BERLIN and OSS, The Netherlands, September 19 /PRNewswire-FirstCall/ -- Schering AG, Germany (FSE: SCH; NYSE: SHR) and Organon announced today that they will continue research in male fertility control separately. Their research collaboration will therefore conclude at the end of the phase II clinical trial.
“For both Organon and Schering, as well as our clinical and scientific colleagues worldwide, this has been a long and demanding research program. However, we accept the challenge of developing what we have learned so far into a convenient contraceptive method for men. Male fertility control remains an important research area for Schering,” said Phil Smits, M.D., Head of Gynecology&Andrology at Schering AG.
Commenting on the collaboration, David Nicholson, Executive Vice President, Global Research and Development, Organon, said: “The phase II trial was important as it showed that a progestogen combined with testosterone can work as a male contraceptive. Our next step is to find a way to make it easy to use and acceptable to the population.”
Both companies described the collaboration as constructive, but came to the conclusion that the administration route investigated in the trial, which combined an annual implant with three-monthly injections, would unlikely result in a product that would be acceptable for widespread everyday use. Both companies remain committed to research in male contraception and will build on the knowledge gained from the collaboration to seek improvements in how such a contraceptive can be better administered.
The collaboration started in November 2002. The phase II trial which started in January 2004, was designed to test the reliability and acceptability of two hormones in combination which were known to have a suppressive effect on sperm production.
The trial medication and modes of administration were based on results from earlier studies showing that sperm production could be suppressed to contraceptive levels by the progestogen etonogestrel given as a subcutaneous implant, which was developed by Organon. While, at the same time, the resulting testosterone deficiency could be minimized with an injection of long-acting testosterone undecanoate, developed by Schering. Data from the trials will be jointly published upon final analysis.
About Schering AG
Schering AG is a research-based pharmaceutical company. Its activities are focused on four business areas: Gynecology&Andrology, Oncology, Diagnostic Imaging as well as Specialized Therapeutics for disabling diseases. As a global player with innovative products, Schering AG aims for leading positions in specialized markets worldwide. With in-house R&D and supported by an excellent global network of external partners, Schering AG is securing a promising product pipeline. Using new ideas, Schering AG aims to make a recognized contribution to medical progress and strives to improve the quality of life: making medicine work.
It is planned that Schering AG will be renamed Bayer Schering Pharma Aktiengesellschaft. A corresponding resolution was passed at the Extraordinary General Meeting of Schering AG on September 13, 2006. Until the name change has been registered in the commercial register, the company will continue to operate under the name Schering AG. According to the resolution of the General Meeting, the Executive Board will not file an application for registration before December 1, 2006.
Find additional information at: www.schering.de/eng
About Organon
Organon - with shared head offices in Roseland, JN, USA and Oss, the Netherlands - creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to remain or become one of the leading biopharmaceutical companies in each of its core therapeutic fields: fertility, gynecology, anesthesia and neuroscience. Research areas also include immunology and oncology. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.
Find additional information at: www.organon.com
Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Schering AG’s plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Certain factors that may cause such differences are discussed in our Form 20-F and Form 6-K reports filed with the U.S. Securities and Exchange Commission. Schering AG undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.
Safe Harbor Statement*
This press release may contain statements which address such key issues as Organon’s growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. 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 2005 Annual Report on Form 20-F will be available at the end of the second quarter of 2006.
* Pursuant to the U.S. Private Securities Litigation Reform Act 1995. Your contacts at Schering AG: Media Relations: Oliver Renner, T: +49-30-468-124-31, oliver.renner@schering.de Investor Relations: Dr. Jost Reinhard, T: +49-30-468-150-62, jost.reinhard@schering.de Pharma Communication: Astrid Kranz, T: +49-30-468-120-57, astrid.kranz@schering.de
Your contacts at Organon : Monique Mols, Director Media Relations, N.V. Organon, Tel: +31-412-665440, Fax: +31-412-662568, E-mail: monique.mols@organon.com
