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Antisoma Boosts Pipeline with $52M Xanthus Buy
[May 16, 2008]

Antisoma Boosts Pipeline with $52M Xanthus Buy

(BioWorld Today Via Acquire Media NewsEdge) Also Lands $41M Funding

LONDON - Antisoma plc will take over privately held oncology specialist Xanthus Pharmaceuticals Inc. in an all-paper deal valued at $52.2 million, and simultaneously has raised ?21 million (US$41 million) in a placement to fund the development of its newly-acquired products.

The deal expands London-based Antisoma's clinical portfolio to seven products, with one in registration and two in Phase III. "What we get with this deal is a mature pipeline, which is more diversified, and with reduced risk than either portfolio alone," said Glynn Edwards, CEO of Antisoma.

"We've had a huge response to this transaction. The fundraising was oversubscribed, with one-third coming from Xanthus investors and two-thirds from Antisoma investors," Edwards said in a conference call. He added, "This has given us a fantastic opportunity to take a fully funded program forward."

The acquisition adds three major assets to Antisoma's pipeline: U.S. rights to oral fludarabine, a niche oncology product that is in registration with the FDA; Xanafide, which is currently in Phase III in the treatment of secondary acute myeloid leukemia; and a preclinical program, Flt-3 for the treatment of autoimmune diseases, including multiple sclerosis.

Antisoma is parking two of Xanthus's programs, preferring to be in a position to fully fund seven products over the next two years. The fundraising gives the combined entity cash of about ?67 million, which Edwards claims is one of the strongest balance sheets in the UK sector.

"That's really important in the current funding climate," he said. "None of us know when things are going to pick up. It's possible we are going to have a nuclear winter on the financing front for the next two years."

The new assets will provide opportunities for out-licensing deals and, with potential milestone receipts, could push cash reserves beyond the results of the pivotal Phase III trial of Antisoma's lead program, ASA404. That is licensed to Novartis AG, which said when it started the Phase III trial in lung cancer last month that it hopes to file for approval in 2011. The acquisition of Xanthus and the associated fundraising are conditional on approval by Antisoma's shareholders.

Antisoma's usual model is to license in early stage programs for onward development, so the acquisition of the oral formulation of a marketed drug, fludarabine, is a slightly unusual move. The drug is marketed in Europe, where it has largely replaced the intravenously-administered version.

In the U.S., it has been submitted to the FDA for the second-line treatment of chronic lymphocytic leukemia and has orphan drug status.

Antisoma said that represents an attractive niche opportunity with U.S. sales of the intravenous version reaching $54 million in 2007.

Edwards is far more excited about the acquisition of Xanafide, which is in a pivotal Phase III trial in secondary acute myeloid leukemia. That means it has the potential to be the first drug to gain a specific marketing authorization for the indication, which Antisoma believes will open up the possibility of wider application in other hematological cancers.

The drug, a DNA-intercalating agent with the ability to evade multidrug-resistance mechanisms, has orphan drug status in both the U.S. and Europe and has been granted special protocol assessment status by the FDA, which means the ongoing 350-patient trial will be acceptable for registration. Antisoma is reviewing the trial design and statistical powering, and expects it to complete by the end of 2010/2011.

The third program Flt3, is outside Antisoma's oncology focus, but Edwards said it represents a very attractive outlicensing opportunity. The inhibitors have shown a high level of efficacy in animal models. For example, in standard models of multiple sclerosis, they halt demyelination, and there is evidence of remyelination. "Xanthus has built up a series of novel inhibitors that are orally available. We need to do more work to generate lead candidates, but if we can generate leads with this kind of profile, the program will be of value to large pharma," he said.

Another Xanthus product, P2045, has completed Phase I trials in non-small-cell lung cancer, and Antisoma currently is deciding on the next steps on the program, while development of two other products, Clomet and Symadex will be halted. Edwards said, "It's not that these are bad drugs; it's the luxury of being able to prioritize things."

Overall, he said, "Xanthus is a very good fit, giving a more mature pipeline and diversifying and reducing the overall risk." It also will provide critical mass with Antisoma maintaining Xanthus's facilities and staff in Cambridge, Mass. n



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