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UPDATE 3-GSK partner Pronova settles drug case with Apotex
March 30, 2011 / 6:56 AM / 7 years ago

UPDATE 3-GSK partner Pronova settles drug case with Apotex

* 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 (Reuters) - 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 alongside cholesterol.

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) ($1=.6257 pound)

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