Antisoma of the UK is ending the year on a high and has been reflecting on the significant progress its key pipeline products are making.

The company has issued an interim statement noting that its lead compound and potential blockbuster ASA404 is making good progress “in the capable hands of our partner, Novartis”. A 1,200-patient Phase III trial (ATTRACT-1) is testing the drug as a first-line treatment for non-small cell lung cancer and should it produce positive data, “we expect applications for marketing licences in 2011”, Antisoma says.

A second Phase III trial (ATTRACT-2), including 900 patients receiving second-line treatment for NSCLC, will begin shortly and Novartis is also considering options for developing the drug in other cancer types. Antisoma said that in addition to the $100 million already received from the Swiss major, it has “a strategically important option to co-commercialise ASA404 in the USA”.

The London-headquartered firm also mentioned AS1413, a novel chemotherapy drug that was added to the pipeline through the acquisition of Xanthus earlier this year. Along with ASA404, “this drug has become a key asset in the company's portfolio,” Antisoma says, and a Phase III trial is ongoing in secondary acute myeloid leukaemia under a special protocol assessment from the US Food and Drug Administration.

The Xanthus purchase also gave Antisoma certain rights to fludarabine for chronic lymphocytic leukaemia. It is currently available in the USA only as an intravenous infusion but the firm has US rights to the oral formulation of the drug and have submitted a marketing application to the FDA.

The company expects a decision on its approval “some time between now and the end of June”. The oral drug is marketed by Bayer outside the USA as Fludara and it has gained a substantial share of the fludarabine market since launch.

Given this, “we believe the drug represents an attractive niche sales opportunity in the USA”, Antisoma said, and it has initiated talks with a number of potential partners. Chief executive Glyn Edwards said “we are finishing 2008 in a strong position, with a broad and maturing portfolio of cancer drug candidates, a valuable partnership with Novartis and significant cash resources at our disposal".