Clavis Pharma receives US Orphan Drug Designation for CP-4126 to treat pancreatic cancer

12-Jan-2010 - USA

Clavis Pharma announced that the US food & Drug Administration (FDA) has granted Orphan Drug Designation to CP-4126 for the treatment of pancreatic cancer. The designation follows the equivalent designation given by the European Commission in October last year.

“There is an urgent need for new drugs to treat pancreatic cancer, which currently has very limited treatment options and high mortality. The incentives provided by orphan drug designation in US may accelerate the clinical development of Intravenous CP-4126,” said Geir Christian Melen, CEO of Clavis Pharma. “We are therefore pleased to receive this orphan drug designation for CP-4126, in addition to the European Commission designation received last year.”

The US Orphan Drug Act provides incentives to encourage the development of drugs for rare disease conditions affecting fewer than 200,000 persons in the United States of America (USA). The designation allows for amongst others a possible exemption from the FDA-user fee and assistance in clinical trial protocol design. If CP-4126 receives marketing approval for pancreatic cancer in the USA, the designation will entitle the marketing authorisation holder to exclusive marketing rights for pancreatic cancer for seven years following the approval.

Clavis Pharma entered a partnership agreement with Clovis Oncology Inc., in November last year for the further development and commercialisation of the Clavis Pharma drug candidate, CP-4126, currently in Phase II development in pancreatic cancer. CP-4126 is a novel, patented, lipid-conjugated form of the anti-cancer drug gemcitabine that has the potential to improve treatment outcomes in a large subset of patients with pancreatic cancer and certain other solid tumours.

https://www.bionity.com/en/news/111600/clavis-pharma-receives-us-orphan-drug-designation-for-cp-4126-to-treat-pancreatic-cancer.html