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Teva and MODAG Announce Licensing Collaboration for Neurodegenerative Disease Drug Candidate

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Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders

TEL AVIV & WENDELSHEIM, Germany, October 26, 2021--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG's lead compound anle138b and a related compound, sery433.

Anle138b targets pathological alpha-synuclein oligomers and is being evaluated in patients with neurodegenerative diseases for potential disease modification. Under the terms of the agreement and pending regulatory clearance, Teva will receive an exclusive global license to develop, manufacture and commercialize anle138b and sery433. The companies will jointly develop the compounds for the multiple system atrophy (MSA) and Parkinson’s disease (PD) indications based on early-stage clinical studies, and consider exploring additional indications based on clinical outcomes.

A Phase 1 (NCT04208152) study examining anle138b in healthy volunteers completed in July 2020 demonstrated favorable benefit-risk profile at all dose levels while achieving higher plasma levels than those required for full therapeutic efficacy in animal models. Anle138b was initially developed in patients with MSA and PD and has the potential to be applied to other neurodegenerative disorders, such as Alzheimer's disease. A Phase 1b (NCT04685265) clinical trial evaluating the safety of the compound, as well as efficacy measures in patients living with PD, is currently being conducted.

"With Teva’s strong foundation in neuroscience and our in-house expertise in neurology and psychiatry, this licensing and collaboration agreement adds a promising new compound to our early-stage pipeline as a possible orphan disease treatment for the growing patient population living with multiple system atrophy, as well as a potential option for patients living with Parkinson’s disease," said Hafrun Fridriksdottir, Executive Vice President, Global R&D. "We at Teva are excited about collaborating with the MODAG team and look forward to future developments as we continue to follow the science and explore additional indications for both partnered compounds."

Dr. Matthias, CEO of MODAG added, "We are pleased to partner and work alongside Teva, an organization that has longstanding, extensive expertise in the development of therapeutics. In addition to the previous support we have received from the Michael J. Fox-Foundation and the Cure Parkinson's Trust, this partnership further underscores the heightened potential of our lead candidates to do what no drug is currently capable of: blocking the progression of synucleinopathies. Building upon our notable preliminary results, we look forward to the continued development of anle138b alongside Teva to help patients living with currently untreatable neurodegenerative diseases, including MSA, PD and Alzheimer’s disease. With the introduction of small-molecule medication, we open a new chapter in the fight against neurodegenerative diseases and have the chance to improve the lives of millions of patients drastically."

Multiple System Atrophy

Multiple system atrophy (MSA) is a rare neurodegenerative disorder classified clinically as "atypical parkinsonism" and belongs to the group of synucleinopathies. MSA is characterized histopathologically by abnormal deposits of the α-synuclein protein, mainly in oligodendroglial cells (glial cytoplasmic inclusions) and also in certain nerve cells. Typically, there is a dysfunction of the autonomic nervous system, i.e., disturbances of bladder function, erectile function, intestinal mobility, or the regulation of blood pressure in combination with a movement disorder. The movement disorder often presents with either Parkinson-like symptoms or a disturbance of cerebellar function, such as ataxia, gait and speech problems. In the US, EU, and Japan, MSA affects about 40,000 people (prevalence of 4 per 100,000), with about 6,000 new cases diagnosed each year (incidence of 0.6 per 100,000). Post-diagnosis life expectancy is about 7-10 years. Due to the relatively small number of affected patients and lack of effective therapy, MSA qualifies for orphan status, allowing a shorter development path. This unmet medical need for MSA disease modification is the driver to develop new therapies that could potentially impact the lives of patients.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

About MODAG

MODAG, a privately held German biotech company, is focused on the research and development of therapeutics and diagnostics for neurodegenerative diseases. MODAG's innovative approach offers a unique combination of early diagnosis and targeted disease-modifying therapies for severe neurological disorders. MODAG's collaborations with the top-tier US and European research institutions, combined with its founders and management team's interdisciplinary research and development expertise, provide ideal conditions for accelerated implementation of clinical applications. Built upon an extensive portfolio of patented active compounds, MODAG is developing a new oligomer modulator for MSA, PD and other synucleinopathies such as Alzheimer's disease, intending to deliver novel, first-in-class drugs with the potential to halt disease progression. For more information, see www.modag.net.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as "should," "expect," "anticipate," "estimate," "target," "may," "project," "guidance," "intend," "plan," "believe" and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, including AUSTEDO®, AJOVY and COPAXONE®; our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including uncertainty regarding the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general, our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith, costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the section captioned "Risk Factors." Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

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Contacts

IR Contacts
United States
Kevin C. Mannix (215) 591-8912
Yael Ashman 972 (3) 914-8262

PR Contacts
United States
Kelley Dougherty (973) 658-0237
Yonatan Beker (973) 264 7378

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