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Biogen to Acquire Novel Clinical Stage Asset with Application in Alzheimer's Disease and Parkinson's Disease from Pfizer Inc.
CAMBRIDGE, Mass., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced an agreement to acquire from Pfizer Inc. (NYSE: PFE) PF-05251749, a novel CNS-penetrant small molecule inhibitor of casein kinase 1 (CK1), for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases. In particular, Biogen plans to develop the Phase 1 asset for the treatment of Sundowning in Alzheimer’s disease (AD) and Irregular Sleep Wake Rhythm Disorder (ISWRD) in Parkinson’s disease (PD). The purchase will include an upfront payment of $75 million with up to $635 million in potential additional development and commercialization milestone payments, as well as tiered royalties in the high single digits to sub-teens. “This asset is highly complementary to our existing pipeline of potential disease-modifying therapies in Alzheimer’s and Parkinson’s diseases,” said Alfred Sandrock Jr., M.D., Ph.D., Executive Vice President, Research and Development and Chief Medical Officer at Biogen. “Many patients with Alzheimer’s and Parkinson’s suffer from debilitating sleep disorders and agitation, and we believe that the regulation of the circadian rhythm may hold promise in addressing these challenging behavioral and neurological symptoms.” CK1 is a key regulator of the ‘central clock,’ the suprachiasmatic nucleus of the hypothalamus, that controls circadian rhythm and impacts nearly all vital physiology and metabolism. The disruption of circadian rhythm is associated with various psychiatric and neurological diseases, including certain important symptoms of AD and PD. Sundowning is a symptom that impacts 20% or more of AD patients who become confused, anxious, aggressive, agitated or restless later in the day. ISWRD is a circadian rhythm disorder where patients experience fragmented nighttime sleep leading to daytime sleepiness, severe fatigue and difficulty with activities of daily living. It is one of the non-motor symptoms of PD, and usually increases in frequency over the course of the disease and disability progression. Biogen will explore the potential of PF-05251749 to improve behavioral disturbances of Sundowning in AD by correcting circadian rhythm, as well as its potential to treat symptoms of ISWRD to impove daytime wakefulness, sleep quality, behavior and daily function. PF-05251749 has previously demonstrated an acceptable safety profile and proof of mechanism in a Phase 1a clinical study. Biogen aims to initiate a Phase 1b study in Q4 2020. This transaction will be accounted for as an asset acquisition and is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart Scott Rodino Antitrust Improvements Act of 1976 in the United States. Biogen expects the transaction to close in the first quarter of 2020. About Biogen We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube. Safe Harbor These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation: risks that the proposed transaction will be completed in a timely manner or at all; the possibility that certain closing conditions to the proposed transaction will not be satisfied; uncertainty as to whether the anticipated benefits of the proposed transaction can be achieved; risks of unexpected hurdles, costs or delays; uncertainty of success in the development and potential commercialization of PF-05251749, which may be impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risks factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this news release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise. Contact: MEDIA: INVESTOR CONTACT:
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