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Biogen's Tecfidera MS pill exceeds early expectations

This article was originally published in Scrip

Demand for Biogen Idec’s multiple sclerosis pill Tecfidera appears to be exceeding expectations, prompting some Wall Street analysts to raise their sales estimates for the newly approved drug.

At least one analyst is predicting the drug’s sales will be more than double an average estimate that forecasts around $300 million in US revenue for the pill in 2013.

“This launch is absolutely amazing,” ISI Group analyst Mark Schoenebaum said.

ISI analysis shows that Tecfidera (dimethyl fumarate) sales “could easily exceed $700 million even if trends decline substantially from here,” Dr Schoenebaum said.

He and other analysts are responding to the most recent figures provided by IMS Health, which show Tecfidera prescriptions jumped almost 40% in the drug’s fifth week on the US market over the prior week. Almost 1,300 prescriptions were written in the week ending May 3.

While Biogen and a number of analysts who cover the company expect Tecfidera will take sales from competitors, Stifel Nicolaus analyst Joel Sendek notes that rival drugs appear to be holding up so far.

“We expected Tecfidera would reduce growth rates of competitive drugs but scripts of (rival) drugs have stayed relatively strong and the overall market has growth,” Mr Sendek said.

Overall prescriptions for MS treatments rose 2% from the prior week to 35,941, he said.

Looking farther out, Dr Schoenebaum said he believes Biogen potentially takes a sizable chunk of the MS drug market.

Biogen is competing with Novartis’ MS pill Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide). It’s also competing with its own injected treatments, Avonex and Tysabri, and Teva Pharmaceutical Industries’ Copaxone (glatiramer).

“Tecfidera’s efficacy, across a variety of clinical endpoints, surpasses” Copaxone and Biogen’s Avonex (interferon beta-1a), DataMonitor analyst Daniel Chancellor said in a recent report.

Gilenya became the first approved oral treatment for MS when the US FDA cleared it for sale in 2010. The introduction of a pill to treat a condition historically treated with injected drugs was a huge breakthrough. However, Tecfidera is outpacing launches for Gilenya and Aubagio (approved by the FDA last year), according to analysts' interpretation of the IMS data.

On a dollar basis, Tecfidera sales were down in week five, compared with the prior week, according to a separate analysis by Wolters Kluwer Health. The firm said total prescription dollars were about $1.5 million in the week ending May 3, compared with $2.1 million the prior week. That analysis also showed dollar declines for Gilenya and Aubagio, according to Robert W. Baird analyst Christopher Raymond, who notes there are a lot of pricing variables to consider with the figures.

BioMedTracker predicts that Tecfidera will reach peak annual global sales of $6 billion by 2019.

Biogen isn’t discussing the early sales of the drug and won’t comment on the outside analysis of the launch, company spokeswoman Kate Niazi-Sai said.

“We’re clearly excited about Tecfidera,” she said, adding that it was too early to publicly draw conclusions about the early sales.

Shares of Biogen jumped more than 4% to $222.74 in Nasdaq Stock Market trading May 13. The stock is up more than 52% this year.

Biogen’s top executives haven’t been shy about touting their drug’s potential dominance. In a conference call last month announcing first-quarter earnings company officials said they are moving aggressively to promote the drug, sell insurers on its merits and win approval outside the US. Biogen execs said again on the call that they expect the drug to trounce rival products sold by Novartis and Sanofi. (scripintelligence.com April 26)

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