Vertex cancels CF trials in France

French cystic fibrosis patients may not receive access to treatments under development by Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) after the company canceled French sites for three planned Phase III trials slated to evaluate combinations of the biotech's CF transmembrane conductance regulators (CFTRs).

Although Vertex did confirm the cancellations to BioCentury, the company declined to offer an explanation. Three French CF associations told BioCentury that Vertex’s decision came after the company reached a stalemate in reimbursement negotiations for its CF drug Orkambi ivacaftor/lumacaftor with the French government. The groups -- Overcoming Mucoviscidosis, the Grégory Lemarchal Association and the French Cystic Fibrosis Society -- provided BioCentury with an excerpt from what they described as an official explanation sent by Vertex on Feb. 5 to French laboratories that had previously been retained to participate in the trials, which said that despite more than 18 months of "good faith" negotiations there has been no resolution on the reimbursement of Orkambi and that therefore the pathway for CF patients in France to gain access to the drug is "unpredictable" and conducting the trials "would raise false hope."...