Business Wire

Biogen and Neurimmune Announce Option Exercise for Alzheimer’s Disease Investigational Treatment Aducanumab

Jaa

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.”

About Aducanumab
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.

About Biogen
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.

About Neurimmune
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.

Contact information

Neurimmune:
Fabian Buller, +41 44 755 4623
Chief Business Officer
fabian.buller@neurimmune.com
or
Biogen:
MEDIA CONTACT:
David Caouette, +1 617-679-4945
public.affairs@biogen.com
or
INVESTOR CONTACT:
Matt Calistri, +1 781-464-2442
IR@biogen.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

V-CAT to Begin a New Type of Crowdfunding, Using Digital Currency23.1.2019 03:00Tiedote

V-CAT Vietnam will develop a new type of crowdfunding services that uses digital currency. A platform that uses the JC-coin digital currency will be built, and all data involved in transactions will be safely protected with leading-edge blockchain technology. Any user with JC-coins can exchange any physical or digital assets they might own on the platform for more JC-coins. This will provide the funding needed to develop revolutionary new products and services, together with users worldwide, and will enable new investments in all kinds of different businesses. V-CAT is proceeding with development of the MALLLESS platform in advance of an April 2019 launch of services. The goal is to host 10 million users worldwide by 2020. What makes MALLLESS unique is that businesses and individuals can take advantage of the point-transfer transaction model website and the proprietary wallet mechanism, both of which enable any selling of new or used goods, or of intangibles. There is also conversions

Prominent Trade Consulting Firm in South Korea Switches to Rimini Street Support for Its Oracle Database23.1.2019 02:00Tiedote

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today announced that EC21, a leading export marketing and trade consulting firm in Korea, has switched to Rimini Street support for its Oracle Database software. By switching to Rimini Street, EC21 is able to dramatically reduce the total cost of maintenance of its Oracle Database by approximately 75 percent, and improved productivity within its IT department as resources can be reallocated to more strategic projects across the organization. EC21 can also maintain its robust, stable database platform for a minimum of 15 years from the time the company moved to Rimini Street, avoiding any unnecessary upgrades just to retain full support from the vendor. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190122005104/en/ Prominent Trade Consulting Fir

IFF to Release Fourth Quarter and Full Year 2018 Results February 1323.1.2019 00:15Tiedote

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of scent, taste, and nutrition, announced that it will release its fourth quarter and full year 2018 earnings results following the market close on Wednesday, February 13, 2019. The management team will host a live webcast on Thursday, February 14, 2019 at 10:00 a.m. ET to discuss results and outlook with the investor community. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Meet IFF International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF) is a leading innovator of scent, taste, and nutrition, with over 110 manufacturing facilities, 100 R&D centers, and 33,000 customers globally. At the heart of our company, we are fueled by a sense of discovery, constantly asking “what i

Gilead Sciences to Release Fourth Quarter and Full Year 2018 Financial Results on Monday, February 4, 201923.1.2019 00:05Tiedote

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its fourth quarter and full year 2018 financial results will be released on Monday, February 4, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the fourth quarter and full year 2018 and provide a business update. The live webcast of the call can be accessed at the company’s Investors page at http://investors.gilead.com/. Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 3826138 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, February 6, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (int

Oxford Nanopore Prevails in Patent Ruling against Pacific Biosciences22.1.2019 20:04Tiedote

Today the European Patent Office revoked Pacific Biosciences patent EP3045542 with claims to a single molecule sequencing process wherein two strands of DNA are linked by a connecting nucleic acid. The validity of the patent had been challenged by Oxford Nanopore. The EPO ruled that the claims to a single molecule sequencing process were unsupported in the application and that the application only supported a template-directed synthesis sequencing method. As Pacific Biosciences were unwilling to accept this change, the patent was revoked. The decision by the EPO is consistent with a recent decision by the International Trade Commission (ITC) to limit the claims of a related Pacific Biosciences US patent to template-directed synthesis. View source version on businesswire.com: https://www.businesswire.com/news/home/20190122005733/en/ Contact information Oxford Nanopore Zoe McDougall media@nanoporetech.com Website: https://nanoporetech.com/

Citi Announces Inaugural Green Bond Issuance22.1.2019 20:00Tiedote

Citi today announced the issuance of the firm’s first green bond, further enhancing its commitment to environmental and climate finance. The bond will fund renewable energy, sustainable transportation, water quality and conservation, energy efficiency and green building projects financed as part of Citi’s $100 billion Environmental Finance Goal. In the deal, which priced on 22nd January 2019, Citi issued €1 billion 3-year fixed rate notes. The transaction marks the first green bond offering from Citigroup Inc. “We are proud to start the year with the launch of our inaugural green bond,” said Jamie Forese, President of Citigroup and Head of the Institutional Clients Group. “This transaction represents an important next step in expanding Citi’s commitment to sustainable growth. This bond also further enhances our green bond expertise, strengthens our partnerships with clients around the world and responds to increasing investor interest in sustainable finance.” In 2015, Citi announced a

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme