US drug delivery company SCOLR has been knocked back by the decision by one of its partners not to go ahead with a project based on its technology. But the company insists it will go it alone in tackling the pharmaceutical sector.
The partner - referred to only as a Fortune 100 company - has given SCOLR back all rights to the product, which was based on the US firm's CDT (Controlled Delivery Technology) platform.
The first supplement using this technology - a nutraceutical product based on the joint health ingredients glucosamine and chondroitin - was introduced in Canada in 2002, and is now sold in more than 6,000 US retail outlets including Wal-Mart, Rite Aid and GNC stores.
Since then, the company has launched a number of other CDT-based nutritional products to provide near-term revenues. But its long-term strategy has been to reposition itself in the pharmaceutical sector, as it sees more commercial potential in using CDT for pharmaceuticals.
"Health supplement application of CDT will continue to provide increasing near-term revenue. The home-run potential, however, lies in the OTC and prescription drug applications," commented analysts at Cohen Independent Research Group in a recent note on SCOLR.
Shrugging off the disappointment, SCOLR said that the partner's decision was unrelated to the efficacy of the CDT platform in achieving controlled release of the active drug.
"In addition to having the contracted formulation returned to us, we are now developing our own growing portfolio of formulations," said Daniel Wilds, the company's chief executive.
SCOLR plans to initiate human studies on a 12-hour CDT formulation of the painkiller ibuprofen later this year. The firm is also working on CD versions of the decongestant pseudoephedrine, tramadol (an analgesic) and niacin (vitamin B3). Together these four compounds currently generate $3.5 billion (€2.9bn) in annual sales.
Clearly, the loss of its partner means that SCOLR could yield greater rewards by taking on more of the development burden for its portfolio, licensing projects out at a later stage, but also hikes its risk. It places much more emphasis on the success of its in-house portfolio, which will be funded using the proceeds of a $10.4 million placement completed in February.
SCOLR's CDT platform is in fact three separate technologies. The first is a so-called 'dual polymer' format, developed specifically for the controlled release of highly soluble active ingredients, such as propranolol, diltiazem, verapamil, theophylline and metformin.
The second relies on a phenomenon called 'salting out' to liberate an active drug alongside electrolytes from a polymer matrix. The primary benefit of this approach is its low production costs compared to rival technologies, such as complex osmotic pump or multi-layer tablets.
Finally, SCOLR has an amino acid platform, deigned to improve the solubility of hydrophobic (poorly-soluble) drugs. This is based on a matrix containing a granulated active ingredient, ionic resins or gums, and amino acids. Upon hydration the hydrophobic drug reacts with the amino acids to form weak complexes that are more soluble and can leach out of the matrix.
SCOLR maintains that the CDT platform is capable of delivering capability of delivering precise amounts of active ingredients over a programmable time period, and do away with the initial 'burst' of release and slow tailing off that is seen with rival technologies.