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Therapy Now in a Pump

Thursday, February 16, 2012

Galderma Announces Availability of New Metrogel^® 1% Pump Dispenser for the Treatment of Papulopustular Rosacea
Pump Delivery Provides Consistent Dosing, Minimizes Waste and May Help Increase Patient Compliance

FORT WORTH, TX - Galderma Laboratories, L.P. today announced the availability of a new pump dispenser design for MetroGel^® (metronidazole) Gel, 1%, the most powerful strength of topical metronidazole available in a gel to treat the inflammatory lesions (bumps and blemishes) associated with rosacea. The MetroGel^® 1% Pump, which the U.S. Food and Drug Administration approved in October 2011, is now available by prescription to patients in pharmacies nationwide.

Results from a new survey of 207 physician-diagnosed rosacea patients, ages 25 to 65, found 69 percent of patients prefer a pump over a tube. Patients in the survey also felt the pump was more aesthetically pleasing and reported the pump delivery facilitates product handling and storage and minimizes waste. Additionally, patients thought the pump delivery would help them to follow their doctor's instructions on product usage.¹

"MetroGel^® 1% is the most widely prescribed branded topical medication for rosacea by physicians, and it makes sense to provide this proven treatment to patients in a way that suits their desire for more convenience," said leading dermatologist and clinical instructor of dermatology at University of California Los Angeles's Geffen School of Medicine Debra B. Luftman, M.D., of Beverly Hills, Calif. "Not only will the pump make it simpler for patients to use the treatment, it may help provide consistent dosing so that patients use the correct amount of medication. I also think that these types of packaging advances help my patients more readily comply with the treatment regimens that I prescribe."

More than 16 million Americans are estimated to have rosacea, and while there is no cure, proper treatment can make it manageable.² Patients who used MetroGel^® 1% experienced a 71% median reduction in inflammatory lesions (bumps and blemishes) after 10 weeks of treatment.³ MetroGel^® 1% has an exclusive formula that contains HSA-3^®, which is a combination of ingredients including betadex, niacinamide (vitamin B3), and propylene glycol. In a 92% water-based gel, these ingredients work together to help skin retain moisture while enhancing absorption of metronidazole. In clinical trials, the most common side effects reported are sore throat/nasal congestion, upper respiratory tract infections, headaches, skin irritation, burning, dryness and transient redness. Patients also sometimes report a metallic taste and tingling or numbness in the extremities when using topical metronidazole.³

About Rosacea⁴
Rosacea is a chronic inflammatory disorder affecting the face. It is prevalent amongst fair-skinned individuals, especially of Celtic and northern European origin and is more common in women. The characteristic skin lesions (redness, visible blood vessels, papules and pustules) appear in the middle of the face (forehead, nose, cheeks) between the ages of 20 and 50, but typically are most common in men and women between the ages 30 to 65. Flushing due to triggers, including spicy food, alcohol, weather changes, sun, and hot showers, often have a negative impact on the patients' social life. Stinging, burning and sensitivity of the skin and intolerance to cosmetics are also very common and in some cases the eyes can become red, dry and itchy. The pathogenesis of the disease is not yet fully known, however the inflammatory response and facial vessels may play an important role, particularly in the pustulopapular form of the disease. It is currently held that there is no bacterial pathogen directly related to the etiology of rosacea.⁵ Presently, there is no cure for rosacea, but topical medication, systemic therapy and laser treatments may suppress its signs and symptoms. Patients should avoid triggering factors, use sun protection and gentle skin-care products. Early diagnosis and management of the disease can help limit its progression.

About Galderma
Galderma, created in 1981 as a joint venture between Nestle and L'Oreal, is a fully-integrated specialty pharmaceutical company dedicated exclusively to the field of dermatology. The Company has a presence in 65 countries with over 1,000 sales representatives and is committed to improving the health of skin with an extensive line of products across the world that treat a range of dermatological conditions including: acne, rosacea, fungal nail infections, psoriasis & steroid-responsive dermatoses, pigmentary disorders, medical solutions for skin senescence and skin cancers. With a research and development center in Sophia Antipolis, France, Galderma has one of the largest R&D facilities dedicated exclusively to dermatology. Leading worldwide dermatology brands include Differin^®, Oracea^®, MetroGel^® 1%, Rozex^®, Clobex^®, Tri-Luma^®, Loceryl^®, Cetaphil^®, Vectical^®, Silkis^® and Epiduo^®.

