Mayne Pharma Launches Budesonide Capsules in the United States

Mayne Pharma announces the U.S. launch of budesonide capsules in a 3 mg dose. Budesonide is a generic alternative to Entocort EC®, which is used as a treatment for patients with mild to moderate Crohn’s disease. The capsules reflect the company's focus on developing and manufacturing controlled-release and potent pharmaceuticals.

Greenville, NC, October 29, 2016 --( Mayne Pharma Inc. (Mayne Pharma) is pleased to announce the U.S. launch of budesonide capsules, a generic version of branded Entocort EC®, which is used to treat mild to moderate Crohn’s disease.

Mayne Pharma’s budesonide capsules are available in a 3 mg dose with shipment commencing today.

“This latest addition to Mayne Pharma’s fast-growing generic portfolio reflects the company’s core strengths in complex drug delivery formulations and technologies,” said Stefan Cross, president of Mayne Pharma USA. “This expertise paves the way to creating more high-quality generic alternatives that ultimately provide patients with greater choices, better access and more affordable solutions for their improved health.”

According to IMS Health, branded and generic sales of budesonide in the United States were approximately $322 million for the 12 months ending Aug. 31.

Mayne Pharma markets more than 50 products and has a growing pipeline of more than 40 generic and branded drug products for the U.S. market representing IMS Health sales greater than $7 billion. Currently, Mayne Pharma has 19 product applications pending at the U.S. Food and Drug Administration.

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, including Doryx®, an oral anti-bacterial drug, and
· Metrics Contract Services, which provides contract pharmaceutical development services to third parties globally.

Learn more about the company online. Entocort EC® is a registered trademark in the United States of Perrigo Pharma International.
Mayne Pharma USA
Karen Stinneford