Heron works Magic to conjure trial win
Heron Therapeutics could not have hoped for better timing for the release of positive pivotal data for its chemotherapy-induced nausea drug Sustol, coming as it did on the eve of the Asco cancer meeting when the sector’s attention is turned to all things oncology.
The California-based group reported that its long-acting granisetron injection outperformed the similar ondansetron in preventing vomiting or use of rescue medications in patients with delayed nausea. Shares rose 47% to $18.19 in early trading today as investors gained confidence that Sustol’s third run at the FDA will be a winner.
The Magic trial aimed to show that Sustol was effective against the standard of care in reducing delayed-onset nausea and vomiting following treatment with highly emetic chemotherapy agents such as cisplatin or dacarbazine. These agents cause vomiting in 90% of people who receive them – Asco guidelines recommend a regimen of a 5-HT3 antagonist like ondansetron with dexmethasone and a neurokinin 1 antagonist to relieve symptoms.
Sustol with fosaprepitant and dexamethasone prevented vomiting or use of rescue medications 24-120 hours post-treatment in 64.7% of patients randomised to take that regimen, compared with 56.6% of those taking ondansetron with the other two drugs; that eight percentage point difference was statistically significant, Heron said.
Significantly more patients taking Sustol also reported no more than mild or infrequent nausea, or none at all, when compared with the patients taking ondansetron, which GlaxoSmithKline sells as Zofran.
Heron reasons that the bioerodible formulation technology used in Sustol allows for more sustained release of granisetron, the active ingredient in Roche’s now off-patent Kytril. A similar approach has been taken by Kyowa Hakko Kirin with its granisetron patch Sancuso.
Leerink Research analyst Jason Gerberry wrote that Sustol is the only 5HT3 antagonist that has shown a benefit in the delayed nausea setting, suggesting it will receive a differentiated label and become the standard of care. He forecasts $430m in peak sales.
Work some Magic
Heron said it will be submitting the data to the FDA mid-year, making it the third time regulators have reviewed the data – the first two occurred when the company was called AP Pharma.
The company was quick to point out that Magic was the first trial to follow Asco guidelines, thus hinting that regulators will be much more receptive to the data. A complete response letter in 2013 cited the need for more specific data from highly and moderately emetogenic therapy.
Should Sustol win approval, Leerink’s Mr Gerberry believes that the data should allow Heron to argue for premium pricing over the market leader, Eisai and Helsinn Group’s Aloxi, currently priced at about $2,000 per patient a year, according to EvaluatePharma’s Sales, Volume and Pricing module. That agent has never been proven in delayed onset nausea, so it might not necessarily be seen as a direct competitor.
Indeed, the direct comparison in clinical trials was with Zofran, and as that is an off-patent product, Sustol could be sensitive to pricing. Heron executives said today they also are anticipating that generic Aloxi will enter the market in 2018.
With payers increasingly conscious of costs as expensive new speciality drugs like Harvoni and the cholesterol-lowering biologicals come into broad use, it may take some persuasion for the group’s medical affairs specialists to justify a significantly higher price to buy an eight percentage point improvement in nausea and vomiting prevention over a generic drug.
Heron needs to hope that pharmacy benefit managers do not have a counter-spell to Magic.