Eli Lilly and Company | August 25, 2021
Eli Lilly and Company and Lycia Therapeutics, Inc. today announced a multi-year research collaboration and licensing agreement focused on the discovery, development and commercialization of novel targeted therapeutics using Lycia's proprietary lysosomal targeting chimera, or LYTAC, protein degradation technology.
Lycia uses its next-generation degradation approach to target the untapped extracellular proteome, including cell surface receptors and secreted proteins. The LYTAC platform may enable the development of several therapeutic modalities, including antibodies and small molecules, with the potential to inhibit many targets previously considered intractable across a spectrum of therapeutic areas and diseases.
Under the terms of the agreement, the companies will utilize Lycia's LYTAC platform to discover and develop novel degraders for up to five targets that aim to address key unmet medical needs in Lilly's therapeutic areas of focus, including immunology and pain. Lilly will be solely responsible for preclinical and clinical development of candidates and receives an exclusive worldwide license to commercialize potential medicines resulting from the agreement.
"This collaboration with Lycia furthers Lilly's strategy to utilize innovative new technology to treat challenging disease areas, such as immunology and pain," said Ajay Nirula, M.D., Ph.D., vice president of immunology at Lilly. "We believe Lycia's technology may allow us to develop targeted therapeutics that were not previously feasible and make advances for patients in areas of high unmet need."
"We are extremely pleased to establish this strategic collaboration with Lilly, a global leader in therapeutic innovation," said Aetna Wun Trombley, Ph.D., President and CEO of Lycia. "With our differentiated LYTAC platform for targeted extracellular protein degradation, we look forward to collaborating with Lilly to advance novel therapies against challenging targets in underserved disease areas while we simultaneously advance our in-house pipeline of first-in-class LYTAC-based therapeutics."
Lycia will receive an upfront payment of $35 million. The company is also eligible to receive over $1.6 billion in potential milestone payments based on the achievement of prespecified preclinical, development and commercial milestones, as well as tiered royalties from mid-single to low double-digits on sales resulting from the agreement.
This transaction will be reflected in Lilly's reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly's 2021 non-GAAP earnings per share guidance as a result of this transaction.
About Lycia Therapeutics, Inc.
Lycia Therapeutics, Inc. is a biotechnology company using its proprietary lysosomal targeting chimeras platform to discover and develop first-in-class therapeutics that degrade extracellular and membrane-bound proteins that drive a range of difficult-to-treat diseases, including cancers and autoimmune conditions. Headquartered in South San Francisco, Lycia was established in 2019 within founding investor Versant Ventures' Inception Therapeutics Discovery Engine in collaboration with academic founder Carolyn Bertozzi, Ph.D., professor of chemistry and HHMI investigator at Stanford University.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
Merck | July 17, 2020
Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a worsening heart failure event in patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), in combination with other heart failure therapies. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Jan. 20, 2021. Vericiguat is being jointly developed with Bayer AG.
“This submission builds on Merck’s commitment to patients with cardiovascular disease and long legacy of advancing cardiovascular research to meet unmet medical needs,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We look forward to working with the FDA as they review this New Drug Application for vericiguat.”
Cancer Prevention Pharmaceuticals, CPP-1X/sul | June 29, 2020
Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for CPP-1X/sul for treatment of adults with familial adenomatous polyposis (FAP).
FAP is a rare genetic disease that if left untreated progresses to colorectal cancer in nearly 100% of patients. The clinical development of CPP-1X/sul was designed to establish this fixed dose combination product as a potential pharmaco-preventive drug treatment specifically for FAP patients.
“The NDA submission for our lead drug candidate, CPP-1X/sul, represents a significant milestone for FAP patients and their families,” said CPP CEO Jeff Jacob. “For most FAP patients, current medical practice involves a lifetime of periodic monitoring as well as highly invasive surgical procedures. If approved, CPP-1X/sul could provide an alternative to surgery for many patients, significantly improving their quality of life.”