MS Portfolio
Jerome Hanna, MB BCh BAO, MRCS, MFPM, Senior Medical Director
R&D Day
September 21, 2021
Forward-looking statements
This presentation contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: our strategy and plans; potential of, and expectations for, our commercial business and pipeline programs; capital allocation and investment strategy; clinical development
programs, clinical trials, and data readouts and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our and our collaboration partners' products and investigational therapies; the anticipated benefits and potential of investments, collaborations, and business development activities; and our future financial and operating results. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "potential," "possible," "prospect," "will," "would," 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: our dependence on sales from our products; uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; failure to compete effectively due to significant product competition in the markets for our products; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives;
difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; our dependence on collaborators, joint venture partners, and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks associated with current and potential future healthcare reforms; risks related to commercialization of biosimilars; failure to obtain, protect, and enforce our data, intellectual property, and other proprietary rights and the risks and uncertainties relating to intellectual property claims and challenges; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications;
risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; risks relating to the distribution and sale by third parties of counterfeit or unfit versions of our products; risks relating to the use of social media for our business; risks relating to technology failures or breaches; risks relating to management and key personnel changes, including attracting and retaining key personnel; failure to comply with legal and regulatory requirements; the risks of doing business internationally, including currency exchange rate
fluctuations; risks relating to investment in our manufacturing capacity; problems with our manufacturing processes; fluctuations in our effective tax rate; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations, and financial condition; fluctuations in our operating results; risks related to investment in properties; the market, interest, and credit risks associated with our investment portfolio; risks relating to share repurchase programs; risks relating to access to capital and credit markets; risks related to indebtedness; change in control provisions in certain of our collaboration agreements; environmental risks; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission (SEC).
These statements are based on our current beliefs and expectations and speak only as of the date of this presentation. We do not undertake any obligation to publicly update any forward-looking statements.
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For >40 years, Biogen has been a pioneer in neuroscience and developing transformative treatments for multiple sclerosis
1978 | 1996 | 2004 |
Biogen is founded by a | Biogen launches AVONEX, the | TYSABRI, Biogen's highly |
small group of visionary | first interferon treatment for RMS | efficacious MS product, |
scientists | receives FDA approval |
BIIB061
2014 | 2013 | 2013 | 2013 | FAMPYRA, | 2011 | ||||||||
Biogen's | |||||||||||||
2016 | Biogen launches | BIIB061 first in | Biogen acquires | TECFIDERA | symptomatic MS | AVONEX IM | |||||||
PLEGRIDY, our | human dosing | full rights to | launches and | treatment, receives | |||||||||
FAMPYRA, | most recent MS | TYSABRI from | becomes the most | conditional EC | Pen approved | Orela- | |||||||
Biogen's | portfolio addition | Elan | prescribed oral MS | approval | by the FDA | ||||||||
symptomatic MS | therapy | brutinib | |||||||||||
treatment, receives | |||||||||||||
full EC approval | BIIB107 | ||||||||||||
BIIB091 | |||||||||||||
2017 | 2017 | 2018 | 2019 | 2019 | 2020 | 2020 | 2021 | ||||||
Biogen partners | Biogen acquires | Reinvigorated LCM | Biogen launches | BIIB091, reversible | BIIB107, novel anti- | EU approval of | US approval of plegridy IM, | ||||||
with Siemens | global rights for | trials for TYSABRI | Vumerity | BTKi first in human | VLA4 agent first in | plegridy IM | EU approval of Tysabri SC, | ||||||
Healthcare to | Vumerity from | and Biogen | dosing | human dosing | acquisition of BIIB128 | ||||||||
develop advanced | Alkermes | platform | orelabrutinib), worldwide | ||||||||||
MS MRI tools | treatments | filing activities of Vumerity |
3
The Biogen MS pipeline demonstrates leadership in RMS while expanding our footprint in PMS and Neurorepair
TRANSFORMATIVE
THERAPIES FOR RMS by developing agents with improved benefit risk profile
ADVANCE CARE IN
PROGRESSIVE DISEASE
by targeting CNS-
compartmentalized immune
cells
IMPROVE DISABILITY
AND RESTORE
FUNCTION
by targeting remyelination
and neurorepair
Hit ID | Lead ID | Lead OP | R2D | Phase 1 | Phase 2 | Phase 3 | LCM |
TYSABRI IV & SC
PLEGRIDY IM & SC
VUMERITYTM
TECFIDERA
AVONEX
BIIB091 (periphBTK)
BIIB107 (anti-VLA4)
Orelabrutinib
Undisclosed Asset
Undisclosed Asset
Undisclosed Asset
Undisclosed Asset
BIIB061
Undisclosed Asset
Undisclosed Asset
CNS = central nervous system; ID = identification; OP = optimization; R2D = research to development; IM = intra-muscular; LCM = lifecycle management; PMS = progressive multiple sclerosis; RMS = relapsing multiple sclerosis; SC = subcutaneous; IV = intravenous
4
Multiple Sclerosis - pathophysiology
Overview
MS involves an immune-mediated process directed against the CNS
- Aberrant inflammatory response triggered
- Immune system cells attack CNS myelin and nerve fibers
- Demyelination, nerve dysfunction, and axonal loss occurs
- Nerve impulses traveling to / from brain and spinal cord are distorted or interrupted
- Clinically characterized by episodes of acute neurological worsening (relapses) and progressive disability accumulation
CNS = central nervous system
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Biogen Inc. published this content on 21 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 September 2021 19:21:03 UTC.