Court opens door for new PD vaccine

Pharmaq won the right to sell its Alpha Ject 1 PD vaccine in Norway and the UK by successfully challenging a 2014 ruling that gave MSD (Intervet) an extended patent covering PD vaccines until 2020.

Other manufacturers will also be able to enter the market.

In its ruling, the Norwegian Appeals Court considered the comparative efficacy and stated that "[the] Court of Appeal's overall assessment of the research data presented and the other evidence is that there are significant differences in vaccine efficacy, and that Pharmaq's vaccine in actual practice has a significantly better effect against SAV-3 infection than Intervet's vaccine. The differences are consistent and systematic".

No surprise

Pharmaq president Morten Nordstad says: "This decision is no surprise, we always knew our vaccine was significantly more effective for pancreatic disease in salmon in Norway.”

The vaccine became available last week and has already been adopted by two Norwegian operations, Fister Smolt and Grieg Seafood Rogaland.

Pharmaq sales director Bernt Martinsen says: “We expect to take a slice of the market from MSD, but it is not possible to say anything about how much at the present time.

“Vaccination season does not fully start before June.”

Exagerration

Petter Frost, managing director of MSD Animal Health Innovation AS, responded by pointing out that Pharmaq’s

‘one hit’ application method which allows the vaccine to be delivered on its own or with other vaccines required special equipment. “Functionality there remains to be seen and it is possible it will go just fine, but to produce it as a technological advance is perhaps an exaggeration when an everything-in-a-bottle vaccine already exists,” he says.

“The 'new' vaccine, apparently fully developed 8-9 years ago, was in field trials in Norway many years ago, but was for unknown reasons not finally approved until 2015, as we know, after a process simplified documentation requirements.”

Frost adds: “It is true that the Court of Appeal in autumn 2016 considered it likely that the virus isolate in Pharmaq monovalent PD vaccine may be better in the field against SAV3 infection than the isolate in MSD AH monovalent vaccine. It was here that the disagreement was and still is.

“There are currently, as far as we know, still no scientific data to support the theory that the virus isolate is vital. On the contrary we are well aware of the variables that actually mean something in relation to vaccine efficacy, after many years of continuous development.”