On 6/1/09, Antigenics (NASDAQ:
AGEN) announced results of an interim analysis from the Company's ongoing global patient survival registry, which showed that patients with kidney cancer at intermediate risk of disease recurrence demonstrated an approximately 46% lower risk of death when treated with Oncophage (vitespen) cancer vaccine compared with observation (n = 362; P = 0.036; hazard ratio (HR) = 0.54). The interim analysis from the patient registry, INSPIRE, reflects a median follow-up of 4.5 years from the largest, randomized Phase 3 kidney cancer trial ever completed to date in the adjuvant setting. The patient registry was launched in order to confirm encouraging overall survival trends observed from the Phase 3 non-metastatic kidney cancer study. Final results from INSPIRE are expected mid-2010.
In October 2008, AGEN submitted a marketing authorization application to the European Medicines Agency (EMEA) requesting conditional approval for Oncophage in earlier-stage, localized renal cell carcinoma (kidney cancer). AGEN expects a decision on its European marketing application by late 2009 and the Company has not filed for U.S. marketing approval of the drug as of yet. On 10/21/09, AGEN announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMEA has verbally informed the Company at an oral meeting to anticipate a negative opinion on the marketing authorization application (MAA) for Oncophage in early-stage, localized renal cell carcinoma.
On 10/21/09, Shire (NASDAQ:
SHPGY) announced that it plans to file a BLA with the FDA for REPLAGAL (agalsidase alfa), its enzyme replacement therapy for Fabry disease, by the end of 2009. The Company also announces that a treatment protocol for REPLAGAL, filed at the request of FDA, has been approved, and that it will support emergency IND requests as part of the early access program in place due to the supply restriction of the only currently marketed treatment for Fabry disease in the US. REPLAGAL is a human form of enzyme alpha-galactosidase A (a-Gal A) manufactured in a human cell line by gene activation.
REPLAGAL is approved in 45 countries worldwide. REPLAGAL is not currently approved for commercial sale in the U.S.
