RedHill Biopharma Announces a Successful Pivotal Bioequivalence Trial with RHB-102 for the Prevention of Nausea and Vomiting in Cancer Patients

Plans to Request a Pre-NDA Meeting with the FDA in the Coming Weeks, as Part of its Preparations for the Filing of a US Marketing Approval Application

The Trial Demonstrated Bioequivalence Between RedHill Biopharma's Once-Daily RHB-102 and GSK's Three-Times-Daily Zofran®

TEL AVIV, Israel--(BUSINESS WIRE)--Apr 18, 2012 - RedHill Biopharma Ltd. (TASE: RDHL), an emerging Israeli biopharmaceutical company focusing primarily on development of late clinical-stage (Phase II/III), new formulations and combinations of existing drugs, announces positive results in an advanced bioequivalence clinical trial with RHB-102 for the prevention of nausea and vomiting in cancer patients. RedHill intends to approach the FDA in the coming weeks to request a Pre-NDA meeting to discuss US marketing approval pathway.

The draft final report summarizing the objectives and results of the trial demonstrates that the trial met its objectives and FDA's criteria for bioequivalence between RedHill's once daily RHB-102, and GlaxoSmithKline's Zofran® - a leading, approved antiemetic drug administered three times per day.

The trial, conducted in Montreal, Canada, was the third clinical trial in the RHB-102 development program. Prior to the trial, RedHill obtained both an IND (Investigational New Drug Application) approval from the FDA and a CTA (Clinical Trial Application) approval from the Canadian Health Authority.

RHB-102, which combines a patent–protected, once-daily, controlled release technology named CDT®, with the active pharmaceutical ingredient Ondansetron, belonging to the family of inhibitors of the Serotonin receptor 5-HT3, is designed to prevent nausea and vomiting over 24 hours in order to avoid the need for additional drug administrations during the 24 hours post-treatment. The 24 hour time window is significantly longer than the effective time of the oral drugs currently available on the market. Thus, RHB-102 potentially holds a promise for cancer patients who are undergoing radiotherapy and suffer considerable difficulty in eating and swallowing.

RHB-102 is targeting a significant segment in the oncology treatment support market. The global market for treatment of nausea and vomiting was estimated at over $2 billion in 2010, of which the market share of Serotonin receptor 5-HT3 drugs was estimated at approximately $1 billion. GSK's Zofran® - the reference drug in the clinical trial – is a leading drug in the family of inhibitors of the Serotonin receptor 5-HT3, which together with its generic derivatives has global sales of approximately $400 million.

Gilead Raday, VP Corporate & Product Development at RedHill stated today: "We are very pleased with the success of the RHB-102 trial. The results were achieved thanks to the significant development activity carried out at RedHill. RedHill conducted the trial according to the highest standards and under approvals from FDA and Canadian Health. We intend to request a pre-NDA meeting with the FDA in the coming weeks to discuss a US NDA marketing approval application for RHB-102."

Dror Ben Asher, RedHill's CEO, added: "These results demonstrate the capabilities of RedHill's R&D. Within approximately one year from the Company's IPO on the Tel Aviv Stock Exchange, in accordance with our work plan, we have achieved an important milestone toward the future commercialization of RedHill's advanced product pipeline. We are looking forward to continuing the successful collaboration with our license partner SCOLR Pharma.”

About RedHill Biopharma Ltd.:
RedHill Biopharma is an emerging Israeli biopharmaceutical company focused primarily on development of late clinical-stage new formulations of existing drugs. In addition to RHB-102 for the prevention of radiotherapy-induced nausea and vomiting, the Company's current product pipeline includes a once-daily formulation of a leading congestive heart failure and high blood pressure drug, an oral thin film formulation of a leading triptan for the treatment of acute migraine, a combination therapy for the treatment of MAP infection in Crohn's as well as a companion diagnostic test for detection of the MAP bacteria, a combination therapy for the treatment of resistant H. pylori bacteria causing ulcers, and a patent protected encapsulated formulation for bowel preparation ahead of certain gastro procedures. The Company's team includes prominent pharmaceutical experts. For more information please visit: www.redhillbio.com.

This Press Release does not constitute an offer or solicitation to acquire and/or sell the Company's securities or to participate in any investment in the Company. Statements in this Press Release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. All of these forward-looking statements are subject to risks and uncertainties that may change at any time, and, therefore, actual results may differ materially from those expected. 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 made by us or on our behalf as a result of new information, future events or other factors.

 

Contact: PR contact:
Gelbert-Kahana
Hagai Schwartz
Senior Financial PR Account Manager
+972 (0)54-4569-120
hagais@gk-biz.com
or
Company contact:
RedHill Biopharma
Adi Frish
VP Business Development & Licensing
+972 (0)54-6543-112
adi@redhillbio.com

 

 

Posted: April 2012

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