Biogen and Neurimmune Announce Option Exercise for Alzheimer’s Disease Investigational Treatment Aducanumab
Biogen (Nasdaq: BIIB) and Neurimmune announced today that Biogen has exercised its option to further reduce the previously negotiated royalty rates payable on potential future sales of aducanumab, Biogen’s Phase 3 investigational treatment for early Alzheimer’s disease.
Biogen will make a one-time $50 million payment to Neurimmune in exchange for a 5% reduction in the original royalty rates on potential commercial sales of aducanumab, which follows the 15% reduction in royalty rates announced in October 2017. The reduced royalty rates on potential commercial sales of aducanumab will be in the high single digits to low-teens. Biogen licensed the worldwide rights to aducanumab from Neurimmune in 2007.
“Biogen values our collaboration with Neurimmune, and this step is aligned with our amended agreement from 2017,” said Michel Vounatsos, chief executive officer of Biogen. “As we progress our pipeline of candidates for Alzheimer’s disease including aducanumab, we hope that a potential treatment for this devastating and debilitating disease will be realized.”
“At Neurimmune, we are pleased with the continuous progress of our long-term successful collaboration with Biogen,” said Roger Nitsch, chief executive officer of Neurimmune. “This non-dilutive financing supports our growth strategy focused on bringing human-derived antibodies through clinical proof-of-concept in disease areas with high medical need.”
Aducanumab (BIIB037) is an investigational compound being developed for the treatment of Alzheimer’s disease. Aducanumab is a human recombinant monoclonal antibody (mAb) derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune’s technology platform called Reverse Translational Medicine (RTM). Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.
Aducanumab is thought to target aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils which can form into amyloid plaque in the brain of Alzheimer’s disease patients. Based on pre-clinical and Phase 1b data to date, treatment with aducanumab has been shown to reduce amyloid plaque levels.
In August 2016 aducanumab was accepted into the European Medicines Agency’s PRIME program. In September 2016 the U.S. Food and Drug Administration accepted aducanumab into its Fast Track program and in April 2017 aducanumab was accepted into the Japanese Ministry of Health, Labour and Welfare’s (MHLW) Sakigake Designation System.
As of October 2017, Biogen and Eisai entered into a global collaboration agreement to jointly develop and commercialize aducanumab.
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.
Biogen routinely posts information that may be important to investors on its website at www.biogen.com. To learn more, please visit www.biogen.com and follow Biogen on social media – Twitter, LinkedIn, Facebook, YouTube.
Neurimmune is a biopharmaceutical company dedicated to the development of human-derived therapeutic antibodies for the treatment and prevention of human diseases with a high unmet medical need. Established in 2006, Neurimmune has rapidly grown into a leader in the field of recombinant human monoclonal antibody therapeutics. Neurimmune’s pipeline comprises high-potential drug candidates at both clinical and advanced preclinical development stages. Aducanumab, an investigational treatment for Alzheimer’s disease, partnered with Biogen, is currently in phase 3 clinical trials. Rights in antibodies BIIB054 for Parkinson’s disease and BIIB076 for Alzheimer’s disease were acquired by Biogen. In 2016, Neurimmune partnered with TVM and Eli Lilly’s Chorus unit to advance an antibody for the treatment of amyotrophic lateral sclerosis. In 2017, Neurimmune entered into a collaboration with Ono Pharmaceutical in Japan. Neurimmune’s pipeline includes human antibody programs for cardiomyopathy, type-2 diabetes and progressive multifocal leukoencephalopathy, with potential therapies in advanced preclinical stages.
