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SCOLR Pharma, Inc. (DDD)'s Partner Announces Successful Results in Pivotal Bioequivalence Trial and Plans for a Pre-NDA Meeting


4/19/2012 10:50:01 AM

BOTHELL, Wash., April 19, 2012 /PRNewswire/ -- SCOLR Pharma, Inc. (OTCQB: SCLR) announced today that RedHill Biopharma Ltd., its license partner in developing an extended release version of the popular drug ondansetron (GlaxoSmithKline's brand name Zofran®), has reported successful results in a pivotal bioequivalence trial and intends to meet with the Food and Drug Administration to discuss an approval pathway.

RedHill said its draft final report demonstrates that the trial met its objectives and the FDA's criteria for establishing bioequivalence between RedHill's once-daily formulation of ondansetron, called RHB-102, and GlaxoSmithKline's Zofran®, a leading, approved antiemetic drug administered three times per day. Reported sales of Zofran® and its generic derivatives have global sales of approximately $400 million.

If approved, RHB-102 would be the first prescription drug using SCOLR Pharma's patented technology for extended release formulations.

Stephen Turner, President and CEO of SCOLR, said: "We are pleased that RedHill achieved success in its pivotal clinical trial. We wish them continued success as they advance the extended-release version of ondansetron towards FDA approval and commercialization."

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 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.

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, the results of a bioequivalence trial, anticipated future plans related to approval of the drug formulation by the Food and Drug Administration, and the development and marketing of the drug formulation. Factors that could cause these forward-looking statements to differ from actual results include adverse regulatory determinations related to the trial, 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.

Contacts:
Investor Relations:
SCOLR Pharma, Inc.
425.368.1050

SOURCE SCOLR Pharma, Inc.



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