Recombinant hyaluronidase: higher effectiveness and an outstanding safety profile. Fidia’s CEO Giorgio Foresti: “A great industrial and therapeutic asset produced by Italian research: it will contribute to attract investments and improve the patients’ quality of life”.
Abano Terme (Pd), October 21, 2013 – Research by Fidia Farmaceutici, the leading company in the production and marketing of innovative products that have attained levels of excellence in the field of hyaluronic acid, has some new offers in store: Research & Development efforts carried out in the R&D laboratories located in Noto (Syracuse, Sicily), have enabled to study, identify and isolate a hyaluronidase with high enzymatic activity from a non-pathogenic microbial strain. Moreover, it has been possible to reproduce it by a recombinant pathway thanks to non-pathogenic microorganisms (safe) with outstanding safety levels.
This molecule, safe and effective in all its many applications, will be “on display” from October 22 to 24 in Frankfurt, during CPhI Worldwide 2013, the world’s leading pharmaceutical networking event involving all segments of the pharmaceutical industry, from the production of active ingredients and chemicals to the supply of excipients and formulations. Fidia will be present at the exhibition with booth n° 30B18.
“The development of Fidia’s hyaluronidase is an excellent example of a virtuous circle triggered by excellent research,” said Giorgio Foresti, CEO of Fidia Farmaceutici. “Starting from an intuition, we were able to obtain, namely to ‘distillate’, a great asset for our company and for the ‘Made in Italy’ in general. Our new hyaluronidase is a proprietary, patented product that offers, in the first place, high efficacy and a remarkable, innovative safety profile. Just as important will be the future developments of this protein that, in association with other active ingredients, will pave the way for successful partnerships with major pharmaceutical companies in the treatment of high impact diseases. The message is very clear: this is a great industrial and therapeutic asset, developed by Italian research, which will attract investments in order to improve patients’ quality of life. Needless to say, we are proud to take this successful achievement to the upcoming CPhI in Frankfurt”.
Hyaluronidase is a hydrolytic enzyme that breaks down hyaluronic acid into its fundamental constituents (D-glucuronic acid and N-acetyl-D-glucosamine) and bestows on substances a remarkable ability to penetrate tissue. For this reason, hyaluronidase is found at high concentrations, for example, in the mouths of leeches, the poison of snakes, bees and scorpions, as well as in various pathogenic microorganisms such as pneumococcus and streptococcus. Put simply, it could be said that its function is to make the substances it carries unrecognisable to the defence mechanisms of organisms. Hence, its numerous and significant applications in the pharmaceutical field, but also its historic limitations, due to the traditional extraction process from substances potentially hazardous for the human body (with the consequent risk, for example, of transmitting spongiform encephalopathy, so-called “mad cow disease”). The leap forward by Fidia’s R&D lies in its capacity to obtain a recombinant hyaluronidase, with a remarkably high safety profile, from non-pathogenic microorganisms. Fidia’s hyaluronidase, which has the same efficacy as native hyaluronidase of extraction origin, ensures higher purity levels and the absence of risks related with the transmission of viral material.
In addition, hyaluronidase – as a carrier able to promote the dispersion and absorption of the therapeutically active ingredients it delivers – enables avant-garde applications in areas with high socio-economic impact (such as oncology, diabetes, immunodeficiency) and to optimise the efficacy of gene therapies, as well as the subcutaneous bioavailability of biologicals, thereby reducing the use of the intravenous route These are some areas in which hyaluronidase can be used effectively: in pharmaceutical preparations for the treatment of edema, local inflammation, chilblains, haemorrhoids and myocardial infarctions; in ophthalmic surgery, added to the local anaesthetic solution; as a component of a transdermal drug delivery system, to improve the uptake by the body; in cosmetics, to limit adverse reactions or misplacement in filling treatments, even with hyaluronic acid; in oncology, as a tumor cell suppressor; in veterinary practice, used in antibiotic solutions for the treatment of animal diseases, such as bovine mastitis.
Information about FIDIA Farmaceutici S.p.A.
An Italian company recognised at the international level, Fidia Farmaceutici S.p.A., develops, produces and markets innovative products (drugs, medical devices and supplements) with high added value as regards safety and efficacy, focussing the business on the very precise therapeutic areas identified with its brand such as pathologies connected to movement and tissue repair, where it is the world leader in the development of specific products based on hyaluronic acid and its derivatives. More than fifty years of research into this molecule, which has become a corporate asset thanks, in part, to the considerable number of patents obtained, has put Fidia today in pole position in research, product portfolio and global turnover, determined in its leadership on Research & Development and marketing biological products with high technological content. For further information about the Company: www.fidiapharma.com