LEO Pharma Inc. Announces Availability of Finacea® (azelaic acid) Foam, 15%, for Treatment of Mild-to-Moderate Rosacea

Madison, N.J., April 15, 2020 – LEO Pharma Inc. today announced availability of Finacea® (azelaic acid) Foam, 15%, indicated for the topical treatment of the inflammatory papules and pustules of mild-to-moderate rosacea. LEO Pharma Inc. is the U.S. affiliate of Denmark-based LEO Pharma A/S, a global leader in medical dermatology.

Finacea Foam is the first and only prescription foam approved by the U.S. Food and Drug Administration (FDA) for the treatment of rosacea. It is a light water-based (hydrophilic) foam that is alcohol-free and fragrance free.

LEO Pharma acquired Finacea in its 2018 acquisition of Bayer’s prescription dermatology business in the United States. However, beginning in mid-2019, a manufacturing delay had suspended product supply. The company fully investigated the root cause and supply has been restored.

“We are pleased to bring Finacea Foam back on the market as an option for healthcare providers and their patients in the treatment and management of mild-to-moderate rosacea,” said Christopher Posner, President and CEO, LEO Pharma Inc. “People affected by rosacea are challenged by a chronic condition that affects the face, with symptoms including raised spots and pimple-like bumps. Helping patients is our mission at LEO Pharma, and we remain committed to supporting the medical dermatology community.”

Finacea Foam is again available at the local and specialty pharmacy levels; patients with further questions about local availability should contact their pharmacy for more information.

Through LEO Pharma Connect, eligible commercially insured patients may pay as little as $20 for each Finacea Foam prescription co-pay. Certain restrictions apply, and patients are not eligible if enrolled or participating in any state or federally funded health care program. For more information on LEO Pharma Connect, visit http://leopharmaconnect.com/.

About Rosacea
Rosacea is a chronic condition that mostly affects the skin on the face. Rosacea has many symptoms, including raised spots and pimple-like bumps, sometimes with pus inside.[i] Without treatment, the symptoms of rosacea may get worse.[ii] Rosacea is common, especially in women with fair or light-colored skin. It often appears when a person is in their 30s or older.[i]

About Finacea® (azelaic acid) Foam, 15%
Finacea Foam is a topical prescription medicine used to treat the inflammatory papules (raised spots) and pustules (pimple-like bumps) of mild to moderate rosacea. It’s a water-based (hydrophilic) foam that is light and airy.

IMPORTANT SAFETY INFORMATION

What should I tell my healthcare professional about CHANGES IN MY SKIN COLOR during use of Finacea® Foam?

Report abnormal changes in skin color to your healthcare professional. There have been isolated reports of loss of skin color (hypopigmentation) after the use of azelaic acid (the active ingredient in Finacea® Foam). If you have a dark complexion, your healthcare professional will monitor you for early signs of loss of skin color.

What should I AVOID when using Finacea® Foam?

  • Avoid contact with the eyes, mouth, and other mucous membranes. Azelaic acid has been reported to cause irritation of the eyes. If Finacea® Foam does come in contact with the eyes, wash the eyes with large amounts of water, and consult your healthcare professional if eye irritation persists.

  • Avoid fire, flame, and smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C). The propellant in Finacea® Foam is flammable.

  • Avoid the use of tight dressings or wrappings where you apply Finacea® Foam.

  • Avoid use of alcoholic cleansers, tinctures and astringents, abrasives, and peeling agents.

What SAFETY FACTS should I follow when applying Finacea® Foam?

  • Finacea® Foam is for topical use only.

  • Do not use in the mouth, eye, or vagina.

What are the MOST COMMON SIDE EFFECTS of Finacea® Foam?

Local site:

  • pain (described as burning, stinging, “pins and needles,” and/or tenderness)

  • itching

  • dryness

  • redness

Indication

What is Finacea® Foam used for?

Finacea® Foam is a topical prescription medicine used to treat the inflammatory papules (raised spots) and pustules (pimple-like bumps) of mild to moderate rosacea.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

You may also report side effects to LEO Pharma Inc. at 1-877-494-4536, option 1, or by email at usdrugsafety@leo-pharma.com.

For important risk and use information, see the full U.S. Prescribing Information at www.finaceafoam.com.


About LEO Pharma Inc. and LEO Pharma A/S
LEO Pharma Inc. is the U.S. affiliate of Denmark-based LEO Pharma A/S, a global leader in dermatology. LEO Pharma products have been available in the U.S. since 1994, and the company opened the U.S. affiliate in January 2010. The company's U.S. offices are located in Madison, N.J. LEO Pharma A/S is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. In 2019, the company generated net sales of DKK 10,805 million. For more information please visit: www.leo-pharma.com

Contacts
Rhonda Sciarra
Associate Director, Global External Communications
+1-862-337-8019

Henrik Kyndlev
Director, Global External Communications
+45 3140 6180

MAT-33380. April 2020.

 


[i] Mayo Clinic. Rosacea. Accessible at https://www.mayoclinic.org/diseases-conditions/rosacea/symptoms-causes/syc-20353815. Accessed March 30, 2020.

[ii] Cedars-Sinai Medical Center. Rosacea. Accessible at https://www.cedars-sinai.org/health-library/diseases-and-conditions/r/rosacea.html Accessed March 30, 2020.