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Mayne Pharma’s New $65M Facility

Mayne Pharma's New $65M Facility Will Double U.S. Manufacturing Capacity, Expand Contract Services

September 23, 2015

At an event today celebrating the start of construction, Mayne Pharma shared new details about its planned $65-million, 126,000-square-foot oral-dose facility in Greenville, N.C. The new facility will double the company’s U.S. manufacturing capacity and introduce commercial-scale fluid-bed processing capacity for modified-release bead/pellet drugs. Space within the company’s existing facility will be repurposed to expand contract analytical and formulation development services offered by Metrics Contract Services.

Greenville, N.C. – At an event today marking the start of construction on a new $65-million pharmaceutical manufacturing facility, Mayne Pharma shared additional details about the 126,000-square-foot oral-dose facility in Greenville, N.C.

The $65-million strategic investment will fund:

  • A new, greenfield 126,000-square-foot, oral-dose commercial manufacturing facility adjacent to the company’s existing building. The new facility will more than double Mayne Pharma’s U.S. manufacturing capacity to support and accelerate organic growth,
  • The re-purposing of space within the existing facility, significantly expanding contract analytical laboratory and formulation development services capacity, and
  • A new visitor and staff administrative center linking the two main buildings.

Mayne Pharma’s New Facility:
The new facility will house commercial manufacturing and packaging operations for Mayne Pharma’s generic and branded drug products. These operations also create new business opportunities for Metrics Contract Services (MCS) clients by offering expanded downstream commercial manufacturing services.

The expansion means Mayne Pharma can introduce commercial-scale manufacturing capability using solvent-based, fluid-bed processing technologies for modified-release bead/pellet products — an offering Mayne Pharma provides at its Australia facility. The company has seven modified-release products in the pipeline targeting markets with sales greater than $3.5 billion; three have been filed with the FDA.

“Mayne Pharma will triple its global fluid-bed processing capability once this facility opens, strengthening considerably our leadership position in oral drug delivery,” said Stefan Cross, president of Mayne Pharma USA. “The company will have greater flexibility to expand its modified-release product portfolio and support key existing product franchises that include Doxycycline, Morphine Sulfate and Erythromycin.”

The new building has been designed to allow for the safe handling of highly potent products at greater scale. Mayne Pharma has four highly potent products targeting markets with sales greater than $2 billion in the pipeline.

All U.S. distribution will be consolidated to Mayne Pharma’s Greenville campus.

“We’re creating significant additional scale in the United States — ranging from third-party contract services to development, manufacturing and distribution of our company’s own products,” Cross said. “The new facility will more than double our U.S. physical plant footprint, increasing production suites, expanding laboratories for Metrics Contract Services, consolidating distribution, and supporting future growth. Metrics Contract Services also will be able to offer commercial-scale manufacturing of oral solid dose products from the new facility.”

Metrics Contract Services’ Repurposed Facility:
The company will retrofit its existing Greenville facility to grow analytical and formulation development services for Metrics Contract Services clients. The repurposing includes the creation of 10+ new processing rooms and expanded laboratories.

“Metrics Contract Services will become a comprehensive concept-through-to-commercial solution for our clients, thanks to the new capacity for seamless scale-up,” said John S. Ross, executive vice president. “And with the creation of additional development suites and analytical laboratories, we’ll have the internal capacity to support the continuing growth in demand we’ve been experiencing.”

A New Visitor and Staff Administration Center:
The $65-million expansion includes the construction of a new visitor and staff administration center. The center will feature state-of-the-art teleconference rooms, visitor meeting rooms and workstations, a 350+ seat cafeteria, employee development and training classrooms, and an employee fitness center. This hub will serve as the “heart” of the Greenville campus, connecting the two main development and commercial manufacturing buildings.

With construction underway now, Mayne Pharma officials anticipate that the new commercial facility should be fully operational in 2018. Mayne Pharma anticipates hiring up to 110 new scientists, quality assurance specialists and other technicians to support expanded operations.

The company has been working with state and local governmental agencies in support of its capital expansion and secured funding and incentives worth up to $2.7 million. The expansion is made possible in part by a performance-based grant of $550,000 from the One North Carolina Fund, which provides financial assistance, through local governments, to attract business projects that will stimulate economic activity and create new jobs within the state.

About Mayne Pharma Group Limited
Mayne Pharma Group Limited 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, and these technologies have been successfully commercialized in numerous products that have been marketed around the world.

Mayne Pharma has drug development and manufacturing facilities in Salisbury, Australia, with expertise in formulating complex oral dose forms, including controlled substances, modified release products and inherently unstable compounds. Visit www.maynepharma.com to learn more.

About Metrics Contract Services
Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization serving clients worldwide. We deliver proven scientific and operational excellence for oral dosage forms.

Our areas of expertise include quality formulation development; first-time-in-man formulations; Phase I-III clinical trial materials manufacturing; and analytical method development and validation services leading to commercial scale manufacturing. Our technical capabilities include highly potent, cytotoxic and unstable compounds; DEA Schedule II-V controlled substances; and products with poor bioavailability, for which we offer an impressive propriety portfolio of advanced delivery methods.

Located in Greenville, N.C., Metrics Contract Services is a proud member of the Mayne Pharma family