by Youness Bousenna
PARIS, Mar 16 (APM) - France will finally participate in the international Phase III trial evaluating a triple therapy combining experimental drug VX-445 in cystic fibrosis, Vertex said in a written message to APM, reversing its earlier decision.
Vertex has been under fire since mid-February for deciding to deprive France of a clinical trial of another CF drug in the face of a stalemate in pricing negotiations for Orkambi (lumacaftor + ivacaftor) (APMHE 56860
Patient associations had spoken of “blackmail” and MP Olivier Véran had qualified the pharma's decision as as “unacceptable”, but Vertex had previously maintained its position (APMHE 57092
The company told APM on Thursday: “Vertex confirms today that the initiation of the clinical trial for our triple combination with VX-445 is proceeding in France. This study VX-445-102 is a global, randomised, placebo-controlled Phase III trial for patients studying VX-445 triple combination in patients with cystic fibrosis (CF) aged 12+ with F508del/minimal function."
Today Vertex confirms the setting up in France of clinical trial VX-445-102 of a new triple therapy in the treatment of cystic fibrosis,” the group told APM on Thursday.
This is a randomised Phase III trial evaluating the new corrector for the CFTR VX-445 gene in a triple combination in cystic fibrosis patients aged 12 and over heterozygous for the F508del mutation and a copy of a mutation ensuring minimal function only.
Economic daily Les Echos had said on Wednesday that Vertex would reverse its decision. Widely quoted in the article, chair of French pharma industry body Leem Patrick Errard appeared to have an important conciliatory role, looking to “maintain serene dialogue with the authorities”.
“I merely said in Les Echos that I was hopeful everything would be sorted out,” Errard told APM on Wednesday. Asked about his possible role as mediator, he said he had played “role as chairman of Leem” whose duty it is to be present “every time a member needs support”.
“I don't have to tell you what my role is or is not," he added. As for the reaction prompted by the U.S. pharma’s choice, he said “we can only be sad when such things happen”.
On the substance of the case, he said it was “an indirect manifestation of the systemic attractiveness problems we face,” adding that he is “anxious to see innovations reach the market, whether they come from Vertex or elsewhere”.