Independent biotech consultants commissioned to report on Oraxol clinical data of belief Athenex will not receive New Drug Application from FDA.
November 13, 2019 – Viceroy commissioned a report from a highly reputable, independent biotech consulting firm into the prospective New Drug Application (NDA) approval for Oraxol. We have appended the report in its entirety for our readers.
- Consistent with previous expert opinions we have received in relation to Oraxol, this report concludes that “Oraxol will likely not secure approval following Athenex NDA submission in 1Q 2020.”
- Experts refute management claims in Q3 earnings call that “FDA previously provided positive feedback to Athenex that it would accept the results of this one pivotal trial for license application in the U.S. if the primary endpoint is met”, noting that there must also be an acceptable benefit/risk profile.
- Our Experts note that the treatment regiment for the IV Paclitaxel control group is a high-dose, three week regiment. This regimen has tested as inferior to the low-dose, weekly treatment. This would have created a much higher threshold for Oraxol’s primary endpoint.
- It’s noteworthy that oral paclitaxel competitors, such as Daewa Pharmaceutical Co., have not shied away from this low-dose, weekly regimen as a higher threshold control.
- Differing outcomes in safety profile of Oraxol, when compared to IV paclitaxel, “is likely due to the delivery mechanism and formulation which includes the novel, unapproved PGP inhibitor HM30181A”. Our consultants believe this may prompt further studies into the Oraxol delivery method, consistent with our prior reporting about adverse effects.
- The report also highlights issues in relation to the rarity of the FDA approving drugs with no USA clinical patient data. This presents a greater question mark for Athenex, who have already announced plans to commercialize this in the USA.
- Experts have noted Athenex’s absence in providing any detail relating to Oraxol’s adverse effects, in particular those effects which are inconsistent with IV paclitaxel, such as GI complications.
- Viceroy elected to file all our findings to the SEC, FDA and New York Governor due to the highly irregular corporate governance and business practices committed by the company. We note the company have failed to address or deny one issue, despite repeated requests to identify one single falsity.
We await Athenex’s San Antonio presentation, which we believe will provide more granular detail.
Viceroy remain short Athenex and maintain our price target of $2.83.
Athenex management continue to ignore our reports or address any of the issues we have highlighted.