Pronova BioPharma is a Norwegian company. In Denmark it is a bulk manufacturer of omega-3 products with a manufacturing plant in Kalundborg. It was acquired by BASF in 2014.[1]

Pronova BioPharma ASA had its roots in Norway's codfish liver oil industry. The company was founded in 1991 as a spinout from the JC Martens company, which in turn was founded in 1838 in Bergen, Norway.[2] Pronova developed the concentrated omega-3-acid ethyl esters formulation that is the active pharmaceutical ingredient of Lovaza.[3]

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 Teva Pharmaceuticals and Par Pharmaceutical made clear their intentions to file Abbreviated New Drug Applications (“ANDAs”) to bring generics to market, and in April 2009, Pronova sued them from infringing the key US patents covering Lovaza, US 5,656,667 (due to expire in April 2017), US 5,502,077 (exp March 2013). Subsequently, in May 2012, a district court ruled in Pronova's favor, saying that the patents were valid.[10][11][12] The generic companies appealed, and in September 2013, the Federal Circuit reversed, saying that because more than one year before Pronova's predecessor company applied for a patent, it had sent samples of the fish oil used in Lovaza to a researcher for testing. This event thus constituted "public use" that invalidated the patent in question.[13][14] Generic versions of Lovaza were introduced in America in April 2014.[15]

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 MabCent-SFI.

Brand names

References

  1. ^ "Store nedskrivninger giver kæmpetab hos Pronova". MedWatch (in Danish). Retrieved 16 March 2015.
  2. ^ Epax History Page accessed March 31, 2016
  3. ^ Adis Insight Omega-3 ethylester concentrate Page accessed March 31, 2016
  4. ^ Pharma Times. March 22, 2001. Pronova wins Omacor approval
  5. ^ Staff, ICIS Chemical Business. 26 March 2001 Omacor approved
  6. ^ Amanda Ernst for Law360 November 27, 2007 German Court Invalidates Omega-3 Drug Patent
  7. ^ 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)
  8. ^ Staff, Pharmaceutical Technology. Pronova Biopharma Pharmaceutical Production Facility, Denmark. Page accessed March 31, 2016
  9. ^ "OSEAX Constituents". Oslo Stock Exchange. Retrieved 17 November 2010.
  10. ^ U.S. patent 5,656,667
  11. ^ U.S. patent 5,502,077
  12. ^ Pronova BioPharma May 29, 2012 Press Release: US District Court rules in Pronova BioPharma's favour on Lovaza(TM) patents
  13. ^ Ryan Davis for Law360 September 12, 2013 Fed. Circ. Nixes Pronova's Patent Win Against Teva, Par
  14. ^ 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
  15. ^ Tracy Staton for FiercePharmaMarketing April 9, 2014 Teva puts GSK and Amarin on notice with generic Lovaza launch
  16. ^ Ryan McBride for FierceBiotech. November 21, 2012 BASF to snap up fish oil drugmaker Pronova BioPharma in $844M buyout
  17. ^ Eric Palmer for FierceManufacturing. January 22, 2013 BASF lands Pronova making it a top omega-3 maker
  18. ^ 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
  19. ^ Ito MK (2015). "A Comparative Overview of Prescription Omega-3 Fatty Acid Products". P & T. 40 (12): 826–857. PMC 4671468. PMID 26681905.
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