BOTHELL, Wash., Feb. 14, 2012 /PRNewswire/ -- SCOLR Pharma, Inc. (OTCQB: SCLR) announced today that RedHill Biopharma Ltd., a license partner that had previously obtained the exclusive worldwide rights to use SCOLR's patented technology to develop a new version of ondansetron, will conduct a bioequivalence trial in Canada. Both the US Food and Drug Administration (FDA) and Health Canada have reviewed the protocol for the study and have no objections.
RedHill submitted an Investigational New Drug application (IND) to the FDA and a Clinical Trial Application (CTA) to Health Canada seeking permission to compare the bioequivalence of its product, which it calls RHB-102, to Zofran® (ondansetron), which is manufactured by GlaxoSmithKline. Zofran® is an anti-emetic drug (i.e. for prevention of nausea and vomiting) that is administered several times per day. RHB-102 is a once-daily controlled release tablet formulation of ondansetron, a serotonin 5-HT3 receptor antagonist.
RedHill Biopharma said publicly, based on advice received from its regulatory consultants, that subject to certain conditions, the study may be considered a pivotal trial (Phase III-equivalent) that may be used by the Company for a marketing application to the FDA. RedHill Biopharma estimated the development costs of RHB-102, until submission of an application to the FDA, will total $2-3 million.
Stephen Turner, President and CEO of SCOLR, said: "We believe that the RedHill Biopharma announcement again affirms the potential value of SCOLR's patented technology in developing new pharmaceuticals that improve on existing drugs. We look forward to a successful outcome on this study and a promising ongoing relationship with RedHill."
About SCOLR Pharma:
Based in Bothell, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company focused on applying its formulation expertise and patented CDT® platforms to develop novel prescription pharmaceutical, over-the-counter (OTC), and nutritional products. Its CDT® drug delivery platforms are based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. For more information on SCOLR Pharma, please call 425-368-1050 or visit http://www.scolr.com/.
About RedHill Biopharma Ltd.:
RedHill Biopharma is an emerging Israeli biopharmaceutical company focused primarily on development and acquisition of late clinical-stage new formulations of existing drugs. The Company's current product pipeline includes a once-daily formulation of a leading congestive heart failure and high blood pressure drug, a once-daily formulation of a leading radiotherapy induced nausea and vomiting prevention 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 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.
Forward looking statements:
Any statements made in this press release that relate to future plans, events or performance are forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward looking statements include statements regarding RedHill Biopharma's development of a drug formulation, conduct of a bioequivalence studies and future plans related to the development and marketing of the drug formulation. Factors that could cause these forward-looking statements to differ from actual results include delays by RedHill in commencing or completing the bioequivalence study, adverse clinical results or adverse regulatory determinations related to the study, competitive factors related to the drug product, economic factors including RedHill's ability to finance the development and commercialization of the product, and other risks and uncertainties discussed in the company's periodic reports on Form 10-K and 10-Q and other filings with the Securities and Exchange Commission. SCOLR Pharma, Inc. undertakes no obligation to update or revise any forward-looking statements.
SCOLR Pharma, Inc.
SOURCE SCOLR Pharma, Inc.