FREIENBACH, Switzerland
EffRx Pharmaceuticals SA announced today that its Korean partner has received regulatory clearance from the Korean Ministry of Food and Drug Safety (MFDS) to market Binosto® buffered alendronate for the treatment of osteoporosis in Korea.
Binosto® – the first and only buffered solution for the treatment of osteoporosis – delivers gold standard fracture-risk reduction and offers the potential to improve adherence to therapy. Buffering minimizes the possibility of exposing the esophagus (in case of reflux) and the stomach to acidified alendronate1.
Binosto® is marketed in Korea by Ahn-Gook Pharmaceutical who has a strong local sales presence and expertise. Commercial launch activity in Korea is anticipated early January 2016. Jin Auh, Ahn-Gook President & CEO, said that the Korean market is worth 115M USD, with alendronate accounting for more than 90%. “We expect Binosto® to overcome certain limitations of oral bisphosphonates and to provide improved adherence to therapy for patients suffering from osteoporosis.”
Lorenzo Bosisio, Chief Commercial Officer of EffRx Pharmaceuticals, comments “we are pleased to receive the Korean regulatory approval for Binosto®, expanding physician and patient access to our product. Korea is a sizeable and important pharmaceutical market. We expect continued momentum as we launch in new territories around the world.”
Binosto® is currently available by prescription in the United States, Italy, Spain, Portugal, and the UK. The initial uptake in Europe with almost half a million monthly prescriptions in the first year has been very promising. Binosto® is licensed in over 50 countries and in the process of gaining regulatory clearance in several territories, hence further expanding its global footprint.
About EffRx Pharmaceuticals
EffRx Pharmaceuticals is an innovative specialty pharmaceutical company that develops and commercializes novel therapeutic entities for orphan and specialty indications by applying its proprietary technology platform. EffRx developments focus at improving the quality of life of patients with unmet medical needs.
About Ahn-Gook
Ahn-Gook Pharmaceutical Co., Ltd. is a Korean-based pharmaceutical company. The Company’s products include respiratory agents, gastrointestinal agents, anti-inflammatories, analgesics, ophthalmics and circulatory system agents. It also provides antibiotics, antifungal drugs, antihyperlipidemics, antiallergic drugs, anti-diabetic drugs, urinary system drugs and skin disease remedies. Anh-Gook also markets OTC and ethical drugs.
About Binosto®
Binosto® – the first and only buffered solution for the treatment of osteoporosis – delivers gold standard fracture-risk reduction and offers the potential to improve adherence to therapy. Buffering minimizes the possibility of exposing the oesophagus (in case of reflux) and the stomach to acidified alendronate1. Binosto® is taken once a week as an easy-to-swallow, buffered solution with no risk of a tablet getting lodged in the oesophagus. Binosto® has the potential to improve long-term patient adherence to therapy, thereby decreasing the risk of disabling fractures.
Disclaimer
Please refer to the official Binosto® Prescribing Information and approved indications, contraindications, and warnings in your country.
1Approved SmPC in Europe: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1447998343651.pdf
View source version on businesswire.com: http://www.businesswire.com/news/home/20160107005695/en/
CONTACT
EffRx Pharmaceuticals SA
Pamela Saredi
Communications
Manager
+41 44 503 78 64
psaredi@effrx.com