Forest Laboratories (Forest) has entered into an agreement to acquire additional rights to NXL 104. This amends the terms of its prior agreement with Novexel covering the combination of NXL 104 with Ceftaroline and adds additional rights to the combination of Ceftazidime and NXL 104, through a transaction with AstraZeneca following AstraZeneca’s acquisition of Novexel.
In transaction with AstraZeneca, Forest has expanded its overall interests in NXL 104, acquiring full worldwide rights to the Ceftaroline/NXL 104 combination while simultaneously licensing rights outside the US, Canada and Japan to AstraZeneca.
Furthermore, Forest is also expected to receive royalties on AstraZeneca’s international sales of the Ceftaroline/NXL 104 combination. The transaction eliminates all future milestone payments (totaling E75m) and royalty payments of approximately 10% on sales of Ceftaroline/NXL 104, which Forest would have owed Novexel under the original license.
In addition, Forest gains co-development and full commercialisation rights in the US and Canada to the Ceftazidime/NXL 104 combination currently under development by Novexel, and in addition, receives commercialisation right to any other combinations involving NXL 104.
The company said that a composition of matter patent which claims NXL 104 provides protection for the combination of NXL 104 with Ceftaroline, Ceftazidime and any other agents until 2022, subject to possible patent term extension.
Under a separate agreement, Forest and AstraZeneca have agreed that Forest will pay Novexel $210m in consideration for the additional rights to NXL 104 being acquired, which represents approximately 50% of AstraZeneca’s acquisition and related transaction costs. Forest may also be obligated to pay certain additional costs and half of certain future development milestone payments in connection with the transaction.
Forest will share with AstraZeneca the costs of worldwide development of the Ceftaroline and Ceftazidime combinations with NXL 104. The transaction is expected to close in Forest’s fiscal fourth quarter following satisfaction of customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Howard Solomon, chairman and CEO of Forest, said: “This transaction broadens Forest’s antibiotic product portfolio which will now include drugs principally active against both gram-positive pathogens (Ceftaroline/NXL 104) and gram negative pathogens (ceftazidime/NXL 104), to address virtually the entire spectrum of infectious bacterial pathogens and to bring more useful antibacterial therapies to patients suffering from serious and potentially life-threatening infections.
“We are also delighted to expand our existing relationship with AstraZeneca and to collaborate with them on the development and commercialisation of these important antibiotics.”