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GlaxoSmithKline plc

Drug Names(s): omega-3-acid ethyl ester, Eskim (Italy), Omacor, TAK-085, Lotriga (Japan), Zodin

Description: Lovaza is the first omega-3 fatty acid formulation approved as a prescription drug in the US, with an indication to lower triglycerides. It is derived from fish oil, and its primary components are ethyl esters of eicosapentaenoic acid (EPA) anddocosahexaenoic acid (DHA).

The mechanism of action of Lovaza is not completely understood, and may include: inhibition of acyl CoA:1,2-diacylglycerol acyltransferase, increasedmitochondrial and peroxisomal b-oxidation in the liver, decreased lipogenesis in the liver,and increased plasma lipoprotein lipase activity. Lovaza may reduce the synthesis oftriglycerides in the liver because EPA and DHA are poor substrates for the enzymesresponsible for TG synthesis, and EPA and DHA inhibit esterification of other fatty acids. Gene transcription factors may also be involved in the drug's mechanism, including PPAR, SREBP-1, and ChREBP.

Deal Structure: Reliant and Pronova
In 2004, Reliant acquired the U.S. rights to Lovaza from Pronova BioPharma. Reliant is required to make certain payments to Pronova based on the achievement of predetermined milestones and to pay a royalty on all future sales of the product. Reliant is also obligated to purchase their total requirements for the active ingredient of Lovaza from Pronova (15-year supply agreement through 2020). The total of the API supply price and royalties is in the high teens as a percentage of the wholesaler price of Lovaza. Under the terms of the agreement, Reliant has exclusive marketing and distribution rights in the United States and Puerto Rico and maintain the NDA.

Pronova and Takeda
In November 2005, Takeda and Pronova entered into a License- and Supply Agreement for Omacor. Under the agreement, Pronova has granted Takeda an exclusive development, marketing and distribution right in Japan. Takeda will pay to Pronova an up-front amount,...See full deal structure in Biomedtracker

Partners: Takeda Pharmaceutical Company Ltd Sigma-Tau S.p.A. Societa Prodotti Antibiotici S.p.A. BASF AG Kuhnil Pharmaceutical, Co. Ltd.

Lovaza News

Pink Sheet GSK buying Reliant

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