While most politicians are happy clamouring for four more years when its comes to extending their careers, Astex Pharmaceuticals and Johnson & Johnson late last week managed to secure 10 more for their pipeline workhorse Dacogen, thanks to European approval in the new indication of acute myeloid leukaemia (AML).
Securing the green light in the crucial European market has gone a long way towards making up for the groups’ failure to do the same in the US. With a new source of royalty revenues now assured, Astex can start to concentrate on adding much-needed new strings to its pipeline bow.
Touch and go
Following the thumbs down from the US regulator back in March after a negative advisory committee claiming that the risks of the drug outweighed its benefits in patients aged over 65 who were ineligible for chemotherapy, there had been doubts about the approvability of the drug in the more important European market (Dacogen looking to Europe following initial US disappointment, February 10, 2012).
Instead the drug passed with flying colours, despite what looked like limited efficacy in phase III trials. Astex needed European approval because Dacogen is already marketed in the US for myelodysplastic syndrome (MDS) and was facing a patent expiry in 2013, meaning that even if US regulators had said yes its marketing exclusivity would only have lasted months.
Having previously garnered no sales in Europe Dacogen now has a patent clock counting down from 10 years, and partner Johnson & Johnson is set to give Astex a handsome royalty stream that Edison Investment Research believes will be amount to $65m a year, handily replacing revenues that will be lost when Dacogen comes off patent in the US.
Flying start
Thanks to its orphan drug designation in Europe and very limited or no competition in the front-line setting of this hard-to-treat patient population, Dacogen will almost certainly become the standard of care.
Few challenges are on the horizon. The handful of late-stage drugs behind Dacogen are all unlikely to come to the market before 2014, giving a clear run to establish dominance.
Earlier this month, Sunesis Pharmaceuticals caused some investor panic when it announced that it would be extending its phase III trial of vosaroxin, an action that now means the pivotal data, expected by the end of 2012, are unlikely to read out before next year (Sunesis disclosure farrago leaves markets in the dark, September 13, 2012).
Daiichi Sankyo and Cyclacel in May announced the start of enrolment for a 100-patient phase II/III trial whose outcome would determine whether the drug would be taken into larger phase III trials. Novarits’s multi-targeted kinase inhibitor, midostaurin, is due to report phase III results in 2014.
Moving on
With the vital European approval under its belt and future revenue streams secured, Astex, which is sitting on a cash pile of about $126m, is likely to turn its attention to the rest of its pipeline. In the coming months the company expects a slew of data from several key phase II trials.
AT13387, an HSP90 inhibitor, is due to report results from a 36-patient trial in gastrointestinal stromal tumours in November. The TKI inhibitor amuvatinib is due to report results from its small-cell lung cancer study in the same month. The group is also expecting data from a 180-patient phase I/II trial in AML and MDS in December for its second-generation hypomethylating agent, SGI-110, and this will be very closely watched.
Astex has already seen its shares rise by 67% this year to $3.15, and if these trials are positive it could see even more upside and prove that it can move out of the shadow of Dacogen.
To contact the writer of this story email Lisa Urquhart in London at [email protected]
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