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Antisoma to divest oral fludarabine in first half

This article was originally published in Scrip

Antisoma is on track to sell its oral fludarabine by the end of the first half, boosting its cash position until mid-2011, it says in its interim management statement.

The company said the deal would recover a "substantial part" of the £26.8 million it paid for Xanthus last year. Antisoma acquired the US rights to oral fludarabine through the Xanthus acquisition (scripnews.com, May 23rd, 2008).

Antisoma told Scrip that it was close to concluding an auction process for the drug and had narrowed down the number of potential buyers.

Genzyme owns Fludara, which is available in the oral and intravenous presentations and is the same formulation as Antisoma's oral fludarabine, after it bought the brand from Bayer last month.

However, Genzyme only markets the oral version of Fludara in Europe, as Xanthus had already bought the US rights to oral fludarabine in the US.

Genzyme's acquisition of Fludara raises the possibility that it may buy Antisoma's oral fludarabine after the US FDA approved it as a second-line treatment for chronic lymphocytic leukaemia in December.

The oral formulation has advantages over the iv presentations, including convenience of dosing and potentially greater cost-effectiveness.

Antisoma said that it wanted to sell the drug outright and get cash up front rather than find a development partner. Although it was an attractive asset, its sales potential was in the tens of millions of dollars, rather than in the hundreds of millions, it added.

extra cash

Antisoma had cash of around £53 million at the end of 2008 which is sufficient to fund product development until mid-2010. However, the divestment will provide funding beyond the release of key data, it said.

The company's potential blockbuster ASA404, a tumour-vascular disrupting agent in development with Novartis, is in two pivotal Phase III trials in non-small cell lung cancer.

Data from ATTRACT-1, which is evaluating the drug in previously untreated patients, is expected in 2011 and will support filings during the year. Meanwhile, ATTRACT-2, which is evaluating patients who have received treatment with other drugs, should be completed during 2011.

Novartis, which has the worldwide rights to ASA404, is also investigating the drug in metastatic breast cancer.

Antisoma also expects Phase III data for AS1413, a novel chemotherapy drug for secondary acute myeloid leukaemia being evaluated under a US special protocol assessment, in late 2010/early 2011. The company believes that worldwide sales could reach hundreds of millions of dollars as there are no drugs currently licensed for secondary AML.

The company announced today that it has finished recruiting patients for Phase II trials of its aptamer drug AS1411 in renal cancer, with initial data expected later this year. The drug has also shown promise in a Phase II trial in AML. Antisoma has also completed recruiting 110 patients for a Phase II trial of its antibody AS1402 for breast cancer.

Analysts at Piper Jaffray said a deal for oral fludarabine should alleviate concerns about the company's cash position and its ability to focus on the pipeline and delivery timelines.

"With a stronger cash balance, we believe the stock will become more attractive to a larger audience. The AS1411 Phase II data would provide the icing on the cake, if positive."

Antisoma's share price closed at30.50 pence on the London Stock Exchange yesterday, up from the opening price of 29 pence.

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