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Mayne Pharma USA

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Mayne Pharma Launches Temozolomide Capsules in U.S. – Generic Alternative to Temodar®

Greenville, NC, November 23, 2016 --( Mayne Pharma Inc. (Mayne Pharma) is pleased to announce the U.S. launch of temozolomide capsules, 5mg, 20mg, 100mg, 140mg, 180mg and 250mg, which is a generic version of branded Temodar®. Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed cancerous brain tumors known as glioblastoma multiform concomitantly with radiotherapy and then as maintenance treatment.

Temozolomide capsules had U.S. sales of approximately US$150m for the 12 months ending 30 September 2016, according to IMS Health.

Mayne Pharma will distribute the drug on behalf of its partner, IDT Australia Ltd (IDT), which developed the product and is manufacturing the product.

“Since entering the United States in 2012, Mayne Pharma has aggressively expanded its product portfolio, through internal product development, strategic acquisition, in-licensing and working collaboratively with partners like IDT,” said Stefan Cross, president of Mayne Pharma USA. “Mayne Pharma now directly markets more than 50 products and we have a growing pipeline of more than 40 generic and branded drug products targeting U.S. markets with IMS Health sales greater than $6 billion.”

For further information, contact:
Karen Stinneford, +1.919.833.9102 or
Lisa Pendlebury, +61.3.8614.7777 or

About Mayne Pharma
Mayne Pharma is a publicly traded specialty pharmaceutical company listed on the Australian Securities Exchange (ASX: MYX). The company develops and manufactures branded and generic products globally - either directly or through distribution partners — while applying its drug-delivery expertise for contract development and manufacturing services.

Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems; these technologies have been successfully commercialized in numerous products marketed around the world. Mayne Pharma has drug development and manufacturing facilities in Greenville, North Carolina, USA, and Salisbury, Australia, and offers expertise in formulating complex oral dose forms including highly potent compounds, controlled substances, modified-release products and inherently unstable compounds. Within the United States, Mayne Pharma’s operations consist of:

· U.S. Generic Products, which develops, manufactures, markets and distributes generic drug products,
· U.S. Specialty Brands, which markets and distributes branded pharmaceuticals within the United States, and
· Metrics Contract Services, which provides contract pharmaceutical development services to third parties globally. Learn more about the company online at

Temodar® is the registered trademark of Merck Sharp & Dohme Corp.
Contact Information
Mayne Pharma USA
Karen Stinneford

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