Biogen Safe Harbor Statement
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to the anticipated benefits and potential of Biogen’s collaboration agreement with Neurimmune; the potential of Biogen’s commercial business and pipeline programs, including aducanumab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as “aim,” “anticipate, “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty as to whether the anticipated benefits and potential of Biogen’s collaboration agreement with Neurimmune can be achieved; risks of unexpected costs or delays; uncertainty of success in the development and potential commercialization of aducanumab, 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 Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this press release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Fabian Buller, +41 44 755 4623
Chief Business Officer
David Caouette, +1 617-679-4945
Matt Calistri, +1 781-464-2442
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
The We Company FY 2018 Financial Results Conference Call18.3.2019 23:44:00 CET | Pressemelding
WeWork Companies Inc. (the “Company”), as issuer of its 7.875% Senior Notes due 2025 (the “Senior Notes”), will hold a conference call on Monday, March 25, 2019, at 5:00 P.M. Eastern Time for the benefit of certain qualified participants in order to discuss the Company’s financial results for the fiscal year 2018. Current holders and beneficial owners of the Senior Notes, bona fide prospective purchasers of the Senior Notes who are qualified institutional buyers (as defined in Rule 144A under the Securities Act of 1933) or non-U.S. persons (as defined in Regulation S under the Securities Act of 1933), securities analysts, and market-making financial institutions may gain access to the call information for the conference call by registering on the Company’s secure website at investors.wework.com. Additional information about the call (including dial-in number) will be provided on the secure website. Parties requesting access to the Company’s secure website will be required to provide ce
FANCL Regains Control of Their IT Roadmap by Switching to Rimini Street Support for its SAP Application18.3.2019 23:00:00 CET | Pressemelding
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that FANCL, a leading additive-free cosmetics and health food products company in Japan, has switched to Rimini Street support for its SAP ECC 6.0 system. Rimini Street has enabled FANCL to take full control of their ERP roadmap and chart its direction based on the company’s business needs -- like advancing their digital transformation initiatives -- versus continuing to follow a vendor-dictated roadmap. Additionally, FANCL now receives premium-level, ultra responsive support for its current, stable SAP system for a minimum of 15 years from the time the company transitioned to Rimini Street. The company also immediately realized savings of 50 percent in annual support fees. FANCL is able to reinvest this significant cost saving into updating and modernizing the company’
OnMiners Changing the Game in Cryptocurrency Mining18.3.2019 20:25:00 CET | Pressemelding
OnMiners S.A (www.onminers.com) has recently earned the distinction becoming the first company ever to introduce an extraordinary range of endothermic cryptocurrency mining rigs. A team of investors working towards making crypto mining simple and profitable, OnMiners has introduced three highly efficient mining rigs utilizing the latest endothermic chip technology. Each of these products offers biggest hash-rates available in the market while minimizing power consumption and heat/noise generation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005779/en/ On2U (Photo: Business Wire) The three OnMiners mining rigs named On2U, On4U, and OnTower can mine Bitcoin, Litecoin, Ethereum, Monero, Dash, and Zcash. Users can start mining their preferred coins immediately because all the units come pre-configured and just need to be plugged in. The most noteworthy feature of these mining rigs is their endothermic nature. Unlike any
AGCO Announces Strategic Partnership with Solinftec18.3.2019 19:31:00 CET | Pressemelding
AGCO Corporation (NYSE:AGCO), a world-leading manufacturer and distributor of agricultural equipment solutions, announces a commercial and technological partnership with Solinftec, a world-leading developer and distributor of digital agriculture solutions. The partnership will give AGCO customers direct access to Solinftec´s portfolio of solutions including on-board computers, weather stations, soil sensors, telemetry networks, proprietary algorithms and the real-time generation of actionable insights generating operational efficiency and agronomic efficacy. The new solutions will launch in Brazil beginning in early 2019 for growers of sugarcane, soybean, corn and cotton and will launch in the United States for the 2020 crop cycle for corn and soybean growers. Solinftec’s offerings will complement the fleet and farm solutions already available through AGCO’s Fuse® smart farming portfolio. For 11 years, Solinftec has brought solutions to its clients that capture and process data real-ti
Epiphany Partners with Konsentus to Advance Open Banking Era18.3.2019 17:00:00 CET | Pressemelding
Fintech software and solution innovator, Epiphany SRI, today announced a partnership with regtech company, Konsentus. As a result of this partnership, financial organizations will be able to build open digital banking platforms that comply with PSD2 regulations. The deadline for organizations to comply with PSD2 regulations was 14 March 2019. The regulations require legacy banking and financial service providers, that hold online accessible client accounts, to provide Application Programming Interface (API) so that new operators, Third Party Providers (TPP), can develop new services including order placement, payment or account information. The Epiphany Open Digital Banking Platform helps banking and financial organizations remain relevant, and satisfy their customers’ current and future banking needs, by providing access to an ecosystem of advanced financial services. Konsentus is the only live Software as a Service (SaaS) based API solution available to check TPP Identity and Regulat
HubHead Certifies NRX AssetHub 7.0 for Use with SAP NetWeaver®18.3.2019 16:15:00 CET | Pressemelding
HubHead announces that NRX AssetHub 7.0 has been certified by SAP NetWeaver® 7.3. This SAP certification states that NRX AssetHub 7.0 integrates with SAP NetWeaver and that it complies with all the technical requirements for the SAP certification procedures. This certification means that NRX AssetHub 7.0 can efficiently integrate with SAP® solution environments. NRX AssetHub 7.0 can easily be implemented into SAP® infrastructure, quickly and at a low cost. Dennis Wu, the senior vice president of engineering at HubHead says, “We are excited to receive the SAP NetWeaver certification for the next generation of the NRX AssetHub solution.” HubHead Corp is Sponsoring SAP-Centric EAM: The HubHead team is at SAP-Centric EAM in San Antonio as a Silver Sponsor. SAP-Centric EAM is North America’s only asset management conference powering SAP users. You are encouraged to visit the HubHead team and take advantage of the coffee barista station. A HubHead customer in the oil and gas industry will be