New Formulation Rebif for Relapsing Multiple Sclerosis Lowers Immunogenicity and Improves Tolerability: Presented at ECTRIMS

MADRID, SPAIN –

September 30, 2006 –

At 48 weeks into a 96 week phase 3b trial, a new formulation of Rebif (interferon beta-1a), researchers report that 44 mcg given subcutaneously 3 time a weeks significantly improves tolerability and reduces antibody formation compared with historical 48-week data on the currently available formulation of the drug in patients with relapsing multiple sclerosis (MS).  The data were presented here on September 28[th at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). 

 "Rebif is already effective," said lead investigator Gavin Giovannoni, MD, consulting neurologist at the Institute of Neurology, University College in London, UK.  "But here, with this new formulation, we see lower immunogenicity emerging, which is very important for relapse reduction.  Notably, we also see a 3-fold lower rate of injection site reactions, and they were all mild to moderate," he added. 

 Historical data comes from the Evidence for Interferon Dose-response European-North American Comparative Efficacy (EVIDENCE) study of Rebif. 

 Rebif is currently available in a 22 mcg and 44 mcg ready-to-use pre- filled syringe and titration pack. 

 The new formulation has no animal or human-derived components.  It is also delivered with a new auto-injector, which uses the thinnest needle in a ready-to-use syringe for use in MS treatment. 

 In Dr.  Giovannoni's new open-label study, 227 of the 260 subjects enrolled remained on the new formulation Rebif at week 48. 

 The primary endpoint of this ongoing study is the proportion of neutralizing antibody detected in patients at the last assessment. 

 At 48 weeks, 13.9% of subjects treated with new-formulation Rebif were neutralizing-antibody positive.  In the EVIDENCE trial, 24.4% were positive at 48 weeks.  In the new study, persistent neutralizing antibodies appeared in 2.5% of subjects compared with 14.3% in EVIDENCE. 

 In EVIDENCE at 48 weeks, 83.8% of subjects reported injection site reactions.  At 48 weeks in the new study, 29.3% reported such reactions. 

 "[Rebif New Formulation] RFN offers the treatment benefits of a high- dose, high frequency [Interferon] beta 1-a, but with lower immunogenicity and improved overall tolerability compared with currently marketed product," the researchers concluded.  "It is anticipated that RNF will bring still greater benefits to patients with relapsing forms of MS."

 "We welcome this new data as clinicians and, most importantly, for our patients," Dr.  Giovannoni said. 

 The study was supported by Serono, Inc. 

 [Reduced Immunogenicity With a New Formulation of Interferon-Beta-1a (Rebif): 24-Week Results of a Phase IIIb Study.  Abstract P675]