For more information on Galderma, visit www.galdermaUSA.com.

Important Safety Information
METROGEL^® (metronidazole) Gel, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. The most common adverse reactions that have been reported with the topical use of METROGEL^® 1% are nasopharyngitis, upper respiratory tract infections and headaches, as well as dryness, scaling, itching, and stinging. Transient redness, metallic taste, tingling or numbness of extremities and nausea have also been reported with the topical use of metronidazole. METROGEL^®1% therapy should be reevaluated if these symptoms occur. Caution should be used when prescribing metronidazole products for patients with blood dyscrasia, and patients using blood thinning agents such as coumarin or warfarin may experience prolonged prothrombin times. METROGEL^® 1% is contraindicated in patients with a history of hypersensitivity to metronidazole or any other ingredient in the formulation. For more information about MetroGel^® 1%, including full prescribing information, visit www.Metrogel.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References:
1. Consumer Packaging Preference Study, May 2010. Respondents were drawn from Greenfield Online's healthcare consumer panel. The study was supervised by CM&B, Inc., an independent market research firm. Slide 8.
2. The National Rosacea Society. "What Is Rosacea". http://www.rosacea.org/index.php. Accessed on November 15, 2010.
3. MetroGel 1% Prescribing Information
4. Galderma S.A. Rosacea. http://www.galderma.com/OurFocus/Rosacea.aspx. Accessed on October 22, 2010.
5. Webster. Topical and Systemic Treatments in the Management of Rosacea. April 6, 2010.

Contact Information
Media Contacts:
Erin Bittner
WCG
212-301-7226

Awareness Month in April

Thursday, February 2, 2012

Emotional stress and physical pain are among the invisible components of rosacea beyond its red-faced, conspicuous appearance, according to new patient surveys by the National Rosacea Society (NRS). The NRS has designated April as Rosacea Awareness Month to alert the public to the warning signs of this chronic and often life-disruptive facial disorder now estimated to affect more than 16 million Americans.

“Emotional stress is not only a common rosacea trigger but is often the result of its symptoms, creating a tailspin for many patients,” said Dr. John Wolf, chairman of dermatology at Baylor University. “Add to this the social impact and potential physical discomforts of the disorder, and there are many aspects of rosacea that go well beyond its effects on personal appearance.”

In recent NRS surveys, 69 percent of rosacea patients said they experienced a flare-up related to emotional stress at least once a month, and more than 90 percent of the respondents said they had suffered some form of physical discomfort from their condition. In earlier surveys, more than 76 percent said rosacea had lowered their self-esteem, and 88 percent of those with severe symptoms reported that it had adversely affected their professional interactions.

“It’s important for people to know that rosacea can be effectively controlled with medical therapy and lifestyle modifications,” Dr. Wolf said. “This can substantially improve the quality of their lives.”

During Rosacea Awareness Month and throughout the year, the NRS will conduct public education activities to reach the millions of rosacea sufferers who may not realize they have a medical condition that can be treated, emphasizing the warning signs and urging those who suspect they may have rosacea to see a dermatologist. Educational materials are also available to health professionals for their patients through the NRS Web site at www.rosacea.org.

Although rosacea varies from one patient to another, the primary signs may include flushing or transient erythema (redness), persistent or nontransient erythema, papules (bumps) and pustules (pimples), or telangiectasia (visible blood vessels), according to the NRS standard classification of rosacea, developed by a consensus committee and review panel of 17 experts worldwide. Secondary features may include burning or stinging, plaques (raised patches on the skin), a dry appearance, edema (swelling), ocular manifestations and phymatous changes, in which the skin thickens.

The standard subtypes of rosacea reflect the most common patterns of signs and symptoms, and characteristics of more than one subtype may occur at the same time. Subtype 1 (erythematotelangiectatic) rosacea is characterized by flushing and persistent redness on the central portion of the face, while subtype 2 (papulopustular) rosacea also features papules and pustules.

Subtype 3 (phymatous) rosacea includes thickening of the skin, irregular nodularities and enlargement, especially of the nose. Subtype 4 is ocular rosacea, where the eyes may have a watery or bloodshot appearance, the sensation of a foreign body, burning or stinging, dryness, itching, light sensitivity or a host of other signs and symptoms.

For more information, visit All About Rosacea.