ANI focuses on data insights to ramp up its arthritis and MS flare-up therapy

ANI Pharmaceuticals ventured into new territory last November with its first-ever branded product in Purified Cortrophin Gel and is tapping cloud software company Veeva Systems to help it identify best practices for reaching patients and doctors.

Under the aegis of a new business unit focused on rare diseases, the Minnesota-based specialty drug company is throwing down the gauntlet against Mallinckrodt PharmaceuticalsActhar Gel, which since 1954 has been the established repository corticotropin injection for refractory symptoms of autoimmune disorders like rheumatoid (RA), multiple sclerosis (MS) and nephrotic syndrome. 

ANI's head of rare disease, Christopher Mutz, explained that the company wants the gel to be top of mind for physicians and their RA and MS patients dealing with refractory symptoms whose only go-to has been high-dose steroids.

“While there are obviously many patients with MS and arthritis diagnoses, there are few who are dealing with the more acute flares—more severe disease and symptoms that just aren't controlled by first-line therapeutics,” he said in an interview.

“This is a patient population that has often lived many years with these [autoimmune] diseases, and really suffer tremendously from flare-ups, acute episodes that many patients just don’t experience.”

To elbow into the tight space for this specialty drug, ANI Pharma acquired the NDA for purified corticotropin from Merck in 2016 for $75 million and got FDA approval for the gel formulation in November last year, launching in January this year.

According to Mutz, Veeva’s data and software offerings constitute a turnkey approach for a company that, as a manufacturer of generics, hadn’t needed a data-driven DTC and HCP marketing strategy in the past, the kinds of services that Mutz said are especially important for reaching patients dealing with long-term, complex scenarios involving multiple therapies and interactions with providers and payers.

“Generics is a very different type business. So, the relationship with Veeva felt unique for us and powerful because it combines data service and software with one partner,” he said. “A better understanding of the patient journey through longitudinal data informing the entire team has been a really great opportunity for us.”

To get the word out to physicians, the company established a sales team focused on neurology, nephrology and rheumatology. DTC efforts include “Cortrophin in your Corner” to help patients navigate such challenges as insurance reimbursement, assistance programs and copay assistance, according to Mutz.

“From a patient perspective, we've really invested significantly in these efforts,” he said, adding that because of the severity of the disease, physician outreach is key. “It’s the most valuable place for us to start, while evaluating all the time how we can better engage the patient.”

He added that 2022 net revenue guidance for Purified Cortrophin Gel was $35 million to $40 million dollars, and that, early in the launch, the company began discussions with insurers to get the treatment under payer umbrellas.

In a 2020 release, the company pegged the current annual market for Cortrophin Gel at approximately $950 million and said it spent more than four years and over $100 million to reestablish and validate the commercial corticotropin active pharmaceutical ingredient and its manufacturing processes.