T B
`
`ioCentury
`
`TH: BEIINSTUN Rzrorr on Broliusmrss
`
`Biocentury on BioBusiness, Finance
`
`Clean label for Biogen MS drug Tecfidera translates into $3.7B market cap bump
`
`Tecfidera cleans up
`-- Erin McCallister
`
`Published on Monday, April 1, 2013
`
`Biogen ldec Inc. (NASDAQ:Bl|B) added $3.7 billion to its market cap after FDA approved Tecfidera dimethyl
`fumarate with the cleanest label among oral MS drugs.
`
`Doctors have told BioCentury they like the safety advantage of Tecfidera (BG-12) after Phase III studies
`showed flushing and abdominal pain as the most common serious adverse events (see BioCentury, April 18,
`201 1).
`
`Last week, FDA approved Tecfidera for adults with relapsing-remitting MS (RRMS) with a 12-page label that
`includes just one warning about the potential for lymphopenia. The agency recommends a complete blood
`count (CBC) test prior to the first dose and annually thereafter. Abdominal pain and flushing are mentioned in
`the adverse reactions section.
`
`The dimethyl fumarate that activates the NF-E2 related factor 2 (Nrf2) pathway is the third oral MS drug to be
`approved by FDA. Gilenya fingolimod from Novartis AG (NYSE:NVS; SlX:NOVN) was approved in 2010 and
`Aubagio teriflunomide from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) was approved last
`September.
`
`Even though Tecfidera is late to the party, doctors last year told BioCentury they would use it first among the
`oral drugs because of its benign safety profile (see BioCentury, Oct. 1, 2012).
`
`Gilenya's label is 17 pages and lists six different risks under the warnings and precautions section, including
`decreased heart rate. Doctors are instructed to monitor patients for bradycardia for at least six hours after the
`first dose. The drug also comes with a REMS to address the cardiovascular risks.
`
`Aubagio's label is 27 pages and includes a boxed warning about the risks of hepatotoxicity and teratogenicity.
`The drug's label also includes six different risks under the warnings and precautions section and is
`contraindicated in pregnant women or women of childbearing potential.
`
`Novartis dropped $0.57 to $70.44 and lost $1.4 billion in market cap on March 27, the day Tecfidera was
`approved, but the pharma ended the week up $0.41 to $71.24 and a market cap of $172.3 billion.
`
`Sanofi dropped $0.39 after Tecfidera's approval to $50.15 and lost $1 billion in market cap, but also was up on
`the week. It added $0.39 to $51.08 to a market cap of $135 billion.
`
`BIoCentun/ Terms of Use,
`conbnts of Ins Web Site are protected under U.S. and foreigl copyright and lltelectual property laws, and no part otthls Web
`Agreement a
`' Inc 1993-2016 BioCentur¥T2bliwtions. Inc, ALL RIGHTS RESERVED. All use dthis Web She and its con_terIts is governed by the Blocentury User _
`All contents
`Site or its oaltents may be photocopied. reproduced (I retralsmibd ii aiy tonn without the written consent of Biocaltuy, which may be requested from ReprintsIPem1IssIons a
`www,bIocentury,con1. Biocenturyo; The Bernstein Report on BioBus'ness"‘; The Biocentury 1(1)“; The Clear Route to ROI"'; Because Real lrleligence is Hard to Hnd"‘;
`BCIQ"‘; and BioPham1a's Knowledge CenIer"'; are trademarks of Biocentuy
`lnc,_ P.0. Box 1246. San Calos, CA 94070. SCBXO aid SciB)C ScienoeBusiness
`exchmgeo we tradernaks of Nahle America. Inc. that are jointly used by Biooentury Publications, Inc. all Naure America, Inc.
`
`Page 1 0‘ 1
`
`Biogen Exhibit 2043
`Coalition V. Biogen
`IPR2015—01993