Healthcare Industry News: Organon
News Release - June 19, 2007
Organon's Once-a-Month Contraceptive Ring, NuvaRing(R) Completes European AuthorizationOSS, The Netherlands, June 19 (HSMN NewsFeed) -- Organon announced today that NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring), the company's once-a-month contraceptive, has successfully completed the European Mutual Recognition Procedure (MRP) in an additional 13 countries (1).
NuvaRing is already approved in 14 European Union territories using the Mutual Recognition Procedure with the Netherlands as the Reference Member State. National marketing authorizations for the latest countries - including the UK, Poland and Czech Republic - have been applied for, and will extend NuvaRing's availability throughout the EEA (EU countries and Iceland and Norway) to over 40 countries globally.
NuvaRing was developed to increase the convenience of contraceptive use. It is a flexible ring that is inserted into the vagina by a woman herself and remains there for 21 days. It combines protection against pregnancy with a low incidence of side effects. Compared to commonly used combined oral contraceptives, in addition to its once-a-month contraceptive regimen, NuvaRing reduces women's estrogen exposure, providing 15 mcg of ethinyl estradiol and 120 mcg etonogestrel daily.
"We are delighted to be able to extend the availability of NuvaRing throughout Europe," said Emile van Dongen, executive vice president Global Sales at Organon. "Its uptake is increasing in all European countries where it is already available and even more in the US. There is an exciting momentum growing around this product, used by more than 1.5 million women."
Since its introduction in 2002, sales of the once-a-month ring have grown strongly year-on-year - from slightly more than EUR 6 million in 2002 to EUR 216 million at the close of 2006 - as awareness has gradually increased among women and the medical fraternity. Currently used by over 1.5 million women worldwide, the uptake of NuvaRing® is continuing to grow by at least 25 percent in all major markets. Latest figures even show a 42 percent increase in sales in the U.S. market.
(1) A national marketing authorization for NuvaRing was granted in the Netherlands on February 14, 2001. A mutual recognition procedure was subsequently completed on June 12, 2001 with the Netherlands acting as Reference Member State. A repeat use/second wave mutual recognition procedure was undertaken in 2003 leading to NuvaRing's approval and subsequent introduction in France. This latest repeat use mutual recognition procedure was approved in and applies to Bulgaria, Cyprus, Czech Republic, Malta, Poland, Romania, Slovenia, the UK, Estonia, Hungary, Latvia, Lithuania, and Slovak Republic.
Organon creates, manufactures and markets innovative prescription Medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.
Safe Harbor Statement(2)
This press release may contain statements which address such key issues as growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals of Organon. Such statements should be carefully considered, and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, progress of drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more comprehensive discussion of the risk factors affecting our business please see our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission, a copy of which can be found on the Akzo Nobel corporate website www.akzonobel.com. The 2006 Annual Report on Form 20-F will be available in the second quarter of 2007.
(2) Pursuant to the U.S. Private Securities Litigation Reform Act 1995.
Source: N.V. Organon
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