Sustol was approved in combination with other agents to prevent nausea and vomiting associated with some forms of chemotherapy, excluding platinum-based regimens, Heron said.
The absence of platinum-based therapies from the label is a bit disappointing, given that Sustol showed a strong response in patients in this class of chemotherapy, Cowen & Co’s Boris Peaker wrote in a note.
This exclusion reduces Sustol’s addressable population by about 7 percent, company executives said on a conference call.
Heron did not disclose Sustol’s price, but said it would reference recently approved CINV treatments. Cowen’s Peaker estimates a price of $200 per patient.
Tesaro Inc’s oral CINV treatment, rolapitant, was approved last September and works by blocking the activation of neurokinin (NK)-1 receptor.
Sustol, like Aloxi, targets the serotonin-3 (5-HT3) receptor, which plays a role in nausea and vomiting.
Sustol, which is an injectable version of the generic granisetron, will be launched in the fourth quarter.
Heron said it had a support plan in place, consisting of co-pay assistance, extended financing until practices receive reimbursement, and would potentially reimburse patients if insurance claims are rejected.
The treatment is expected to generate peak sales of $306.3 million by 2021, according to Thomson Reuters Cortellis.
Heron’s stock, which had lost about a quarter of its value this year up to Tuesday’s close, was up about 9 percent in morning trading on Wednesday.
(Reporting by Natalie Grover and Samantha Kareen Nair in Bengaluru- Editing by Saumyadeb Chakrabarty)
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