The prospect of an end to at least some of the injections required for people with diabetes moved a little closer yesterday, after a European Medicines
Agency (EMEA) advisory committee recommended approval of Pfizer and
Sanofi-Aventis’ inhaled insulin product Exubera.
The EMEA said that Exubera had been backed for use in both type 1 and type 2 diabetes as an alternative to short-acting insulin injections given around mealtimes. Some patients would still need to take long-acting insulins to maintain their background insulin levels.
The news comes shortly after a similar approval recommendation from a US
Food and Drug Administration advisory committee, which last month voted in favour of approving Exubera for both forms of diabetes, despite doubts being raised about its efficacy in type 1 diabetes in an earlier FDA briefing paper [[09/09/05a]].
Current estimates put the number of people with diabetes worldwide at nearly
180 million, a number expected to jump to 300 million in the next 20 years because of rising levels of obesity, and analysts predict that the first non-injectable insulin to reach major world markets stands to achieve sales upwards of $1.5 billion dollars a year.
While Exubera still has to go through formal approval, the recommendations bring Pfizer and Sanofi-Aventis towards the end of a long and arduous path in bringing the drug to market. It was filed for approval last March, after a three-year delay caused by concerns over the product’s potential to cause deteriorations in lung function with chronic use [[03/03/05c]]. The companies have agreed to carry out long-term follow-up studies, out to 2019, to monitor the drug's safety.
Meantime, the delay has allowed some potential competitors to close the gap with the leaders, but the two green lights now suggest that Pfizer and
Sanofi-Aventis should have a comfortable lead in the marketplace. Following behind include inhaled insulins from Eli Lilly/Alkermes and Novo Nordisk/Aradigm - both in Phase III testing - and a product from Mannkind, which is in Phase II.
But even if Exubera does win through to market, it will be unable to claim to be the first non-injectable insulin product to be commercialised. In May, Canadian biotech firm Generex Biotechnology won its first approval, in Ecuador, for an insulin oral spray called Oral-Lyn. Generex is currently scaling up production in anticipation of a launch of the product, which is in various stages of clinical trials elsewhere in the world.
Pfizer is said to be planning to buy Sanofi-Aventis’ interest in Exubera should it win a green light [[09/09/05a]], according to a recent research note from analysts at UBS Investment Research.
Meanwhile, the new European recommendation is also a boost for US drug delivery company Nektar Therapeutics, which developed the formulation and inhaler device used in Exubera. Nektar’s most established business is in
PEGylation - attaching polyethylene glycol polymers to biologics to improve their pharmacokinetics and improve dosing frequency - and its technology is behind all the pegylated drugs currently on the market.
However, royalty rates on sales of pegylated drugs are thought to be in the low single digits, while the rate for Exubera are in the double-digits, so the inhaled product could give the company a valuable new revenue stream at a time when it is just gearing up to start developing its own in-house products.
A spokesman for Nektar told Pharma Times News Online earlier this week that the company plans to start clinical trials of its first pegylated biologics - which it refers to as supergenerics‚ because they will be improved versions of off-patent biologic drugs - by the end of the year.