Sanofi SA said late Wednesday it got a green light from U.S. regulators to sell its new insulin product Toujeo, a crucial launch for the French drug maker as it struggles to keep a firm grip on the all-important diabetes market. Sanofi is counting on Toujeo to help offset sales it will lose when its top-selling drug, the insulin Lantus, loses U.S. patent protection, which is expected later this year. Encouraging doctors to switch patients to Toujeo and ensuring that the new insulin is paid for by health insurers will be one of the first major challenges for the French drug maker's new chief executive, Olivier Brandicourt. Mr. Brandicourt, a 59-year-old drug industry veteran who led Bayer AG's health-care business after holding senior roles at Pfizer Inc., is scheduled to take over in April, nearly six months after the board abruptly ousted Christopher Viehbacher, citing his lack of communication and management style. Sanofi's diabetes portfolio will be a major focus for Dr. Brandicourt, as the company grapples with growing competition and pricing pressure in the U.S., Europe, and other markets. Diabetes is one of the world's biggest drug markets, generating more than $38 billion in yearly sales, according to EvaluatePharma. In 2013, Sanofi had No. 2 in market share, behind Novo Nordisk A/S, in large part due to sales of Lantus, the world's top-selling diabetes drug. But the market's size and growth also makes it among the industry's most competitive. Companies including Eli Lilly & Co. and Merck & Co. have been racing to sell low-price versions of Lantus. Earlier this month, Sanofi said that sales at its diabetes division, which accounts for about 20% of its EUR33.7 billion in total annual revenue, would be flat this year. David Kliff, publisher of the Diabetic Investor newsletter, warned that Sanofi could encounter resistance from health insurers and drug-benefit managers who don't see the company's newer insulin as being clinically different enough from cheaper insulins to warrant a higher price. "Sanofi is saying physicians will automatically switch Lantus patients to Toujeo nothing could be further from the truth. Payers are not going to allow that," Mr. Kliff said. Doctors might also balk because the differences aren't big, as well as because Toujeo is dosed differently than Lantus, Mr. Kliff said. Pierre Chancel, senior vice president for diabetes at Sanofi, said the company would do everything to ensure that patients' access isn't an issue. "We will push for Toujeo," said Mr. Chancel. Toujeo is a long-acting insulin taken once daily. It was approved for use by people with Type 1 and Type 2 diabetes. Sanofi said it expects Toujeo to be available in the U.S. at the beginning of the second quarter. Credit Suisse estimates that Toujeo sales could reach about $2 billion annually by 2018. That won't be close to the revenues that have been generated by Lantus, however. Mr. Brandicourt's experience at Pfizer includes protecting a big product. While heading the U.S. firm's primary-care business, Mr. Brandicourt was given credit for helping keep sales strong for the cholesterol drug Lipitor. The drug was once both Pfizer's and the world's top selling medicine, notching more than $81 billion in sales from its launch in 1997 until losing U.S. patent protection in 2011. After becoming an executive in 2012, Mr. Brandicourt also led Pfizer's push to expand sales in emerging economies, a key market for Sanofi. The move was important for the company as it sought new revenues to replace aging drugs. But some of his bets failed. While heading the primary-care drugs business, he sought to expand Pfizer's portfolio of pain drugs by buying King Pharmaceuticals in 2011 for $3.6 billion. But Remoxy, a crown jewel of the King deal, didn't win FDA approval. Pfizer last year returned all rights to partner Pain Therapeutics Inc. He was also in charge of the launch of Exubera, an inhaled insulin that Pfizer had high hopes could be an alternative to injections. The product failed to take off, and Pfizer said in 2007 it would take a $2.8 billion in charge to stop marketing the medicine. At Sanofi, Mr. Brandicourt will get another chance at succeeding with inhaled insulin. Sanofi is joining with MannKind Corp. on sales of Afrezza. The inhaled insulin received FDA approval last June and was launched in the U.S. early this month. Source: MarketWatch
