RedHill Biopharma Submits BEKINDA™ (RHB-102) European Marketing Authorization Application for Oncology Support
- RHB-102, newly branded as BEKINDA™, is a proprietary once-daily oral pill formulation of the antiemetic drug ondansetron
- The European marketing authorization application (MAA) seeks approval of BEKINDA™ for cancer patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting
- BEKINDA™ is also being developed for acute gastroenteritis and gastritis, with a Phase III study ongoing in the U.S. and top-line data expected during H2/2015
TEL-AVIV, Israel, December 9, 2014 RedHill Biopharma Ltd. (NASDAQ: RDHL; TASE: RDHL) (the “Company” or “RedHill”), an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that it has submitted a Marketing Authorization Application (“MAA”) to the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) and several other member states seeking European marketing approval of RHB-102 for cancer patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting (“CINV” and “RINV” respectively). RHB-102, newly branded as BEKINDA™, is a proprietary, oral, extended-release, once-daily pill formulation of the antiemetic drug ondansetron. BEKINDA™ is targeting a considerable segment of the 5-HT3 antiemetic market, with estimated worldwide sales of approximately $940 million in 2013.
- Terry F. Plasse MD, RedHill's Medical Director, commented: "Nausea and vomiting are a major burden on patients undergoing cancer chemotherapy and radiotherapy. This European marketing application filing for BEKINDA™ brings us closer to offering patients a simple, once-daily oral antiemetic in place of rectal suppositories or multiple oral doses to prevent nausea and vomiting for a full 24 hour period. We believe that, if approved, BEKINDA™ will make it easier for patients to overcome these troubling side effects of chemotherapy and radiotherapy."
Dror Ben-Asher, RedHill’s CEO, added: “The BEKINDA™ MAA for oncology support is RedHill’s third marketing application to date, following the RIZAPORT™ U.S and European marketing applications for migraines. With three ongoing Phase III studies in our core therapeutic area of gastrointestinal diseases - RHB-104 for Crohn’s disease, RHB-105 for H. pylori eradication and BEKINDA™ for gastroenteritis and gastritis, top-line results from the RHB-105 and BEKINDA™ studies expected in the second quarter and second half of 2015, respectively, a partnership in place with Salix Pharmaceuticals for the encapsulated bowel cleanser RHB-106 and a strong balance sheet, RedHill is well positioned for 2015.”
In addition to pursuing a marketing approval of BEKINDA™ (RHB-102) in Europe, RedHill held early this year a pre-New Drug Application (“pre-NDA”) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of BEKINDA™ for CINV prevention. Following the pre-NDA meeting, and in light of FDA's feedback, RedHill provided the FDA with supplementary information and is currently awaiting the FDA's response. Along with the data generated from prior studies, RedHill plans on using post-marketing data from Europe to further support the planned submission of a U.S. NDA for BEKINDA™ for CINV.
In parallel with pursuing the oncology support indications for BEKINDA™ in both Europe and the U.S., RedHill is also pursuing an indication of acute gastroenteritis and gastritis - inflammations of the gastrointestinal tract which cause, among other symptoms, nausea and vomiting, with an annual potential worldwide market estimated to exceed $650 million. A Phase III clinical study of BEKINDA™ is ongoing in the U.S. for this indication (the GUARD study). The randomized, double-blind, placebo-controlled, parallel group Phase III GUARD study is intended to support potential future submissions of marketing applications for this indication in both the U.S. and Europe, 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 indicated for this indication.
About BEKINDA™ (RHB-102):
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 of BEKINDA™ for acute gastroenteritis and gastritis is ongoing in the U.S., 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 U.S. for CINV.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) 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. RedHill’s current pipeline of proprietary products includes: (i) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection, with an ongoing first Phase III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease, with an ongoing first Phase III study; (iii) BEKINDA™ (RHB-102) - a once-daily oral pill formulation of ondansetron with an ongoing Phase III study in the U.S. for acute gastroenteritis and gastritis and a European marketing application for chemotherapy and radiotherapy-induced nausea and vomiting submitted in December 2014 (iv) RHB-106 - an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) MESUPRON® - a Phase II-stage uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers; (vi) RP101 - currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; (vii) RIZAPORT™ (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA currently under discussions with the FDA and a European marketing application submitted in October 2014; and (viii) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol. For more information please visit www.redhillbio.com
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