Benzinga | Apr 6, 2021 06:57AM EDT

ANI Pharmaceuticals Acquires New Drug Applications For OXISTAT Lotion, VEREGEN Ointment And Pandel Cream And Abbreviated NDA For ApexiCon E Cream

ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ:ANIP) today announced that it has acquired the new drug applications ("NDAs") for OXISTAT(r) Lotion, VEREGEN(r) Ointment, and Pandel(r) Cream and the abbreviated new drug application ("ANDA") for ApexiCon(r) E Cream from Sandoz Inc. Pandel(r) Cream will be transitioned later upon receiving the requisite approvals. Collectively, these products generated net revenues of $13.2 million in 2020. The acquisition was funded through borrowings under the Company's pre-existing revolver credit facility.

In conjunction with the acquisition, ANI and Sandoz have entered into a multi-year manufacturing and supply agreement for OXISTAT(r) Lotion, Pandel(r) Cream and ApexiCon(r) E Cream. ANI intends to transfer the manufacture and packaging of these three products to its own manufacturing sites in the future.

"This acquisition is in line with our strategy to expand our established brands business through accretive deals. Importantly, ANI will ensure that patients in need continue to receive these high-quality dermatology products. The acquisition leverages our innovative brand commercialization infrastructure and our North American manufacturing footprint," stated Nikhil Lalwani, President and CEO.

The Company previously shared the four pillars of its strategy for delivering sustainable future growth:

* Build a successful Cortrophin franchise;

* Strengthen the Generics business by enhancing development capabilities and increased focus on niche opportunities;

* Maximize the value from established brands through programmatic business development and innovative access and go-to-market strategies; and

* Expand CDMO business leveraging unique North American-based manufacturing capabilities. About OXISTAT(r) (oxiconazole nitrate) Lotion 1% OXISTAT Lotion is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. About Pandel(r) (hydrocortisone probutate) Cream 0.1% Pandel is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older. About VEREGEN(r) (sinecatechins) Ointment 15% VEREGEN is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. About ApexiCon(r) E Cream (diflorasone diacetate cream USP 0.05% [emollient]) ApexiCon E Cream is a topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. For more information, including the complete list of indications and usages, please see the Full Prescribing Information.