Valeant Suffers Psoriasis Setback

(RTTNews) - Shares of Valeant Pharmaceuticals International Inc. (VRX, VRX.TO) are falling more than 6 percent in Monday's trading following news that the U.S. Food and Drug Administration has failed to approve the Canada-based company's Duobrii lotion for the treatment of plaque psoriasis.

Ortho Dermatologics, a division of Valeant Pharmaceuticals, said it has received a Complete Response Letter or CRL from the FDA regarding the company's New Drug Application or NDA for Duobrii, or IDP-118.

"The CRL did not specify any deficiencies related to the clinical efficacy or safety of DUOBRII and no issues with CMC processes. The CRL only noted questions regarding pharmacokinetic data," said Joseph Papa, chairman and CEO of Valeant.

Valeant said it is working to resolve the matter expeditiously and has already requested a meeting with the FDA.

Psoriasis is a condition that causes the body to make new skin cells in days rather than weeks. It is a chronic, painful and frequently life-altering immune-mediated inflammatory skin disease associated with serious co-morbidities as well as substantial impairment of physical and psychological quality of life.

According to the American Academy of Dermatology or AAD, psoriasis affects about 7.5 million people in the U.S.

Plaque psoriasis is the most common type of psoriasis. More than 75 percent of patients with moderate-to-severe plaque psoriasis experience significant itching, and greater than 55 percent report moderate or worse levels of pain.

IDP-118 is a fixed combination of Halobetasol, a corticosteroid, and Tazarotene, a retinoid, formulated as a once-daily lotion.

If approved, IDP-118 will be the first and only topical lotion that contains the unique combination of Halobetasol and Tazarotene in one formulation for the treatment of plaque psoriasis in adult patients, allowing for a potentially expanded duration of use.