FDA meeting confirms Orexo regulatory submission of OX219 NDA on track

“It is very good news for Orexo. Our meeting with FDA was constructive and we received a general confirmation of the approaches we have taken in developing OX219 for the US market”

A meeting with the US regulatory agency FDA held on July 17 has confirmed that the Swedish pharmaceutical company Orexo (STO:ORX) is on track with its preparation for a regulatory submission of a new drug approval (NDA) for its medicine for treatment of opioid dependency, OX219.

The meeting was a scheduled pre-NDA consultation and was undertaken to review critical regulatory issues, including adequacy of the clinical program and pre-clinical documentation, as well as the planned documentation on the product including the chemistry, manufacturing and control (CMC) plans, prior to submission of the actual documentation.

The feedback Orexo appreciated was an understanding that the two pivotal clinical studies for OX219 were adequate to support a regulatory submission and that no further clinical data were required pre-approval. The agency also concurred with pre-clinical documentation compiled by Orexo and did not request further data prior to submission of the NDA.

As previously communicated, Orexo is currently awaiting completion of certain technical stability data for OX219 during Q4-2012, related to transfer of the production process to the designated US manufacturing site. Based on the feedback received during the pre-NDA meeting, Orexo is confident that it can advance a part of this program, and now projects completion of the needed technical documentation during Q3-2012. Once these data have been achieved, an update of the projected submission date will be published.

"It is very good news for Orexo. Our meeting with FDA was constructive and we received a general confirmation of the approaches we have taken in developing OX219 for the US market," says Anders Lundström, CEO of Orexo. He adds:

"And it is also very good news for the two million people, who suffer from dependency of opioid pain killers in the US. Many are not treated today and I do think that we can offer a good alternative to the current treatment."

This supports the ambition of Orexo to be the first company to offer an alternative to the drug Suboxone ®, which reached sales of 1.3 billion USD in 2011 and has exhibited a steady growth of more than 15 per cent annually over the past years. Orexo estimates potential peak sales of 3-500 million USD annually of its new drug.