Shares of RedHill Biopharma Ltd. (RDHL) received a significant boost after the company announced that the UK Medicines and Healthcare Products Regulatory Agency has validated its Marketing Authorization Application for its pipeline candidate Bekinda (RHB-102) for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting (CINV and RINV, respectively).
The agency initiated the formal review process on Dec 30, 2014 and a response is expected during second half of 2015.
Bekinda is an extended-release once-daily oral pill formulation of GlaxoSmithKline's (GSK) Zofran with an estimated potential market of $940 million on a worldwide basis.
Meanwhile, RedHill is working to getting the candidate approved in the U.S. Earlier, in Mar 2014, RedHill had held a pre-New Drug Application (pre-NDA) meeting with the FDA regarding the development of Bekinda for CINV in the U.S. RedHill has provided the FDA with additional information based on the feedback from the meeting. The company plans to use data from Europe along with data generated from prior studies to further support its planned submission of an NDA for Bekinda for the prevention of CINV in the U.S.
Bekinda is also being evaluated for acute gastroenteritis and gastritis in an ongoing phase III study in the U.S. Top-line data from this study is expected during the second half of 2015.
Successful development and commercialization of pipeline is important for RedHill, which currently does not have any approved product in its portfolio.
RedHill Biopharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader health care sector include Sucampo Pharmaceuticals (SCMP) and Biodel Inc. (BIOD). Both carry a Zacks Rank #1 (Strong Buy).
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