NovaThera and Pharming to develop new bioactive materials

NovaThera and Dutch biotech company Pharming have pooled their resources to develop a new generation of bioactive materials aimed at the delivery of therapeutic transgenic proteins.

These new materials are based on a combination of the two companies' technologies - TheraGlass (a non-ceramic glass) and recombinant human proteins.

TheraGlass is a novel bioactive material, which interacts with the body's tissues to stimulate cell growth and provide vital anti-bacterial, structural or regenerative proteins. NovaThera claims it is non-toxic and is reabsorbed and excreted through the bodies natural metabolic processes.

The utilisation of TheraGlass in the delivery of Pharming's recombinant human (rH) proteins, including rH C1-inhibitor, rH fibrinogen, rH collagen and rH lactoferrin, can be used in a number of applications such as soft tissues regeneration, bone repair and device coatings, including cardiac stents, said the two firms.

The two companies claim that the new material called TheraGlass-rH has "the potential to extend the power of therapeutic transgenic technologies into the arena of medical devices and materials technologies," and that it can be used for the localised delivery of therapeutic proteins.

However, the initial focus is on the development of stents containing materials able to release recombinant human proteins such as collagen, fibrinogen, lactoferrin and C1 inhibitor.

The potential of transgenically produced proteins, such as recombinant proteins in milk, for the production of biopharmaceuticals is enormous with sales expected to reach $12bn (€10bn) by 2012 according to recent market report by Kalorama.

The main reason for this growth is that the costs involved in transgenic technology are much lower compared to the production of biopharmaceuticals in bacterial or mammalian cell culture facilities or through cell lines.

Interest for this new technique surged last June when the European regulators gave their initial approval for the world's first drug made from a genetically engineered protein, after an initial refusal in February.

"The first transgenic protein products are now moving towards regulatory approval," said Dr. Francis Pinto, CEO of Pharming.

Pharming is developing a new drug based on a recombinant C1 inhibitor - made in the milk of transgenic rabbits - for patients with a rare genetic disorder called hereditary angioedema. The drug in currently under review with the European Agency for the Evaluation of Medicinal Products (EMEA).