Bausch's (BHC) Arazlo Gets FDA Approval For Acne Vulgaris

Bausch Health Companies Inc.’s (NYSE:BHC) dermatology business, Ortho Dermatologics, announced that the FDA has approved the New Drug Application for its acne lotion Arazlo (tazarotene).

Arazlo Lotion 0.045% has been approved for the topical treatment of acne vulgaris in patients nine years of age or older.

The approval was based on two phase III multicenter, randomized, double-blind, vehicle-controlled clinical trials in 1,614 patients with moderate-to-severe acne. In both studies, all primary efficacy endpoints were met with statistical significance. Arazlo was also generally well-tolerated in the clinical study population.

The approval will broaden Bausch’s dermatology portfolio, expanding its acne portfolio to help approximately 50 million Americans who are affected by this prevalent skin condition. Per the company, Arazlo is the first tazarotene acne treatment available in a lotion form.

The Ortho Dermatologics business comprises treatments for a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The business consists of Duobrii, Bryhali and Siliq product lines as well.

Bausch is on track to build its psoriasis and acne product portfolios, with a focus on topical gel and lotion products over injectable biologics as they promise potential. The company recently expanded its Ortho Dermatologics sales force to drive growth.

Bausch’s stock has surged 61.9% in the year so far compared with the industry’s growth of 6.8%.

Bausch has narrowed its focus on seven products — Vyzulta, Siliq, Bryhali, Lumify, Duobrii, Relistor and SiHy Daily. These have now been launched and hence the company expects the top line to get a boost. Bausch + Lomb/International and Salix segments maintain momentum on the back of several established brands, such as Xifaxan, BioTrue ONEday and Bausch + Lomb ULTRA. Newer products, such as Lumify and Thermage FLX, continue to perform well too.

Zacks Rank & Stocks to Consider

Bausch currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare space are Alkermes, Inc. (NASDAQ:ALKS) , Anika Therapeutics Inc. (NASDAQ:ANIK) and Innoviva Inc. (NASDAQ:INVA) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings per share estimates have increased from 37 cents to 52 cents for 2019 in the past 60 days.

Anika’s earnings per share estimates have increased from $1.75 to $2.03 for 2019 in the past 60 days.

Innoviva’s earnings per share estimates have increased from $1.71 to $2.03 for 2019 in the past 60 days.

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