IMS Company Profiles - Report Buyer

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IMS COM PANY PRO FILES NOVARTIS Product Sales 2008 Expiry USA Lescol (fluvastatin) Myfortic (mycophenolate sodium) Simulect (basiliximab) Starlix (nateglinide) Vectavir/Denavir (penciclovir) Visudyne (verteporfin) Xolair (omalizumab) Zelmac/Zelnorm (tegaserod) Zometa (zoledronic acid) $645m Oct 2011 Nov 2008 (extended) N/A May 2009 Dec 2012 (extended) (extended) N/A Feb 2020 Jul 2013 (extended) N/A Sep 2009 Mar 2011 (extended) (extended) Expiry Japan Expiry Europe Analyst Sales Forecast 2012 Mainly SPCs to Aug 2008 (Switzerland, Liechtenstein, Luxembourg Nov 2008; Portugal Apr 2009) Patents to Dec 2007, SPCs to Nov 2010 Patents to Mar 2011, SPCs to Apr 2013, Portugal May 2015 (SPC rejected in UK) Patents to Mar 2006, SPCs in France, Germany Switzerland UK to Mar 2011 N/A Sep 2010 Aug 2004 Mainly SPCs to Aug (extended) 2009 $179m (2007 sales) $140m (2007 sales) $88m (2007 sales) Source: IMS Pat ent Fo cus Sep 2011 Jul 2014 (extended) (extended) Patents Jul 2009 but mainly SPCs to Jul 2014 Jun 2017 Aug 2012 Patents to Aug 2012, (extended) SPCs to Aug 2017 $382-477m $500m N/A N/A N/A $82m $256-275m Jul 2016 Mar 2012 Mar 2012 (Switzerland $13m (extended) SPC to Oct 2016) $1,382m Mar 2013 Nov 2012 (extended) (extended) Patents Nov 2007 but mainly SPCs to Nov 2012 $2,063-2,111m *Note: Pat ents on com po si tions of valsartan with amlodipine ex pire around 2019; pat ents on com po si - tions with hy dro chlo ro thi a zide ex pire around 2017 **Note: Also some SPCs on com po si tion pat ents; pat ents ex pire in 2016, with SPCs to 2019-2020 © 2009 IMS Health In cor po rated or its af fil i ates Page 22
IMS COM PANY PRO FILES NOVARTIS Sales of Novartis’ core Pharmaceuticals busi ness grew by 10% (5% in lo cal cur rency) in 2008 to $26.3 bil lion, driven mainly by the on col ogy fran chise and steady growth of the car dio vas cu lar port fo lio: the fig ure in cludes $2.9 bil lion from re cently launched prod ucts. There was strong growth in Eu rope, Latin Amer ica and key emerg ing mar kets, but in the USA net sales fell 2% to $8.6 bil lion due to ge neric com pe - ti tion. Five prod ucts achieved over $1 bil lion in sales in 2008: Diovan (valsartan) with sales of $5,740 mil - lion, up 15%, Gleevec/Glivec (imatinib) with sales of $3,670 mil lion up 20%, Zometa (zoledronic acid) with sales of $1,382 mil lion, up 7%, Femara (letrozole) with sales of $1,129 mil lion, up 20%, and Sandostatin (octreotide) with sales of $1,123 million, up 9%. Re cently-launched prod ucts that have per formed well in 2008 in clude Lucentis (ranibizumab) for the treat ment of age-re lated macular de gen er a tion with sales up 125% to $886 mil lion, Exforge (valsartan + amlodipine) for hy per ten sion with sales up 294% to $406 mil lion, and Exjade (deferasirox) for iron over - load with sales up 49% to $531 mil lion. The launch of the Exelon Patch (rivastigmine) for the treat ment of Alz hei mer’s dis ease has re vived the flag ging Exelon fran chise, with to tal sales of the fran chise up 29% in 2008 to $815 mil lion. Other new mar ket en trants are Tekturna/Rasilez (aliskiren) for hy per ten sion, Aclasta/Reclast (zoledronic acid) for os teo po ro sis, and Tasigna (nilotinib) for cancer. Novartis was hit by pat ent ex pi ries and ge neric com pe ti tion in 2007 and this ef fect was still be ing felt in 2008, in clud ing Lotrel sales down 48% and Trileptal sales down 52%. Novartis’ lead ing drug Diovan is mar keted world wide for the treat ment of hy per ten sion and has now also been ap proved in more than 50 mar kets for use in pa tients with heart fail ure and at those at high-risk af - ter sur viv ing a heart at tack. Com bined sales of Diovan/Co-Diovan (valsartan + HCTZ) came to $5.7 bil - lion in 2008, up 15%. In Jan u ary 2009, Co-Diovan was ap proved in Ja pan, where it will be sold as Co-Dio. Diovan’s pat ent ex clu siv ity in the USA ex tends to Sep tem ber 2012 and pat ents be gin to ex pire in Eu rope in 2011, and ac cord ing to Mor gan Stan ley an a lysts (Jan u ary 2009), sales could peak at $5.8 bil lion in 2010. Novartis’ com bi na tion prod uct Exforge (valsartan + amlodipine) is be ing rolled out world wide, in - clud ing in July 2008 in the USA. This prod uct will not pro tect the com pany from the loss of sales of Diovan fol low ing pat ent ex piry, how ever: Mor gan Stan ley an a lysts (Jan u ary 2009) predict peak sales of $874 million in 2011-12. In sec ond po si tion, Gleevec/Glivec, a ty ro sine kinase in hib i tor, is a ma jor driver for Novartis’ on col ogy fran chise with sales up 20% in 2008. It was first ap proved in 2001 for use in the treat ment of CML. It is now mar keted in over 80 coun tries for CML and in the treat ment of gas tro in tes ti nal stromal tu mors (GIST) and other rare dis eases. In De cem ber 2008 Gleevec was ap proved by the US FDA for adjuvant treat ment of GIST fol low ing sur gery for tu mor re moval. Novartis has filed for ap proval in use in this in di - ca tion in the EU, Swit zer land and other mar kets with launches expected in 2009. Novartis’ num ber three prod uct, Zometa, a bisphosphonate for pa tients with bone can cer ex pe ri enced growth of 7% in 2008, ac cord ing to Novartis, due to im proved com pli ance, but in the lat ter half of the year due to good clin i cal trial re sults of its use in breast can cer that could ex pand its use con sid er ably. Zometa in com bi na tion with hor mone ther apy was found to sig nif i cantly re duce the risk of re cur rence or death in pre-meno pausal women with hor mone-sen si tive early stage breast can cer com pared to hor - mone ther apy alone. Phase III tri als in this set ting are on go ing with a first fil ing pro jected for 2010, but Mor gan Stan ley an a lysts (De cem ber 2008) re port that it is al ready in creas ingly be ing used in this set ting by clin i cal oncologists in the USA and in Europe, where funding allows. Femara, an oral, non-steroidal aromatase in hib i tor, was first launched in the UK in 1996. It is now avail - able in more than 90 coun tries for ad vanced breast can cer in post-meno pausal women. Since its first launch the prod uct’s in di ca tion has steadily been broad ened based on ex cel lent trial re sults. It is also ap - proved for use in the early adjuvant treat ment of breast can cer in the US and in the EU. It was Novartis’ num ber four prod uct in 2008, with sales up 20%. Femara could face ge neric com pe ti tion in 2011. Mylan has filed an ANDA for a ge neric ver sion and has re ceived ten ta tive ap proval, but in De cem ber 2008 Mylan © 2009 IMS Health In cor po rated or its af fil i ates Page 23
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IMS COM PANY PRO FILES APPENDIX - C
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