* Apotex can sell generic Lovaza in U.S. from Q1 2015
* Patent litigation continues with Teva and Par
* Fish oil-derived Lovaza seen a $1 bln drug for GSK in 2011
* Pronova shares up 18 percent
(Adds comment from analyst & Pronova executive, updates shares)
By Ben Hirschler
LONDON, March 30 Norway's Pronova BioPharma
PRON.OL, which supplies the omega-3 heart medicine Lovaza to
GlaxoSmithKline (GSK.L), settled a U.S. patent row with generics
company Apotex, sending Pronova shares sharply higher.
The deal lessens the threat of competition to the fish
oil-derived drug by delaying the arrival of a cheaper rival and
may pave the way for similar agreements with other generics
firms lining up copycat versions of the blockbuster product.
The settlement gives Apotex the right to sell a generic
version of Lovaza in the United States from the first quarter of
2015, or earlier depending on certain circumstances, Pronova
said on Wednesday. Other terms were not disclosed.
Lovaza is covered by various U.S. patents that have been
challenged by cut-price generics manufacturers. They expire from
2013 to 2025 and there had been fears among investors that
generics could arrive as early as 2013.
Pronova is still involved in a U.S. court case with Teva
Pharmaceutical (TEVA.TA) and Par Pharmaceutical, but there may
now be scope for scope for further deals.
"Given that one deal has been struck, I think there will be
pressure on the other generic players to come up with agreements
with Pronova as well," said Navid Malik, an industry analyst at
Matrix Corporate Capital.
GSK holds the U.S. marketing rights for Lovaza and the
prescription drug generated sales of 530 million pounds ($847
million) for the British company in 2010. It is expected to be a
$1 billion seller for GSK in 2011, according to consensus
forecasts compiled by Thomson Reuters Pharma.
Pronova -- a world leader in producing pharmaceuticals from
fish oil, which is a rich source of omega-3 fatty acids -- is
dependent on revenue from sales of Lovaza to GSK.
Hamed Brodersen, Pronova's vice-president for investor
relations and communication, said the deal with Canada's Apotex
"sends a signal" to Teva and Par.
"Whether it means that we are actually going to get an
agreement or that the trial will continue and we must wait a
court order, it is too early to say," he said.
Shares in the Norwegian company jumped 18 percent to 10.10
crowns by 0955 GMT. GSK was up 0.9 percent.
Pronova's stock hit 22 crowns 12 months ago but it has since
fallen heavily on worries about patents and concerns over a
rival medicine from Amarin (AMRN.O).
Amarin's new heart pill AMR101 produced strong results in a
pivotal clinical study in November, giving the Nasdaq-listed
Irish company ammunition to take on Lovaza.
Both drugs contain heart-protecting omega-3 fatty acids and
are designed to treat patients with high levels of
triglycerides, a blood fat that contributes to heart disease
Importantly, AMR101 does not seem to increase levels of
low-density lipoprotein (LDL), or "bad cholesterol" -- a side
effect of Lovaza.
Lovaza is currently the only omega-3 derived prescription
drug approved in Europe and the United States.
(Additional reporting by Mikael Holter in Oslo; Editing by Kate
Kelland and David Holmes)