Phase III Investigational Trial of Azelaic Acid 15% Foam Meets Both Co-Primary Endpoints in Subjects with Papulopustular Rosacea

WHIPPANY, N.J., July 24, 2014 /PRNewswire-USNewswire/ -- Bayer HealthCare today announced positive results from a Phase III trial that evaluated a 15% foam formulation of its compound azelaic acid (AzA) for the topical treatment of inflammatory papules and pustules of rosacea. An AzA foam formulation is a potential treatment option to complement the currently available AzA gel formulation. Papulopustular rosacea is a skin disease causing inflammatory lesions (papules and pustules) as well as erythema (redness) on the nose, cheeks, chin and forehead.

This Phase III clinical trial, examining the efficacy and safety of the investigational drug AzA 15% foam (not approved by the US Food and Drug Administration, the European Medicines Agency, or other health authorities) compared to unmedicated vehicle foam in the topical treatment of papulopustular rosacea, met both of its primary efficacy endpoints. Compared to the foam vehicle, treatment with AzA 15% foam resulted in a higher clinician-assessed treatment success rate (32.0% vs. 23.5%, p=0.001) as well as statistically significant greater reduction in the mean nominal change of inflammatory lesions (-13.0 vs. -10.2, p<0.001).

The Phase III trial also evaluated safety and tolerability. The overall frequency of adverse events (AEs) was 31% in the AzA 15% foam group and 25% in the vehicle group. The vast majority of AEs in both groups were mild to moderate. In the AzA 15% foam group, no severe drug-related and no serious drug-related AEs were reported. Overall, less than 2% of subjects discontinued treatment due to an AE, the frequency being slightly lower in the AzA 15% foam group. Detailed results of the trial will be presented at upcoming scientific meetings.

"It is important to offer patients a range of therapeutic options to take into account their needs and preferences," said Zoe Diana Draelos, MD, Consulting Professor, Department of Dermatology at the Duke University School of Medicine, Durham, NC, and coordinating investigator for this trial.

"We are pleased with the positive results from this Phase III trial of our AzA 15% foam. This study is an important milestone for the product as we plan to use it in support of a marketing application. If approved, this product has the potential to expand the treatment options available to doctors and patients who are managing rosacea," said Dario Mirski, MD, Vice President of US Medical Affairs, Bayer HealthCare Pharmaceuticals, Inc.

About the Phase III Trial
The Phase III study of AzA 15% foam for the topical treatment of inflammatory papules and pustules of rosacea was a randomized, double-blind, vehicle-controlled, multi-center study. It enrolled more than 960 adult patients with rosacea, showing 12-50 inflammatory lesions at the time of inclusion in the study. The severity of the condition was based on Investigator Global Assessment (IGA) scale scoring as well as a count of the inflammatory lesions.

Patients were randomized in a 1:1 ratio to receive either AzA 15% foam or the unmedicated vehicle foam twice daily for 12 weeks. Safety and tolerability were evaluated during the full 16-week study course, while the efficacy endpoints were assessed at the end of the 12-week treatment period.

ABOUT ROSACEA
Rosacea is a chronic cutaneous disorder primarily affecting the convexities of the central face. There is no known cure. Rosacea is most frequently seen in adults between 30 and 50 years of age. Although the exact etiology of rosacea remains unknown, both genetic and environmental factors are thought to have an impact on the pathogenesis of this disease. To learn more about rosacea, please visit www.rosacea.org.

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 18.9 billion (2013), 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 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.

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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 www.bayer.com. The company assumes no obligation whatsoever to update these forward-looking statements or to adjust them to include future events or developments.

SOURCE Bayer HealthCare

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