Munich, Germany – October 22, 2014 (US-EST) –Santen GmbH. (Munich, Germany) (Santen) announced the positive outcome of the Decentralized Procedure (DCP) for TAPTIQOM® in Europe. The announcement follows the issuance of the Final Assessment Report from the Reference Member State (RMS), the Federal Institute for Drugs and Medical Devices of Germany (BfArM), and the agreement of all the Concerned Member States (CMS) in DCP that TAPTIQOM® is approvable.
The regulatory process will now enter the national phase of the DCP in which the RMS Germany and each of the CMS grants its national license.
TAPTIQOM® is a preservative-free eye drop solution (in single dose containers) of a fixed dose combination of the prostaglandin tafluprost (15 micrograms/ml) and the beta blocker timolol (5 mg/ml). These two components lower intraocular pressure (IOP) by complementary mechanisms of action and the combined effect results in additional IOP reduction compared to either compound alone. TAPTIQOM® was co-developed by Santen and Asahi Glass Co., Ltd.
TAPTIQOM® will be indicated for the reduction of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta blockers or prostaglandin analogues and require a combination therapy, and who would benefit from preservative free eye drops.
"Santen was the first company to develop a preservative-free prostaglandin eye drop, tafluprost (TAFLOTAN®, SAFLUTAN®), back in 2008 as a response to an unmet medical need. TAPTIQOM® will complete Santen's glaucoma portfolio of preservative-free products". Auli Ropo, M.D., PhD, Director, Clinical Research & Medical Affairs, Santen Oy, added "Santen will continue to work hard to make TAPTIQOM® available as soon as possible for patients suffering from open angle glaucoma or ocular hypertension who would benefit from preservative-free eye drops".
The European Glaucoma Society (EGS) guidelines* state that long-term topical glaucoma medications may cause and/or exacerbate pre-existing ocular surface disease (OSD), such as dry eye, meibomian gland dysfunction and chronic allergy, which, in glaucoma patients, has a much higher prevalence than in the general population. Such signs and symptoms can diminish if preserved drops are substituted with non-preserved drops.
"Achieving a favorable conclusion for TAPTIQOM® in Europe is a significant milestone. We believe it is very helpful for the many patients who would benefit from this treatment. It encourages us to continue developing new innovative ophthalmic solutions for unmet medical needs to improve patient's quality of life." concludes Masamichi Sato, Head of Santen European group and President of Santen Holdings EU BV.
*EGS Terminology and Guidelines for Glaucoma 4th edition, 2014.
As a specialty company dedicated to the ophthalmic and anti-rheumatic fields, Santen carries out the research, development, sales, and marketing of pharmaceuticals. The company has 15 bases in 12 countries globally and delivers products to consumers in more than 50 countries. In Japan, Santen holds the No. 1 share in the prescription ophthalmic pharmaceutical market. As a leading company in the field of ophthalmology, Santen aims to contribute to society by supplying valuable products and services to satisfy unmet medical needs.
Santen Forward-looking Statements
Information provided in this press release contains so-called "Forward-looking Statements". The realizations of these forecasts are subject to risk and uncertainty from various sources. Therefore, please note that the actual results may differ significantly from the forecasts. Business performance and financial condition are subject to the effects of change in regulations made by the governments of Japan and other nations concerning medical insurance, drug pricing and other systems, and to fluctuations in market variables such as interest rates and foreign exchange rates.
This press release is also prepared in other languages. However this English document is the original document, and documents prepared in other languages are for your reference only. In case of any discrepancy between the English and translated versions, the English version will prevail. Please refer to http://www.santen.eu for the original English document.
Nicolas Merigeau / Emmanuel Huynh
Corporate Communication Director - Santen Europe