Piramal Announces the Launch of Cinacalcet by its Partner, Slate Run Pharmaceuticals, in the U.S.

News provided by

Mar 12, 2019, 08:32 ET

MUMBAI, India, March 12, 2019 /PRNewswire/ -- 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.

Piramal will continue to focus on assisting its partners with a culture that is built around the pillars of Customer Centricity, Quality, and Innovation. For more information: www.piramal.com

About Piramal Enterprises:

Piramal Enterprises Limited is one of India's large diversified companies, with a presence in Financial Services, Pharmaceuticals and Healthcare Insights & Analytics. PEL's consolidated revenues were over US$1.6 billion in FY2018, with ~46% of revenues generated from outside India.

In Pharma, through an end-to-end manufacturing capabilities across 13 global facilities and a large global distribution network to over 100 countries, PEL sells a portfolio of niche differentiated pharma products and provides an entire pool of pharma services (including in the areas of injectable, HPAPI etc.). The Company is also strengthening its presence in the Consumer Product segment in India. PEL's Healthcare Insights & Analytics business is the premier provider of healthcare analytics, data & insight products and services to the world's leading pharma, biotech and medical technology companies and enables them to take informed business decisions.

In Financial Services, Piramal Capital & Housing Finance Ltd is registered as a housing finance company with National Housing Bank (NHB) and engaged in various financial services businesses. It provides both wholesale and retail funding opportunities across sectors including real estate, infrastructure, SMEs etc. PCHFL through its group companies provides customized strategies for institutional and retail investors such as Mumbai Redevelopment Fund and Apartment Fund focused (through Piramal Fund Management) and strategic partnerships with leading global pension funds such as CPPIB, APG and Ivanhoe Cambridge. The division also has a Distressed Asset Investing platform with Bain Capital Credit – India Resurgence Fund that will invest in equity and/or debt in assets across sectors (other than real estate) to drive restructuring with active participation in turnaround. PEL also has long term equity investments worth ~US$1 billion in Shriram Group, a leading financial conglomerate in India.

PEL is listed on the BSE Limited and the National Stock Exchange of India Limited in India.

For Investors:

For Media:

Hitesh Dhaddha | Investor Relations

Contact: +91-22-3046-6444

Email: [email protected]

Dimple Kapur | Corporate Communications

Contact: +91-22-3351-4269

Email: [email protected]

About Slate Run Pharmaceuticals:

Slate Run Pharmaceuticals is a privately held pharmaceutical company founded in 2014 in Columbus, Ohio, with a leadership team with over 40 years' of experience in the generic pharmaceutical market. Slate Run is focused on the sourcing and marketing of generic pharmaceuticals for the United States market through global partnerships.

For more information: www.slaterunpharma.com; [email protected]

SOURCE Piramal Enterprises Limited