Clovis Oncology Inc (NASDAQ:CLVS) is wasting no time in raising funds for its US application for ovarian cancer drug rucaparib.
Just hours after the shares had soared on news the drug, to be called Rubraca, had sailed past its endpoints in a final phase trial, the Boulder, Colorado-based firm said it would seek US$250mln.
The money will fund Rubraca’s launch in the US and in Europe once approval is received from the European Medicines Agency.
Rubraca is one of a new type of cancer treatment called PARP-inhibitors that block the enzymes that allow damaged cancer cells to repair themselves, causing them to die.
It will compete with Tesaro’s (NASDAQ:TSRO) Zejula and AstraZeneca’s (LON:AZN) Lynparzra in a rapidly growing market.
Of 564 patients treated in the ARIEL3 trial, the timespan without the disease recurring doubled to 10.8 months on average, while those in remission saw reduced tumours and in some cases the disease disappearing.
Rucaparib has already received approval from the US Food and Drug Administration for cases of defective BRCA genes, seen as a key cause of ovarian and breast cancers.
This latest trial success though means the label can be broadened, which may quadruple the potential number of patients.
The new labelling will be as a second line treatment initially and then as maintenance treatment for patients who have gone into remission.
Clovis will submit the drug with new labelling to the FDA within the next four months.
Patrick Mahaffy Clovis’s chief executive said yesterday: “These results reinforce the potentially foundational role of rucaparib in the management of advanced ovarian cancer, as demonstrated by both investigator review and the blinded independent central review.”