Pronova BioPharma
Pronova BioPharma is a Norwegian company. In Denmark it is a bulk manufacturer of
Pronova BioPharma ASA had its roots in Norway's
Lovaza
Pronova won approvals to market the drug, called Omacor in Europe (and initially in the US), in several European countries in 2001 after conducting a three and a half year trial in 11,000 subjects;[4] The company partnered with other companies like Pierre Fabre in France.[5] In 2004, Pronova licensed the US and Puerto Rican rights to Reliant Therapeutics, whose business model was in-licensing of cardiovascular drugs.[6] In that same year, Reliant and Pronova won FDA approval for the drug,[7] and it was launched in the US and Europe in 2005. Global sales in 2005 were $144M, and by 2008, they were $778M.[8] By 17 November 2010, the constituent companies of the OSEAX included Pronova BioPharma.[9]
In 2009, generic companies
Pronovo has continued to manufacture the ingredients in Lovaza, and in 2012, BASF announced it would acquire Pronova for $844 million.[16] The deal closed in 2013.[17]
Research
Pronova BioPharma is a commercial partner in
Brand names
- Lovaz (US)/Omacor (Europe), sold by Woodward Pharma Services, LLC in the US; created and manufactured by Pronova.[18] It was approved in the United States in 2004.[19]
References
- ^ "Store nedskrivninger giver kæmpetab hos Pronova". MedWatch (in Danish). Retrieved 16 March 2015.
- ^ Epax History Page accessed March 31, 2016
- ^ Adis Insight Omega-3 ethylester concentrate Page accessed March 31, 2016
- ^ Pharma Times. March 22, 2001. Pronova wins Omacor approval
- ^ Staff, ICIS Chemical Business. 26 March 2001 Omacor approved
- ^ Amanda Ernst for Law360 November 27, 2007 German Court Invalidates Omega-3 Drug Patent
- ^ VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. October 2005 National PBM Drug Monograph Omega-3-acid ethyl esters (Lovaza, formerly Omacor)
- ^ Staff, Pharmaceutical Technology. Pronova Biopharma Pharmaceutical Production Facility, Denmark. Page accessed March 31, 2016
- ^ "OSEAX Constituents". Oslo Stock Exchange. Retrieved 17 November 2010.
- ^ U.S. patent 5,656,667
- ^ U.S. patent 5,502,077
- ^ Pronova BioPharma May 29, 2012 Press Release: US District Court rules in Pronova BioPharma's favour on Lovaza(TM) patents
- ^ Ryan Davis for Law360 September 12, 2013 Fed. Circ. Nixes Pronova's Patent Win Against Teva, Par
- ^ United States Court of Appeals for the Federal Circuit. Pronova Biopharma Norge AS vs Teva Pharmaceuticals, Inc and Par Pharmaceutical. 2012-1498, -1499. Decided September 12, 2013 Federal Circuit Decision
- ^ Tracy Staton for FiercePharmaMarketing April 9, 2014 Teva puts GSK and Amarin on notice with generic Lovaza launch
- ^ Ryan McBride for FierceBiotech. November 21, 2012 BASF to snap up fish oil drugmaker Pronova BioPharma in $844M buyout
- ^ Eric Palmer for FierceManufacturing. January 22, 2013 BASF lands Pronova making it a top omega-3 maker
- ^ University of Utah Pharmacy Services (August 15, 2007) "Omega-3-acid Ethyl Esters Brand Name Changed from Omacor to Lovaza" Archived March 3, 2016, at the Wayback Machine
- PMID 26681905.