New firm to tackle poor solubility head on

Formac Pharmaceuticals, a spin-off company from the University of Leuven, raised $1.7m to launch its business and plans to distinguish itself by using proprietary oral drug delivery technologies to deal with poorly soluble molecules whilst maintaining drug stability. While there are many companies riding the drug delivery wave, most focus primarily on controlled release formulations, leaving poorly soluble molecules to be tackled by a much smaller group of firms. The drug delivery technologies that are currently used to deal with poor solubility essentially revolve around polymer-based systems. However, these technologies tend to result in problems with poor stability, as once molecules are dispersed from a polymer base, they are able to diffuse back into agglomerates causing solubility to drop again. Thanks to this problem, there are only a handful of drug products on the market using these kinds of systems. The Formac technologies, however, can deal with poor solubility whilst keeping the stability of the drug at a level that makes it a viable, marketable product, says the company's CEO, Laurens Theunis. The firm has four proprietary drug delivery technologies, three focussing on immediate release formulations and the fourth on controlled release. The flagship technology is CMO, a silica-based carrier system that accelerates the release of poorly soluble compounds. Drug molecules are loaded onto the mesoporous silica material, and when the drug-silica matrix enters the gastrointestinal system it attracts water molecules, which then rapidly force the drug molecules out into solution. Formac plans to use its technology platform in house to develop improved delivery forms of generic products and branded drugs nearing patent expiration, and currently has two products in development due to enter the clinic in mid 2008. At present, the company is focusing on small molecule drugs, but Theunis revealed that branching into larger molecules may not be so far away, with the firm currently evaluating a new programme not based on small molecule compounds. However, the company is also providing access to its technologies for external firms to apply to their own drugs in development, and despite only officially launching the company today, Theunis told in-PharmaTechnologist.com that Formac already has contracts with a US "big pharma"​ and a Belgian company, with a third contract due to be signed today. "Every pharma company, small or big, always has compounds are put on hold because of solubility,"​ said Theunis. "Over 40 per cent of the compounds in development are poorly soluble or have some issues with solubility. And that causes a lot of frustration for companies because they're sitting on really potent and selective molecules, but if you can't get them into the body they're kind of useless." ​ As such, the company believes there is a significant market for its technologies and expertise, and according to Theunis is "convinced​" its systems can help solve compound solubility problems. Despite the increasing prominence of biologic drugs and large molecule therapeutics in pharmaceutical R&D efforts, the quantity of potential drugs sitting on the shelf unused due to solubility issues could provide a previously unavailable revenue stream for pharma firms struggling to fight the onslaught of generic competition and patent expiries. "Today the market is still based on small molecules and it will be for quite a long time,"​ says Theunis. "Of course antibodies will be there, and of course proteins will come into the game more and more, but the market for small molecules is still the biggest and the problems there in terms of solubility are huge." ​