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Diversified Bio-Pharma Firm Gains FDA Approval for Adrenocorticotropic Hormone Gel for Multiple Indications

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Shares of ANI Pharmaceuticals Inc. traded 50% higher after the company reported the U.S. FDA approved its Purified Cortrophin Gel for use in treating multiple sclerosis, rheumatoid arthritis and nephrotic syndrome.

Integrated specialty pharmaceutical company ANI Pharmaceuticals (ANIP:NASDAQ), a developer, manufacturer and marketer of branded and generic prescription medicines, today announced that "the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) (Cortrophin Gel) for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), in addition to excess urinary protein due to nephrotic syndrome."

The company explained that Cortrophin Gel is an adrenocorticotropic hormone (ACTH) that serves as an important treatment option for individuals diagnosed with several chronic autoimmune disorders.

ANI Pharmaceuticals' President and CEO Nikhil Lalwani commented, "The FDA's approval of Cortrophin Gel enables us to bring a much-needed treatment choice to patients with acute exacerbations of multiple sclerosis and rheumatoid arthritis as well as nephrotic syndrome, who are coping with a devastating disease on a daily basis…We anticipate a full-scale commercial launch by early in the first quarter of 2022."

The company's Chief Medical Officer Mary Pao Seideman, M.D., Ph.D., remarked, "Patients who are refractory or intolerant to corticosteroids have an especially urgent need for effective alternatives and are at risk of ongoing organ damage with long-term disease…For over 30 years, there has only been one available treatment in the ACTH category. With the FDA approval of Cortrophin Gel, patients will now have a significant new treatment option."

The firm noted that Cortrophin Gel was first approved in 1954 for use in treating chronic autoimmune conditions. The company stated that in 2016 that it acquired the NDA for Cortrophin Gel from Merck & Co. Inc. (MRK:NYSE) and advised that it has spent the last five years revamping the manufacturing processes with the objective of establishing a reliable U.S.-based supply chain for the product.

The medicine has now been approved by the FDA for several indications via injected subcutaneous or intramuscular delivery as an adjunctive therapy for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and acute gouty arthritis. It also is now available as a maintenance therapy in select cases of systemic lupus erythematosus and systemic dermatomyositis (polymyositis), severe erythema multiforme (Stevens-Johnson syndrome) and severe psoriasis.

There are also numerous other prescribed uses for atopic dermatitis, symptomatic sarcoidosis and severe acute and chronic allergic and inflammatory conditions affecting the eyes such as allergic conjunctivitis, keratitis, diffuse posterior uveitis and choroiditis and many other approved applications.

ANI Pharmaceuticals is a diversified bio-pharmaceutical company based in Baudette, Minn. The firm is focused on developing, manufacturing and marketing specialty branded and generic medicines for diseases with high unmet medical needs.

ANI Pharmaceuticals Inc. began the day with a market cap of around $477.0 million with approximately 12.76 million shares outstanding and a short interest of about 3.7%. ANIP shares opened more than 13% higher today at $42.46 (+$5.08, +13.59%) over Friday's $37.38 closing price and reached a new 52-week high price this morning of $60.2267. The stock has traded today between $42.11 and $60.2267 per share and is currently trading at $56.14 (+$18.79, +50.19%).


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