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FDA Approves Sorilux

Stiefel, a GSK company, Receives FDA Approval of Sorilux (calcipotriene) Foam, 0.005%

Research Triangle Park, N.C. – October 12, 2010 – Stiefel, a GSK company, today announced that the U.S. Food and Drug Administration (FDA) has approved Sorilux (calcipotriene) Foam, 0.005%, for the topical treatment of plaque psoriasis in patients aged 18 years and older. Stiefel received the approval approximately two weeks in advance of the anticipated FDA action date. Plaque psoriasis is a chronic, non-contagious, inflammatory skin condition that appears as red patches covered with silvery flakes often found on the elbows, scalp and knees but can also affect other parts of the body.

"Plaque psoriasis affects up to six million Americans each year," said Bill Humphries, president, Stiefel, "Which is why Stiefel is so committed to bringing new therapy options, like Sorilux Foam, to patients."

Sorilux Foam was found to be effective in treating mild to moderate plaque psoriasis. It contains the vitamin D3 analog calcipotriene, a synthetic compound similar to natural vitamin D3; however, the exact mechanism of action contributing to the clinical efficacy in the treatment of psoriasis is unknown. Based on consistent and good-quality patient-oriented evidence, vitamin D3 analogs are a recommended treatment for psoriasis according to the American Academy of Dermatology’s guidelines. Sorilux Foam is formulated with the proprietary delivery technology, VersaFoam.

"In my experience, it’s important for physicians to be able to offer different topical treatment options to patients with plaque psoriasis," says Steve Feldman, M.D., Professor of Dermatology, Pathology and Public Health Science at Wake Forest University Baptist Medical Center. "Sorilux Foam brings the first calcipotriene foam treatment option for mild to moderate plaque psoriasis." Dr. Feldman was a clinical investigator for the calcipotriene foam clinical trials.

Two placebo controlled clinical trials were conducted comparing Sorilux Foam to vehicle in the treatment of patients with mild to moderate plaque psoriasis. In the studies, efficacy evaluation was carried out at week eight, with treatment success being defined as a score of "clear" (grade 0) to "almost clear" (grade 1) and at least a two grade improvement from the baseline score. In one study, 27% of patients treated with Sorilux Foam experienced treatment success versus 16% using vehicle alone. In another study, 14% of patients treated with Sorilux Foam were classified as successful versus seven percent of patients treated with vehicle only. In this study patients graded as "mild" at baseline showed a greater response to vehicle than to Sorilux Foam.

In the clinical studies, the most common side effects of Sorilux Foam were irritation, redness and itching of the treated skin areas. Redness was the only side effect reported in greater than one percent and in a higher rate of patients treated with Sorilux Foam compared to vehicle (two percent of patients treated with Sorilux Foam versus one percent of those treated with vehicle).

About Sorilux Foam

Sorilux Foam contains calcipotriene, a synthetic vitamin D3 analog. It is indicated for the topical treatment of plaque psoriasis in patients aged 18 years and older. A thin layer of Sorilux Foam should be applied twice daily to the affected areas, and rubbed in gently and completely. Sorilux Foam is for topical use only, and is not for oral, ophthalmic, or intravaginal use. Sorilux Foam should not be used by patients who have elevated blood calcium levels (hypercalcemia). Temporary elevations of calcium have been associated with the use of vitamin D3 analogs and may require interruption or discontinuation of treatment. Patients using Sorilux Foam should avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning beds and sun lamps.

About Stiefel, a GSK company

Stiefel, a GSK company, is committed to advancing dermatology and skin science around the world in order to help people better achieve healthier skin. Stiefel’s dedication to innovation, along with its focus on pharmaceutical, over-the-counter and aesthetic dermatology products, has established Stiefel as a world leader in the skin health industry. To learn more about Stiefel, visit www.stiefel.com.

GlaxoSmithKline cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the ‘Business Review’ in GSK's Annual Report on Form 20-F for 2009.

Posted: October 2010

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