Bayer AG (BAYRY) 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 studies.
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. (KYTH) 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 Europe.
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 (JNJ) 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. Cytokinetics Inc. (CYTK) currently looks better positioned in the pharma space carrying a Zacks Rank #1 (Strong Buy).
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