PEGylation specialist Neose Technologies says that it has now refocused its R&D focus since the demise of its lead drug candidate last year, and will concentrate on two drugs for neutropenia and haemostasis in 2008.
CEO George Vergis said that, having recently discontinued its development of PEGylated erythropoietin candidate NE-180, the firm has now turned to GlycoPEG-GCSF, a long-acting white blood cell growth factor that will compete with Amgen's Neulasta (pegfilgrastim), and its programme on GlycoPEGylated clotting factors.
Vergis said that Neose's development of the neutropenia treatment GlycoPEG-GCSF, which is being carried out in partnership with Germany's BioGeneriX, achieved significant progress in 2007. He went on to say that the agent had elicited a dose response and demonstrated favourable safety, tolerability and pharmacokinetic profiles in one of the Phase I trials completed to date.
A second study examining GlycoPEG-GCSF indicated that, in addition to comparable safety and tolerability to Neulasta, GlycoPEG-GCSF treatment elicited a 30 per cent improvement in neutrophil count compared with the market-leading drug.
Vergis said that the results provide a suitable foundation for further development, and added that they had increased Neose's confidence in GlycoPEG-GCSF's ability to compete in the $4.4bn neutropenia market. BioGeneriX is expected to begin large-scale Phase II trials of the drug in the next few months.
He also said in a conference call that Neose's work in the field of GlycoPEGylated haemostasis had made significant progress last year. In collaboration with partner Novo Nordisk, the firm is continuing to move forward with its factor VIII and IX programs.
Vergis added that data presented at the 2007 meetings of both the American Society of Haematology and International Society on Thrombosis and Haemostasis indicate that the firm's PEGylation technology significantly prolongs the half-life of recombinant factor VII, thereby improving its bioavailability.
Fourth quarter revenue cuts 2007 losses
Neose's chief financial officer Brian Davis was also upbeat about the company's standing. He reported that, although the firm net loss for 2007 at $28.5m was $1.4m higher than the deficit in 2006, the reported year had included a $6.6m decrease in its fair value warrant liability in contrast with a $7.3m gain the previous year.
Mr Davis added that the company's net loss for the fourth quarter was $3.2m, or $0.06 per share, compared to a net loss of $9.5 million or $0.29 per share in the comparable period the year earlier. This benefited from a more than tripling in revenues to $2.7m for the final three months of 2007.
In his outlook for 2008, Mr Davis said that the firm's net cash utilization would "be approximately $15m," adding that "our existing cash expected proceeds from collaborations [primarily with Novo Nordisk and BioGeneriX], some license agreements and interest income should be sufficient to meet our operating and capital requirements at least into the third quarter of 2009."