Naturlose

Treatment for Diabetes Type 2

Inalco SpA to Supply D-tagatose

Spherix D-tagatose to be Supplied by Inalco SpA

BETHESDA, Md., April 30, 2008 /PRNewswire-FirstCall/ -- Spherix Incorporated announced today that it has signed letters of intent with Inalco SpA, an Italy-based manufacturer of bulk pharmaceutical ingredients, to supply a portion of the D-tagatose used in the Spherix Phase 3 clinical trial of the unique sugar as a treatment for Type 2 diabetes. Inalco will also provide cGMP (current Good Manufacturing Practice) production batches of D- tagatose for the Spherix New Drug Application (NDA) and will hold a Drug Master File (DMF). The Phase 3 clinical trial is scheduled to be completed at the end of 2009. If the clinical trial demonstrates efficacy of D-tagatose as a treatment for Type 2 diabetes, Spherix plans an initial purchase of 100 metric tons of D-tagatose from Inalco and a long-term supply agreement. Financial terms were not disclosed.

"This is a significant accomplishment toward achieving our goal of putting in place all the elements needed for a complete NDA submission," said Claire Kruger, CEO of Spherix.

Spherix is currently seeking approval from the US Food and Drug Administration (FDA) in order to market D-tagatose nationwide as a drug. If granted US approval of its NDA, Spherix plans to also apply for approval of D-tagatose to treat diabetes in the European Union (EU).

Certain statements contained herein are "forward looking" statements as defined in the Private Securities Litigation Reform Act of 1995. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied. Factors that could cause actual results to differ materially from those expressed or implied include, but are not limited to, those discussed in filings by the Company with the Securities and Exchange Commission, including the filing on Form 8-K made on October 10, 2007.

Spherix's mission is to create value and increase shareholder wealth through innovations that benefit our clients and the human condition. Spherix offers innovations in biotechnology, and provides technical and regulatory consulting services to biotechnology and pharmaceutical companies.

Posted: April 2008

Naturlose (tagatose) FDA Approval History

View comments

Hide
(web3)