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UK MHRA validates RedHill Biopharma’s MAA for Bekinda

Tel Aviv, IsraelSaturday, January 3, 2015, 13:00 Hrs  [IST]

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated the RedHill Biopharma’s Marketing Authorization Application (MAA) for Bekinda (RHB-102), a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron indicated for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV, respectively), and initiated the formal review process for the application on December 30, 2014. RedHill expects to receive feedback from the MHRA regarding the MAA during the second half of 2015.

With Bekinda, RedHill is targeting a considerable segment of the 5-HT3 oncology support antiemetic market, with estimated worldwide sales of approximately $940 million in 2013.

The MAA was submitted to several member states under the European Decentralized Procedure, with the UK as the Reference Member State. The MAA submission followed a positive European Scientific Advice meeting with the UK MHRA and is backed by several pharmacokinetic studies which support the safety and efficacy of Bekinda for prevention of nausea and vomiting following chemotherapy and radiotherapy treatments.

Dror Ben-Asher, RedHill's CEO, added: "The acceptance for review of the Bekinda MAA, our third marketing application filed to date, positions us to receive regulatory feedback for Bekinda in the second half of 2015. We are entering 2015 with three ongoing phase III studies in our core therapeutic area of gastrointestinal diseases, and we expect to have top-line results from two of these studies, with RHB-105 for H. pylori infection and Bekinda for gastroenteritis, in the second quarter and second half of 2015, respectively."

RedHill is also pursuing marketing approval of Bekinda in the US Following a pre-NDA meeting held earlier this year, and in light of the FDA's feedback, RedHill has provided the FDA with supplementary information. RedHill plans on using post-marketing data from Europe, along with the data generated from prior studies, to further support the planned submission of a US New Drug Application (NDA) for Bekinda for prevention of chemotherapy induced nausea and vomiting.

RedHill is pursuing an additional indication for Bekinda, as a treatment for acute gastroenteritis and gastritis -- inflammations of the gastrointestinal tract which cause, among other symptoms, nausea and vomiting. A phase III clinical study with Bekinda is ongoing in the US for this indication (the GUARD study), with top-line data expected during the second half of 2015. If approved for marketing for the treatment of acute gastroenteritis and gastritis, Bekinda could become the first-ever 5-HT3 antiemetic drug approved for this indication, targeting an annual potential worldwide market estimated to exceed $650 million.

Bekinda is a patent-protected, extended-release (24 hours) oral pill formulation of ondansetron, the active ingredient in GlaxoSmithKline's Zofran. RedHill is developing Bekinda for the treatment of acute gastroenteritis and gastritis as well as for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV, respectively). A phase III clinical study with Bekinda for acute gastroenteritis and gastritis is ongoing in the US, with top-line data expected during the second half of 2015. RedHill submitted in December 2014 a Marketing Authorization Application (MAA) seeking marketing approval of Bekinda in Europe for the oncology support indications of CINV and RINV prevention and has also held a pre-NDA meeting with the FDA regarding the potential submission of a New Drug Application (NDA) in the US for CINV.

RedHill Biopharma Ltd. is an emerging Israeli biopharmaceutical company focused on the development and acquisition of late clinical-stage, proprietary drugs for the treatment of inflammatory and gastrointestinal diseases, including gastrointestinal cancers.

 
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