News Feature | August 11, 2014

Access And Norgine Enter Licensing Agreement For MuGard In EU

By Estel Grace Masangkay

Emerging biopharmaceutical firm Access Pharmaceuticals announced that it has signed into an exclusive licensing partnership with European specialty pharmaceutical company Norgine for the marketing of MuGard in EU.

MuGard is an oral mucositis product indicated for the management of oral mucositis/stomatitis caused by radiotherapy and/or chemotherapy. Oral mucositis occurs in over 40 percent of cancer patients undergoing radiotherapy and chemotherapy. The product is also indicated for other types of oral wounds such as mouth sores or injuries, including traumatic ulcers, canker sores, and aphthous ulcers.

The U.S. Food and Drug Administration (FDA) granted 501(k) clearance to MuGard for U.S. commercialization in 2006. MuGard is distributed in the U.S. by AMAG Pharmaceuticals. The company has also licensed MuGard in China and Korea.

Under the terms of the agreement, Norgine will pay up to $10 million to Access in milestone payments and increasing double digit royalty on net sales of MuGard. Commenting on the news, Jeffrey Davis, CEO of Access Pharmaceuticals stated, "Access is excited to announce this partnership with Norgine, a leading European specialty company, as it further validates our global MuGard commercial strategy. ... Norgine is an ideal partner for us, and we believe this partnership will drive commercial adoption in Europe and facilitate access of a proven treatment option to help protect patients from oral mucositis, a debilitating side effect."

Peter Stein, CEO of Norgine, said, “This new partnership with Access Pharmaceuticals represents an excellent opportunity to ensure that cancer patients affected by oral mucositis can access MuGard, to help manage this condition for which there are limited effective treatment options. This collaboration is further evidence of Norgine's commitment to acquire specialty pharmaceutical products to strengthen its portfolio.”

Norgine will commercialize MuGard in the EU as well as Switzerland, Norway, Lichtenstein, and Iceland. The company expects to launch MuGard in 2015.