Product, Press Release

Hikma receives FDA approval for Temozolomide Capsules

London, 29 March 2016 – Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its wholly-owned subsidiary West-Ward Pharmaceuticals, through its Columbus facility (the newest facility added to the Hikma network from the Roxane Laboratories acquisition), has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Temozolomide Capsules 5mg, 20mg, 100mg, 140mg, 180mg and 250mg. Temozolomide Capsules are the therapeutic equivalent to the reference listed drug Temodar® Capsules of Merck Sharp & Dohme Corp.

Temozolomide is an important chemotherapy agent used to treat a severe form of brain cancer. According to IMS, total U.S. sales of Temozolomide Capsules 5mg, 20mg, 100mg, 140mg, 180mg and 250mg were approximately $200 million for the 12 months ending January 2016.
Said Darwazah, Chairman and CEO of Hikma said, “We are very pleased to announce our first approval from the Columbus portfolio (formerly Roxane Laboratories) since we closed the transaction on 29 February 2016. West-Ward has an excellent pipeline of differentiated products and proven R&D, supply chain and operational capabilities that we expect will drive accelerated and sustainable future growth."