Patent expiry means 2012 is ‘marked in red’ for Sanofi

 French pharmaceutical giant Sanofi is looking to its drug pipeline, including products from the recently-acquired Genzyme business, to ensure the company’s growth in a year when patent expiries are forecast to cut its profits by 15%.

Sanofi CEO Chris Viehbacher (pictured) said that 2012 had been “marked in red” in his personal diary as the year when cardiovascular drugs Plavix and Avapro would fall over the patent cliff.

Sanofi has filed five new drugs for regulatory approval in the US and Europe in the last seven months, which Viehbacher claimed was “a record for the industry”.

The company plans to launch 18 new drugs by the end of 2015 – and moving forward, to adopt an ‘open innovation’ approach to R&D through partnership with biotech companies and academic organisations.

The acquisition of biotech company Genzyme for $20.1bn in April 2011, which increased Sanofi’s costs for the year by 5.6%, promises to deliver a range of new therapies for rare diseases.

Viehbacher said that Genzyme’s new treatment for relapsing MS, Lemtrada, was a potential market-leading product, with its filing for US and EU regulatory approval expected in the second quarter of 2012.

In 2012, generic competition on blood-thinning drug Plavix and hypertension drug Avapro in the US is expected to cost Sanofi $1.86bn profit, up to 15% of its global total.

“2012 has been marked red in my diary for years,” Viehbacher commented. “We cannot compensate for that in one year but we can compensate over time. As we come out of the cliff, Sanofi is extremely well positioned for growth.”

Sanofi’s fourth-quarter profit in 2011 rose by 13%, due to the Genzyme acquisition and an 18% increase in sales of its Lantus insulin, which exceeded $1bn in quarterly sales for the first time.

The FDA’s recent approval of a new manufacturing facility in Framingham, Massachusetts, will enable Genzyme to resolve problems with production of two rare-disease medicines.

Sanofi has identified growth prospects in six ‘platform’ areas where products are less vulnerable to patent expiry: vaccines, diabetes care, biological therapies for rare diseases, emerging markets, consumer healthcare and veterinary medicine.

A new formulation of the long-acting insulin Lantus, Sanofi’s biggest-selling drug, is currently going through a phase III clinical trial programme.

“2011 was a key year in transforming Sanofi,” Viehbacher said. “We successfully acquired and integrated Genzyme, our growth platforms recorded double-digit growth, we delivered cost savings as planned and submitted filings to regulatory authorities for five new products.

“Beyond the remaining patent cliff in 2012, the robust performance of our diversified growth platforms, the reduced exposure to future patent expiries and progress on R&D position Sanofi for a period of sustainable growth.”

To see Chris Viehbacher discussing Sanofi’s 2011 performance and prospects for 2012 and beyond, click here

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