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GPC tries to stay positive after satraplatin blow

By Anna Lewcock, 08-Aug-2007

Related topics: Materials & Formulation, Drug delivery systems, Tabletting, coating & ancillary equipment

GPC Biotech announced its second quarter financial results this week, trying to put a brave face on its outlook despite the recent disappointments regarding its lead oral cancer drug.

With revenues for the half year dropping 35 per cent to €7.5m compared to last year, the figures do not make for happy reading - though the company puts this decreased figure down to lower development funding from partner Pharmion, and the expiration of research collaborations with Atlanta Pharma.

R&D costs were pretty much stable compared to last year, though general and administrative costs jumped a hefty 129 per cent to €23.4m. These inflated costs were mainly thanks to the company's efforts to establish a strong sales and marketing force in the US, in anticipation of gaining approval for the firm's lead candidate satraplatin.

Unlike other platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound that can be given as capsules that patients can take at home.

The company had high hopes for gaining US approval of the product and a potential launch as early as the end of this year, and as such had put a great deal of effort into building up a sales force to commercialise the new drug.

Unfortunately, last month the company was forced to withdraw its new drug application (NDA) for the drug, after a US advisory committee recommended that the US Food and Drug Administration (FDA) hold off on approval of the drug until the results of a final survival analysis from the company's clinical trial are in.

Potentially delaying approval by up to a year, this was a major blow to the company and its satraplatin plans.

To make matters worse, the company is now also being sued for allegedly making false public statements relating to the prospects of satraplatin, and thereby artificially inflating the price of GPC Biotech securities.

Satraplatin had been submitted for the treatment of hormone-refactory prostate cancer (HRPC) in patients for whom prior chemotherapy has failed, and according to earlier analyst estimates, represented a billion dollar opportunity.

Back in June, analysts Piper Jaffray forecast peak sales of €515m in HRPC alone, with the potential to exceed $1bn in all indications.

The trip-up in approval, and the associated potential delay in kicking off sales and marketing actvities in a team that is already set up in the US, is therefore likely to have unpleasant side-effects on the company coffers.

Despite this, the company has tried to remain upbeat in its outlook, citing recent cost-cutting measures that are expected to save around €10m, and payments from Pharmion and Japanese partner Yakult Honsha that total over €13m.

"Despite the recent setback, we remain in a solid financial position and believe we have sufficient cash under current expectations to carry us through to a potential regulatory submission based on the overall survival analysis," said CEO Bernd Seizinger.

Revenues for the year are expected to be in the range of €17-19m, with the company expecting to end 2007 with approximately €60m in cash and equivalents.

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