Building a diversified biopharma company across rare disease, branded, and generics to serve patients in need

For the employees of ANI, it’s personal. We strive to make the lives of patients better as a result of the work we do every day. I have seen the debilitating impact of disease in my own family and knowing that ANI can play a role in alleviating suffering for other families is an enormous responsibility. In fact, it is our mission to find new therapies to serve as many patients in need as we can.

ANI’s story began in the 1930s, when a father-and-son team tapped freshwater fish in Baudette, Minnesota, to produce a therapeutic fish oil that was much higher in vitamins A and D than others. Those initial research and development efforts led to expansion into related areas, and the company was formally incorporated as ANI Pharmaceuticals in 2001. Today, ANI is a fully integrated U.S.-focused biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceuticals.

Our humble beginnings serve as the cornerstone of ANI’s rich history, which is grounded in the drive to provide differentiated treatment options for patients and their physicians to address unmet needs and improve outcomes for as many patients as possible. This includes developing new treatments, preserving neglected therapies, acquiring promising drugs and product candidates, and reliably manufacturing and supplying medicines.

The reach of ANI Pharmaceuticals

For many years, ANI has served patients in the U.S. through its generics, established brands, and contract development and manufacturing organization (CDMO) business lines. Our strategic approach focuses on building our new rare disease business unit, enhancing our R&D capabilities with a focus on niche opportunities, maximizing the value of our brands through commercial innovation, and expanding our CDMO business by leveraging our North American manufacturing footprint. This multi-pronged growth strategy is designed to build ANI into a leading biopharmaceutical company.

As part of our focus on niche opportunities, we have acquired NDAs from companies such as Merck, Sandoz and AstraZeneca over the years. These acquisitions have resulted in the addition of several products to our pipeline and portfolio, including autoimmune, cardiovascular, dermatology, and oncology pharmaceuticals. By working to bring medicines across these and other therapeutic areas to market, ANI aims to broaden therapeutic choice and help physicians and patients achieve the best care possible.

Looking ahead for ANI

In 2021, ANI achieved significant milestones across the key pillars of our growth strategy:

• ANI’s recent acquisition of Novitium Pharma added a best-in-class R&D engine to bring complex, limited-competition generics and 505(b)(2) products to patients. Novitium’s R&D team has a proven track record of innovation excellence including achieving the largest number of Competitive Generic Therapy (CGT) approvals.
• ANI and Novitium have achieved 15+ new product approvals since deal signing and will continue to work towards bringing new therapies to patients.
• As part of the Novitium acquisition, we added a third U.S.-based manufacturing facility to our supply chain, increasing the scale of our generics and CDMO business.
• ANI’s recent sNDA approval is allowing us to reintroduce an established treatment option to physicians and a patient population in need. We look forward to a commercial launch in early 2022.

These achievements form a foundation for many major future milestones for ANI. ANI is truly at an inflection point, transforming into a leading biopharmaceutical company serving patients in need and well positioned for the next period of significant growth.

I am humbled to serve the teams at ANI as their leader and help us realize our full potential. I enjoy cultivating a culture of innovation and excellence to serve our patients and physicians in need. Given the recent organizational additions to ANI as a result of the Novitium acquisition and the creation of our rare disease business unit, I am particularly excited about how our teams can work together to continue identifying patient populations that are underserved and medicines that can help them.

There has never been a time in history like this, where healthcare innovation has the potential to benefit so many lives. With approximately one hundred commercial products and a robust pipeline, we are fulfilling a shared dream of helping as many patients in need as possible. We look forward to demonstrating our continued commitment to providing high-quality medicines that benefit the patient communities we serve.

For more information, visit anipharmaceuticals.com.