Comparative MS study examines drug activity, Tolerability of Betaferon and Rebif

BERLIN, June 17 (PROTEXT/PRNewswire) - Schering AG, Germany(FSE: SCH, NYSE: SHR) announced that today at the EuropeanNeurological Society annual meeting in Istanbul, data waspresented that showed its (MS) treatment, Betaferon(R)/Betaseron(R), was associated with three times less injection pain thancompetitor Rebif(R). In addition, the data reported in the studyshows twice as many skin reactions at the injection site withRebif. Both medications are high-dose beta interferon regimensthat require multiple injections per week. Nearly half of all MSpatients worldwide use either drug.

"The findings show that Betaferon administration results inconsiderably less pain and discomfort than Rebif," said AyadAbdulahad, MD, PhD, Vice President, Medical Director, CNS, ofBerlex Laboratories, Inc., the U.S. affiliate of Schering AG,Germany. "We believe that if patients can better tolerate theirMS treatment, they'll be more likely to maintain a high-dose,high-frequency regimen such as Betaferon and, therefore, derivethe intended clinical benefit from therapy."

This Phase I trial was designed to examine the effects ofBetaferon and Rebif on biological response markers (BRM's). Thesemarkers provide information on the activity of different betainterferon formulations. The results showed that Betaferon andRebif induce similar levels of neopterin, a BRM.Injection pain was self-assessed by participants, while skinreactions at the injection site were evaluated by blindedinvestigators. The results showed that with Rebif there wassignificantly more injection pain that increased over time andsignificantly more frequent injection site reactions. Betaferonand Rebif appear to have similar efficacy profiles based on datafrom their respective pivotal trials.Among the key findings: The overall proportion of painful injections was threetimes greater with Rebif than Betaferon (43 per cent versus 14per cent). The percentage of Rebif injections that caused injectionsite reactions was nearly twice that of Betaferon injections (53per cent versus 30 per cent). The pain from Rebif injections was unpredictable: Roughlytwo-thirds(64 per cent) of subjects who were pain-free after fiveminutes reported pain at 30 minutes. Conversely, Betaferoninjections that were painless at five minutes never caused painat 30 minutes. Thirty minutes after injection, Rebif's mean visualanalogue scale (VAS) score was 11 (higher severity of pain),compared to 0.9 for Betaferon. Rebif caused more grade II injection site reactions (11per cent; e.g., inflammation, swelling, phlebitis) than Betaferon(one per cent).

"This is the first objective, comparative study that showsBetaferon and Rebif exhibit similar activity," said Dr.Abdulahad. "By dispelling certain misconceptions about dose andoffering new insights into the tolerability of these regimens,the findings can assist patients and physicians in makinginformed treatment decisions."About the Study

This Phase I study was a rater blinded, randomised, parallelgroup of 64 healthy volunteers over a four-week period. Duringthe study, 32 people received Betaferon 250 mcg every other dayand 32 received Rebif 44 mcg three times a week. Participantstwice examined each injection on the severity and type of pain,totalling 1,636 evaluations. Investigators assessed eachinjection for site reactions (a total of 434 blinded Betaferoninjections and 384 blinded Rebif injections). BRM's wereevaluated during the second, third and fourth weeks of treatment(in week one, participants were given baseline injections at halfdose).

Schering AG is a research-based pharmaceutical company. Itsactivities are focused on four business areas:Gynaecology&Andrology, Diagnostics&Radiopharmaceuticals,Dermatology as well as Specialised Therapeutics for disablingdiseases in the fields of the central nervous system, oncologyand cardiovascular system. As a global player with innovativeproducts Schering AG aims for leading positions in specialisedmarkets worldwide. With in-house R&D and supported by anexcellent global network of external partners, Schering AG issecuring a promising product pipeline. Using new ideas, ScheringAG aims to make a recognised contribution to medical progress andstrives to improve the quality of life: making medicine work.This press release has been published by Corporate Communicationof Schering AG, Berlin, Germany.

Certain statements in this press release that are neitherreported financial results nor other historical information areforward-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 placedon such statements because, by their nature, they are subject toknown and unknown risks and uncertainties and can be affected byother factors that could cause actual results and Schering AG'splans and objectives to differ materially from those expressed orimplied in the forward-looking statements. Certain factors thatmay cause such differences are discussed in our Form 20-F andForm 6-K reports filed with the U.S. Securities and ExchangeCommission. Schering AG undertakes no obligation to updatepublicly or revise any of these forward-looking statements,whether to reflect new information or future events orcircumstances or otherwise.Your contacts at Corporate Communication:Business: Oliver Renner, tel +49-30-468 124 31,oliver.renner@schering.deInvestor Relations: Niels Matusch, tel +49-30-468 150 62,niels.matusch@schering.de orYour contacts in the United States:Media Relations: Jeanine O'Kane, tel +1-973-487 2095,jeanine_o'kane@berlex.comInvestor Relations: Joanne Marion, tel +1-973-487 2164,joanne_marion@berlex.comFind additional information at: http://www.schering.de/eng(Corporate Communication) Business: Oliver Renner, tel +49-30-468124 31, oliver.renner@schering.de, Investor Relations: NielsMatusch, tel +49-30-468 150 62, niels.matusch@schering.de or(United States) Media Relations:Jeanine O'Kane, tel +1-973-487 2095, jeanine_o'kane@berlex.com,InvestorRelations: Joanne Marion, tel +1-973-487 2164,joanne_marion@berlex.com

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