BioWorld Today Correspondent

LONDON – A new Anglo-Russian biopharmaceutical company has been formed with $300 million from the Russian government, matched by a further $300 million from investors in the London-based private equity firm Celtic Pharma Holdings.

Pro Bono Bio arrives on the stage as a fully formed entity, which is poised to launch its first product in the UK, having spent three years acquiring and developing technologies.

Rusnano did not invest at the start, but has been involved for a while, Pro Bono Bio's Chief Operating Officer Michael Earl told BioWorld Today. "They were around and aware of what we were doing at the beginning, and although not one of the original investors, they soon came on board."

As a state-owned private equity/venture capital firm, Rusnano has a brief to promote the development and application of nanotechnologies across industrial sectors, including medicine.

Earl added that discussions with Rusnano, "Showed there was an overlap of interests, in terms of what they do with their fund and what we wanted to do."

Specifically, that will involve Pro Bono Bio in building a manufacturing facility near Moscow, and a sister plant in the UK, complying with European Medicines Agency regulations. It will also require Pro Bono Bio to carry out some of its clinical trials in Russia.

Pro Bono Bio is in the late stages of commercializing three products based on its nanotechnology platform Sequessome, with the first of these, Flexiseq – a pain killer for use in osteoarthritis – due to be launched in the UK this month.

Flexiseq does not contain any pharmaceutical ingredients, being made up of phospholipid vesicles that are able to penetrate the skin and reach damaged cartilage, absorbing pro-inflammatory compounds and providing localized relief of joint pain.

Earl said that Sequessomes are too large to get into the vasculature, but after sequestering pro-inflammatory compounds, they are absorbed and removed via the lymph system.

Flexiseq is formulated as a topical gel, and because it does not contain any pharmaceutical ingredients, can be licensed as a medical device. Its mode of action allows it to be used in combination with orally delivered anti-inflammatory drugs. A European trial in 698 patients comparing Flexiseq, celecoxib (Celebrex) and placebo, completed in 2009, showed Flexiseq was as effective as celecoxib in treating osteoarthritis pain. Earl said Flexiseq will be available over the counter, but Pro Bono Bio will also be seeking an agreement for it to be reimbursed.

Following behind Flexiseq are two other products based on the Sequessome technology. Exoseq will deliver the phospholipid vesicles to the upper dermal layers of the skin, sequestering prostaglandins involved in the inflammatory cascade that lies behind eczema and seborrheic dermatitis. The product is due to be launched at the beginning of 2012.

The third product Rossoseq, which delivers the vesicles into the lower dermal tissue to treat psoriasis, is due to be launched before the end of the year.

The technology originates in Germany, and at present the products are manufactured there. Following behind these is a preclinical program of long-acting blood-clotting factors for treating hemophilia, which are based on a delivery technology in-licensed by Pro Bono Bio.

Earl said the two products "have gone through extensive preclinical development and are now ready for the clinic."

Pro Bono Bio is also working on anti-infectives, where the lead product is targeting chronic Clostridium difficile infections.

Pro Bono Bio hopes to stand out for its humanitarian ethos, which will see the company distribute its products free of charge in Africa, where it will donate an amount of goods matching paid-for sales in developed markets.

With Pro Bono Bio now poised to start bringing in revenues, Earl said the aim is to list the company in London and Moscow in the next three to four years, providing investors with the possibility to make an exit.