August is slow and I'll be on vacation all next week, so I'm using this week's Biotech Stock Mailbag to tie up some loose ends.
Tobin R. asks, "Heron Therapeutics (HRTX) got approval for Sustol [Wednesday] and it looks good, as they were able to make the label include the benefit for stopping delayed-onset nausea and vomiting in patients undergoing highly emetogenic chemotherapy. You had mentioned this claim as important for Heron to be successful with Sustol. The stock reaction since approval wasn't as strong as I expected so am I right about the Sustol approval news? If not, can you explain if I missed something."
Beyond moderately emetogenic chemotherapy, Heron secured a claim in the Sustol label to cover acute and delayed nausea and vomiting associated with anthracycline and cyclophosphamide (AC) chemotherapy regimens. This is a narrower claim than all highly emetogenic chemotherapy (HEC), but Heron says getting "delayed" AC in the Sustol label will cover about 93% of targeted patients.
The FDA-approved Sustol indication looks better than Aloxi, the chief competition marketed by Eisai. However, Heron was unable to convince Food and Drug Administration to include some important Sustol clinical data in the label which would have helped the company ease insurance reimbursement hurdles.
Heron submitted to the FDA results from a phase III study dubbed "MAGIC" which showed Sustol to be superior to standard of care for the prevention of nausea and vomiting after highly emetogenic chemotherapy. Heron submitted these Sustol data from the MAGIC study to the FDA and wanted them included in the drug's approved label.
FDA rejected Heron's request. The Sustol label approved Wednesday omits the MAGIC study data, including any superiority claim over standard of care. What's left in the label is a Sustol statistical non-inferiority (equivalence) claim compared against Aloxi.
Heron will still be able to tell doctors about the more positive MAGIC study, but not having those superiority data in the FDA-approved label give insurers a reason to place reimbursement restrictions on Sustol. This may not matter for the next year or so because Sustol will be priced at parity with Aloxi, but it will become more important in 2018 when a generic (and cheaper) version of Aloxi is launched on the U.S. market.
Questions about Sustol's commercial launch due to the contents of the label explain the muted reaction in Heron's stock price. Patients treated with Sustol are also prone to painful reactions at the injection site, which is another issue investors will be watching as Heron begins marketing the drug in the fourth quarter.
Moving on. A few biotech observations from the week past mentioned on Twitter already but emphasized here:
An interesting decision by Acadia Pharmaceuticals (ACAD - Get Report) to raise $200 million in a follow-on stock offering. Does this financing suggest a lack of interested buyers for the company at its current valuation? Or does raising money now signal Acadia management's confidence in the nascent Nuplazid commercial launch and desire to stay independent until the highly anticipated Alzheimer's psychosis study data are announced towards the end of the year?
Rockwell Medical (RMTI - Get Report) posted another quarter of zero Triferic sales. The kidney dialysis drug was approved in January 2015 and "sales" began in September 2015. Except there are no reported sales and no clear indication from Rockwell's management when sales might trickle in.
— Adam Feuerstein (@adamfeuerstein) August 11, 2016