Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.
Late last week, Sunesis Pharmaceuticals, Inc. (SNSS) announced that the Pediatric Committee of the European Medicines Agency (EMA) accepted Sunesis’ Pediatric Investigation Plan (PIP) for Qinprezo (vosaroxin) for first relapsed or refractory acute myeloid leukemia (AML). Sunesis is looking to get Qinprezo approved in the EU for the pediatric treatment of first relapsed or refractory AML.
Sunesis said that the EMA’s Pediatric Committee has issued a positive opinion for its Pediatric Investigation Plan (PIP) for Qinprezo. The PIP for any candidate has to be accepted by the EMA before a marketing authorization application (MAA) can be submitted in the EU. However, completing the studies mentioned in the PIP is not mandatory for MAA submission, if deferral for completion is received.
According to the American Cancer Society, in the U.S., approximately 18,860 new patients are expected to be diagnosed with AML in 2014, with nearly 10,460 deaths expected due to the disease.
Qinprezo, in combination with cytarabine, is in a pivotal phase III randomized, double-blind, placebo-controlled study (VALOR) for first relapsed or refractory AML. Results should be out in the third or fourth quarter of 2014. Additionally, a phase Ib/II study in older patients suffering from previously untreated AML and high-risk myelodysplastic syndrome (MDS) is ongoing.
Qinprezo has orphan drug status in the U.S. and the EU for the treatment of AML.
Given that the number of patients suffering from AML across the globe is more than 50,000, we believe there is need for new treatments in this market.
Qinprezo is the lead candidate at Sunesis. We are encouraged by the Pediatric Committee’s opinion on Qinprezo’s PIP since it has strengthened Sunesis’ path towards filing a MAA for the candidate. The company is also preparing to file a new drug application for Qinprezo with the FDA.
Seattle Genetics (SGEN) is developing SGN-CD33A for the treatment of AML in adults. Data from a phase I study is expected in 2014.
Sunesis carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Biogen Idec Inc. (BIIB) and The Medicines Company (MDCO). Both carry a Zacks Rank #1 (Strong Buy).
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