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A European Specialty Pharmaceutical Group COMPANY PROFILE and STRATEGY

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A European Specialty Pharmaceutical Group COMPANY PROFILE and STRATEGY Jefferies 2010 Global SpecPharma & European Healthcare Conference London, October 5-6 2010 A European specialty pharmaceutical group COMPANY PROFILE AND STRATEGY Company Profile • Mid sized pharmaceutical company with a European focus ((py,2800 employees, of which 1400 field force ) OE • R&D in the cardiovascular and urology fields and in OE treatments for rare diseases OE • Marketing operations in the main Western European OE markdiRiCEEdTkkets and in Russia, CEE and Turkey OE OE OE OE • Proprietary drugs sold worldwide through licensees OE OE OE • Expanding through organic development and through OE acquisitions OE OE OE OE OE – Orphan Europe subsidiaries Develop product portfolio by Pursue further geographical expansion by • High focus on new corporate products • Entering new markets characterized by high • Maximizing existing products growth in CEE • Acquiring new product rights • Launching new corporate products and existing proprietary products in these markets • Prioritizing specialty care products • Takinggppy the opportunity of establishin g a direct • Enriching pipeline of products in development presence in the U.S, for the marketing of treatments for rare diseases 1 GEOGRAPHICAL BREAKDOWN OF PHARMACEUTICAL REVENUE Portugal 5.2% Spain 4.1% Germany 8.4% UK 1.4% Other W. European countries 3.7% Russia, Turkey, other CEE 9. 1% France 19.8% Other international sales 19.2% Italy 29.1% Data: First half 2010 Pharmaceutical revenue € 363.4 m 2 COMPOSITION OF REVENUE BY BUSINESS Zanipress 3.9% Other corporate products 7.5% Zanidip 21.8% Orphan drugs 8. 3% Pharmaceutical chemicals 3.4% Local product portfolios 49.7% Other revenue 5.4% Entact®/Elopram® 6% (escitalopram/citalopram) - Italy Peptazol® (pantoprazole) – Italy 3% Methadone – France 3% Tergynan® ‐ France export and C.I.S. 2% Tora-DlDol® (ketorolac) – Italy 2% Claversal® (mesalazine) – Germany 2% Data: First half 2010 Breakdown of pharmaceutical revenue: Hexa line (biclotimol) - France and C.I.S. 2% Total revenue € 376.3 m Prescription 84% Tenstaten® (cicletanine) - France 2% OTC 10% Other revenue 6% 3 CORPORATE PRODUCTS ZANIDIP® (lercanidi p ine ) • Calcium channel blocker indicated for the treatment of hypertension. Lipophilic dihydropiridine discovered and developed by Recordati. Efficacy as best in class, superior tolerability. • On the market in 95 countries. • Patent expired end January 2010 in main markets. Generic competition present in France, Italy, UK, Germany, Spain, and other European countries • Strategy is to match, or nearly match, the generic price to keep sales volumes • In most markets, at the same price, the branded drug is preferred • Promotion continues in markets where brands maintain their value • In some markets where brands are more likely to lose their value, an own generic of lercanidipine is or will be sold 4 CORPORATE PRODUCTS ZANIPRESS® (lercanidi pi ne+enal april) • Fixed combination of lercanidipine (a CCB) • Fixed combinations will play a significant role in the future and enalapril (an ACE-I) indicated for the hypertension market treatment of hypertension. Two strengths: • New aggressive targets for blood pressure control. 10mg lercanidipine/10mg enalapril, and Combination of drugs needed for most patients 10mg lercanidipine/20mg enalapril . • Increased patient compliance • Clinical data exclusivity until 2016 • Large clinical outcome trials show that cardiovascular events are drastically reduced by using modern antihypertensive • Approved in Germany in July 2006. drug combinations (CCB, ACE-I, ARB) as opposed to using Approval recognition in EU, Norway and older trea tmen ts. Iceland granted in March 2008. Approved • The NICE (National Institute for Clinical Excellence, UK) in Australia in February 2008 and guideline for the treatment of hypertension in primary care subsequently in other ex-EU countries. was updated to incorporate new evidence (1) • On the market in sixteen countries, further • “In hypertensive patients aged 55 or over, or black patients of launches expected in 2010. any age, the first choice for initial therapy should be either a CCB or a thiazide-type diuretic.” (1) • To be approved and launched in all • “If initial treatment was with a CCB or a thiazide-type diuretic lercanidipine markets and a second drug is required, add an ACE inhibitor. If initial therapy was with an ACE inhibitor, add a CCB or a thiazide- type diuretic.” (1) (1) National Collaborating Centre for Chronic Conditions. Hypertension: management in adults in primary care: pharmacological update. London: Royal College of Physicians, 2006. 