Ondansetron is the active pharmaceutical ingredient used in the prescription drug Zofran to treat chemotherapy-induced nausea. In 2003, Cerenex Pharmaceuticals and GlaxoSmithKline reported $1.1 billion of US Zofran sales.
The development of an extended release form of Ondansetron is the second application of the company's amino acid technology to safely improve solubility and availability of insoluble and poorly soluble compounds, such as raloxifene.
Indeed, the Company's first filing for a provisional patent of its amino acid technology was for raloxifene. Raloxifene is used to prevent and treat osteoporosis, which is a $900+ million market.
Provisional patents allow the filer to establish a priority filing date for the disclosed invention and, if a conventional new patent application is filed at a later date, to receive the benefit of the earlier (provisional) filing date while maintaining the full term of the new patent.
SCOLR Pharma reported positive results from animal studies utilizing its patented amino acid platform. Results showed a significant increase in the total bioavailability and absorption rates with SCOLR Pharma's novel CDT formulations for both raloxifene and ondansetron. The company will continue to advance the development of CDT raloxifene towards submission of an NDA filing at the end of 2005.
SCOLR's amino acid platform is based on a matrix containing a granulated active ingredient, ionic resins or gums, and amino acids. Upon hydration the hydrophobic drug reacts with the amino acids to form weak complexes that are more soluble and can leach out of the matrix.
In commenting on the latest animal studies, Stephen Turner, vice president, Chief Technology Officer, was adamant that the company was not going to get carried away. He said: "We are cautiously optimistic about the initial results from the amino acid platform animal studies, especially in light of the key fact that we achieved such solid results on both formulations."
"The maximum plasma concentrations (Cmax) were double that of the control formulations and the absorption rate of the novel Ondansetron formulation was significantly faster as compared with the control."
SCOLR are set to go ahead with additional studies designed to provide further insight into the capabilities of the amino acid patent with a view to enhance availability.
"While we still have additional animal and human testing to undertake and ultimately FDA filings to submit on compounds utilizing the amino acid patent, we believe that this platform holds truly significant promise for SCOLR Pharma," concluded Turner.
Should SCOLR's amino acid platform actually improve both solubility and bioavailability of insoluble and poorly soluble compounds, SCOLR could be sitting on a potential goldmine as the platform addresses a large, important and potentially lucrative segment of the drug delivery marketplace.
Stephen Turner, chief technology officer at SCOLR emphasised the magnitude of this research by saying: "If we continue to demonstrate successful results, we believe that the future commercialisation of products from this single proprietary CDT technology could ultimately add as much or more value to the company as our other patented technologies combined."
"We have only begun to scratch the surface of these two technologies."
SCOLR's R&D underlies a growing need for an effective treatment option to better manage the side effects that result from many chemotherapeutic products. There is currently no FDA-approved treatment to prevent or reduce neuropathy caused by chemotherapy drugs.
However, the problem of developing such treatments is exacerbated by fact that chemotherapy side effects, their severity and the frequency of episodes differ from person to person.
Japanese pharmaceutical company, Takeda, recently entered into collaboration with Bionumerik Pharmaceuticals, with the intention of marketing Bionumerik's chemoprotective drug Tavocept (dimensa).