Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal
`of Marketing Authorizations for ZINBRYTA® (daclizumab) for
`Relapsing Multiple Sclerosis
`investors.biogen.com/news-re eases/news-re ease-deta s//b ogen-and-abbv e-announce-vo untary-wor dw de-w thdrawa
`
`March 2, 2018 at 5:07 AM EST
`
`Patient safety is the top priority for Biogen and AbbVie.
`The European Medicines Agency has initiated an Article 20 referral procedure following reports
`of inflammatory encephalitis and meningoencephalitis.
`Given the nature and complexity of adverse events being reported, characterizing the evolving
`benefit/risk profile of ZINBRYTA will not be possible going forward given the limited number of
`patients being treated. Therefore, Biogen and AbbVie believe it is in the best interest of patients
`to voluntarily withdraw worldwide marketing authorizations for ZINBRYTA.
`Biogen will continue to work collaboratively with regulatory authorities and with healthcare
`providers in their management of ZINBRYTA patients.
`
`CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.--(BUSINESS WIRE)--Biogen (Nasdaq:BIIB) and AbbVie
`(NYSE:ABBV) today announced the voluntary worldwide withdrawal of ZINBRYTA for relapsing
`multiple sclerosis. The companies believe that characterizing the complex and evolving
`benefit/risk profile of ZINBRYTA will not be possible going forward given the limited number of
`patients being treated.
`
`“Biogen believes the voluntary worldwide withdrawal of ZINBRYTA, a treatment for relapsing
`multiple sclerosis, is in the best interest of patients,” said Alfred Sandrock, M.D., Ph.D., executive
`vice president and chief medical officer at Biogen. “Biogen and AbbVie continue to prioritize
`patient safety and the care of multiple sclerosis patients worldwide.”
`
`Biogen will continue to work collaboratively with regulatory authorities in the withdrawal of
`product and with healthcare providers worldwide in their support of ZINBRYTA patients.
`
`Patients currently treated with ZINBRYTA should contact their healthcare provider if they have
`any questions or concerns.
`
`About ZINBRYTA
`
`ZINBRYTA (daclizumab) is currently available in the EU, U.S., Switzerland, Canada and
`Australia. ZINBRYTA is a prescription medicine used to treat adults with relapsing forms of
`multiple sclerosis (MS). Because of its risks, ZINBRYTA is generally used in people who have tried
`two or more MS medicines that have not worked well enough. It is not known if ZINBRYTA is safe
`and effective for use in children under 18 years of age.
`
`About Biogen
`
`1/4
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`Biogen Exhibits 2148
`Mylan v. Biogen
`IPR 2018-01403
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`Page 1 of 4
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`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. Founded in 1978 as one of the world’s first global biotechnology
`companies by Charles Weissman, Heinz Schaller, Kenneth Murray and Nobel Prize winners
`Walter Gilbert and Phillip Sharp, today Biogen 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. 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 – , , , YouTube .
`
`Biogen Safe Harbor
`
`This press release contains forward-looking statements, including statements relating to the
`potential benefits, safety, and efficacy of ZINBRYTA, our strategy and plans, and our future
`expenses and other financial and operating results. These statements may be identified by
`words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “except,” “forecast,” “may,” “plan,”
`“potential,” “possible,” “will,” and similar expressions, and are based on our current beliefs and
`expectations. 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: the occurrence of adverse safety
`events; restrictions on use of our products or product liability claims; risks of unexpected costs
`or delays; the estimates and assumptions we make in preparing our financial statements; and
`the other risks and uncertainties that are described in the Risk Factors section of Biogen’s most
`recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities
`and Exchange Commission. Any forward-looking statements speak only as of the date of this
`press release, and we assume no obligation to update any forward-looking
`statement, whether as a result of new information, future developments, or otherwise.
`
`About AbbVie
`
`AbbVie is a global, research-driven biopharmaceutical company committed to developing
`innovative advanced therapies for some of the world's most complex and critical conditions. The
`company's mission is to use its expertise, dedicated people and unique approach to innovation
`to markedly improve treatments across four primary therapeutic areas: immunology, oncology,
`virology and neuroscience. In more than 75 countries, AbbVie employees are working every day
`to advance health solutions for people around the world. For more information about AbbVie,
`please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.
`
`AbbVie Forward-Looking Statement
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`Some statements in this news release are, or may be considered, forward-looking statements for
`purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect,"
`"anticipate," "project" and similar expressions, among others, generally identify forward-looking
`statements. AbbVie cautions that these forward-looking statements are subject to risks and
`uncertainties that may cause actual results to differ materially from those indicated in the
`forward-looking statements. Such risks and uncertainties include, but are not limited to,
`challenges to intellectual property, competition from other products, difficulties inherent in the
`research and development process, adverse litigation or government action, and changes to
`laws and regulations applicable to our industry. Additional information about the economic,
`competitive, governmental, technological and other factors that may affect AbbVie's operations
`is set forth in Item 1A, "Risk Factors," of AbbVie's 2017 Annual Report on Form 10-K, which has
`been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to
`release publicly any revisions to forward-looking statements as a result of subsequent events or
`developments, except as required by law.
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`BIOGEN MEDIA CONTACT:
`
`David Caouette, +1 781-464-3260
`public.affairs@biogen.com
`
`or
`
`BIOGEN INVESTOR CONTACT:
`
`Matt Calistri, +1 781-464-2442
`IR@biogen.com
`
`or
`
`ABBVIE MEDIA CONTACTS:
`
`Jack Hirschfield, 224-458-0943
`Jack.hirschfield@abbvie.com
`
`or
`
`Markeisha Marshall, 224-501-4425
`Markeisha.marshall@abbvie.com
`
`or
`
`ABBVIE INVESTOR CONTACT:
`
`Liz Shea, 847-935-2211
`Liz.shea@abbvie.com
`
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