Spherix D-tagatose to be Supplied by Inalco SpA
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BETHESDA, Md., April 30 /PRNewswire-FirstCall/ -- Spherix Incorporated
(Nasdaq: SPEX) 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.
Spherix's Internet address is http://www.spherix.com.
SOURCE Spherix Incorporated
Investor Relations of Spherix Incorporated, +1-301-897-2540, info@spherix.com
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