8-7-2014 Italian biopharmaceutical group Dompé is

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Italian biopharmaceutical group Dompé is accelerating clinical development of recombinant human nerve growth factor (rhNGF) drops for a range of eye diseases, including neurotrophic keratitis (NK), retinitis pigmentosa (RP), dry eye syndrome and glaucoma.

In 2012, Dompé successfully developed the only human variant of NGF available for clinical assessment, produced in Escherichia coli and designed specifically for the treatment of ocular diseases.

Preliminary data from the phase I/II REPARO study, the first international clinical trial evaluating rhNGF eye drops in NK, show corneal healing in more than 70 per cent of masked subjects at eight weeks, with observed reductions in lesion size and symptom improvements (Table 1).1
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NGF is an endogenous neurotrophin discovered initially as a molecule that stimulates the survival and maturation of developing neurons in the peripheral nervous system. Data from an uncontrolled study show that topically applied exogenous NGF restored corneal integrity in patients with corneal neurotrophic ulcers, with best-corrected visual acuity progressively improving during treatment and follow-up (range, 3 to 12 months).2

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In January 2011, Anabasis signed a licensing and co-development agreement with Dompé, which acquired a 49% stake in Anabasis and patent rights for the use of NGF to treat neurotrophic keratitis (NK). By the end of 2011 Dompé - thanks to its considerable experience in the manufacturing of recombinant proteins - has successfully achieved the development of a stable process suitable for industrial production of recombinant human NGF (rhNGF) at its biotechnological plant based in L’Aquila (Italy), which operates in compliance with GMPs and is authorized to produce recombinant proteins for human use.

Today, under the terms of the agreement, Dompé has become the sole shareholder of Anabasis by acquiring remaining 51% of its share capital for an undisclosed amount, including an immediate upfront and subsequent milestone payments related to the development and commercialization of NGF in pathological conditions.

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Amgen and Dompe Biotec to Combine Commercial Operations in Italy

Single Company for Amgen Products in New Arrangement

ZUG, Switzerland. (Oct. 4, 2007) -- Amgen, the world's largest biotechnology company and Dompe Biotec, S.p.A., its co-marketing partner in Italy, announced today that they have agreed to combine their current commercial operations with respect to Amgen products under a single company to be called Amgen-Dompe S.p.A.

Based in Milan, Amgen-Dompe will be organised as an Amgen affiliate and comprise current Amgen and Dompe staff plus current Amgen R&D staff in Italy.

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