Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based Sorrento Therapeutics has received exclusive rights to Cynviloq (marketed as Genexol-PM in South Korea and other countries) in Australia, Canada and Mexico from a South Korean firm Samyang Biopharmaceuticals (Samyang).
Subscribe to our email newsletter
The company already has exclusive rights of Cynviloq from Samyang in the US and the 27 countries of the European Union (EU).
Sorrento president and chief executive officer Henry Ji said the company has made significant progress carving out the clinical and regulatory path for the Cynviloq program, and it continues to build on the global commercial opportunity for this product.
"With these expanded rights, Sorrento now covers the vast majority of its targeted Cynviloq markets," Ji said.
Cynviloq is a next-generation branded paclitaxel formulation for the treatment of metastatic breast cancer, non-small cell lung cancer, pancreatic cancer, and other solid tumors.
In July 2013, the FDA Division of Oncology Products 1 agreed that the data available are supportive for a 505(b)(2) pathway, using Abraxane and Taxol as the Reference Listed Drugs, to pursue approval.
The company intends to start a single Bioequivalence trial required for registration, in the first quarter of 2014.