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Nov 20, 2009

Newron Raises CHF 7.9M to Help Progress Clinical Trials and Pipeline Development

  • Newron Pharmaceuticals raised CHF 7.9 million ($7.75 million) through a private placement with institutional investors. The CHF 18.00 per share price represented a 3.23% discount to the closing price of the company’s shares yesterday. The new shares represented just over 7% of Newron’s total share capital before the issue, and 6.71% of the total share capital after the capital increase.

    Newron said it will use the funds to fund its pipeline development and clinical trials. “While safinamide is progressing into completion of final studies to allow for regulatory filing, ralfinamide is undergoing a potentially pivotal trial as a first-in class treatment for a blockbuster indication and is, as yet, unpartnered,” commented Luca Benatti, Newron CEO. “We intent to develop our pipeline with advancing preclinical and earlier clinical candidates.”

    Newron’s lead candidate, safinamide, is an orally administered, alpha-aminoamide derivative in development as an adjunctive therapy for Parkinson’s disease. The drug is being partnered with Merck Serono, under a 2006 agreement giving the latter exclusive worldwide rights to develop, manufacture, and commercialize safinamide in Parkinson disease, Alzheimer disease, and other therapeutic applications.

    In June the companies reported results from the first Phase III safinamide trial. The data confirmed that adding safinamide to other Parkinson disease therapies, including levodopa, significantly increased patients’ total “On” time without increasing dyskinesia. Two additional Phase III trials in Parkinson disease patients are also in progress.

    Ralfinamide is pain relief drug candidate believed to mediate its potent analgesic effect through the inhibition of sodium channels, including Nav 1.7, as well as N-type calcium channels and NMDA receptor. Earlier this year Newron intiated a Phase IIb/III trial evaluating ralfinamide in patients with neuropathic lower back pain.

    In October the company returned the rights to a Phase I-stage low molecular weight heparin compound, HF0420, to its inventors. The compound originally came to Newron as part of the company’s acquisition of Hunter-Fleming in 2008. With potential applications in certain CNS diseases, HF0420 had been licensed to Hunter-Fleming by its inventor at Loyola University Medical Center, Chicago. Under the new agreement the Loyola University researchers will continue development of the drug, and pay Newron milestones and royalties on successful development and commercialization of the compound in any indication.

    Newron also acquired a more advanced compound, HF0220, through the Hunter-Fleming buyout last year. HF0220 is a potential first-in-class disease-modifying agent that has already shown good safety and tolerability in a Phase II trial in Alzheimer’s disease patients.

     



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