LEO Pharma Inc. Announces U.S. Food and Drug Administration (FDA) Expanded Regulatory Approvals for Enstilar® Foam and Taclonex® Topical Suspension in Treatment of Plaque Psoriasis

– FDA approves Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis in patients 12 years and older; Agency grants pediatric exclusivity extending U.S. market exclusivity –

– FDA approves Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension for the treatment of plaque psoriasis of the scalp and body in patients 12 years and older–

MADISON, N.J.–(BUSINESS WIRE)–LEO Pharma Inc., a wholly owned subsidiary of LEO Pharma A/S, announced today the U.S. Food and Drug Administration (FDA) has expanded the approved indication for Enstilar^® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. The FDA granted Enstilar Foam pediatric exclusivity, extending the period of U.S. market exclusivity by an additional six months to Dec. 10, 2031.

This expanded indication is supported by the Enstilar Pediatric Study (NCT02387853) in adolescents age 12 to 17 with psoriasis of the body and scalp, as well as data from adequate and well-controlled trials in adults.

“Healthcare professionals now have a once-daily topical treatment option with Enstilar for their adolescent patients age 12 and older who are affected by plaque psoriasis,” said Joyce Teng, MD, PhD, Professor of Dermatology and Pediatrics at Stanford University, and study investigator. “Managing adolescents with body and scalp plaque psoriasis can be very challenging for dermatologists. We welcome this U.S. FDA approval for these children with unmet medical needs.”

Enstilar is the leading prescribed branded topical treatment for plaque psoriasis.¹

Additionally, the FDA approved Taclonex^® (calcipotriene and betamethasone dipropionate) Topical Suspension in the topical treatment of scalp and body plaque psoriasis in patients 12 years and older.

“Our mission is to help people achieve healthy skin,” said Chris Posner, U.S. President and Chief Executive Officer of LEO Pharma Inc. “These regulatory milestones expand the potential we have to make a difference in the lives of adolescents 12 years and older who are affected by plaque psoriasis. Plaque psoriasis is a condition that can cause physical and social discomfort, and can significantly affect quality of life.”

Clinical trial details and study results can be found at clinicaltrials.gov.

The safety and effectiveness of Enstilar Foam and Taclonex Topical Suspension in pediatric patients under 12 years of age have not been established.

About Enstilar^® Foam

Enstilar Foam is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid.

INDICATION AND USAGE

Enstilar (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.

Apply Enstilar to affected areas once daily for up to four weeks. Patients should discontinue use when control is achieved. Patients should not use more than 60 grams every four days.

PATIENT INFORMATION

ENSTILAR^® (EN-still-ar)

(calcipotriene and betamethasone dipropionate)

Foam, 0.005%/0.064%

Important information:

Enstilar Foam is for use on skin only (topical). Do not get Enstilar Foam near or in your mouth, eyes, or vagina.

There are other medicines that contain the same medicine that is in Enstilar Foam and are used to treat plaque psoriasis. Do not use other products containing calcipotriene or a corticosteroid medicine with Enstilar Foam without talking to your healthcare provider first.

What is Enstilar Foam?

Enstilar Foam is a prescription medicine that is used on the skin (topical) to treat plaque psoriasis in patients 12 years of age and older. It is not known if Enstilar Foam is safe and effective in children under 12 years of age.

Before using Enstilar^® Foam, tell your healthcare provider about all of your medical conditions, including if you:

• have a calcium metabolism disorder
• are pregnant or plan to become pregnant. It is not known if Enstilar Foam can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Enstilar Foam passes into your breast milk and if it can harm your baby. If you use Enstilar Foam, do not apply Enstilar Foam to your nipple or areola to avoid getting Enstilar Foam into your baby’s mouth.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

How should I use Enstilar Foam?

See the “Instructions for Use” for detailed information about the right way to use Enstilar Foam.

• Use Enstilar Foam exactly as your doctor tells you to use it.
• Do not use more than 60 grams of Enstilar Foam every 4 days.
• Do not use Enstilar Foam longer than prescribed. Using too much Enstilar Foam, or using it too often, or for too long can increase your risk for having serious side effects.
• Apply Enstilar Foam to the affected areas of your skin 1 time a day for up to 4 weeks. You should stop treatment when your plaque psoriasis is under control unless your doctor gives you other instructions.
• Shake the Enstilar Foam can before you use it.
• Avoid using Enstilar Foam on your face, groin, or under your arms, or if you have thinning of your skin (atrophy) at the treatment site.
• If you accidentally get Enstilar Foam on the face, in the mouth or in the eyes, wash the area with water right away.
• Wash your hands after using Enstilar Foam unless you are using the medicine to treat your hands.
• Do not bandage or tightly cover the treated skin area, unless instructed by your doctor.
• Enstilar Foam is flammable. Avoid heat, flame, or smoking during and right after applying.

   

What should I avoid while using Enstilar Foam?

