Pharmaxis reimbursement talks delayed in France

Pharmaxis (ASX:PXS) will scale back its resources committed to launching cystic fibrosis treatment Bronchitol in France, blaming delays reaching an agreement on reimbursement.

The company will cut the number of personnel and contractors working on Bronchitol in the market from six to one and will scale down its marketing investments.

The marketing resources will be reallocated to campaigns in markets where Bronchitol has launched - Germany, the UK, Denmark and Australia - and to securing access to more European markets.

“Negotiations with the French Healthcare Products Pricing Committee (CEPS) have been protracted and, given the current economic climate and prevailing healthcare policy in France, I do not believe we are yet close to agreement on an acceptable price for Bronchitol,” Pharmaxis CEO Gary Phillips explained.

“Our pricing has already proved acceptable to some of the world’s most rigorous reimbursement authorities in the UK (NICE) and Australia (PBAC) and I remain optimistic that we will eventually reach agreement in France.”

Pharmaxis gained marketing approval for Bronchitol in Europe in April 2012 and received approval for a UK NHS listing six months later.

In Australia, Pharmaxis secured a PBS listing in March 2012. Last month, the listing was simplified to replace the lung function improvement requirement with a more flexible set of clinician and patient-determined criteria.

After the US FDA recommended that Pharmaxis conduct another clinical trial for Bronchitol before it can be approved in the US, the company decided to seek a marketing partner to conduct the remainder of clinical development and commercialisation in the nation.

Pharmaxis (ASX:PXS) shares were trading 3.57% lower at $0.135 as of around 12.30 pm on Thursday.