Conditional Approval for Roche's Erivedge
Roche (RHHBY) recently received encouraging news with its skin cancer drug Erivedge gaining conditional approval from the European Commission for the treatment of symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC in adults who are not suitable for surgery or radiotherapy.
We remind investors that EU conditional approval was expected as the Committee for Medicinal Products for Human Use (CHMP) had recommended for the same in Apr 2013.
We note that conditional marketing authorization is generally granted to a pharmaceutical product when the benefit of the same outweighs its inherent risk. It is usually granted to candidates that fulfill an unmet medical need.
Roche is, however, required to submit additional data.
The conditional approval was based on positive results from a phase II study, ERIVANCE, wherein it was observed that Erivedge substantially shrank lesions in approximately 43% of patients with locally advanced BCC and 30% of patients with metastatic BCC.
We also note that Roche is developing Erivedge under a collaboration agreement with Curis, Inc. (CRIS). Roche is currently assessing the safety profile of Erivedge in an open label study, STEVIE.
Erivedge was approved in the US in Jan 2012 for treating patients with advanced BCC and initial uptake of the drug has been encouraging. Erivedge is approved in Switzerland, Australia, Israel, South Korea, Mexico and Ecuador.
Erivedge generated sales of CHF 13 million in the first quarter of 2013. The conditional approval in Europe and subsequent full approval will boost sales further.
Roche was in the news recently when it was rumored that it is eyeing Alexion Pharmaceuticals (ALXN) in a bid to diversify its product portfolio.
Alexion Pharma’s sole marketed drug Soliris is approved for the treatment of paroxysmal nocturnal hemoglobinuria, a rare genetic disorder.
We expect investor focus to remain on further updates on Roche’s portfolio expansion plans.
Roche currently carries a Zacks Rank #4 (Sell). Right now, Jazz Pharmaceuticals (JAZZ) looks attractive with a Zacks Rank #1 (Strong Buy).
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