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<strong>IMS</strong> COM PANY PRO FILES NOVARTIS<br />
Events with Major Potential Impact for Novartis<br />
EVENT SUMMARY<br />
Competition for Diovan Diovan is set to lose patent protection in Europe in 2011 (September<br />
2012 in USA). At this point it stands to lose nearly $5 billion in sales.<br />
However the first test will be in 2010 when rival product Cozaar<br />
(losartan) loses patent protection in the USA and cheap generic losartan<br />
products will be launched. Morgan Stanley analysts give peak Diovan<br />
sales in 2010 of $5.8 billion falling to almost $1.3 billion by 2012.<br />
Potential generic<br />
competition in the US<br />
Ongoing generic<br />
competition in the US<br />
Femara, Lescol, Focalin/Ritalin LA and Comtan/Stalevo are subject of<br />
ongoing US patent litigation. The loss of exclusivity of some of these<br />
products could have a significant adverse effect on Novartis’ results. In<br />
December 2008 Mylan and Novartis settled patent litigation allowing<br />
Mylan to launch a generic Femara prior to patent expiry, but few details<br />
of the agreement were disclosed.<br />
Generic competition for Lotrel, Lamisil, Famvir and Trileptal in the US<br />
started in 2007. These four products had combined 2006 annual net<br />
sales of around $2.6 billion in the US. As a result of generic competition,<br />
combined net sales in 2007 declined 38% to $1.6 billion, and declined<br />
even further in 2008. In addition, Neoral and Voltaren, which are still<br />
among Novartis’ top ten products and had combined net sales of $1.8<br />
billion in 2008, have encountered generic competition in many markets,<br />
which may cause sales to decline significantly in the future.<br />
Zelnorm withdrawal The IBS therapy Zelnorm was withdrawn from the US market in 2007<br />
due to safety concerns. Subsequently other countries also requested its<br />
withdrawal. It could return to the market but analysts think sales would<br />
be low because of negative publicity. Zelnorm sales fell from over $500m<br />
in 2006 to $88m in 2007. Annual sales around $13 million are now<br />
anticipated by analysts.<br />
Galvus delayed in the US Novartis is continuing discussions with the FDA on steps needed for<br />
approval of its Type 2 diabetes drug Galvus following an approvable<br />
letter in February 2007 that included a request for additional clinical<br />
data. A US resubmission is not expected before 2010.<br />
New product<br />
launches/Acquisition of<br />
new companies<br />
Novartis had 15 positive regulatory decisions in 2007 in the US and<br />
Europe. These include Tekturna/Rasilez, Lucentis, Exforge, Exelon Patch,<br />
Aclasta/Reclast, Tasigna, Tyzeka/Sebivo, Lucentis, and Galvus. These<br />
new products contributed $2.9 billion to sales in 2008 and are expected<br />
to continue to fuel growth. Combined with the 2008 Alcon, Speedel and<br />
Protez acquisitions, these new product launches should help offset loss of<br />
sales from products going off patent. In 2008, Novartis made 14 major<br />
regulatory submissions, led by Afinitor, QAB 149, ACZ 885 and Menveo.<br />
© 2009 <strong>IMS</strong> Health In cor po rated or its af fil i ates Page 14
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