Lyndra Inc. and Global Drug Commercialization Center Announce Joint Venture to Develop Lyndra’s Ultra-long-acting Oral Dosage Form for Chinese Market

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”.

Dr Bob Langer at Opening Ceremony
Dr Bob Langer at Opening Ceremony

*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.

Lyndra Inc. was incorporated in 2015 and is based in Watertown, Massachusetts. For more information, visit www.lyndra.com and follow the company on Twitter @LyndraInc.

Press Contact:

Rebecca Braun: media@lyndra.com; +1-857-301-6039