SANOCHEMIA Pharmazeutika AG, Vienna, listed in the Prime Segment of the Frankfurt Stock Exchange (ISIN AT0000776307) announces that a US patent has been granted for the manufacture of PVP hypericin formulations and their use in the diagnosis and treatment of bladder cancer. Given this patent protection in the world’s largest pharmaceutical market, further development steps linked to SANOCHEMIA’s novel photosensitiser for photodynamic diagnosis (PDD) and, in due course, possible photodynamic therapy (PDT) of bladder cancer can now be fast tracked.
New therapeutic concepts
The awarding of US patent 10/527016 entitled “Preparation of hypericin bonded with poly-N-vinylamides" provides patent protection of these formulations and their use until at least 2020. SANOCHEMIA has developed a manufacturing process for the premium quality active pharmaceutical ingredient (API) and the formulation, and intends to use this for the manufacture of the API and the finished product at its pharmaceutical facility in Neufeld, Austria
One important advantage offered by the patented formulation is its tumour selectivity and a possible means of treating such carcinomas with minimal side effects.
“The granting of this patent is one key aspect of this extremely promising project and a clear confirmation of our competence in the development of innovative products,” remarks CEO of SANOCHEMIA, Herbert Frantsits. “Yet again we have reinforced our position as a specialty pharmaceuticals company. In line with our corporate strategy, adequate patent protection is an absolute must for commercial success.”
High potential for SANOCHEMIA’s key project
“The US patent exclusivity on the formulation and the use of this API is an important milestone in the clinical development of the substance for the US and Europe – the two main target markets for SANOCHEMIA’s bladder cancer diagnostic,” Frantsits adds. Annually, around four million cystocopes are performed in the US and Europe. The global turnover in the area of bladder cancer diagnostics currently lies at around USD 625m, and is forecast to grow at 11%. Furthermore, 50% of all fatal tumours affect organs which can be investigated using fluorescence endoscopic diagnosis methods.
PVP hypericin: earlier and improved diagnosis of bladder cancer
Bladder cancer is the third most common form of cancer worldwide. In Austria, around 2,500 to 3,000 new diagnoses take place every year, with the number of cases unfortunately rising. Around 500 Austrians die of bladder cancer every year. The final diagnosis takes place by means of a cystoscopy. If the tumour is discovered at an early stage of development and promptly followed by appropriate treatment, then patients have good chances of survival.
PVP hypericin, a pigment which selectively accumulates in tumour cells and which, due to its fluorescent properties, makes these easily visible when exposed to blue light, is a promising development candidate for the early diagnosis of bladder cancer. It enables tumours to be detected easier, earlier and more reliably than previously – whereupon these can be surgically removed. This, in turn, represents a major leap forward in the early recognition and treatment of bladder cancer.
Further national and regional patent applications in association with the internationally published patent specification (WO01089576) are being sought under the European Patent Convention.
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