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New drugs raise hopes

new drugs
نوشته شده توسط دکتر افشین عشقی

In the immediate future, it seems as if the diabetes market will be more evolutionary than revolutionary, governed by refinements in insulin delivery rather than major breakthroughs. Still, there are improvements to be made and healthy profits on top of that Case in point,

Sanofi’s Toujeo (insulin glargine), a reformulated long-lasting insulin, could preserve the company’s income stream as Lantus loses patent protection.

The FDA accepted Toujeo’s NDA in July, and approval is expected in the first half of this year. EvaluatePharma’s projection comes in at $1.4 billion in sales by 2018. Thomson Reuters forecasts $1.6 billion by 2019.

Lilly/Boehringer’s insulin glargine, Basaglar, received tentative FDA approval in August 2014, but Sanofi is claiming patent infringement. As a result, approval has been delayed for up to 30 months while the case makes its way through the courts. EvaluatePharma projects $401 million in sales by 2018.

Lilly/Boehringer is also working on insulin peglispro, an insulin analog for type 1 and type 2 diabetes. A recently concluded trial showed daily therapy compared favorably to treatment with insulin glargine. Lilly plans to submit insulin peglispro early this year. EvaluatePharma estimates sales of $406 million by 2018.

Focusing on type 2 diabetes, Lilly’s long-acting glucagon-like peptide-1 (GLP-1) agonist Trulicity (dulaglutide) received FDA approval last September. GLP-1 is a hormone that balances blood sugar, making it a particularly tempting target for type 2 diabetes treatments. With EvaluatePharma projecting sales of $912 million by 2018, Trulicity could be bad news for Novo Nordisk and AstraZeneca.

“We think Trulicity could be a $1.5 billion drug and a meaningful competitor to Novo’s Victoza,” noted Fernandez. “I think it’s going to do a lot of damage to AstraZeneca’s Bydureon.”

However, Novo has big plans for Victoza (liraglutide), which has recently been found safe and effective against obesity. Last September, an FDA panel voted to recommend the drug for approval for that indication. In December, FDA
approved Victoza for chronic weight management.

Perhaps more interesting, Novo has combined liraglutide with long-lasting insulin degludec (Tresiba) to create IDegLira for type 2 diabetes. Recent data have shown the combination works better than liraglutide and insulin degludec do alone. Thomson Reuters puts IDegLira at $815 million by 2019. EvaluatePharma estimates $517 million by 2018.

Merck’s omarigliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor to treat type 2 diabetes, is continuing through fairly massive Phase 3 trials. Taken weekly, the drug may reduce glucose as well as daily treatments. EvaluatePharma pegs sales at $412 million by 2018.

Zafgen’s obesity drug Beloranib, which modulates fatty acid metabolism, is turning heads. A Phase 2 trial in 2013 produced rapid weight loss in severely obese patients and was well tolerated. An effective weight-loss drug with few side effects could have tremendous potential. This is definitely one to watch.

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