Enstilar Foam is flammable. Avoid fire, flame, and smoking when applying and right after you apply Enstilar Foam.

What are the possible side effects of Enstilar Foam?

Enstilar Foam may cause serious side effects, including:

• Too much calcium in your blood or urine. Your healthcare provider may tell you to stop or temporarily stop treatment with Enstilar Foam if you have too much calcium in your blood or urine.
• Enstilar Foam can pass through your skin. Too much Enstilar Foam passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems.
• Cushing’s syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol.
• High blood sugar (hyperglycemia) and sugar in your urine. Your healthcare provider may do blood and urine tests to check your calcium levels and adrenal gland function while you are using Enstilar Foam.
• Skin problems, including reactions where Enstilar Foam is applied, and allergic reactions (allergic contact dermatitis).
• Eye problems. Using Enstilar Foam may increase your chance of getting cataracts and glaucoma. Do not get Enstilar Foam in your eyes because it may cause eye irritation. Tell your healthcare provider if you have blurred vision or other vision problems during treatment with Enstilar Foam.

The most common side effects of Enstilar Foam include:

• irritation
• itching
• inflamed hair pores (folliculitis)
• changes in skin color
• rash with raised red bumps or skin welts (hives)
• worsening of your psoriasis

These are not all the possible side effects of Enstilar Foam.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

How should I store Enstilar Foam?

• Store Enstilar Foam at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not expose Enstilar Foam to heat or store at temperatures above 120°F (49°C).
• Do not puncture or burn the Enstilar Foam can.
• Do not freeze Enstilar Foam.
• Enstilar Foam has an expiration date (exp.) marked on the can.
• Do not use after this date.
• • Throw away (dispose of) unused Enstilar Foam 6 months after the can has been opened.

Keep Enstilar Foam and all medicines out of the reach of children.

General information about the safe and effective use of Enstilar Foam.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Enstilar Foam for a condition for which it was not prescribed. Do not give Enstilar Foam to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Enstilar Foam that is written for health professionals.

What are the ingredients in Enstilar Foam?

Active ingredients: calcipotriene and betamethasone dipropionate.

Inactive ingredients: white petrolatum, polyoxypropylene stearyl ether, mineral oil, all-rac-alphatocopherol, and butylhydroxytoluene.

Propellants: dimethyl ether and butane.

For more information, please see Full Prescribing Information and Enstilar.com/.

About Taclonex^® Topical Suspension

Taclonex Topical Suspension is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid.

INDICATION AND USAGE

Taclonex Topical Suspension is a prescription medicine that is to be used on the skin to treat plaque psoriasis of the scalp and body in patients 12 years of age and older.

Apply Taclonex Topical Suspension to affected areas on the scalp and body one time a day for up to 8 weeks. You should stop treatment when your plaque psoriasis is under control, unless your doctor gives you other instructions. Patients greater than 18 years should not use more than 100 grams per week. Patients age 12 to 17 years should not use more than 60 grams per week. Use Taclonex Topical Suspension exactly as your doctor tells you to use it.

PATIENT INFORMATION

TACLONEX^® (TAK-lo-NEKS) (calcipotriene and betamethasone dipropionate) Topical Suspension

Important: Taclonex Topical Suspension is for use on skin only (topical). Do not get Taclonex Topical Suspension near or in your mouth, eyes, or vagina.

There are other medicines that contain the same medicine that is in Taclonex Topical Suspension and are used to treat plaque psoriasis. Do not use other products containing calcipotriene or a corticosteroid medicine with Taclonex Topical Suspension without talking to your healthcare provider first.

What is Taclonex Topical Suspension?

Taclonex Topical Suspension is a prescription medicine used on the skin (topical) to treat plaque psoriasis of the scalp and body in people 12 years and older. It is not known if Taclonex Topical Suspension is safe and effective in children under 12 years of age.

Before you use Taclonex Topical Suspension, tell your healthcare provider about all of your medical conditions, including if you:

• have a calcium metabolism disorder.
• have thinning skin (atrophy) at the treatment site.
• are pregnant or plan to become pregnant. It is not known if Taclonex Topical Suspension will harm your unborn baby. Taclonex Topical Suspension may increase your chance of having a low birth weight baby. If you use Taclonex Topical Suspension during pregnancy, use Taclonex Topical Suspension on the smallest area of the skin and for the shortest time needed.
• are breastfeeding or plan to breastfeed. It is not known if Taclonex Topical Suspension passes into your breast milk. Breastfeeding women should use Taclonex Topical Suspension on the smallest area of the skin and for the shortest time needed. Do not apply Taclonex Topical Suspension directly to the nipple and areola to avoid contact with your baby. 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Taclonex Topical Suspension?

See the “Instructions for Use” for detailed information about the right way to use Taclonex Topical Suspension.

