PRODUCT

Neratinib, an oral HER2 targeted therapy, was approved by the U.S. Food and Drug Administration in 2017 and by the European Commission in 2018. It has been included as a recommended treatment option in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for early and metastatic breast cancer.¹⁾ HER2 plays a role in the rapid development and metastases of breast cancer, thus being the main target. Approximately 20 to 25 percent of breast cancer tumors overexpress HER2.^{2) 3)} HER2 targeted therapy began in 1998 and has been widely used since.⁴⁾ However, existing therapies being large molecules have difficulty passing through the Blood Brain Barrier (BBB) and hence, there is a limitation in the treatment and prevention of brain metastases which occur in approximately 30 to 50% in patients with advanced HER2+ breast cancer.^{5) 6)} Neratinib, as a small molecule, is a next generation therapy developed to overcome the limits of the existing options.⁷⁾

Regulatory Approval

USA, Canada, EU, Australia, New Zealand, Singapore, China, Hong Kong, Taiwan, Malaysia, Brunei, Israel, Argentina, Ecuador, Chile, Switzerland, Peru

· Early Breast Cancer : As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.

· Metastatic Breast Cancer : In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

· Early Breast Cancer : As a single agent, for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.

MUCOSAMIN

Medical device for Oral Mucositis(OM) and Dry Mouth(DM)

Mucosamin® is a CE marked medical device and is an oral liquid formulation that helps prevent and treat oralmucositis caused by chemotherapy or radiation therapy 1)2). In 25-45% of chemotherapy patients, 25-60% of radiotherapy patients, and 5-15% of bone marrow transplant patients, grade 3/4 severe oral mucositisdevelops3). The primary symptom of oral mucositis is serious pain, which can lead to secondary inflammationand nutritional problems beyond just discomfort. Currently, oral mucositis treatment is empirically performed and there is lack of products to meet unmet needs.

Hyaluronic acid, the main ingredient of mucosamin, prevents cell damage through antioxidant activity and helps wound healing by physically forming a protective film. In addition, the patented cluster of amino acids (Glycine, L-Proline, L-Leucine, L-Lysine), collagen precursor restores mucosal ulcers and protects fibroblasts4)5)6)7).

Mucosamin® has proven efficacy in treating and preventing oral mucositis through functional differentiation and is a competitive medical device that can expand to the dry mouth market with hydration effect.

1) Professional Dietetics. Mucosamin® Mouthwash Instructions for Use
2) Professional Dietetics. Mucosamin® Spray Instructions for Use

3) Trotti A et al. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62

4) Colella, G. et al. Aminoacid-enriched sodium hyaluronate enhances keratinocyte scattering, chemotaxis and wound healing through integrin 1-dependent mechanisms. J Stomatol Invest. 2009: 3; 21-29 

5) Mariggio, M. A. et al. Enhancement of fibroblast proliferation, collagen biosynthesis and production of growth factors as a result of combining sodium hyaluronate and amino acids. Int J Immunopathol Pharmacol. 2009: 22; 485-492

6) Favia, G. et al. Accelerated wound healing of oral soft tissues and angiogenic effect induced by a pool of amino acids combined to sodium hyaluronate (Aminogam®). J Biol Regul Homeost Agents. 2008: 22; 109-116 

7) Corsetti, G et al. Topical application of dressing with amino acids improves cutaneous wound healing in aged rats. Acta histochemical. 2010: 112: 497-507 

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