A summer Friday is not complete without a Biotech Stock Mailbag.
Adam F. asks, "I laughed at your Heron Therapeutics (HRTX) watch on Twitter, but seriously, what do you think is going on at the FDA to delay Sustol decision for this length of time? What a strange story to this point. Any guesses?"
Hey, that name sounds familiar.
Almost three months (77 days to be exact) have passed since Heron told investors the Food and Drug Administration was engaging the company in negotiations to finalize the label for Sustol. Furthermore, the FDA has found "no substantive deficiencies" in the Sustol filing, Heron said.
Seventy-seven days (and counting) to nail down a label for a drug to reduce nausea and vomiting in cancer patients undergoing chemotherapy -- far from medically ground-breaking territory -- is an insanely long time. So, yes, I agree with the other Adam F. that the Heron story is strange.
Heron isn't talking about Sustol or offering an explanation for the long FDA delay but here's my best guess: FDA has already offered to approve Sustol but only with a limited label that would curtail sales significantly. Heron, and not the FDA, is responsible for the delay as it tries to convince the agency to allow a more expansive label.
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Broadly speaking, the chemotherapy-induced nausea and vomiting (CINV) drug market is divided into four buckets of patients encompassing two types of chemotherapy (moderately and highly emetogenic) and two stages of CINV prevention (acute and delayed.)
Aloxi, the most-prescribed CINV drug sold by Eisai, is approved for three of the four CINV patient buckets. Aloxi sales totaled approximately $550 million (converted from yen) in Eisai's 2015 fiscal year ended on March 31. The patents on Aloxi have started to expire, however, which means generic versions of the drug are launching soon.
Sustol won't be able to compete against cheap, generic Aloxi (palonosetron) unless the FDA allows a prescribing label which includes a claim for the prevention of delayed-onset CINV in patients undergoing highly emetogenic chemotherapy. That's the magical, highly desirable fourth bucket in the CINV treatment market.
Heron submitted data to the FDA supporting the approval of Sustol for the prevention of delayed-onset CINV in patients undergoing highly emetogenic chemotherapy.
Again, my guess: FDA found something not to its liking in those data. I believe FDA has told Heron that Sustol is approvable for months now, just not with a commercially viable label. That's why Heron can tell investors truthfully that labeling discussions are ongoing and FDA has not identified "substantive deficiencies" with the filing.
Adam F. asks, "I laughed at your Heron Therapeutics (HRTX) watch on Twitter, but seriously, what do you think is going on at the FDA to delay Sustol decision for this length of time? What a strange story to this point. Any guesses?"
Hey, that name sounds familiar.
Almost three months (77 days to be exact) have passed since Heron told investors the Food and Drug Administration was engaging the company in negotiations to finalize the label for Sustol. Furthermore, the FDA has found "no substantive deficiencies" in the Sustol filing, Heron said.
Seventy-seven days (and counting) to nail down a label for a drug to reduce nausea and vomiting in cancer patients undergoing chemotherapy -- far from medically ground-breaking territory -- is an insanely long time. So, yes, I agree with the other Adam F. that the Heron story is strange.
Heron isn't talking about Sustol or offering an explanation for the long FDA delay but here's my best guess: FDA has already offered to approve Sustol but only with a limited label that would curtail sales significantly. Heron, and not the FDA, is responsible for the delay as it tries to convince the agency to allow a more expansive label.
JUST UPDATED – TheStreet's Biotech Bible! Before you invest one single dime in any biotech stock you have got to KNOW WHAT YOU ARE BUYING! Get THE most comprehensive text covering the 186 biotech companies that have gone public since 2013! There’s nothing else like it for digging into this highly speculative group of stocks. Grab a FREE copy today!
Broadly speaking, the chemotherapy-induced nausea and vomiting (CINV) drug market is divided into four buckets of patients encompassing two types of chemotherapy (moderately and highly emetogenic) and two stages of CINV prevention (acute and delayed.)
Aloxi, the most-prescribed CINV drug sold by Eisai, is approved for three of the four CINV patient buckets. Aloxi sales totaled approximately $550 million (converted from yen) in Eisai's 2015 fiscal year ended on March 31. The patents on Aloxi have started to expire, however, which means generic versions of the drug are launching soon.
Sustol won't be able to compete against cheap, generic Aloxi (palonosetron) unless the FDA allows a prescribing label which includes a claim for the prevention of delayed-onset CINV in patients undergoing highly emetogenic chemotherapy. That's the magical, highly desirable fourth bucket in the CINV treatment market.
Heron submitted data to the FDA supporting the approval of Sustol for the prevention of delayed-onset CINV in patients undergoing highly emetogenic chemotherapy.
Again, my guess: FDA found something not to its liking in those data. I believe FDA has told Heron that Sustol is approvable for months now, just not with a commercially viable label. That's why Heron can tell investors truthfully that labeling discussions are ongoing and FDA has not identified "substantive deficiencies" with the filing.