Novo Nordisk (OMX: NOVO B) could be under some pressure on Monday as Amylin Pharmaceuticals and Alkermes, Inc could announce on Friday after European markets had already closed that the US FDA finally approved type 2 diabetes drug Bydureon. The FDA had rejected the drug twice demanding more data where as EMA already approved the drug in 2011. Bydureon, which is long-acting release formula of Byetta (exenatide) will go compete against Novo’s blockbuster drug Victoza (liraglutitide).
Victoza has managed to gain market share from Byetta on active marketing supported by favourable data comparison from LEAD-6 clinical trial. However, Byetta has been enjoying some tier advantages in the US and it had been holding on somewhat better than expected. All of the drugs mentioned here belong to a class called glucagon-like-peptide-1 GLP-1 (which is an incretin) receptor agonists.
Victoza, is injected daily where as Byetta on which Bydureon is based is injected twice a day. Presumably the main advantage that Bydureon will have is that it only needs to be administered once a week, a fact made possible by Alkermes’ proprietary technology for controlled release of medications. Efficacy will still be a selling point for Novo’s drug as studies conducted so far compare Victoza’s blood sugar level control favourably to that of Bydureon’s. Each injection of Bydureon is also more cumberrsome and done with a larger needle than an injection of Victoza.
Victoza sells well north of a billion U.S dollars at the moment, with around half of that coming from the United States. Analysts’ predict that Bydureon will eventually reach blockbuster status as well and its approval this time was expected. Bydureon will carry a warning on pancreatitis and possible elevated risk on a certain type of thyroid cancer risk. Victoza also carries a warning on similar issues. Both drugs are indicated as an adjunct to diet and exercise. Novo Nordisk will report quarterly earnings next Thursday.
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