Tysabri – U.S.
At the end of June 2012, approximately 31,900 patients were on commercial therapy, which represents an increase of 4% over the approximately 30,800 patients who were on therapy at the end of March 2012 and 12% over the approximately 28,500 patients who were on therapy at the end of June 2011.
In the U.S. market, Elan recorded net sales of $211.5 million for the second quarter of 2012, an increase of 16% over net sales of $183.1 million in the same period of 2011, principally reflecting a 9% increase in units sold, along with the impact of price increases. Almost all of these sales are for the multiple sclerosis (MS) indication.
Tysabri – ROW
At the end of June 2012, approximately 36,400 patients, principally in the European Union, were on commercial therapy, an increase of 3% over the approximately 35,200 patients (revised) who were on therapy at the end of March 2012 and 13% over the approximately 32,100 patients (revised) who were on therapy at the end of June 2011.
ROW in-market net sales decreased in the second quarter of 2012 to $184.0 million, from $205.9 million for the same period of 2011. While units sold increased by 11%, ROW in-market net sales were negatively impacted by the $16.3 million revenue reserve in Italy, and foreign currency movements, including the 11% decrease in the average dollar-euro exchange rate from the second quarter of 2011 to the second quarter of 2012.
The revenue reserve for Italy relates to a notification received by Biogen Idec from the Italian National Medicines Agency during the fourth quarter of 2011, stating that sales of Tysabri had exceeded a limit established by the agency in 2007. Biogen Idec filed an appeal in December 2011 seeking a ruling that Biogen Idec’s interpretation is valid and that the position of the agency is unenforceable, and hopes to have resolution in 2012. As a result of this dispute, Biogen Idec deferred $16.3 million of revenue recognized on in-market net sales of Tysabri in Italy during the second quarter of 2012, having previously deferred $16.5 million of revenue in Italy during the first quarter of 2012 and $13.8 million during the fourth quarter of 2011. Elan expects that Biogen Idec will continue to defer a portion of in-market revenues on future sales of Tysabri for Italy until the matter is resolved. As a consequence of this deferral of in-market net sales by Biogen Idec, Elan has deferred $7.8 million of revenue in the second quarter of 2012 related to these sales, $15.7 million in the first half of 2012 and $22.6 million to date, reflecting the operating and accounting arrangements between the companies.