Galderma’s Mirvaso Joins Rosacea Market With Indication For Facial Erythema
This article was originally published in The Pink Sheet Daily
Executive Summary
The dermatology company is able to offer a continuum of care for patients with the skin condition now that it has received FDA approval for a third product to treat the condition. The latest offering treats the most mild form of the condition.
Galderma Laboratories Inc. is expanding its offerings to the 16 million Americans that suffer from rosacea, a skin condition that has severe social consequences and few treatments that are approved to treat the redness most commonly associated with the disease.
The Swiss drug maker announced Aug. 26 that it received a green light from FDA for Mirvaso (brimonidine) topical gel 0.33% for the treatment of facial erythema, or redness, associated with rosacea. The once-daily gel is approved for patients 18 years and older.
“Facial redness is the most common symptom of rosacea, but until now, physicians have been without prescription treatment options to specifically address this patient need,” said Mark Jackson, Clinical Professor of Medicine at the University of Louisville, dermatologist and a principal investigator in the Phase III trials of the drug.
The late-stage clinical program included a total of 550 patients across two one-month studies that showed the gel was able to help constrict the blood vessels in the face, therefore reducing redness. A year-long study of the drug in 276 patients was also conducted. Mirvaso was shown to be safe and well-tolerated in clinical trials. The most common adverse reactions included erythema, flushing, skin burning sensation, and contact dermatitis.
According to Galderma Laboratories’ head of North American operations Francois Fournier, the company expects to have the product available for sale by September. Galderma will use its existing sale forces to promote the product and educate dermatologists about its use. Fournier said Mirvaso will be priced similarly to its other rosacea offerings, but the price will take into account the “unique, innovative nature of the product,” he added.
The company’s oral rosacea medication Oracea for inflammatory lesions has a wholesale acquisition price of $417.60 for 30 pills, while its other topical rosacea medication has a WAC of $246.45 for a 55g supply, according to Elsevier’s Gold Standard ProspectoRx pricing database. Galderma has been in “constant contact” with payers and expects significant levels of reimbursement for the product. Fournier noted that payers were excited about having an offering for the new indication, a product “that could change the lives of patients,” he said.
Unmet Need
According to the National Rosacea Society, the condition can be extremely detrimental to the social lives and mental wellbeing of patients. In a survey of 801 patients conducted by NRS, 61% of those with subtype 1 rosacea or erythematotelangiectatic (the most mild form of the condition), which is characterized by facial redness, said their rosacea had inhibited their social lives; that the number rose to 72% among those patients who reported their redness was moderate to severe. Forty-three percent said they had been the subject of stares, misconceptions, rude comments or jokes, and 39% of participants had refused or canceled social engagements because of rosacea’s effects on appearance.
Galderma currently has two other products to treat different rosacea indications: Oracea (doxycycline) and MetroGel (metronidazole). Oracea is an oral medication approved for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients, while MetroGel is a topical antibiotic that is also approved for the inflammatory lesions. Metronidazole is available in generic form in the U.S. to treat other bacterial infections and is marketed under a variety of names.
Allergan Inc. has a competing product to Mirvaso in its pipeline. The dermatology company acquired the drug through its 2011 acquisition of privately-held Vicept Therapeutics Inc. Under the terms of the deal, the Irvine, Calif-based specialty pharma agreed to pay $75 million upfront plus another $200 million in regulatory and development milestones. The treatment, which is also for erythema, is currently in Phase II, according to Allergan’s website (Also see "Vicept Acquired By Allergan For $75M Upfront" - Pink Sheet, 19 Jul, 2011.).