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Posted On: 10/20/2004
SCOLR and UPM Work on 12-Hour Dosage Release Tablet
| SCOLR Pharma Secures Contract Manufacturer for Pseudoephedrine Tablets for Use in Q1 '05 Human Trials |
| Seattle - BELLEVUE - SCOLR Pharma, Inc. announced today that it had entered into an agreement with UPM Pharmaceuticals for the manufacture of the CDT-based extended release 12-hour pseudoephedrine tablets to be used in SCOLR Pharma's pending human clinical evaluations targeted to commence in Q1, 2005. SCOLR Pharma previously announced an agreement with UPM Pharmaceuticals to manufacture CGMP CDT-based 12 hour extended release Ibuprofen for its current human clinical testing in Canada. Under the new agreement, UPM Pharmaceuticals will be responsible for manufacturing the CGMP clinical and U.S. product registration batches of CDT(R) Pseudoephedrine. The Company also announced encouraging preliminary results from its initial review of interim data from the first two of five dosing periods for CDT 12-hour extended release dosage form of Ibuprofen. A comprehensive analysis of data derived from the completed study is expected to be available in November. The Company cautioned that final test results could vary significantly from the preliminary data. Initial human testing of the Company's first CDT-based Ibuprofen formulations began on September 24th and SCOLR Pharma has completed four of five planned subject dosing periods. There are currently no extended release formulations of Ibuprofen approved for use in North America. This initial CDT Ibuprofen human study involves ten subjects comparing the plasma levels of two CDT-based formulations of 12-hour Ibuprofen to currently marketed immediate release tablets. The study is intended to provide data for the Company to make any necessary formulation and clinical design refinements ahead of a larger scale human study needed for U.S. regulatory approval. The Company expects to continue to advance the development of CDT Ibuprofen towards submission of an NDA filing in the summer of 2005. SCOLR Pharma also reported that it is accelerating internal development of Raloxifene (used to prevent and treat osteoporosis). The development of CDT Raloxifene embodies the technology of the Company's third issued patent which addresses insoluble and poorly soluble compounds -- a new, important and potentially lucrative market segment. It is estimated that up to approximately 40% of new chemical entities are poorly soluble. In 2003, Eli Lily (NYSE:LLY) reported $922 million in global Evista(R) sales representing 12% growth from 2002. Evista is Eli Lily's immediate release Raloxifene product for osteoporosis utilizing different solubilization technology. SCOLR Pharma expects to commence human trials in Q2, 2005, and estimates it will file an ANDA in late 2005 for an immediate release product. The Company will continue to pursue internal development activities for previously identified formulations of Niacin and Tramadol only after it identifies corporate partners. Based in Bellevue, Washington, SCOLR, Inc. is a specialty pharmaceutical company leveraging formulation expertise and its patented CDT(R) platform to introduce distinctive and novel OTC products, prescription drugs and dietary supplements. SCOLR's CDT drug delivery platform provides distinctive products with tangible benefits for the consumer and competitive commercial advantages for licensees. For more information on SCOLR, please call 425.373.0171 or visit http://www.SCOLR.com/. |