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Sanofi predicts end of patent cliff in 2013

New launches to overcome generic competition

Sanofi

Sanofi continued to feel the impact of patent losses on blockbuster drugs in the fourth quarter of 2012, but says it expects to see growth return to the business in the second half of this year.

The onset of generic competition last year to anticoagulant megabrand Plavix (clopidogrel) and other big sellers such as blood pressure drug Avapro/Aprovel (irbesartan) kept fourth-quarter sales flat at €8.53bn ($11.57bn), while net income slipped by nearly a quarter to €1.57bn.

For the full-year, reported sales rose nearly 5 per cent to €34.95bn - flattered by favourable exchange rate factors and a good performance by specialty medicines unit Genzyme - while business earnings per share fell 13 per cent to €6.20.

"Despite the effect of the patent cliff, Sanofi was able to grow sales and mitigate the impact on business EPS," commented the firm's chief executive Chris Viehbacher, who added the effects will still be felt in the first half of 2013 to the tune of around €800m.

The latter half of the year will however see a return to growth on the back of newer products that already account for more than two thirds of group sales, he stressed. Meanwhile, the firm's pipeline is delivering new products, with the European Commission granting approvals for diabetes product Lyxumia (lixisenatide) and Zaltrap (aflibercept) for colorectal cancer just this week.

Much of the impact on Plavix was felt in the second and third quarters, but the brand continued to slide in the last three months of the year and was down 6 per cent at constant exchange rates to €503m.

Among the other products affected by patent expiries and competition, Aprovel fell 34 per cent to €212m, anticoagulant Lovenox (enoxaparin) came in at €441m, a drop of 13 per cent, and cancer stalwart Eloxatin (oxaliplatinl) was down more than 80 per cent to €68m.

Sanofi's diabetes franchise helped offset the losses with record growth of more than 20 per cent - led by long-acting basal insulin Lantus (insulin glargine), which grew 23 per cent to €1.34bn, cementing its position as Sanofi's biggest product.

Other positive highlights included a return to form for fast-acting insulin Apidra (insulin glulisine), which recovered from lingering supply issues and rocketed ahead more than 80 per cent to €65m, and a strong performance by Sanofi's vaccines unit Sanofi Pasteur which rose 21 per cent to €1.02bn.

Recovery from supply constraints also benefitted Genzyme's rare disease products, which helped the unit post a 22 per cent increase in turnover to €481m, with much of the gain due to  restored supplies of Fabry disease drug Fabrazyme (agalsidase beta) which rose 96 per cent to €84m.

Sanofi expects EPS to be 5 per cent lower this year than in 2012.

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