Humira gets the nod in Europe

Peptech-licensed monoclonal antibody Humira, produced by pharma Abbott, has been granted a positive opinion for the treatment of rheumatoid arthritis in Europe.

"This is good news. It opens up a very good market. Humira will be the first big one for us in Europe, so we see the market as being substantial, very good," said Peptech MD Stephen Kwik.

Humira will become the first human monoclonal antibody approved in Europe for RA, and the first tumour necrosis factor alpha (TNF-a ) antagonist approved with an indication for use with methotrexate or as monotherapy.

The European Medicines Evaluation Agency (EMEA) granted a positive opinion on Humira, which is the precursor to full approval and consequent sales, said Kwik. He said the next stage of approval, authorisation, is usually issued within 90 days of approval.

Abbott has a non-exclusive license to use TNF-a intellectual property in Humira, and once authorisation is approved, Peptech can expect to receive a second milestone payment from Abbott.

"Once that has happened we can start sales. [RA treatment] Remicade has been selling very well in Europe, sales are increasing spectacularly. We are hoping, and expecting, that HUMIRA sales will go the same way," said Kwik.

Remicade (Infliximab) is a similar TNF-neutralising drug marketed by J&J subsidiary Centocor.

When questioned about ongoing negotiations with Centocor concerning its as-yet unsigned license for Peptech's IP, Kwik said negotiations were continuing, and that an outcome would be arrived at some time.

"Negotiations with Centocor for licensing on Remicade are progressing. We have always been confident they will be resolved in our favour," he added.