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`BioCentury on BioBusiness, Finance
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`Clean label for Biogen MS drug Tecfidera translates into $3.7B market cap bump
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`Tecfidera cleans up
`-- Erin McCallister
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`Published on Monday, April 1, 2013
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`Biogen Idec Inc. (NASDAQzBllB) added $3.7 bilion 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,
`2011).
`
`Last week, FDA approved Tecfidera for adults with relapsing-remitting MS (RRMS) with a 12-page label that
`includes just one waning about the potential for lymphopenia. The agency recommends a complete blood
`count (CBC) test prior to the frst dose and annudly therealter. Abdominal pain and flushing are mentioned in
`the adverse reactions section.
`
`The dimethyl fumarate that activates the NF-E2 related factor 2 (Ner) pathway is the third oral MS dug to be
`approved by FDA. Gilenya fingolimod from Novartis AG (NYSEzNVS; SIX:NOVN)was approved it 2010 and
`Aubagio teriflunomide from the Genzyme Corp. unit of Sanofi (EuonextSAN; NYSE:SNY) was approved last
`September.
`
`Even though Tecfidera is late to the party, doctors last year told BioCentury they would use i fist among the
`oral drugs because of its benign safety profile (see BioCentury, Oct. 1, 2012).
`
`Gienya's ldrel is 17 pages and lists six diferent risks under the warnings and precautions section, including
`decreased heart rate. Doctors are instructed to monitor patients for bradycardia for at least six hours alter 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 dmg's label also includes six different risks under the warnings and precautions section and is
`contraindicated in pregnant women or women of childbearing potential.
`
`Novatis (topped $0.57 to $70.44 and lost $1.4 bilion in market cap on March 27, the day Tecfidera was
`approved, but the pharrna ended the week up $0.41 to $71.24 and a market cap of $172.3 billion.
`
`Sanoti dropped $0.39 alter Tecfidera's approval to $50.15 and lost $1 billion in maket cap, but also was up on
`the week. It added $0.39 to $51.08 to a market cap of $135 billion.
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`Biogen Exhlblt 2205
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`Mylan v. Biogen
`IPR 2018-01403
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