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Perrigo Company Gets FDA Approval for Generic Topical Gel

Perrigo Company plc PRGO announced that it has received final approval from the FDA for its AB rated generic version of AbbVie Inc.'s ABBV Androgel Topical Gel. The drug is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Annual market sales for Androgel Topical Gel, 1.62% packets for the 12 months ending May 2017 were about $88 million.

Shares of Perrigo have significantly underperformed the Zacks classified Medical Products industry so far this year. The stock has declined 12.8% against the broader industry’s gain of 21.3%.

Simultaneously, Perrigo also declared that its subsidiary has filed a Paragraph IV Abbreviated New Drug Application (ANDA) with the FDA for a generic version of Galderma’s Soolantra (ivermectin) cream, 1% indicated for the treatment of inflammatory lesions of rosacea. Soolantra’s annual market sales for the 12 months ending May 2017 were $87 million.

However, on the same date, Perrigo settled the litigation related to Meda Pharmaceuticals Inc. and Cipla Ltd’s generic version of Dymista (azelastine hydrochloride and fluticasone propionate) nasal spray. Dymista is indicated for the relief of symptoms of seasonal allergic rhinitis in patients between six years of age and older, who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief.

The approval for the generic version of a drug bodes well for the company as it will help in boosting revenues. The ANDA once approved will also lead to increased revenues.

Meanwhile, the company has been constantly making acquisitions to expand its business and drive growth. In fact, we are impressed by Perrigo’s growth-by-acquisition strategy. Perrigo has also undertaken certain restructuring initiatives that are expected to support the bottom line, going forward.

Perrigo Company Price and Consensus


Perrigo Company Price and Consensus | Perrigo Company Quote

Zacks Rank & Stocks to Consider

Perrigo currently carries a Zacks Rank #3 (Hold). Better-ranked health care stocks in the same space include Enzo Biochem, Inc. ENZ and Sanofi SNY. While Enzo Biochem sports a Zacks Rank #1 (Strong Buy), Sanofi holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Enzo Biochem’s loss per share estimates narrowed from 12 cents to 7 cents for 2017 and from 11 cents to 3 cents for 2018, over the last 60 days. The company delivered positive earnings surprises in each of the trailing four quarters, with an average beat of 55.83%. The share price of the company has increased 68.1% year to date.

Sanofi’s earnings per share estimates increased from $3.08 to $3.18 for 2017 and from $3.26 to $3.30 for 2018, over last 60 days. The company came up with positive earnings surprises in three of the trailing four quarters, with an average beat of 5.10%. The share price of the company has increased 18.9% year to date.

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