) recently presented positive results on ATX-101 at the 11th
Anti-Aging Medicine World Congress (AMWC) 2013. ATX-101 is being
developed for the reduction of unwanted fat deposits under the
chin- submental fat (SMF).
Results from a phase IIa study showed that ATX-101
significantly and consistently reduces SMF. The level of SMF
reduction was sustained in more than 90% patients who responded
to treatment. Moreover, treatment satisfaction was sustained in
more than 80% of these patients.
Results from another phase I pharmaco-kinetic study showed
that the permanent destruction of fat cells (adipocytolysis) made
by ATX-101 did not have any clinically significant impact on the
serum lipid levels of the patients in the study. Notably, ATX-101
is the first injectable candidate being evaluated as a
non-surgical treatment for SMF reduction in a comprehensive
clinical trial setting.
In Feb 2013, Bayer presented positive results from two
European phase III studies on ATX-101 at the International Master
Course on Aging Skin (IMCAS). Results from the studies showed
that ATX-101 reduced SMF more than placebo. ATX-101 demonstrated
significant improvement in clinician-reported measurements of
SMF, supported by objective caliper measurements of SMF
thickness, in comparison to placebo.
Results also revealed that patients were more satisfied with
their chin appearance and their treatment with ATX-101 than
placebo. The candidate was well tolerated in both the
We note that the studies are part of the ATX-101 clinical
development program which is being conducted jointly by Bayer and
Kythera Biopharmaceuticals Inc.
) since 2010. As per the 2010 licensing deal between the
companies, Bayer acquired rights to ATX-101 in markets outside
the US and Canada.
Kythera is eligible to receive tiered double-digit royalties
on the sales of the drug made by Bayer outside the US and Canada.
Kythera and Bayer have however collaborated to develop ATX-101 in
In Nov 2012, Kythera had reported positive interim results
from a multicenter, open-label, long-term study on ATX-101. The
study revealed that the candidate was well tolerated and
demonstrated a similar safety profile to that observed in
previous studies conducted with the candidate.
We note that Bayer suffered a huge setback last month when the
company and its partner
Johnson & Johnson
) received a second complete response letter (CRL) from the US
Food and Drug Administration (FDA) for their supplemental New
Drug Application (sNDA) for Xarelto (2.5 mg twice daily) for the
reduction of the risk of secondary cardiovascular events in
patients suffering from ACS.
The second CRL for Xarelto is a big disappointment for the
company. Bayer carries a Zacks Rank #4 (Sell). The setback
regarding Xarelto is primarily responsible for the bearish rank
carried by the company.
) currently looks better positioned in the pharma space carrying
a Zacks Rank #1 (Strong Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis
CYTOKINETCS INC (CYTK): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
KYTHERA BIOPHRM (KYTH): Free Stock Analysis
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