PlasmaTech Biopharmaceuticals' Partner Receives Marketing Approval

PlasmaTech Biopharmaceuticals, Inc. (NASDAQ: PTBI) recently announced that its Korean marketing partner, Hanmi Pharmaceutical Co., Ltd has received marketing approval in Korea from the country’s Ministry of Food and Drug Safety (MFDS) and the Korea Testing & Research Institute (KTR) for MuGard, its oncology supportive-care treatment for the management of oral mucositis. Under the terms of the previously announced marketing agreement, Hanmi will import MuGard from the US and marketing will commence. Hanmi intends to market MuGard in Korea under the trade name Mucogard.

“Hanmi receiving marketing approval is a critical step in the launch of MuGard in Korea and complements our broad commercialization strategy of MuGard in the global market,” said Steven Rouhandeh, Executive Chairman of PlasmaTech Bio. “We look forward to working with them on next steps, including arrangement of commercial product, and leveraging their expertise and extensive distribution throughout the region.”

“We are pleased with the continued progress being made on commercializing MuGard in Korea. We remain on track and look forward to providing doctors and patients in Korea access to MuGard, an effective treatment for oral mucositis, in 2015,” added Dr. Gwan Sun Lee, President and Chief Executive Officer of Hanmi.

In 2014, PlasmaTech announced the publication of positive MuGard clinical data in Cancer, the journal of the American Cancer Society. The publication, entitled Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck, is available to the public at http://onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.

Oral mucositis is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.

MuGard Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the US FDA and is marketed by AMAG Pharmaceuticals, Inc. in the US. MuGard is licensed in Korea through Hanmi Pharmaceuticals and in Europe, Australia, and New Zealand through Norgine, B.V.

PlasmaTech is a biopharmaceutical company focused on advancing protein biologic therapies and oncology supportive care products. Exploiting two proprietary platforms, Salt Diafiltration (SDF) Process and Polymer Hydrogel Technology (PHT), PlasmaTech is active in the development and commercialization of human plasma-derived therapeutics, including its proprietary alpha-1 protease inhibitor, SDF Alpha. The company has a robust product pipeline that includes two commercial stage products, MuGard and ProctiGard, and follow-on products in development. For more information, visit www.plasmatechbio.com.