The acquisition of Amylin by Bristol-Myers Squibb and AstraZeneca is designed to enhance their existing diabetes collaboration. Integration of the Bydureon franchise provides access to a likely blockbuster and the GLP-1 market. While these can be viewed as positive developments, there remain challenges ahead. FirstWord looks at three key questions for the acquirers of Amylin.
Can approval be secured for a more convenient dosing mechanism for Bydureon?
Bydureon may be the first and only GLP-1 agonist that is administered on a once-weekly basis, however, in its current form, it is cumbersome to use, notes Sanford C. Bernstein analyst Tim Anderson. The product must be mixed in a number of stages by the patient and is administered using a larger needle than Novo Nordisk's once-daily Victoza, which remains the market leading GLP-1 agonist.
A pre-filled pen version of Bydureon is in development and remains on track for launch in 2013; successful approval and commercialisation of this device will presumably be a priority for Bristol-Myers Squibb and AstraZeneca given the potential upside to revenue, note analysts. Management also indicated that suspension formulations for weekly and monthly dosing remain under investigation, with Phase III studies for the weekly formulation expected to begin later this year.
How far from the market are other GLP-1 agonists?
The current GLP-1 market is in effect a duopoly – Bydureon (and the once-daily Byetta) competes with Victoza. Uptake of Bydureon has largely come at the expense of Byetta and not Victoza market share. However, while launch of Bydureon has grown the overall GLP-1 agonist market, analysts anticipate that subsequent entrants to the market will gain a greater proportion of share at the expense of existing products.
Furthermore, the GLP-1 class will get more competitive very soon, notes Anderson, with several products in Phase III development including Eli Lilly’s dulaglutide, GlaxoSmithKline’s albiglutide, Novo Nordisk’s semaglutide (all once-weekly) and Sanofi’s lixisenatide (once-daily). Some of these products are likely to launch within 18 months, adds Anderson.
What about GLP-1 inhibitor/long-acting insulin combinations?
Potential extension of the GLP-1 class could come via their combined use with long-acting insulins, note analysts; for example Sanofi’s lixisenatide with Lantus or Novo Nordisk’s Victoza with degludec. A potentially lucrative market, but one which Bristol-Myers Squibb and AstraZeneca’s current diabetes portfolio would be unable to exploit due to the lack of an insulin.
The positioning of GLP-1 agonists between the usage of oral therapies, but before patients progress to insulins, is central to the development of GLP/insulin combinations, note analysts, as combination use could bring the usage of insulins forward in the treatment algorithm, taking advantage of their greater glycaemic control versus GLP-1 agonists and acting as a defence strategy for leading players in the long-acting insulin class (primarily Sanofi and Novo Nordisk).
In a conference call on Monday, Bristol-Myers Squibb management said that GLP-1/insulin combinations were multi-faceted and interestingly noted the potential use of Byetta plus insulin as an alternative to shorter-acting insulins. Noted as an important opportunity – and given that the acquisition of Amylin has enhanced a sequential portfolio of diabetes therapies at Bristol-Myers Squibb and AstraZeneca, one could expect a subsequent move to access the insulins segment.
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