SOLVAY GROUP London Morning Meeting. June 26, 2009

Transcription

1 SOLVAY GROUP London Morning Meeting June 2, 9 1

2 Our fenofibrate franchise Klaus Kirchgassler, MD Sr VP Solvay Pharmaceuticals 2

3 Summary of lipid lowering market performance in Value Growth vs. previous MAT based on LC in % Volume Growth vs. previous MAT based on SU in % LLA Market* -.0. Statins Fibrates Lip/Tricor WW Tricor US 11.. Lip/Tricor ex US 9.2. SOLVAY 2/0/9

4 The global lipid lowering market has seen increased volume growth accompanied by losses in value Value [M LC] % +% +% +% -% -% C10A1 C10A9 C10C0 C10A2 C11A1 Volume [M CU] % +1 +9% +9% +9% +% SOLVAY 2/0/9

5 The volume market trend is in line with a continuing modest increase in the patient population with dyslipidemia Forecasted prevalence of dyslipidemia in the top pharmaceutical markets Distribution of patient types with dyslipidemia in +% +% Prevalent Pop. [Mio] US EU Japan Almost 2/ of subjects with dyslipidemia could be candidates for either monotherapy with fibrates and/or for combination therapy with statins Source: Mattson Jack, EpiDB, Source: Decision Resources SOLVAY 2/0/9

6 LLA Market - Overview by Class Market Share in M LC MAT 12/0 US EU Asia CEE Latin Canada Ezetimibe Ezetimibe/Simvastatin Fibrate Nicotinic Acid Statins SOLVAY 2/0/9

7 Statin Market - Overview by Molecule Market Share in M LC MAT 12/0 US [M LC EU1 [M LC Canada Asia CEE Latin [M LC [M LC 9 1 [M LC ATORVASTATIN FLUVASTATIN LOVASTATIN PRAVASTATIN ROSUVASTATIN SIMVASTATIN SOLVAY 2/0/9

8 Fibrate Market - Overview by Molecule Market Share in M LC MAT 12/ US EU1 Canada Asia CEE Latin BEZAFIBRATE CIPROFIBRATE FENOFIBRATE GEMFIBROZIL SOLVAY 2/0/9

9 Fenofibrate - Generic Penetration MAT 12/0 [M MOT] Fenofibrate original Fenofibrate generics % [M MOT] 11 % 2 % % 22 1% 1 29% 21 % Original Fenofibrate Generic Fenofibrate 2% % 2% 9% 1% 1% Asia CA CEE EU-1 Latin US -21% (-2 ) Growth [% MOT] 20 Fenofibrate generics Fenofibrate original + (+2 ) 1 10 Price [LC ] US CA Latin Asia CEE EU SOLVAY 2/0/9 9

10 Success factors of our fenofibrate franchise Positive long term use well established Addresses residual cardiovascular risk on statins Current flagship product : important clinical benefits of 1 mg NFE being introduced in all major markets by (incl. Russia) IP formulation protection until Jan. 202 in US and 201 in Europe patent litigation vs generic manufacturers ongoing Ongoing discussions of EMEA recommendation concerning class review of fibrates SOLVAY 2/0/9 10

11 A significant residual risk of cardiovascular events persists despite control of LDL cholesterol by statins Statin better Control better RR (9% CI) p-value All-cause mortality 0. ( ) < CHD mortality 0.1 (0.-0.) < Nonfatal MI Any major coronary event Coronary revascularization 0. ( ) < (0.-0.0) < (0.-0.0) < % of the risk of major coronary events remains unaddressed Stroke (0.-0.) < Relative risk with 9% confidence intervals 1 Cholesterol Treatment Trialists Collaborators. Lancet ;:12-. SOLVAY 2/0/9 11

12 Branded fenofibrate commands a decent share of the overall lipid lowering market Market Size in m LC USD Solvay Sales in m LC USD Solvay in % Solvay Rank Total 2,12 -% 1,9 +11%.% (.9%) () North America* 1,9 -% 1,0 +12% 9.2% (.%) () EU-11**, % 2.1% (2.) 9 (11) Japan* 2,9 +% 1 +% 2.% (2.%) 10 (11) * Including Abbott s Tricor sales in US and fenofibrate sales of Aska, Kaken and Teijin in Japan **EU-11 comprises more than 9 of the total EU-0 market in SOLVAY 2/0/9 12

13 Tricor Performance US MAT 12/0 Value [M LC] % % % % 112 US Volume [M SU] % 2 +9% 1 +1% +9% +% SOLVAY 2/0/9 1

14 Tricor / Lipanthyl Performance ex US MAT 12/0 + +% -% -% +9% -2% +2% -1% -% +% Value 220 [M LC] Asia EU-1 CEE CA Latin Volume [M SU] [M LC] % 19% 2% % 1% [M SU] 2 1 1% 1% 21% 2% 2 0 % % % 2% % 2% 9% % % 9% % % % 12% 1% 1% 1% 11% 1% 1 11% % 2% % 2% 1% 1% 1% 12% 1% 1% % % % 1% % 1% % 1% % 1% SOLVAY 2/0/9 1

