BAYER REPORTS POSITIVE RESULTS OF PHASE-III ATX-101 TRIALS (ENG)

     (The following press release from Bayer was received by e-mail. It was not 
confirmed by the sender.) 
Not intended for U.S. and UK media - IMCAS Congress 2013
Positive results of Phase-III trials suggest that ATX-101 is effective as a
non-surgical treatment for the reduction of unwanted submental fat 
Paris, France, February 1, 2013 - At the International Master Course on
Aging Skin (IMCAS) in Paris, France, Bayer presented at a symposium the
results of two pivotal European Phase-III studies with ATX-101, an
investigational injectable drug for the reduction of unwanted fat deposits
under the chin known as submental fat (SMF). Based on efficacy measures,
analysis of the Phase-III data demonstrated that ATX-101 significantly
reduced SMF compared to placebo.(1,2) These trials are part of the ATX-101
clinical development program conducted jointly by Bayer and KYTHERA
Biopharma-ceuticals since 2010. 
ATX-101 reduces subcutaneous fat by localized fat-cell-membrane disruption
followed by elimination from the treated area, and is the first drug
undergoing comprehensive evaluation in a clinical trial setting for the
reduction of submental fat. Compared to placebo, ATX-101 led to significant
improvements in clinician-reported measurements of SMF, supported by
objective caliper measurements of SMF thickness. Moreover, patients
reported significant reductions in SMF with ATX-101 compared to placebo,
and were significantly more satisfied with their chin appearance and their
treatment as a result. These positive Phase-III results confirm earlier
findings of two Phase-II studies demonstrating positive results for
ATX-101.(3,4) Up to now, the aesthetic correction of fatty deposits under
the chin has predominantly been performed using surgical procedures
involving possible undesirable side effects for the patient. These results
were also presented at the IMCAS as poster.(2) 
"Both of the Phase-III studies demonstrated the injectable drug ATX-101 to
be well tolerated by patients; they yielded a clinically relevant and
statistically significant reduction in unwanted fat deposits under the
chin," said Dr. Benjamin Ascher, Plastic Surgeon, Paris Academy, Director
of the Aesthetic Surgery Clinic IENA in Paris and scientific director of
the IMCAS, in his presentation at the Paris symposium. 
"The positive results of the Phase-II and Phase-III studies for ATX-101
make us confident that we are on the right road with our commitment to
enter the aesthetic dermatology market," said Kemal Malik, M.D., Member of
the Bayer HealthCare Executive Committee and Head of Global Development.
"Based on evidence-based experience, ATX-101 represents a promising
candidate for the reduction of submental fat." 
The European ATX-101 Phase-III studies
The two identical Phase-III multi-center, randomized, double-blind,
placebo-controlled trials enrolled 723 patients and were conducted in 57
centers across the United Kingdom, France, Germany, Belgium, Spain and
Italy. In both trials, patients received one of two dosing regimens (1
mg/cm[<sup style="font-size:0.875em">2</sup>] or 2 mg/cm[<sup
style="font-size:0.875em">2</sup>]) or placebo, administered monthly into
the submental fat area for up to four treatment cycles, and were followed
up for 12 weeks post treatment. The efficacy of ATX-101 compared to placebo
was assessed using a validated 5-point Clinician-Reported Submental Fat
Rating Scale. The Patient-Reported Outcomes were evaluated on the basis of
a 7-point Subject Satisfaction Rating Scale, a validated 5-point
Patient-Reported Submental Fat Rating Scale and a Patient-Reported
Submental Fat Impact Scale. Calipers, an objective measurement of submental
fat thickness, were also used to assess the reduction of submental fat. 
Adverse events were primarily limited to the injection site; most were
temporally associated with treatment. The most common adverse events were
pain, swelling, numbness, bruising and induration. Occurrence was transient
and predominantly mild to moderate in intensity. No systemic
treatment-related adverse events were reported. 
About ATX-101
ATX-101 is a potential first-in-class injectable drug candidate under
clinical investigation for the reduction of unwanted submental fat. ATX-101
is a proprietary formulation of synthetic deoxycholic acid, a
well-characterized endogenous compound that is present in the body to
promote the natural breakdown of dietary fat. ATX-101 reduces subcutaneous
fat by localized fat-cell-membrane disruption followed by elimination from
the treated area.  This mechanism may enable a non-surgical alternative for
the reduction of unwanted subcutaneous fat. Clinical studies to date have
demonstrated that ATX-101 is well tolerated and may effectively reduce
localized fat in the submental region (i.e. under the chin).  In August
2010 Bayer Consumer Care AG signed a licensing and development
collaboration agreement with KYTHERA, thereby obtaining commercialization
rights to ATX-101 outside the US and Canada. KYTHERA and Bayer are
collaborating on the development of ATX-101 in Europe. 
About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical
company focused on the discovery, development and commercialization of
novel prescription products for the aesthetic medicine market. KYTHERA
initiated its pivotal Phase-III clinical program for ATX-101 in March 2012,
and completed enrollment of more than 1,000 patients, randomized to ATX-101
or placebo, in 70 centers across the U.S. and Canada in August 2012. The
company also maintains an active research interest in hair and fat biology,
pigmentation modulation and facial contouring. Find more information at
http://www.kytherabiopharma.com. 
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields
of health care, agriculture and high-tech materials. Bayer HealthCare, a
subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one
of the world’s leading, innovative companies in the healthcare and medical
products industry and is based in Leverkusen, Germany. The company combines
the global activities of the Animal Health, Consumer Care, Medical Care and
Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop,
manufacture and market products that will improve human and animal health
worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec
31, 2011) and is represented in more than 100 countries. More information
at http://www.healthcare.bayer.com. 
Our online press service is just a click away:
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http://www.dermatology.bayer.com 
References
(1) Poster 7588 IMCAS 2013 - Reduction of submental fat with ATX-101: first
results from a European randomized, placebo-controlled, Phase-III clinical
trial.  Berthold Rzany, MD, ScM, Division of Evidence-Based Medicine in
Dermatology, Charité-Universitätsmedizin Berlin and RZANY & HUND,
Privatpraxis für Dermatologie, Berlin, Germany; et al.
(2) Poster 7534 IMCAS 2013 - Patient-reported outcomes from a second
European Phase-III clinical trial of ATX-101, an injectable agent for the
reduction of submental fat. Benjamin Ascher, MD,Clinic of Aesthetic Surgery
IENA, Paris, France; et al.
(3) Poster P259 (Abstract PRA 12-1030) EADV 2012 - ATX-101, a
pharmacological treatment, for the reduction of submental fat: results of
two pooled Phase-IIa studies. Goodman G., Dermatology Institute of
Victoria, South Yarra, VIC, Australia; et al.
(4) Poster P258 (Abstract PRA 12-1028) EADV 2012- Results from a Phase-IIb
study evaluating the efficacy and safety of ATX-101 for reduction of
submental fat using magnetic resonance imaging and investigator and subject
assessment. Dover J., Skincare Physicians, Chestnut Hill, CA, United
States; et al. 
Forward-Looking Statements
This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management.
Various known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results, financial
situation, development or performance of the company and the estimates
given here. These factors include those discussed in Bayer’s public reports
which are available on the Bayer website at http://www.bayer.com. The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments. 
This press release is available here:
http://www.baynews.bayer.de/baynews/baynews.nsf/id/2013-0044-e 
Yours BayNews Editorial Team 
Bayer AG
Communications
Building W11
51368 Leverkusen, Germany 
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