ANI Pharmaceuticals Strengthens CDMO Biz

ANI Pharmaceuticals has struck a $163.5 million deal to acquire Novitium Pharma, a privately held, New Jersey-based pharmaceutical company with development, manufacturing, and commercialization capabilities. ANI’s board has approved and the acquisition is expected to close in the second half of 2021.

“Strengthening our well-established generics business with enhanced development capabilities and increased focus on niche opportunities is a key pillar of ANI’s growth strategy,” said Nikhil Lalwani, president and chief executive officer, ANI. “The acquisition of Novitium aligns with this strategy, adding a best-in-class R&D engine that delivers sustainable growth through new product launches and offering upside through niche 505(b)(2) opportunities. The addition of a U.S. based, state-of-the-art manufacturing facility and enhanced scale to our CDMO business are other attractive advantages of this acquisition.”

R&D Engine Fuels Sustainable Growth

Novitium anticipates launching more than 25 additional products in 2021 and 2022, including products with U.S. FDA Competitive Generic Therapy (CGT) designation. The company currently has 21 abbreviated new drug applications (ANDAs) filed with the FDA and more than 30 additional products under development. Integration of Novitium’s R&D operations will establish a center of excellence for ANI’s generics product development program.

Expands ANI’s R&D Pipeline Focused on Niche Opportunities

Novitium is currently advancing three 505(b)(2) candidates in oncology and hypertension. These 505(b)(2) products will build on ANI’s increasing focus on niche opportunities, including its first Paragraph IV filing in 2020 and the filing of injectables ANDAs in 2021.

Enhances Scale of CDMO Business and U.S.-based Manufacturing Capacity

Novitium adds nine new customers to ANI’s growing CDMO business. Additionally, Novitium brings with it a 50,000 square foott East Windsor, NJ facility, including 27 manufacturing suites and eight clinical suites supporting R&D, commercial manufacturing and packaging. An ongoing 20,000 square foot building expansion will add 18 new manufacturing suites. Novitium’s annual production capacity is approximately two billion units in aggregate across tablets, capsules, liquid suspensions and solutions, powders and powder for oral suspension, controlled release and potent compounds.