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Latest (December 6, 2012) News On K-V Pharmaceutical And Orphan Drug Makena

December 7, 2012

       According to, K-V Pharmaceutical on Wednesday, December 5, 2012, asks US Bankruptcy Judge Allan L. Gropper to approve a $60 million settlement with Hologic Inc, to end the fight over the rights, title, and interest for orphan drug Makena. 

       A hearing on the settlement is scheduled for December 26, 2012. K-V Pharmaceutical must pay Hologic Inc by December 31, 2012. 

       A review of the historical events between K-V Pharmaceutical and Hologic Inc : 

–    Hologic Inc develops Makena & sells rights to Makena in 2008 to K-V Pharmaceutical 

–    K-V Pharmaceutical files for Chapter 11 protection on August 4, 2012, because “its inability to realize full value on its biggest product, Makena.” Also, a $45 million milestone payment is due on a related rights agreement with Hologic Inc  

–    Hologic Inc (a K-V Pharmaceutical creditor) asks a New York bankruptcy judge on September 5, 2012, to lift the automatic stay against K-V Pharmaceutical so it can pursue its rights with respect to its 1st lien on K-V Pharmaceutical’s biggest asset, Makena, saying its value is declining (Chapter 11Case No: 12-13346 (ALG), Filed 09/05/12, US Bankruptcy Court Southern District of New York). Hologic Inc says K-V Pharmaceutical’s mismanagement is decreasing Makena’s value & wants to reacquire its rights to the drug. K-V Pharmaceutical owes Hologic Inc $95 million from the sale 

–    K-V Pharmaceutical files in US Bankruptcy court in New York on Thursday, September 20, 2012, accusing Hologic Inc of “attempting to derail its restructuring efforts in order to reacquire the worldwide rights to Makena”

–  On November 16, 2012, per a article titled, “K-V Pharma Wins 3 More Months To File Ch. 11 Plan”, a New York bankruptcy judge grants K-V Pharmaceutical their request for an extension of the exclusivity period for filing a plan by 3 months. K-V Pharmaceutical now has until February 4, 2013, to file a Chapter 11 plan. The exclusivity period for soliciting plan acceptances is now set to expire April 5, 2013. 

References December 6, 2012 article titled, “K-V to Pay Hologic $60 Million to Settle Fight Over Makena” (May need Subscription or Trial) Blog November 30, 2012 article titled, “K-V Pharmaceutical Owes US $67.1M in Fines, Settlement, Lawsuit Says”

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