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SCOLR Pharma Inc DDD (AMEX)
Sector: Healthcare Industry: Biotechnology & Drugs
SCOLR Pharma, Inc., incorporated on October 12, 1994, is a specialty pharmaceutical company. The Company uses its Controlled Delivery Technology (CDT) platform to develop pharmaceutical, over-the-counter (OTC), and nutritional products. The CDT platform is based on four drug delivery technologies for the programmed release of solid oral medications and nutritional products. The Company is also engaged in the development of CDT-based extended release formulations of ibuprofen, gabapentin, pseudoephedrine, phenylephrine and ondansetron, as well as immediate release formulations of raloxifene and fenofibrate.
The Company's CDT drug delivery technologies enable it to formulate tablets or capsules that release their active agents predictably and programmably over a specified timeframe of up to 24 hours. The CDT technology platform is designed to reduce the frequency of drug administration, improve the effectiveness of the drug treatment, ensure greater patient compliance with a treatment program, and reduce side effects or increase drug safety. In addition, SCOLR Pharma's amino-acid technology can be incorporated into oral formulations to increase the solubility characteristics of previously non-soluble and sparingly soluble drugs without employing costly micro-milling and coated particle technologies.
The Company has developed multiple private label nutritional products incorporating its CDT platform that are sold in national retailers, such as Wal-Mart, Rite-Aid and Trader Joe's and provide it with royalty revenue. In October 2005, the Company entered into an alliance with a subsidiary of Perrigo Company for the manufacture, marketing, distribution, sale and use of certain dietary supplement products in the United States. The Company will receive royalty payments based on a percentage of Perrigo's net profits derived from the sales of products covered by its agreement.
On October 20, 2005, the Company entered into a strategic alliance with a subsidiary of Perrigo Company. Perrigo is a global healthcare supplier and a manufacturer of OTC pharmaceutical and nutritional products for the store brand and contract manufacturing markets.
Ibuprofen
In December 2005, Wyeth Consumer Healthcare, a division of Wyeth, licensed the worldwide rights to use the Company's CDT platform for products containing ibuprofen. Wyeth markets its ibuprofen products under the trade name Advil. Pursuant to the agreement, Wyeth paid SCOLR Pharma an upfront fee and agreed to make additional payments upon achievement of specified milestones. The agreement provides for payment of royalties based on a percentage of Wyeth's annual net sales of ibuprofen based products utilizing CDT technologies that are commercialized under the agreement. Due to the license arrangement with Wyeth, the Company suspended development of an extended release ibuprofen/pseudoephedrine combination formulation.
Pseudoephedrine and Phenylephrine
SCOLR Pharma completed human testing of its 12-hour, CDT-based pseudoephedrine tablets in 2005 and expects to file an Abbreviated New Drug Application (ANDA) submission with the United States Food and Drug Administration (FDA) during 2006. The Company suspended development of a 24-hour extended release pseudoephedrine formulation pending an evaluation of changes in the market. In addition, SCOLR Pharma intends to pursue development of an extended release formulation of phenylephrine, an ingredient used as a substitute for pseudoephedrine in decongestant products.
Raloxifene and Ondansetron
SCOLR Pharma completed an initial human clinical evaluation of a CDT-based immediate release raloxifene formulation during 2005. The results of the first trial supported the advancement of an additional formulation and human clinical work. Raloxifene is used to prevent and treat osteoporosis. Additional studies are planned for 2006 to provide further insight into the capabilities of the amino acid patent and the Company's ability to enhance bioavailability, as well as to support development of a raloxifene product. The Company completed pilot bioavailability testing of its CDT-based ondansetron formulation in Canada during December 2005.
Fenofibrate and Gabapentin
SCOLR Pharma has initiated development work on an immediate release formulation of fenofibrate. The Company has also initiated development work in an extended release version of gabapentin.
The Company's competitors include Alza Corporation, Biovail, Inc., Penwest, Skyepharma PLC, Elan, Flamel, Impax Laboratories, Inc., Labopharm and KV Pharmaceuticals, Inc. |
