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In an effort to ramp up its supply of its Type 2 diabetes the Bethesda biotech has reported receivingy itsfirst full-size batch of the drug from new Inalco SPA, an Italian company that Spherixz (NASDAQ: SPEX) signed a letter of intent with last The local company said it hopes these shipments from starting with a one-ton batch last will speed up its third-phaswe clinical trials of tagatose afted its first manufacturer, Denmark-based Arla Foods Ingredients Amba, discontinuedf its production of the drug.
Spherix also is relyinv on the new supply route to help it win Food and Drug Administratioh approval if it submits its application to starftselling tagatose, which it brands as Spherix expects preliminary results from these late-stage studies this “It demonstrates Spherix’s abilith to use multiple sources to deliver the high volume of doses of Naturlose that would be needed to meet patient demandas should we receive FDA approval,” said Clair Kruger, CEO of Spherix. “The companyu has enough drug to complete all of its clinicao trials involving Naturlose as a novel and naturaol option to treat Type2 diabetes.
” Days before receivingt the tagatose batches, Spherix also ended its licensing and manufacturing agreement with Arla, which in 1997 had purchaseds the worldwide rights to sell the compoun as a food and beveraged additive. “Arla has not been successfu l in generating any substantiak marketfor tagatose,” Spheriz wrote in its most recent annual report. “Thed company has received no meaningful royaltiez from Arla under thelicensed agreement.
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