Bausch (BHC) Resubmits NDA for Duobrii for Plaque Psoriasis

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Bausch Health Companies Inc.'sBHC dermatology division, Ortho Dermatologics announced that the FDA has accepted the New Drug Application (NDA) for Duobrii lotion for the topical treatment of plaque psoriasis.

The FDA accepted the application as a Class 2 resubmission with a PDUFA action date of Feb 15, 2019.

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.

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 is making efforts to further advance its portfolio. Siliq was launched in July 2017. Siliq is approved for the treatment of moderate-to-severe plaque psoriasis in adult patients, who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.

Valeant entered into a collaboration agreement with AstraZeneca plc AZN granting the former an exclusive license to develop and commercialize Siliq globally, except in Japan and certain other Asian countries where the rights are held by Kyowa Hakko Kirin Co., Ltd. The agreement was amended in July 2016 to entitle Valeant the right to develop and commercialize Siliq in Europe.

Bausch narrowed its focus on seven recently launched products or expected to be launched in the near future, pending completion of testing and receiving FDA approval. The products include Vyzulta, Siliq, Bryhali (psoriasis), Lumify, Duobrii, Relistor and SiHy Daily.

Bausch's stock has gained 12.6% in the year so far compared with growth of 6.1% for the industry .

After a tumultuous period, Bausch started a rebuilding process. The company recently changed its name as well. Even though it is still early to comment on the rebuilding process, the company is making efforts to sell non-core assets and pay down huge levels of debt. However, the dermatology market continues to be challenging.

Zacks Rank & Key Picks

Bausch currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma/biotech sector are Gilead Sciences, Inc. GILD and Illumina, Inc. ILMN . Both the stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

Gilead's earnings per share estimates have increased from $6.11 to $6.57 for 2018 in the last 60 days. Estimates for 2019 are also up by 12 cents.

Illumina's earnings per share estimates have moved up from $4.87 to $5.46 for 2018 and from $5.61 to $6.17 for 2019 over the past 60 days.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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