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Josh Baxt casts his eye over what to look out for in the diabetes and obesity treatment markets.
This year it seems like 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 acceptedToujeo's NDA in July, and approval is expected in the first half of 2015. 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, was given tentative approval by the FDA in August, 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 are also working on insulin peglispro, an insulin analog for type 1 and type 2 diabetes. A recently concluded trial showed daily treatment compared favorably to insulin glargine. Lilly plans to submit insulin peglispro in early 2015. EvaluatePharma estimates sales of $406 million by 2018.
Focusing on type 2 diabetes, Lilly's long-acting glucagon-like peptide-1 (GLP-1) agonistTrulicity (dulaglutide) received FDA approval in 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 Victroza," notes 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. In September, an FDA panel voted to recommend the drug for approval for that indication.
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 drug works better than liraglutide and insulin degludec 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 III 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 II 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.