Piramal announces MITIGO and generic cinacalcet hydrochloride tablets in US

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While Piramal Critical Care has announced MITIGO (Morphine Sulfate Injection, USP – Preservative-free), Pirmal Enterprises’s partner Slate Run Pharmaceuticals has launched generic cinacalcet hydrochloride tablets

Piramal Critical Care has announced the launch of MITIGO (Morphine Sulfate Injection, USP – Preservative-free) in 10 mg/mL and 25 mg/mL concentrations in the US market. The firm will continue to work with wholesalers, hospitals, interventional pain doctors, and pain management centers across the country to ensure availability of MITIGO for patients with intractable chronic pain.

Peter DeYoung, Chief Executive Officer, Piramal Critical Care, said, “Piramal Critical Care has established itself as the leader in the US intrathecal therapy with Gablofen which we have successfully integrated post its acquisition from Mallinckrodt. We are pleased to support intrathecal therapy for pain management with FDA approval and our launch of MITIGO. We continue to expand our leadership in intrathecal therapy through this launch, as well as in inhaled anesthesia and the injectable anesthesia and pain management drugs that we acquired from Janssen. We stay committed to executing on our strategy to expand our portfolio, address patient and customer needs, and deliver high-quality critical care solutions to the market.”

Apart from it, Piramal Enterprises has announced that one of its partners for its global pharma businesses – Slate Run Pharmaceuticals (Slate Run), has launched generic cinacalcet hydrochloride tablets (30mg, 60mg and 90mg) in the United States.

Company’s subsidiary, Piramal Healthcare (UK) (‘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 number 9,375,405. Amgen has filed an appeal which is currently pending in the US Court of Appeals for the Federal Circuit.