15 In contrast to the antihypertensive or diabetes market, co-prescription remains low in the lipid lowering market Co-Rx between Statins and Fibrates - US, EU-* (Rx in 000) MAT 0/0 US Statins Co-Rx Fibrates France Statins Co-Rx Fibrates Germany Statins Co-Rx Fibrates , % 0.1% % 0.2% 2 2. Italy Statins Co-Rx Fibrates Spain Statins Co-Rx Fibrates UK Statins Co-Rx Fibrates % 1 2.% 0.9% 1 9.1% 0.% SOLVAY 2/0/9 1

16 ACCORD aims to show incremental benefit of using fenofibrate on top of simvastatin Major features of ACCORD 10,21 patients with T2DM, with/without prior CVD randomly assigned to interventions: Intensive vs standard glucose control Intensive vs standard blood pressure control reduction in TG and increase in HDL-C with fenofibrate+ simva 20-0 vs simva 20-0 (lipid trial, n =,1) Common endpoint: composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death Tight control HbA1c group stopped in for adverse cardiovascular effect The BP and the lipid arm results will report at AHA 09 or early 2010 SOLVAY 2/0/9 1

17 FIELD overall results: effects of treatment on primary and secondary outcomes Endpoint Placebo (n =,900) Fenofibrate (n =,9) HR (9% CI) p-value No. (%) Rate No. (%) Rate Primary outcome Coronary events 2 (%) (%) (0.-1.0) 0.1 CHD mortality 9 (2%). 110 (2%) ( ) 0.22 Nonfatal MI 20 (%). 1 (%). 0. ( ) Secondary outcomes Total CVD events (1%) (1%) ( ) 0.0 CVD mortality 12 (%).1 10 (%) (0.-1.1) 0.1 Total mortality 2 (%) 12.9 (%) ( ) 0.1 Total stroke 1 (%).1 1 (%) ( ) 0. Nonhemorrhagic stroke 1 (%). 1 (%) (0.-1.1) 0. Coronary revascularization (%) (%) (0.-0.9) 0.00 All revascularization 1 (1) (%) ( ) SOLVAY FIELD Study Investigators. Lancet ; e-publication 2/0/9 1 Nov 1

18 Fenofibrate is most effective in patients with marked dyslipidemia Placebo Fenofibrate HR (9% CI) HR P (%) (%) TG 2. mmol/l Low HDL-C* Triglycerides 2. mmol/l plus low HDL-C *M<1.0 mmol/l; F<1.29 mmol/l SOLVAY 2/0/

19 FIELD has demonstrated substantial effects of fenofibrate of microvascular complications of diabetes A significant reduction of progression of albuminuria A significant 1% reduction in the need for first laser eye treatment A significant % reduction of leg amputations SOLVAY 2/0/9 19

20 TriLipix Next generation fenofibrate (fenofibric acid) Regulatory exclusivity & IP Approved and launched in the US (Dec 0) Only fibrate indicated for combination therapy with statins Approved & launched US Regulatory submission files for ROW are being prepared Improved Therapeutic Benefit clinical programs ongoing SOLVAY 2/0/9 20

21 Certriad (TriLipix + Crestor ) Developed by Abbott/AstraZeneca Fixed dose combination for US Dossier filed Rosuvastatin : fastest growing branded statin in US (CRESTOR /AstraZeneca) Convenient single pill for comprehensive lipid treatment Today less than % of US statin users get a fibrate co-prescribed, further growth potential for fixed combination Submission date in US: Q2 9 IP protected SOLVAY 2/0/9 21

22 Simcor Fixed combination of Niaspan and simvastatin Effectively targets all three key lipids (LDL, HDL, TG) reduction of residual risk Co-promotion with Abbott (US territory) Launched in April Launched US Current sales overall below expectations Flat total market Simvastatin generics ENHANCE results SOLVAY 2/0/9 22

23 SLV2 (Zolip) Fenofibrate NFE & simvastatin fixed dose combination for EU & ROW Phase III clinical program close to completion Convenience, compliance and stronger lipid effects IP to 201 with possible extensions Data exclusivity EU 10 years from approval Submission date: H1/2010 Peak sales potential EU/ROW: MEUR ACCORD* NIH study results expected 2010 * Action to Control Cardiovascular Risk in Diabetes SOLVAY 2/0/9 2

24 Conclusions The fenofibrate franchise continues to grow and gain market share Continued medical need to treat patients with mixed dyslipidemia (e.g. in type 2 diabetes) on top of statins Next steps focus on combination treatment with both Trilipix and Certriad SOLVAY 2/0/9 2

25 To the extent that any statements made in this presentation contain information that is not historical, these statements are essentially forward-looking. The achievement of forward-looking statements contained in this presentation is subject to risks and uncertainties because of a number of factors, including general economic factors, interest rate and foreign currency exchange rate fluctuations; changing market conditions, product competition, the nature of product development, impact of acquisitions and divestitures, restructurings, products withdrawals; regulatory approval processes, all-in scenario of R&D projects and other unusual items. Consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "believes," "may," "could" "estimates," "intends", "goals", "targets", "objectives", "potential", and other words of similar meaning. Should known or unknown risks or uncertainties materialize, or should our assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly update any forward-looking statements"