MAYNE PHARMA DEPLOYS 60+ MEMBER TEAM IN UNITED STATES TO PROMOTE DORYX

MAYNE PHARMA DEPLOYS 60+ MEMBER TEAM IN UNITED STATES TO PROMOTE DORYX

The acquisition of Doryx® (doxycycline hyclate delayed-release tablets), indicated for the adjunctive treatment of severe acne*, spearheads the launch of Mayne Pharma's U.S. Specialty Brands division, providing a new business platform for future growth supported by an internal pipeline and targeted in-licensing and/or product acquisitions

4 May 2015, Raleigh, North Carolina: Mayne Pharma has deployed a 60+ member team in the United States to promote its signature acne medication, Doryx®.

Having recently acquired the Doryx trademark, Mayne Pharma now controls the drug's entire value chain from development, manufacture and distribution through to marketing. The company has hired and placed in the field a 60+ person sales team, many of whom have previous Doryx promotion experience.

"Mayne Pharma's ability to quickly transition Doryx from Actavis and underpin it with an entirely new commercial infrastructure demonstrates Mayne Pharma's willingness to invest in products it believes in," said Stefan Cross, president of Mayne Pharma's U.S. operations.

"Doryx is a trusted and well-known brand in the U.S. dermatology market," Cross said. "Mayne Pharma developed Doryx more than 30 years ago, so we know the product intimately and believe that with reinvigorated marketing focus, we can further support the needs of dermatologists and the patients they treat."

The acquisition of Doryx and deployment of the company's dedicated support team also marks the launch of Mayne Pharma's new U.S. Specialty Brands division. This division will be responsible for distributing and marketing branded pharmaceuticals, especially those leveraging Mayne Pharma's expertise in oral drug-delivery technologies.

Leading the new U.S. Specialty Brands division is Andy McClenaghan, who previously ran Warner Chilcott's U.S. commercial operations. There, he was responsible for a 700-member sales team and key brands, including Doryx, before Actavis acquired the drug from Warner Chilcott in 2013.

Joining him is Anne Marie Carullo as senior sales director. She previously served as sales director in Warner Chilcott's dermatology and women's health care divisions.

"I'm personally very excited about the opportunity to build Mayne Pharma in the United States," Cross said. "We now have a diversified business across contract services and generic and branded pharmaceutical products, all of which provide a solid platform for growth moving forward."

Doryx, a tetracycline-class antimicrobial, is indicated as adjunctive therapy for severe acne. 1 Acne is the most prevalent skin disease in the United States, affecting some 45 million people of all ages.2 Dermatologists and physician assistants write 90 percent of the brand's prescriptions. 3 Doryx, designed as a delayed-release tablet, incorporates Mayne Pharma's drug delivery technology to minimize exposure of doxycycline to the upper GI tract.1,4,5

About Mayne Pharma in the United States

Mayne Pharma's U.S. operations consist of three main business divisions that focus on contract pharmaceutical services and the development and manufacturing of branded and generic pharmaceutical products. They are:

U.S. Generic Products, which develops, manufactures, markets and distributes generic products.
U.S. Specialty Brands, which is responsible for the marketing and distribution of branded pharmaceuticals in the United States.
Metrics Contract Services, which provides contract pharmaceutical development services to third parties globally.
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 Doryx® (doxycycline hyclate delayed-release tablets)

*The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours), followed by a maintenance dose of 100 mg daily. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

Indication and Usage

Doryx® (doxycycline hyclate delayed-release tablets) is a tetracycline-class antimicrobial indicated as adjunctive therapy for severe acne. To reduce the development of drug-resistant bacteria, as well as to maintain the effectiveness of Doryx® and other antibacterial drugs, Doryx® should be used only as indicated.

Selected Safety Information about Doryx® (doxycycline hyclate delayed-release tablets)

Doxycycline is contraindicated in patients who have shown hypersensitivity to any of the tetracyclines. Tetracycline-class drugs, like Doryx® (doxycycline hyclate delayed-release tablets), can cause fetal harm when administered to a pregnant woman. Doryx® should be avoided if possible by nursing mothers, taking into account the importance of the drug to the mother. Doryx® should not be used in children during tooth development (up to the age of 8 years). Concurrent use of tetracycline-class antibiotics with oral contraceptives may reduce their effectiveness. Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents including doxycycline, and may range from mild diarrhea to fatal erythema. Photosensitivity can occur with tetracycline-class drugs. Doryx® patients should minimize or avoid excessive exposure to natural or artificial sunlight, and consider using sunscreen or sunblock. Advise patients to discontinue therapy at the first evidence of skin erythema. Overgrowth of non-susceptible organisms, including fungi, may occur. Doryx® should be discontinued if superinfection occurs and appropriate therapy instituted. Adverse reactions observed in patients receiving tetracyclines include anorexia, nausea, vomiting, diarrhea, rash, photosensitivity, urticaria and hemolytic anemia. For additional safety and other information, please click here for Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1.844.825.8500 or the FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.

REFERENCES:

Doryx® [package insert]: Greenville, NC: Mayne Pharma; 2015.
The Burden of Skin Diseases 2004, the Society for Investigative Dermatology and the American Academy of Dermatology Association.
IMS Health. Data accessed December 2014.
Press AG, Hauptmann A, Hauptmann L, et al. Gastrointestinal pH profiles in patients with inflammatory bowel disease. Ailment Pharmacol Ther. 1998; 12: 673-678.
3. Kircik LH, Bilowski JB. Enteric-coated doxycycline pellets, delayed release, in tablets. Suppl Pract Dermatol. 2010:1-16
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For further information contact:

Lisa Pendlebury, +61.419.548.434, [email protected]

Karen Stinneford, +1.919.833.9102, [email protected]

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