Tokyo, Japan, 25 June, 2014 – Astellas Pharma Inc. (“Astellas”; TSE:4503, headquarters: Chuo-ku, Tokyo; president and CEO: Yoshihiko Hatanaka) and UCB Japan Co., Ltd. (“UCB Japan”; headquarters: Shinjuku-ku, Tokyo; President and Representative Director: Joel Peterson; “UCB” for the whole UCB group), which jointly develop and commercialize the pegylated*1 anti-TNF-a (tumor necrosis factor) antibody certolizumab pegol (generic name; brand name in Japan, the US and the EU: Cimzia®) in Japan, are pleased to announce today that they have filed an application for the additional indication.
At present, the use of Cimzia® is restricted to patients of rheumatoid arthritis (RA) with inadequate response to existing therapies. The new application will make it possible to administer Cimzia® to RA patients without previous treatment with anti-RA drugs when rapid progression of structural joint destruction is expected.
The application is based on the findings obtained regarding the inhibition of progression of structural joint destruction, clinical efficacy and safety in the PIII C-OPERA clinical trial in which RA patients without previous treatment with methotrexate (MTX) received certolizumab pegol (CZP) and MTX or MTX alone within one year after onset of RA.
Cimzia® is the world’s first PEGylated anti-TNF-a (tumor necrosis factor alpha) antibody for the treatment of RA. It has a high affinity for TNF-a, which is involved in the onset and exacerbation of inflammatory diseases such as RA, and selectively inhibits the effects of TNF-a. It has an extended blood half-life due to PEG moiety attached to its Fc-free Fab region*2, and is effective in the treatment of RA as a subcutaneous injection either every two weeks or once a month. In global clinical trials, co-therapy with Cimzia® and MTX rapidly improved signs and symptoms of RA and continued to be effective during induction and maintenance therapy. Furthermore, Cimzia® prevented progression of joint bone destruction. In clinical trials conducted in Japan, Cimzia® showed rapid and sustained reduction in signs and symptoms and prevented progression of joint destruction when administered with or without MTX. Cimzia® is supplied in the form of a prefilled syringe to facilitate self-administration by RA patients trained by their healthcare professionals.
In January 2012, Astellas and UCB signed an agreement to jointly develop and commercialize Cimzia® in Japan. Cimzia® was granted Japanese marketing approval in December, 2012 and was launched in March, 2013. Astellas will make a milestone payment to UCB upon additional indication submission. Impact of this payment on Astellas’ financial results of the current fiscal year ending March 31, 2015 will be immaterial.
Astellas and UCB believe that the additional indication of certolizumab pegol will be able to contribute further to improvement of the treatment of RA.
*1: PEGylated – PEGylation refers to the modification of an antibody with polyethylene glycol.
*2: The antibody is a Y-shaped molecule comprised of two antigen-recognizing Fab regions in the upper part and a complement-binding Fc region at the base.