Astellas goes solo in its key urology market

01 Mar 2011 • by Natalie Aster

In a bid to further increase its presence in the urology market, Astellas has announced that it will no longer co-promote Vesicare in the US with its partner GlaxoSmithKline. While Astellas is now faced with driving Vesicare's US sales alone, it is also laying the groundwork for its first-in-class follow-on drug mirabegron and reinforcing its position in the overactive bladder space.

Astellas has terminated its US co-promotion agreement with GlaxoSmithKline for Vesicare (solifenacin succinate), a widely popular drug for the treatment of overactive bladder. The decision to promote its product alone in the US is in line with Astellas's aim to become the leading urology company over the next decade. By increasing its presence in the US, Astellas aims to ensure a successful launch platform for its novel follow-on to Vesicare, mirabegron.

Urinary incontinence affects over 32 million women in the US. However, there are few effective treatments available. The most popular drugs are anticholinergic agents but they are not always effective and are commonly associated with undesirable side effects such as dry mouth and constipation.

While competition in this class is fierce, there have been opportunities for companies with large commercial resources. Indeed, GlaxoSmithKline and Astellas heavily marketed Vesicare in the US through large direct-to-consumer advertising campaigns, helping it become one of the largest selling and fastest growing overactive bladder brands, with US sales of $431m in 2009. Astellas needs to continue this strategy if it is to maintain the momentum and strengthen its US foothold.

To secure long-term growth, Astellas is developing mirabegron, a novel beta-3 adrenergic receptor agonist currently in Phase III trials and forecast to launch in 2012. Clinical data suggest that mirabegron has similar efficacy to anticholinergics but with a better side-effect profile. As such, mirabegron is set to address the highest clinical unmet need in overactive bladder and urinary incontinence, specifically an entirely new mode of action that does not produce cholinergic side effects.

With Vesicare losing US market exclusivity in 2018, there will be a period when the company will be marketing the two products for the same indication. To avoid cannibalizing Vesicare sales, Astellas is likely to position mirabegron as a second-line treatment for patients who cannot tolerate anticholinergics. This is a prudent move, as cheap generics are set to flood the market and increase cost competition.

In the near term, the biggest challenge for Astellas will be to compete with Pfizer, which has dominated the market over the last decade with its Detrol (tolterodine) franchise and the more recent Toviaz (fesoterodine) brand. However, with Pfizer indicating a shift in its therapeutic focus away from genitourinary diseases, the long-term prospects for Astellas in this market are bright. Accordingly, Datamonitor forecasts Astellas's franchise to exceed $1bn in 2019 and, going forward, for the Japanese drugmaker to become a leading player in the overactive bladder space.