SANOCHMEMIA Pharmazeutika AG, Vienna, announces that an Austrian patent was been granted covering its development of a new process for the manufacture of highly pure forms of synthetic galantamine and its derivatives.
Following the awarding of this patent on the new process, SANOCHEMIA aims to secure an extension of its worldwide synthesis patent from 2014 until 2027. This new, high-purity form of the product could potentially become the industry standard for this substance. This status would require that any competitors would have to demonstrate the same qualitative standards as those of SANOCHEMIA’s high-purity form. The awaited global patent protection on this process will make it extremely difficult for third parties to attain the new standard of quality.
This patent, PAT 504.663 entitled “Process for the manufacture of highly pure 4a,5,9,10,11,12-hexahydro-6H-benzofuro[3a,3,2-ef]-benzazepine and its derivatives” relates to the representation of the highly pure form of the active pharmaceutical ingredient (API) with regard to metal catalytic residues.
In terms of the stricter regulatory requirements placed on the new generation of APIs, SANOCHEMIA has been able to set new standards through its development of a qualitatively improved manufacturing process for galantamine. Given its expertise in this field, having been successful in producing this naturally occurring substance in both the laboratory and on an industrial scale, SANOCHEMIA has for years been the exclusive supplier to Janssen, a subsidiary of Johnson & Johnson. Synthetic galantamine is used in an Alzheimer’s drug (Razadyne® / Reminyl®) which is marketed worldwide by Janssen-Cilag and Shire Pharmaceuticals.
Following marketing authorisation granted by the FDA in 2001, SANOCHEMIA was able to begin producing synthetic galantamine for the US market. This milestone in the Company’s history gave SANOCHEMIA access, as the exclusive manufacturer, to the world’s most important pharmaceutical market.
The potential of galantamine as an API is, however, far greater than originally assumed. As a result, this substance is being investigated around the world in a range of other therapeutic options. Given its long and proven track record in the area of API research, SANOCHEMIA was among the first to recognise the potential of galantamine. The Company is currently investigating further uses and new therapeutic approaches based on this remarkable substance.
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