ViewPoints: Five key takeaways from the American Diabetes Association (ADA) meeting

Rivals turn up the heat on Novo Nordisk?

Novo Nordisk will likely see its revenues come under increased pressure from 2015 onwards due to competitor launches, JP Morgan analyst Richard Vosser wrote in a note to investors on Monday. Robust data for Eli Lilly's GLP-1 agonist dulaglutide presented at the American Diabetes Association (ADA) meeting positions the product as the first credible competitor to Novo Nordisk's Victoza, suggests Vosser, having demonstrated comparable efficacy and tolerability, and the benefit of once-weekly dosing.

Key opinion leaders (KOLs) recently interviewed by FirstWord's Therapy Trends team for a forthcoming report on the diabetes market believe that in addition to a less frequent dosing profile, there remains scope for differentiation within the GLP-1 market in terms of side-effect profile, weight loss and how patients feel immediately after using the products – all areas where investors and analysts will be looking to determine if dulaglutide can provide any advantage in the coming months.

Furthermore, the competitive environment for Novo Nordisk's Levemir and Tresiba brands appears set to become tougher in light of positive Phase III data for Sanofi's next-generation version of Lantus – currently known as Lantus U300 (see below).

Too little too late for GlaxoSmithKline's albiglutide?

Positioned front and centre in GlaxoSmithKline's post-Avandia attempts to revive its status in the diabetes market is its GLP-1 agonist albiglutide, data for which has been released from a number of studies over the past few days.

However, in light of Victoza's entrenchment in the market and a strong outlook for dulaglutide, analysts have been left scratching their heads as to where albiglutide will fit into the treatment paradigm. "The totality of the data shows a product with limited differentiation versus approved products, and a less impressive profile than next-generation therapies such as Eli Lilly's dulaglutide," wrote JP Morgan analyst James Gordon.

KOLs agree that although albiglutide is likely to reach the market first, it could see any early traction with physicians and patients rapidly eroded once Eli Lilly's seemingly stronger dulaglutide is launched shortly afterwards. One KOL noted that should Eli Lilly use an existing device to administer dulaglutide – such as the KwikPen (used with its Humalog franchise) – this will also provide an important sense of familiarity for endocrinologists. In addition, Eli Lilly is expected to report data from a head-to-head trial of dulaglutide versus Victoza in 2014, and the company said on Monday at an ADA analyst event that it is very confident of demonstrating non-inferiority and could still be powered for superiority.

A classic primary care battleground

In a note to investors on Monday, International Strategy & Investment analyst Mark Schoenebaum labelled the growing GLP-1 agonist space as a "classic primary care" market, which is likely to dictate that clinical data alone will not shape the commercial performances of these products. Victoza dominates with an approximate 60 percent share of the US GLP-1 market (with AstraZeneca and Bristol-Myers Squibb's once-daily Byetta and once-weekly Bydureon products accounting for the remainder). As Schoenebaum points out, however, Victoza launched in the US some four years after Byetta – which at least partially demonstrates that Novo Nordisk's strong presence in the diabetes space has shaped uptake of the product.

In addition to the less quantifiable measurement of market experience, associated metrics such as the size of sales force and discounting strategies to keep payers onside are likely to also act as key dynamics within the GLP-1 market. One key observation to keep in mind, adds Schoenebaum, is that Eli Lilly may be the only diabetes player with a drug in every diabetes class (orals and insulins), which could be integral to its ability to enhance relationships with payers.

Focus will sharpen on biosimilar insulins in 2014

As part of its efforts to develop a broad portfolio, Eli Lilly is also developing biosimilar insulin products including a version of Sanofi's Lantus. At the ADA meeting, Eli Lilly confirmed that its development/regulatory timescale remains intact and the company hopes to file marketing applications for its insulin glargine product by the end of 2013.

Sanofi's announcement earlier this year that it too has progressed a number of biosimilar insulin products into clinical testing (see Spotlight On: Competition hots-up in biosimilar insulin space – Sanofi announces biosimilar development programme/Novo Nordisk looks to get pre-filled delivery devices listed in Orange Book) is testament to the role that these products will play in the future – possibly by allowing manufacturers to provide 'bundles' of complete offerings to healthcare providers.

Endocrinologists polled by FirstWord have previously suggested they would be much happier prescribing biosimilar insulins developed and marketed by recognised leaders within the diabetes space, such as Eli Lilly and Sanofi, which would at least appear to soften one potential barrier to uptake. See Physician Views Poll Results – Endocrinologists disappointed about Tresiba rejection in US given possible benefits over Lantus/Significantly more likely to prescribe biosimilar insulin marketed by leading branded player.

Sanofi poised to enhance Lantus franchise?

A key takeaway from data presented for Lantus U300, is that Sanofi's follow-on product demonstrated comparable efficacy to Lantus and a benefit on nocturnal hypoglycaemia comparable with Novo Nordisk's Tresiba (approved in the EU/Japan, but delayed in the US until likely 2016-17). This could potentially counter any nocturnal hypoglycaemia benefit that Tresiba is seen to have over 'original' Lantus.

Overall hypoglycaemia reduction for Lantus U300 was lower than that demonstrated by Tresiba (7 percent versus 18 percent) and this will remain a notable talking point until additional data becomes available, notes Vosser.
This may be the case, suggests Morgan Stanley analyst Peter Verdult, but the reality is that U300 could have a 2 to 3 year head start in the US market, which he suggests will not only put increased pressure on Levemir, but also Tresiba, assuming approval is granted once a cardiovascular outcomes study is completed. In short, suggests Vosser, new data for U300 at this year's ADA meeting provides the first real indication that Sanofi can protect and grow its Lantus franchise beyond its 2015 patent expiry.

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