5 CORPORATE PRODUCTS DRUGS FOR THE TREATMENT OF RARE DISEASES • Recordati acquired Orphan Europe, a • A unique distribution network from a • Well trained orphan drug specialists European pharmaceutical company centralized unit in Paris serves patients and scientific product support team dedicated to treatments for rare worldwide collaborate with healthcare diseases, in December 2007 professionals and patient groups to • Orphan Europe employs about 120 improve knowledge and awareness • Orphan Europe operates in a niche personnel and has subsidiaries in nine of rare diseases market. It has a cash gggenerating European countries and in the United portfolio of 9 products with strong Arab Emirates as well as representative growth potential and a promising offices in seven countries pipeline Product Compound Indication Geographical presence Adagen® Pegademase bovine SCID-ADA deficiency Belgium Austria Carbaglu® Carglumic acid NAGS deficiency France Czech Rep. Cystadane® Betaine anhydrous Homocystinuria Germany Denmark Cystagon® Cysteamine bitartrate Nephropathic cystinosis Italy Finland Normosang® Human haemin Porphyria Portugal Netherlands Pedea® Ibuprofen iv Patent Ductus Arteriosus Spain Poland Sucraid® Sacrosidase Sucrase isomaltase deficiency Sweden Turkey Vedrop® Water soluble Vitamin E deficiency due to Switzerland vitamin E CC and CF U.A. Emirates Wilzin® Zinc acetate Wilson’s disease United Kingdom 6 NEW CORPORATE PRODUCTS ® ™ UROREC /SILODYX (ild(silodos i)in) • BPH market in 19 major European markets approx. € 1.0 billion • Highly selective α1A receptor antagonist indicated • In-market peak sales expected: € 100-150 million forfor tthehe ttreatmentreatment ooff sysymptomsmptoms assocassociatediated wiwithth benign prostatic hyperplasia (BPH) positioning • Originator Kissei Pharmaceutical Co., Ltd., • The symptoms associated with BPH (urination Japan. Developed by Recordati for Europe (45 frequency and urgency, hesitancy and weak urinary countries) and other 18 countries (Middle East flow) interfere with daily activities and sleeping. BPH and Africa). Patented in Europe until 2018 (inc. occurs mainly in elderly patients. SPC), clinical data exclusivity until 2020 • Silodosin is the first alpha blocker with very high • Approved by European Commission end selectivity for α1A adrenergic receptors showing January 2010 • Fast onset of action. Significant improvements • Main launches to take place September 2010 in the maximum urinary flow rate within 2-6 hours through March 2011 after the first dose, continuing through 12 weeks of therapy • Silodosin to be sold directly by Recordati in 8 EU markets, in Russia and other C.I.S. countries, • High efficacy on bothersome symptoms and in Turkey. Co-marketing planned in most (nocturia) and obstructive signs (Qmax) countries • Very good cardiovascular safety, no • License granted to Algorithm for the Middle East symptomatic effects on blood pressure or heart (except Israel), to Almirall for Spain, to Nycomed rate when administered in combination with for Italy and Portugal, to Pharmaplan for South antihypertensive medications Africa, to Zambon for France and further • Earlyyp and sustained benefit to patients,,p improving licenses planned for all territories where we are their daily quality of life and nocturnal rest not present directly 7 NEW CORPORATE PRODUCTS LIVAZO® (it(pitavas tti)tatin) • Highly effective HMG-CoA reductase inhibitor positioning indicated for the treatment of • Similar LDL-C reduction of market leading hypercholesterolaemia best-in-class statins • Semi-exclusive license granted by Kowa • Broad-spectrum effects on secondary lipid Pharmaceutical Europe (KPE) for marketing and parameters sales in Italy, France, Spain, Portugal, Greece, Ireland, Cyprus, Turkey, Russia and other C.I.S. • Any time of day dosing allows prescribing countries flexibility • In Ju ly 2010 the Decen tra lize d Proce dure for the • Similar safety to other statins approval of pitavastatin in Europe was concluded • Low risk of drug-drug interactions due to with a positive outcome metabolic pathway • To be launched progressively during 2011 • Apppprop riate for multi-medicated patients • Statins market in the 8 largest of the 21 countries • In high-risk difficult-to-treat patients with covered by the agreement was € 3 billion in 2009 dyslipidemia only pitavastatin allows thorough • In-market peak sales expected: € 100-150 million control due to its dual action both on LDL and HDL. It offers high reduction of aggressive factors (LDL) as well as good increase of protective ones (HDL). 8 R&D Pipeline NAME ORIGINATOR INDICATION DEVELOPMENT STATUS Urorec®/Silodyx™ Kissei Benign prostatic hyperplasia (BPH) Approved Orphan Europe Carbaglu® NAGS deficiency Apppproved in EU and in the U.S. (Recor da ti) lercanidipine 8/16 mg Pharmathen Essential hypertension Approved Livazo®/Alipza® Kowa Dyslipidemia Approved Orphan Europe Carbaglu® Organic acidemias (OA) Pre-registration in EU (Recordati)
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