Mumbai, India, March 12, 2019: Piramal Enterprises Limited (‘PEL’, ‘Piramal’, NSE: PEL, BSE: 500302) announced that one of its partners for its global pharma businesses – Slate Run Pharmaceuticals LLC. (‘Slate Run’), has launched generic cinacalcet hydrochloride tablets (30mg, 60mg and 90mg) in the United States.
Piramal’s subsidiary, Piramal Healthcare (UK) Limited (‘PHL’), has partnered with Slate Run Pharmaceuticals with the goal of developing a non-infringing formulation of cinacalcet hydrochloride tablets. Cinacalcet tablets are indicated for the treatment of secondary hyperthyroidism (‘HPT’) in adult chronic kidney disease patients on dialysis and hypercalcemia in adult patients with parathyroid carcinoma.
“As part of our patient focus strategy, we are working with global pharmaceutical firms, to co-develop products, where our R&D competencies can bring about a differentiated and cost effective value proposition for the global healthcare system. With world class R&D and fully integrated network of manufacturing capabilities across the globe, for both drug substance and drug product, Piramal is uniquely positioned to solve both complex chemistries and formulation challenges in the pharmaceutical domain with innovative solutions for partners.” said Vivek Sharma, CEO – Piramal Pharma Solutions, Piramal Group.
PHL received the final Abbreviated New Drug Application (‘ANDA’) approval for its generic abbreviated bio-equivalent (‘AB’) rated version of Amgen Inc.’s Sensipar® (cinacalcet hydrochloride) tablets on August 1, 2018. Piramal received a favourable US district court ruling which holds that Piramal’s generic version does not infringe any of the asserted claims of Amgen’s Patent No. 9,375,405. Amgen has filed an appeal which is currently pending in the U.S. Court of Appeals for the Federal Circuit.