The 1-mL vial is now available via Cortrophin Gel's existing specialty pharmacy network and will also be available for ordering via national specialty distributors. Cortrophin Gel is already available in a 5-mL vial. Cortrophin Gel is indicated for short-term administration as an adjunctive therapy during an acute episode or exacerbation in acute gouty arthritis. Cortrophin Gel is contraindicated for intravenous administration.
ANI reintroduced Cortrophin Gel to the market in
'More than 9 million people in the US are affected by gout, and each year a portion of these patients experience acute gouty arthritis flares as a symptom of their underlying disease. For some of these patients, Cortrophin Gel may be an appropriate additional treatment option for their flares. The approval of the 1-mL vial for Cortrophin Gel is another step forward in our mission to increase access for appropriate acute gouty arthritis flare patients in need. Scaling up our Rare Disease business is ANI's largest growth driver and key to achieving our goal of building a high-growth biopharma company,' stated
'With this approval, we look forward to continuing the Cortrophin Gel launch momentum we have seen to date,' Lalwani continued. 'The commercial launch of the 1-mL vial will be supported by ANI's existing Cortrophin Gel field sales force, which is already engaging rheumatologists and nephrologists who treat patients with acute gouty arthritis flares. Importantly, we are enhancing Cortrophin in Your Corner, our reimbursement and access hub, to include support for this new 1-mL configuration of Cortrophin Gel.'
'Gout is the most common type of inflammatory arthritis,' said
Cortrophin Gel is an adrenocorticotropic hormone (ACTH), also known as purified corticotropin, and it is approved 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. Cortrophin Gel is the only FDA-approved ACTH therapy indicated for the treatment of appropriate patients with acute gouty arthritis flares.
About ANI
Forward-Looking Statements
To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company's generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as 'anticipates,' 'will,' 'expects,' 'plans,' 'potential,' 'future,' 'believes,' 'intends,' 'continue,' other words of similar meaning, derivations of such words and the use of future dates.
These forward-looking statements include statements regarding the commercial launch of Cortrophin Gel and the potential benefit of Cortrophin Gel to patients as a treatment option. Risks and uncertainties that may cause the Company's actual results to be materially different than those expressed in or implied by such forward-looking statements include, but are not limited to, the costs involved in commercializing Cortrophin Gel, the ability to maintain regulatory approval of the product and maintain sufficiency of the product, the ability to obtain reimbursement from third-party payors for this product, evolving government legislation, the opinions and views of key opinion leaders and physicians who treat patients with chronic diseases and who may prescribe Cortrophin Gel, manufacturing difficulties or delays, ANI's ability to generate projected net product revenue and gain market share on the timeline expected, actions taken by competitors in response to a new market entrant, ANI's reliance on third parties over which it may not always have full control, costs and regulatory requirements relating to contract manufacturing arrangements, increased competition and strategies employed by competitors, uncertainties regarding the COVID-19 pandemic, market trends for our products, regulatory environment and changes, and other risks and uncertainties. More detailed information on these and additional factors that could affect the Company's actual results are described in the Company's filings with the
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