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Bausch's Bryhali Gets Tentative FDA Nod for Plaque Psoriasis

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Bausch Health Companies Inc. (BHC - Free Report) along with its dermatology business, Ortho Dermatologics, announced that the FDA gave a tentative approval to the new drug application (NDA) for Bryhali (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients.

Bryhali Lotion is a new potent to superpotent corticosteroid that contains 0.01% halobetasol propionate in a novel vehicle lotion. The final FDA approval is pending the expiration of exclusivity for a related product, which is expected in early November 2018.

Bryhali Lotion was evaluated in two studies to determine its safety and efficacy. The results of the studies showed that Bryhali Lotion was consistently more effective in achieving treatment success, which was defined as at least a two-grade improvement from baseline in an Investigator Global Assessment (IGA) score, and 'clear' or 'almost clear' skin than the patients who were treated with vehicle.

Topical steroids often come with an increased risk of adverse events and a duration of use limited to two to four weeks. However, in the studies, Bryhali Lotion demonstrated good local tolerability for up to eight weeks of treatment without sacrificing efficacy, making it an important new treatment option for psoriasis patients.

Bausch’s stock has gained 27.5% in the year so far compared with growth of 1.2% for the industry.

We note that Bausch started restructuring its dermatology business in 2017 by taking a number of actions, which included rebranding of the business, recruiting a new experienced leadership team, investing in the pipeline, adjusting the size of the dermatology sales force and reorganizing that sales force in roughly 150 territories. In July 2017, the dermatology business was rebranded as Ortho Dermatologics, with a portfolio of several leading acne, anti-fungal and anti-infective products. The new leadership team is making efforts to further advance its portfolio. 

The company also has another product — Siliq — in its portfolio, which is marketed for the treatment of plaque psoriasis. Bausch is developing another candidate for the same indication. In August 2018, the FDA accepted the NDA for Duobrii lotion for the topical treatment of plaque psoriasis. We note that the NDA was resubmitted to the FDA as the agency had earlier issued a complete response letter (CRL) to the NDA for Duobrii for the treatment of moderate-to-severe plaque psoriasis in adults. The CRL did not specify any deficiencies related to the clinical efficacy or safety of Duobrii or identified issues with the company’s Chemistry, Manufacturing and Controls processes. The letter only noted questions regarding pharmacokinetic data.

 Zacks Rank & Key Picks

Bausch currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Amgen Inc. (AMGN - Free Report) , CRISPR Therapeutics AG (CRSP - Free Report) and Merus N.V. (MRUS - Free Report) . All of them sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Amgen’s earnings per share estimates have moved up from $13.95 to $13.98 for 2018 and from $14.39 to $14.42 for 2019 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 4.29%. Share price of the company has increased 18.2% year to date.

CRISPR Therapeutics’ loss per share estimates have narrowed from $2.95 to $2.92 for 2018 and from $3.08 to $3.04 for 2019 over the past 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters with an average beat of 19.50%. Share price of the company has increased 55.7% year to date

Merus’ loss per share estimates have narrowed from $3.09 to $2.60 for 2018 and from $4.22 to $4.01 for 2019 over the past 60 days.

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