服藥依從性不足就導致每年至少10％的住院和12.5萬人死亡。美國醫療系統每年因此花費近3000億美元，超過了任何疾病導致的實際費用。這是可以完全避免的。研究表明患者遵循每週或每月用藥時間表的情況明顯好於遵循每日服藥要求的情況。依從性的增強可以大大改善療效並提高患者和護理人員的生活質量。長效劑量還可改善藥代動力學特徵，減少副作用並提高藥物療效。
TEDMED演講節目認為
蘭德拉是富有遠見的領導企業
蘭德拉首席執行官Amy Schulman於2017年受委派來到著名的TEDMED Hive視頻節目，做了名為“敢於冒險：想象種種進步和可能性將帶來的一個更加健康的世界”的系列演講。該系列演講的主題是“有遠見的想法和突破性的創新正在影響健康和醫學各個領域的變化”。
演講中，Schulman女士指出了人們不能保持每日服藥的諸多原因，並問道：“如果我們停止嘗試改變患者，而去改變藥片，將會怎麼樣？”
可行性研究
今年1月，蘭德拉在採用同行評議制的《自然通訊》（Nature Communications）雜誌上發表了一項HIV抗逆轉錄病毒治療藥物每週口服輸送平臺的可行性研究。該研究做了使用由藥物 - 聚合物基質組成的新型藥物遞送系統在動物模型中持續口服遞送三種關鍵的有效抗HIV藥物的概念驗證。
發表在2016年《科學轉化醫學》（Science Translational Medicine）雜誌上的蘭德拉早期研究表明，該公司對伊維菌素（一種中斷瘧疾媒介傳播的藥物）的長效控釋可長達14天。
資助情況
從蘭德拉獲得的資助和與其達成合作的機構可以看出業內對團隊專業技術的遠見和信心的興奮深度和廣度。公司很高興能得到美國國立衛生研究院(NIH)和比爾和梅林達蓋茨基金會的資助，還在由Polaris Partners基金領導的A輪融資中籌集了2300萬美元，並與艾爾建達成了1.05億美元的合作。
關於蘭德拉
蘭德拉旨在通過開發超長效、持續釋放的口服藥物來改變患者服用藥物的方式，這些藥物將顯著改善健康狀況。公司團隊正在開發持續一週或更長時間的藥品，並以較為熟知的膠囊形式遞送各種藥物。一旦進入胃中，膠囊就會溶解並釋放一顆星形藥丸，藥效可持續七天或更長時間。
蘭德拉的超長效藥物通過解除每日服藥的負擔來解決普遍存在的患者服藥依從性不足問題。其好處包括改善健康狀況，提高生活質量，並降低醫療成本。蘭德拉的劑型還可改善藥代動力學特徵，減少副作用並提高藥物療效。
蘭德拉公司於2015年註冊成立，總部位於麻省沃特敦。
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翻譯：鄒鑫垠
成都天府國際生物城
微博：@成都天府國際生物城
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