Benzinga | Jan 24, 2022 06:53AM EST

ANI Pharmaceuticals Announces Commercial Availability Of Purified Cortrophin Gel For Multiple Chronic Autoimmune Disorders

ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) (ANI or the Company) today announced the U.S. commercial availability of Purified Cortrophin(tm) Gel (Repository Corticotropin Injection USP) 80 U/mL. The commercial launch of Cortrophin Gel, an adrenocorticotropic hormone (ACTH), also known as purified corticotropin, is being led by ANI's recently established rare disease business unit. Cortrophin Gel is indicated for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), and excess urinary protein due to nephrotic syndrome. For full list of indications, please see below.

"Patients with certain chronic autoimmune conditions often need additional treatment options," said Dr. Mary Pao Seideman, Chief Medical Officer of ANI. "ACTH therapy can be effective across a number of inflammatory diseases. The reintroduction of Cortrophin Gel gives prescribers another ACTH option, which can mean a greater chance for an effective treatment for some patients."

"Choice in the ACTH category is long overdue, with only one available treatment option for over two decades. With today's full-scale commercial launch of Cortrophin Gel, an established treatment, healthcare professionals now have another ACTH therapy option, with U.S.-based development, supply chain and manufacturing," said Nikhil Lalwani, President and Chief Executive Officer of ANI. "This milestone is the culmination of six years of hard work and dedication from ANI employees and external partners, building on ANI's long history and mission to create high-quality medicines for patients in need. I am extremely proud of the high-degree of technical excellence employed by our team in reintroducing this important treatment to a community long in need of alternatives."

"Our goal from the start has been to ensure that Cortrophin Gel is available to as many patients who need it as possible," said Christopher Mutz, Head of Rare Disease for ANI. "As part of our commitment to supporting meaningful access to Cortrophin Gel, we've launched our reimbursement and access support hub, Cortrophin in Your Corner(tm) to provide commercial copay support and other reimbursement assistance for eligible patients."

Cortrophin Gel is now available to healthcare providers through a network of specialty pharmacies and distributors. For appropriate patients, physicians can submit a prescription and initiate access to treatment through a specialty pharmacy by visiting www.cortrophin.com.

ANI is committed to establishing meaningful access to Cortrophin Gel and has created Cortrophin In Your Corner, a dedicated program for patients and their caregivers throughout the treatment journey that includes one-on-one access and reimbursement support, financial assistance for eligible patients, and nurse-provided injection training. Cortrophin In Your Corner also provides access and reimbursement support for healthcare professionals and their staff. To get started with Cortrophin Gel, call Cortrophin In Your Corner (available Monday--Friday from 8 AM - 8 PM ET) at 1-800-805-5258.