Exclusive Interview with PharmaShots: Nikhil Lalwani of ANI Pharmaceuticals Shares Insight on Purified Cortrophin Gel

In an interview with PharmaShots, Nikhil Lalwani, President, and CEO at ANI Pharmaceuticals shared his views on the launch of Purified Cortrophin Gel for the treatment of multiple chronic autoimmune disorders

Shots:

The company launches Purified Cortrophin Gel for the treatment of chronic autoimmune disorders, including acute exacerbations of MS, RA, and excess urinary protein due to nephrotic syndrome
Cortrophin Gel is an adrenocorticotropic hormone (ACTH) inj. treatment that can be administered as SC or IM. The product is available in a 5mL multiple-dose vial containing 80 units/mL
The company has launched the support program i.e., Cortrophin in Your Corner to provide commercial copay support and other reimbursement assistance for eligible patients, healthcare professionals, and staff

Tuba: Tell us about Cortrophin Gel (Dose, dosing regimen, RoA)

Nikhil Lalwani: Cortrophin Gel is an adrenocorticotropic hormone (ACTH) injection treatment. It is supplied in a 5mL multiple-dose vial containing 80 units per mL (400 units per 5 mL vial). Cortrophin Gel can be administered subcutaneously or intramuscularly. Dosing and administration vary by indication and will be determined by a healthcare provider according to a medical condition, the severity of disease, response to treatment, among other things.

Cortrophin Gel has the potential to help patients with certain chronic auto-immune disorders, including acute exacerbations of MS and RA, and excess urinary protein due to nephrotic syndrome. Multiple evidence-based treatment guidelines indicate that corticotropin/ACTH may be considered for patients who require additional treatment beyond the standard of care, which often includes steroids.

A claims-based epidemiology analysis suggests less than 10% of patients who are steroid-resistant and refractory across primary indications receive ACTH therapy.

These patients often need additional treatment options. The reintroduction of Cortrophin Gel gives prescribers another ACTH therapy, which can mean a greater chance for an effective treatment for some patients.

Tuba: Discuss the approval history of Cortrophin Gel.

Nikhil Lalwani: Cortrophin Gel was first approved in 1954 and used for decades to treat certain chronic autoimmune disorders. ANI Pharmaceuticals acquired the NDA for Cortrophin Gel from Merck & Co. in 2016. The Company has made a significant investment over the past six years in establishing and updating manufacturing processes and ensuring a sustainable, U.S.-based supply chain. ANI submitted an sNDA to the FDA in June 2021, which the FDA approved on October 29, 2021, allowing the company to bring Cortrophin Gel back to the market for patients and physicians in need of greater access to ACTH therapies.

Tuba: What types of autoimmune disorders/Indications, can Cortrophin Gel treat?

Nikhil Lalwani: Cortrophin Gel is approved for the treatment of certain chronic autoimmune disorders, including acute exacerbations of MS and RA, as well as excess urinary protein due to nephrotic syndrome. All in all, there are more than a dozen indications in the Cortrophin Gel label. For a list of all approved indications, visit cortrophin.com.

Tuba: Which geographies of Cortrophin gel are approved and where you are planning to commercialize this drug?

Nikhil Lalwani: Cortrophin Gel is FDA approved and commercially available in the United States.

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

Our goal from the start has been to ensure that Cortrophin Gel is available to as many patients who need it as possible.

Tuba: What is the ‘Cortrophin in Your Corner’ reimbursement and access support program?

Nikhil Lalwani: ANI is committed to establishing meaningful patient 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, call Cortrophin In Your Corner (available Monday–Friday from 8 AM - 8 PM ET) at 1-800-805-5258.

Tuba: Put a glance at ANI’s acquisition with Merck & Co.

Nikhil Lalwani: ANI recognized that corticotropin or ACTH therapy was a valuable therapeutic option for patients with neurodegenerative or inflammatory diseases and that choice was lacking in the category. In 2016, ANI acquired the NDAs for purified corticotropin gel and corticotropin-zinc hydroxide from Merck for $75 million cash and a percentage of future net sales. ANI acquired Cortrophin Gel to reintroduce patient and provider choice into a market where, for over two decades, those in need of ACTH therapy have only had one FDA-approved option.

Tuba: Is ANI/ Merck planning for any digital initiatives such as apps, games, educational events, for the engagement and education of patients and HCPs?

Nikhil Lalwani: ANI is committed to supporting patient education across a number of therapeutic areas and is seeking input from advocacy groups in order to provide patients with the tools and resources they need to navigate their conditions. We look forward to providing additional details in the future.

Through Cortrophin in Your Corner, a dedicated program for patients and their caregivers, we are offering nurse-provided injection training to ensure proper administration and management of treatment for the patients we serve.

Tuba: Discuss your efforts in rare diseases.

Nikhil Lalwani: ANI is focused on bringing Cortrophin Gel to physicians and patients with certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), and excess urinary protein due to nephrotic syndrome. An enormous amount of work has gone into this approval over the last six years, and we remain steadfast in our commitment to bringing choice to rare disease healthcare providers and patients in need of options.

We have assembled a team with deep experience gained while working at some of the leading rare disease companies in the world, a team that is unified by a passion to address unmet medical needs for patients with difficult-to-treat conditions. As we continue to grow, we’ll identify patient populations that are underserved and medicines that can help them while leveraging the strong commercial infrastructure and team we have in place. We look forward to demonstrating our continued commitment to providing high-quality medicines that benefit the patient communities we serve.

About Nikhil Lalwani:

Nikhil Lalwani is the President and CEO at ANI Pharmaceuticals. Mr. Lalwani holds a B.S. in Electrical Engineering from Georgia Institute of Technology and an M.B.A. from the Wharton School at the University of Pennsylvania.