• Use Taclonex Topical Suspension exactly as your healthcare provider tells you to use it.
• Your healthcare provider should tell you how much Taclonex Topical Suspension to use and where to use it.
• Apply Taclonex Topical Suspension to affected areas on the scalp and body 1 time a day for up to 8 weeks. You should stop treatment when your plaque psoriasis is under control, unless your healthcare provider gives you other instructions.
• If you are 12 to 17 years of age, you should not use more than 60 grams of Taclonex Topical Suspension in 1 week.
• If you are 18 years of age or older, you should not use more than 100 grams of Taclonex Topical Suspension in 1 week.
• Do not use Taclonex Topical Suspension longer than prescribed. Using too much Taclonex Topical Suspension, or using it too often, or for too long can increase your risk for having serious side effects.
• Do not apply Taclonex Topical Suspension to the scalp in the 12 hours before or after any chemical treatments to your hair. Since hair treatments may involve strong chemicals, talk with your healthcare provider first.
• Do not use Taclonex Topical Suspension in the mouth, eyes, or vagina.
• Do not use Taclonex Topical Suspension on your face, groin, or armpits, or if you have thinning of your skin (atrophy) at the treatment site.
• If you accidentally get Taclonex Topical Suspension on your face or in your eyes, wash the area with water right away.
• Wash your hands after applying Taclonex Topical Suspension.
• Do not take a bath or shower or wash your hair right after applying Taclonex Topical Suspension as the medicine will not work as well to treat your psoriasis.
• Do not bandage or cover the treated skin area, unless instructed by your healthcare provider.

What are the possible side effects of Taclonex Topical Suspension?

Taclonex Topical Suspension may cause serious side effects, including:

• Too much calcium in your blood or urine. Your healthcare provider may tell you to stop or temporarily stop treatment with Taclonex Topical Suspension if you have too much calcium in your blood or urine.
• Taclonex Topical Suspension can pass through your skin. Too much Taclonex Topical Suspension passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems.
• Cushing’s syndrome, a condition that happens when your body is exposed to large amounts of the hormone cortisol.
• High blood sugar (hyperglycemia).
• Skin problems. Tell your healthcare provider if you have any skin problems, including:
  • thinning of your skin
  • dryness
  • burning
  • changes in skin color
  • inflammation
  • redness
  • itching
  • infection
  • irritation
  • raised bumps on your skin
• Eye problems. Using Taclonex Topical Suspension may increase your chance of getting cataracts and glaucoma. Do not get Taclonex Topical Suspension in your eyes because it may cause eye irritation. Tell your healthcare provider if you have blurred vision or other vision problems during treatment with Taclonex Topical Suspension.

The most common side effects of Taclonex Topical Suspension include inflamed hair pores (folliculitis) and skin burning. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Taclonex Topical Suspension?

• Store Taclonex Topical Suspension at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not refrigerate Taclonex Topical Suspension.
• Keep the bottle in the carton when not in use.
• Throw away (discard) unused Taclonex Topical Suspension 6 months after it has been opened.

Keep Taclonex Topical Suspension and all medicines out of reach of children.

General information about Taclonex Topical Suspension.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Taclonex Topical Suspension for a condition for which it was not prescribed. Do not give Taclonex Topical Suspension to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Taclonex Topical Suspension that is written for health professionals.

What are the ingredients in Taclonex Topical Suspension?

Active ingredients: calcipotriene and betamethasone dipropionate.

Inactive ingredients: hydrogenated castor oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, butylhydroxytoluene and mineral oil.

For more information, please see Full Prescribing Information and Taclonex.com.

About Psoriasis

Psoriasis is a chronic, systemic inflammatory skin disease that is estimated to affect about 3.2% of the U.S. population.² About 80% of patients are affected by mild or moderate plaque psoriasis, the most common clinical form of psoriasis.³ Topical treatments are first-line therapies for the majority of patients.

About LEO Pharma

LEO Pharma Inc. is a wholly owned subsidiary of LEO Pharma A/S. LEO Pharma helps people achieve healthy skin. The company 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 5,500 people, serving 76 million patients in 130 countries. In 2018, the company generated net sales of DKK 10,410 million – more than $1.5 billion (USD). For more information, visit www.leo-pharma.us and www.leo-pharma.com.

The LEO Pharma logo, LEO Pharma, Enstilar and Taclonex are registered trademarks of LEO Pharma A/S. ©2019 LEO Pharma Inc. All rights reserved. July 2019 MAT-27179

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¹ IQVIA NPA data on file [May 2018 – June 2019].

²chakonda, T., Schupp, C., and Armstrong, A.W. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014; 70: 512–516

³ Menter A, Gottlieb A, Feldman SR, Van Voorhees AS et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol; 2008 May;58(5):826-50.

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Associate Director, Global External Communications

+1-973-637-8019

+1-862-337-8019

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Director, Global External Communications

+45 3140 6180