Orphan Drug Status for Astellas' Candidate
The US Food and Drug Administration (:FDA) recently granted orphan drug designation to Astellas Pharma, Inc.’s (ALPMY) invasive aspergillosis candidate, isavuconazole.
Isavuconazole is an azole antifungal agent, jointly developed by Basilea Pharmaceuticals AG and Astellas. The companies had entered into an agreement in Feb 2010.
As per the terms of the deal Astellas has exclusive rights to develop and commercialize isavuconazole globally whereas Basilea has an option to co-promote the product in the US, Canada, major European countries and China.
As per information provided by Astellas, invasive aspergillosis is found in 5-13% of bone marrow transplant patients, 5-25% of heart or lung transplant patients and 10-20% of intensive chemotherapy patients for leukemia.
The candidate is currently in three phase III studies, namely, SECURE, VITAL and ACTIVE.
The global double-blind randomized phase III SECURE study evaluates the safety and efficacy of once-daily isavuconazole versus twice-daily Vfend from Pfizer (PFE). Top-line results from the SECURE study are expected in the second half of 2013.
The open-label phase III VITAL study evaluates isavuconazole for the treatment of patients with invasive life-threatening fungal disease and the treatment of aspergillosis patients with pre-existing renal impairment. Top-line results from the VITAL study are expected in the second half of 2013.
The double-blind randomized phase III ACTIVE study evaluates the use of isavuconazole (intravenous and oral) versus Merck & Co, Inc.’s (MRK) Cancidas (intravenous) followed by Vfend (oral) for the treatment of candidemia and other invasive Candida infections. The enrollment in the ACTIVE study will continue till 2014.
While Astellas Pharma currently carries a Zacks Rank #4 (Sell), Pfizer and Merck carry a Zacks Rank #3 (Hold). Currently, companies like Santarus, Inc. (SNTS) look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).
Read the Full Research Report on SNTS
Read the Full Research Report on PFE
Read the Full Research Report on MRK
Read the Full Research Report on ALPMY
More From Zacks.com
