Published on FiercePharmaMarketing (http://www.fiercepharmamarketing.com)
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`Sanofi tags newly OK'd MS drug
`Lemtrada at $158K, ready to tout
`head-to-head Rebif data
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`November 17, 2014 | By Tracy Staton
`Sanofi ($SNY) finally has its FDA approval for Lemtrada. The multiple sclerosis
`drug, previously rejected by the agency, will hit the market after a trio of new
`oral treatments. It will come with a boxed warning and faces tight controls on
`prescribing and distribution.
`But if the company can persuade payers that it's worth $158,000 per two-
`treatment regimen, Lemtrada could still climb its way to blockbuster sales.
`Analysts are expecting a slow ramp-up, with $400 million in sales by 2018 and
`$1 billion by 2021.
`As the latest MS drug to hit the market, Lemtrada follows some big new
`launches. Biogen Idec's ($BIIB) oral med Tecfidera brought in almost $2 billion
`for the first 9 months of 2014, its first full year on the market. Gilenya, launched
`by Novartis ($NVS) in 2010, delivered $1.8 billion for the first 9 months, up
`29% year over year. Sanofi's own pill, Aubagio, hasn't gained as much traction,
`with $378 million in sales for the same period.
`As a long-acting biologic treatment, however, Lemtrada will be playing in a
`different market. It's approved as a third-line therapy, after patients have failed
`on two previous meds. And rather than injections daily or weekly or even twice
`a month, Lemtrada will be infused in two treatment courses, the first for 5 days
`straight, and the second 12 months later, for three days.
`Its head-to-head rival, Rebif, is administered in a similar fashion for $135,000.
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`5/27/2015
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`Sanofi tags newly OK'd MS drug Lemtrada at $158K, ready to tout head-to-head Rebif data - FiercePharmaMarketing
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`It's a long-standing blockbuster for Merck KGaA
`with $2.5 billion in 2013 sales. And here's where
`Sanofi's sales pitch comes in. Lemtrada was tested
`against Rebif in two trials, with one showing fewer
`relapses in Lemtrada patients, and the other
`showing fewer relapses and less progressive
`disability, Sanofi says. For 70% of patients, no
`further infusions were required over a three-year
`period; the drug's effects can last for up to 5 years.
`That's the data Sanofi will be touting with payers. And on that note, the FDA
`delay may have been a plus. To change the agency's mind, Sanofi not only
`handed over a new analysis of trial data the agency initially questioned, but also
`delivered more efficacy data. And the argument worked well enough for the
`notoriously picky cost-effectiveness watchdogs in the U.K., which backed
`Lemtrada earlier this year.
`But doctors may be wary of such a long-lasting treatment. "You write a
`prescription for 5 years and you can't take it back," Columbia University MS
`expert Claire Riley told The Wall Street Journal. "From a physician standpoint,
`it gives you pause."
`Clearly, Sanofi has work ahead to build demand for Lemtrada.
`But at least it finally has the opportunity to try. "About 60% of
`the global market for multiple sclerosis is in the U.S.,"
`Genzyme's MS chief, Bill Sibold, told The Boston Globe. "We
`talk about our aspirations to be leaders in MS. Up until this
`point, we've had Aubagio, which we're very proud of. But this
`Genzyme MS chief
`will give us both products for our U.S. franchise."
`Bill Sibold
`- check out the Sanofi release (PDF)
`- see the Globe article
`- read the WSJ piece (sub. req.)
`Special Reports: Top 10 best-selling multiple sclerosis drugs of 2013 - Rebif -
`Gilenya - Tecfidera
`Related Articles:
`FDA reverses an embarrassing rejection of Sanofi's Lemtrada, OKs MS drug
`Bring out the confetti: 7 of 2013's launches will join Sovaldi, Tecfidera in
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`5/27/2015
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`Sanofi tags newly OK'd MS drug Lemtrada at $158K, ready to tout head-to-head Rebif data - FiercePharmaMarketing
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`http://www.fiercepharmamarketing.com/node/2101/print
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`blockbuster land
`Aubagio approval sets Sanofi up with possible blockbuster
`Sanofi's new MS med scores a spot on U.K.'s NHS formulary
`Source URL: http://www.fiercepharmamarketing.com/story/sanofi-tags-newly-
`okd-ms-drug-lemtrada-158k-ready-tout-head-head-rebif-data/2014-11-17
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`5/27/2015
`
`Sanofi tags newly OK'd MS drug Lemtrada at $158K, ready to tout head-to-head Rebif data - FiercePharmaMarketing
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`http://www.fiercepharmamarketing.com/node/2101/print
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`MYLAN PHARMS. INC. EXHIBIT 1116 PAGE 3