Drug Development

Aeterna Zentaris shares eviscerated by its latest late-stage drug disaster

David Dodd, Aeterna Zentaris

When Aeterna Zentaris $AEZS planned a move to Charleston, SC, a couple of years ago, the biotech promised to create a batch of new jobs as it wrestled to make a comeback following a stinging FDA rejection of its lead drug. This morning, though, the company simply added to its litany of setbacks.

Billed by at least one analyst as the future of the company, the biotech announced that its drug Zoptrex failed a Phase III study for advanced endometrial cancer. And now it’s simply washing its hands of the drug and going back to see if they can wrestle an approval for an old drug that’s already been rejected by the FDA.

Shares of Aeterna Zentaris were eviscerated, dropping 57% in pre-market trading.

Investigators said the biotech’s drug looked remarkably like the doxorubicin comparison arm. Zoptrex scored a 10.9 month overall survival rate compared to 10.8 months for doxorubicin. The secondary endpoints were also a match.

That result follows a Phase III failure of their lead drug Macrilen in January, which the FDA rejected three years ago. Aeterna Zentaris said it was considering what next steps, if any, it would take on the drug after the confirmatory study ended in failure. Then weeks later the company added that the FDA had spelled out the additional data needed that could lead to an approval. And this morning, faced with a separate disaster, they are now talking not only about pursuing the new drug application, but marketing plans as well.

It’s a tough sale, though, as the last bit of credibility at the company takes a bruising hit.

CEO David Dodd had this to say:

Our focus has now shifted entirely to filing our new drug application for Macrilen and, if the product is approved, to its commercial launch as soon as possible. We will also optimize our resources to be consistent with our focus on Macrilen-related efforts. We continue to believe in the potential that Macrilen provides for us to become a focused specialty pharmaceutical company. Our intention is to submit the Macrilen NDA in the third quarter of 2017 and, if the product receives FDA approval, to commercially launch the product in the first quarter of 2018.


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