Development

Alemtuzumab is a monoclonal antibody which binds to the CD52 antigen, which is present on the surface of B and T lymphocytes and other cells.

It is approved as a single agent for the treatment of B-cell chronic lymphocytic leukaemia (B-CLL). It is also in development for multiple sclerosis under the brand name Lemtrada^™.

Genzyme’s clinical development program for Lemtrada^™ included two Phase III studies in which results for Lemtrada^™ were superior to Rebif^® (high dose subcutaneous interferon beta-1a) on clinical and imaging endpoints, including a reduction in relapse rate. In addition, as presented at the 2012 American Academy of Neurology meeting, some patients with pre-existing disability treated with Lemtrada^™ in the CARE-MS II trial were more than twice as likely to experience a sustained reduction in disability over two years than patients treated with Rebif.

Sanofi and its subsidiary Genzyme have submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) and a supplemental Biologics License Application (sBLA) to the FDA , both seeking approval of Lemtrada^™ (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS). An FDA response on the application is expected during H2 2013. An EU regulatory opinion from the Committee for Medicinal Products for Human Use (CHMP) on Lemtrada^™ for the treatment of relapsing multiple sclerosis is expected during Q2 2013. Genzyme is developing Lemtrada^™ in MS in collaboration with Bayer HealthCare.

Rebif^® is a registered trademark of EMD Serono, Inc. or affiliates.

The hormone testosterone stimulates the growth of prostate cancer cells. Abiraterone acetate is an orally active inhibitor of the steroidal enzyme complex 17 (hydroxylase/C17,20 lyase) which is involved in testosterone production.

A Phase I/II trial of abiraterone acetate in patients with advanced breast cancer is ongoing.

In 2011, Zytiga^® (abiraterone acetate) was approved in the US and EU for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

In December 2012 Zytiga^® with prednisone was approved in the US to treat men with metastatic castration-resistant prostate cancer (mCRPC) who have not received prior chemotherapy containing docetaxel. In January 2013 Zytiga^® was also approved in the EU for use in the treatment of metastatic castration-resistant prostate cancer before chemotherapy.