Aeterna Zentaris Inc.
) announced that it has entered into an agreement with Ergomed
Clinical Research Ltd. for co-developing AEZS-108 (doxorubicin
peptide conjugate) for endometrial cancer.
As per the terms of the agreement, Ergomed will bear 30% (up to
$10 million) of the costs (clinical and regulatory) for the phase
III trial evaluating AEZS-108 as a second-line treatment option
for locally-advanced, recurrent or metastatic endometrial cancer
versus doxorubicin (marketed as Doxil by
Johnson & Johnson
), a commonly used chemotherapy drug.
In exchange, Aeterna Zentaris will pay Ergomed an agreed single
digit percentage on net income from AEZS-108 sales for the above
mentioned indication. We note that AEZS-108 will be evaluated
under the US Food and Drug Administration's (FDA) Special
Protocol Assessment (SPA) in the phase III trial.
The open-label, randomized, multi-center (North America and
Europe) phase III trial will enroll approximately 500 patients.
The primary efficacy endpoint of the trial is to find significant
improvement in median overall survival.
Earlier, in Sep 2011, Aeterna Zentaris presented encouraging data
from a phase II study evaluating the efficacy and safety of
AEZS-108 in patients suffering from advanced endometrial cancer.
The candidate demonstrated overall response rate and clinical
benefit rate of 30.8% and 74.4%, respectively. Median overall
survival was 13.7 months, while median time-to-progression was
found to be 7 months. AEZS-108 was well tolerated in the trial.
The candidate is also being evaluated for several other
indications including ovarian cancer (phase II completed),
prostate cancer (phase II), breast cancer (phase II) and bladder
cancer (phase II). We note that AEZS-108 has received orphan drug
status from the FDA for ovarian cancer. The European Medicines
Agency has also granted orphan medicinal product designation to
the candidate for ovarian cancer.
Aeterna Zentaris, a biopharmaceutical company, carries a Zacks #2
Rank (Buy) in the short run. Biopharma stocks that currently look
attractive include companies like
). These companies carry a Zacks #1 Rank (Strong Buy).
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