Announces US launch of authorised generics for Benicar, Benicar HCT, Azor and Tribenzor
Sun Pharmaceutical Industries announced the execution of definitive agreements by its wholly-owned subsidiary for the acquisition of 100 per cent of Ocular Technologies, Sarl (OTS), a portfolio company of Auven Therapeutics (Auven), an international private equity company focused on accelerated development of breakthrough therapeutic drugs. OTS owns exclusive, worldwide rights to Seciera (cyclosporine A, 0.09 per cent ophthalmic solution). Sun Pharma will pay Auven $40 million upfront, plus contingent development milestones and sales milestones as well as tiered royalty on sales of Seciera as consideration for this acquisition.
Seciera is currently in a Phase-3 confirmatory clinical trial for the treatment of Dry Eye Disease, an inflammatory ocular disease affecting approximately 16 million people in the US alone. Seciera is a patented, novel, proprietary formulation of cyclosporine A 0.09 per cent. It is a clear, preservative-free, aqueous solution. In a completed Phase 2b/3 clinical trial in 455 patients, Seciera demonstrated a rapid onset of action and was well tolerated by the study population. Based on the published data in literature, the efficacy and safety endpoints in these trials compared favourably to other formulations of cyclosporine A.
The transaction is subject to approval of the US Federal Trade Commission as required under the Hart-Scott-Rodino Act and other closing conditions, and is expected to be completed by end of 2016.
Sun Pharma also announced that its wholly owned subsidiary has launched in US, the Authorized Generic (AG) versions for all strengths of Olmesartan Medoxomil tablets, Olmesartan Medoxomil-Hydrochlorothiazide tablets, Amlodipine Besylate-Olmesartan Medoxomil tablets, Amlodipine Besylate-Hydrochlorothiazide-Olmesartan Medoxomil tablets.
The launch is pursuant to a distribution and supply agreement between Sun Pharma’s wholly owned subsidiary and Daiichi Sankyo, which grants the Sun Pharma subsidiary, exclusive rights to distribute these tablets in the US for a pre-determined period.
EP News Bureau