Germany’s GPC Biotech has completed its submission to the US Food and Drug Administration for satraplatin for the treatment of patients with hormone-refractory prostate cancer who have failed prior chemotherapy.

In a rolling submission, the firm has presented the third and final portion of its New Drug Application – the clinical section – which is based primarily on data from the SPARC Phase III trial which involved 950 patients and showed highly statistically significant results for prolonging progression-free survival. The FDA now has up to 60 days to determine whether the application meets the regulatory requirements for filing and will also let GPC know if priority review status has been granted to satraplatin.

Describing the submission of the NDA as a major milestone in the corporate history of GPC,” chief executive Bernd Seizinger, said the firm will work closely with the FDA during the review process “to move the application forward as expeditiously as possible.” The news sent the company’s stock up 2.6%.

He added that, if approved, satraplatin has the potential to become an important new treatment option for advanced prostate cancer patients “who today have very little hope” and noted that the firm is currently building up its commercial infrastructure in the USA to prepare for launch. GPC signed a co-marketing deal with US drugmaker Pharmion for satraplatin just over a year ago.

If the drug gets accepted for review, GPC will make a $4 million milestone payment to the USA’s Spectrum Pharmaceuticals, which licensed the drug to the German firm in 2002 while Spectrum will in turn give the UK’s Johnson Matthey $500,000 in shares for the complete submission and $500,000 in cash upon FDA acceptance of the filing.