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Specialty drugmaker ANI to boost CDMO work, generics portfolio with $210M Novitium buyout

Specialty drugmaker ANI Pharmaceuticals has been steadily growing its generics arsenal over the past decade while also striving to expand its CDMO business. Now, the company has inked a deal to fuel both ambitions at once. 

ANI Pharmaceuticals is set to pay up to $210 million for niche generics maker Novitium Pharma. Expected to close in the second half of 2021, the buyout will bolster ANI’s stable of copycat drugs and grow the company’s CDMO business with the addition of a fourth U.S. manufacturing facility, ANI said in a release. 

ANI will take over operations at Novitium’s 50,000-square-foot manufacturing plant in East Windsor, New Jersey, where the drugmaker is already in the midst of a 20,000-square-foot expansion. The upgrade will add another 18 manufacturing suites to the 27 currently running there, the companies said. Novitium’s East Windsor site also houses eight clinical suites for R&D. 

Novitium will fold nine existing customers into ANI’s own CDMO business, which tackles analytical, formulation, clinical and commercial manufacturing work at three facilities—two in Baudette, Minnesota, and a third in Oakville, Ontario, according to the company’s website. Novitium’s annual production capacity stands at roughly 2 billion doses across a range of dosage forms.

As for ANI, the company handles the production and packaging of solid, semi-solid and non-sterile liquid products from phase 2b through the commercial stage. ANI’s development focus centers on narcotics, oncolytics, hormones and steroids, and complex formulations involving extended release and combination products. 

The company will hand Novitium $163.5 million upfront for the buyout, including $89.5 million in cash plus $74 million in equity. The deal also features potential future cash payments of up to $46.5 million, the company said.

Novitium, founded in 2016, boasts operations in East Windsor, New Jersey and Chennai, India. Its founders Samy Shanmugam, Chad Gassert and Vijay Thorappadi will join the ANI once the deal wraps.

Beyond the CDMO boost, Novotium is poised to significantly build out ANI’s generics stable. Novitium has its sights set on more than 25 new product launches in 2021 and 2022. The company has 21 abbreviated new drug applications on file with the FDA and more than 30 additional products in the pipeline, ANI said. Novitium’s R&D operations will become a fixture of ANI’s generic development program, the company said.