Novel approach to drug insolubility strengthens PolyTherics patent estate

Polytherics Ltd, a biopharmaceutical spin-out company from Imperial College London and the London School of Pharmacy that specialises in the targeted application of polymers to biopharmaceuticals, has announced the grant of a European patent on the application of polymer complexation technology to improve drug efficacy.

The technology represents a novel method of formulating poorly soluble drugs as solid dosage forms while also providing a means of reducing their systemic toxicity.

Many drug candidates in development fail to fulfil their therapeutic potential owing to poor solubility and toxic side effects. Liposomal dosage forms can address some of these problems but such formulations have been limited to a small number of active agents, remain costly and are difficult to handle, requiring specialist preparation and use.

PolyTherics' polymer complexation technology, the subject of this new European patent, provides a much simpler solution - it creates drug-polymer complexes in a controlled fashion, generating drug preparations with demonstrably improved solubility profiles which are therefore far more cost-effective than existing drug formulations.

One successful application of the technology has been for the fungicide Amphotericin B. PolyTherics has teamed up with the Drugs for Neglected Diseases initiative (DNDi) and has licensed an improved solubility formulation of Amphotericin B for the treatment of Leishmaniasis (see Editors Notes) in India. PolyTherics has retained exclusive rights to develop the drug for anti-fungal indications and intends to pursue this opportunity independently.

PolyTherics is a company focused on improving both existing and novel protein and small molecule-based drugs, to enhance their performance, longevity and delivery. PolyTherics has developed a proprietary technology, TheraPEG, for the targeted modification of protein pharmaceuticals to improve product quality and pharmacokinetic properties. The Company already has five partnerships in progress for the development of TheraPEG-based products.

Dr Keith Powell, Chief Executive Officer of PolyTherics, said: "We are delighted with the grant of our European patent, which marks an important milestone for PolyTherics. We have already successfully proven this technology by creating an improved solubility formulation for Amphotericin B and we now aim to develop other drug formulations for wider application. Our expanding intellectual property portfolio gives us considerable scope to apply our technologies to both protein and small molecule products and develop drugs with improved efficacy."

Founded in 2002, PolyTherics is a spin-out company from Imperial College London and the London School of Pharmacy that is dedicated to using biomedical polymers to optimise pharmaceuticals for the treatment and cure of disease.

PolyTherics has developed and patented an innovative approach to PEGylation, known as TheraPEG, to prolong the half-life of proteins for development as biopharmaceuticals for use in drug development. PEGylation is the process by which Polyethylene Glycol is attached to proteins and peptides to modify their pharmacokinetic properties. PEGylation increases the residence time of substances administered into the bloodstream, thereby potentially reducing the frequency of treatment, decreasing side effects and improving patient compliance. For example, PEGylated interferon used to treat Hepatitis C can be injected once per week, rather than three times per week in non-PEGylated form.

PolyTherics received initial funding of £850,000 from the Wellcome Trust (now Catalyst Biomedica) and the Bloomsbury BioSeed Fund. The Company secured a further investment of £2.3 million from Imperial Innovations Group plc, Longbow Capital LLP and The Capital Fund in June 2007.