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RedHill Biopharma Announces Acceptance for Review of BEKINDA(TM) European Marketing Application for Oncology Support

  • The UK MHRA has validated the European marketing application for the indications of chemotherapy and radiotherapy-induced nausea and vomiting; MHRA's feedback is expected during H2/2015
  • BEKINDA (RHB-102) is a proprietary once-daily oral pill formulation of the antiemetic drug ondansetron, targeting a worldwide potential market with estimated annual sales of $940 million
  • BEKINDA is also being developed for acute gastroenteritis and gastritis, with an ongoing Phase III study in the U.S. and top-line data expected during H2/2015

TEL-AVIV, Israel, Dec. 31, 2014 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill"), an Israeli biopharmaceutical company primarily focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated the 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 20131.

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 BEKINDAin the U.S. 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 U.S. 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 U.S. 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 million2.

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 with 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 a 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

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; (iv) the clinical development, commercialization, and market acceptance of the Company's therapeutic candidates; (v) the Company's ability to establish and maintain corporate collaborations; (vi) the interpretation of the properties and characteristics of the Company's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; (vii) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (ix) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (x) estimates of the Company's expenses, future revenues capital requirements and the Company's needs for additional financing; and (xi) competitive companies, technologies and the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on February 25, 2014. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.

1 EvaluatePharma 2013, 5-HT3 (serotonin) antagonist, worldwide sales by pharmacological class.

2 Graves S. Nancy, Acute Gastroenteritis, Prim Care Clin Office Pract 40 (2013) 727–741 and Company analysis.

CONTACT: Company contact: Adi Frish Senior VP Business Development & Licensing RedHill Biopharma +972-54-6543-112 adi@redhillbio.com IR contact (U.S.): Lauren Kwiecinski Senior Associate The Trout Group +1-646-378-2934 lkwiecinski@troutgroup.comSource:RedHill Biopharma Ltd.