ANI Pharmaceuticals has completed the acquisition of a portfolio of six generic products, related manufacturing and supply agreements, and equipment and technical know-how from Amneal Pharmaceuticals and Impax Laboratories for cash consideration of $2.3 million. The portfolio of generic products has a combined current annual U.S. market of $1.7 billion according to Iqvia/IMS Health.
This transaction provides ANI with:
- Immediate revenue and profit from twelve SKUs of three currently commercialized products: Ezetimibe-Simvastatin tablets, Felbamate tablets and Desipramine tablets. Starting immediately ANI will commence shipping to customers.
- Approved ANDAs for Aspirin/Dipyridamole ER capsules and Methylphenidate ER tablets; these products require successful validation prior to launch. ANI will immediately begin validation efforts for these two products.
- An option with a date certain launch for Aspirin/Dipyridamole ER capsules of no later than October 1, 2019. The option allows ANI to source the product from Amneal through March 1, 2021 or until ANI launches its own product, whichever date is earlier. If ANI elects to exercise the option to launch product supplied by Amneal it will owe a milestone payment of between $0 and $10 million depending on the number of generic products in the market at the time of launch. Currently this is a $120 million annual U.S. market with only one generic competitor, according to Iqvia/IMS Health.
- Two pipeline products: Erythromycin IR tablets and Diclofenac-Misoprostol DR tablets. ANI acquired a development package for Erythromycin IR tablets and will assume the development work for this product with the goal of filing an ANDA in the near future. Currently there is only one generic competitor for Erythromycin IR tablets. In addition, ANI has assumed a multi-year license, supply and distribution agreement for Diclofenac-Misoprostol DR tablets.
"We are excited to add these products and the revenue and profit generated by today's three product launches to our generic platform. Importantly, we look forward to launching Aspirin/Dipyridamole ER capsules no later than October 1, 2019, Arthur S. Przybyl, ANI's President and CEO said. “At the same time, we will begin validation efforts for Methylphenidate ER tablets, which represents a compelling opportunity for ANI."