Allergan Enters Parkinson's Disease Through Option Arrangement with Lysosomal Therapeutics Inc. (LTI) for its Potential First-In-Class Breakthrough Compounds

DUBLIN and CAMBRIDGE, Mass., Jan. 9, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Lysosomal Therapeutics (LTI) today announced that Allergan has purchased an exclusive option right to acquire LTI.  LTI is focused on innovative small-molecule research and development in the field of neurodegeneration, yielding new treatment options for patients with severe neurological diseases.

LTI-291, LTI's lead program, aims to stimulate the activity of glucocerebrosidase (GCase) in the brain. In several lysosomal storage diseases, the activity of GCase is reduced due to genetic mutations in the GBA1 gene. Importantly, approximately 5 to 10 percent of patients with Parkinson's disease (PD) have mutations of the GBA1 gene,[i] and it is well documented that these patients have a more rapid progression of Parkinson's disease. Thus, it is hoped that activation of GCase by LTI-291 will impact the progression of PD in these patients.

Under the option agreement, Allergan purchased an option right directly from LTI shareholders to acquire LTI following completion of a Phase 1b trial for LTI-291.  In addition, Allergan will provide a separate upfront research and development payment.  Allergan and LTI will establish a joint development committee to oversee the development activities for LTI-291. Additional terms were not disclosed.

Parkinson's disease is an area of strategic alignment for Allergan and represents an attractive adjacency to Allergan's other CNS businesses, with emphasis on neurodegeneration and movement disorders. Allergan's Open Science model enables the Company to enter areas of innovation with leading partners, while leveraging their expertise through creative partnerships.

"Parkinson's disease is an area of medicine where significant unmet need exists, particularly in the development and potential breakthrough of disease-modifying treatments for the more than 2 million people suffering with Parkinson's today," said David Nicholson, Chief Research & Development Officer, Allergan. "The pioneering work of the LTI team in developing its GCase program harnesses the link between GCase activity and disease progression in patients with a GBA mutation who suffer from Parkinson's disease. The intention is to provide therapeutic benefit for the affected patients by modulating GCase activity. We look forward to working with the LTI team to further their work in this area and the potential for positive Phase 1 results."

"LTI is paving a new path in the characterization of Parkinson's disease, including the understanding of a patient's glycosphingolipid profile and its relevance to therapeutic response," said Kees Been, CEO of Lysosomal Therapeutics.  "We are pleased to work with Allergan to support the acceleration of LTI's leading GCase activators to reach as many Parkinson's patients as soon as possible.  The Allergan team matched its commitment to our leading science with a compelling approach to collaboration – we are thrilled to provide our new partner with development candidates for severe neurodegenerative diseases.  We look forward to reaching the milestones that will deliver significant value to both companies, and most of all, to developing much needed therapeutics for patients with PD."

Dr. Kenneth Marek, President and Senior Scientist at the Institute for Neurodegenerative Disorders of the Michael J. Fox Parkinson Progression Marker Initiative, Clinical Professor of Neurology at Yale University and a member of LTI's Scientific Advisory Board added, "The key unmet need for Parkinson's disease patients and families is to slow disease progression. LTI has taken a novel personal medicine approach to Parkinson's Disease, targeting rapidly-progressing patients who carry a mutant GBA1 gene.  The LTI drug candidate, which is designed to reverse the loss of enzyme activity in patients with the genetic mutation, has a chance to be the first drug in its class." 

Covington & Burling LLP served as Allergan's legal counsel.  Goodwin Procter LLP and Faber Daeufer & Itrato PC served as LTI's legal counsel.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, the Company's R&D model, which defines Allergan's approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.

Our Company's success is powered by our more than 15,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live healthier lives every day.

For more information, visit Allergan's website at www.Allergan.com.

About Lysosomal Therapeutics Inc.

Lysosomal Therapeutics Inc. (LTI) is dedicated to innovative small-molecule research and development in the field of neurodegeneration, yielding new treatment options for patients with severe neurological diseases. LTI's strategy leverages the clinically validated link between lysosome-based genetic disorders and neurodegenerative diseases to establish a unique and effective platform for novel drug discovery. LTI's lead program targets Gaucher-related neurodegeneration, Parkinson's disease and other synucleinopathies. Investors include Atlas Venture, Hatteras Venture Partners, Lilly Ventures, Partners Innovation Fund, Roche Venture Fund and Sanofi Genzyme BioVentures. www.lysosomaltx.com

Allergan Cautionary Statement Regarding Forward-Looking Statements

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

ⁱ Ann Med. 2013 Dec;45(8):511-21. Glucocerebrosidase mutations and the pathogenesis of Parkinson disease.

SOURCE Allergan plc

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