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K-V Pharmaceutical Company has also received approval to sign an USD85m debtor-in-possession financing to, among other things, fund the settlement.
This settlement resolves all disputes between both firms regarding Makena(r), confirms K-V's ownership of Makena(r) and allows the company to move ahead with its efforts to pursue a reorganisation plan based on Makena(r).
Jefferies & Company is acting as exclusive financial advisor to K-V in this transaction.Country: USA, Sector: PharmaceuticalsTarget: Nesher Pharmaceuticals IncBuyer: Zydus Pharmaceuticals (USA) IncVendor: K-V Pharmaceutical Company Deal size in USD: 60mType: DivestmentStatus: Agreed
Rosa DeLauro (D., Conn.) wrote to FDA Comrmssioner Margaret Hamburg, appealing her to investigate allegations that K-V was charging $1,500 for each dose of Makena, or an estimated $30,000 for each at-risk pregnancy.
"K-V did not invest in the original research in the drug, though the public did support that research [by way of a 2003 clinical trial] through National Institutes of Health funding," declared DeLauro.
"They quadrupled their K-V take when they started clearcutting in the 1960s."
This sale is an important element of K-V Pharmaceutical Company's declared strategy of transitioning to a branded specialty pharmaceutical company focused on women's health.
"Health care providers and advocacy organizations who are on the front lines of this issue now have access to the benefits of an FDA-approved product," remarks Greg Divis, chief executive officer of K-V Pharmaceutical and president of Ther-Rx Corp.
10 September 2010 - US K-V Pharmaceutical Company (NYSE: KVa/KVb) said today it has received notice from the US Food and Drug Administration (FDA) of the successful completion of an inspection of its facilities and approval to return its first product to market.
Later amendments made sure that the counties also received 25 percent of deposits, such as those under the K-V Act, and of payments in kind, such as the value of roads constructed by timber purchasers.
"A key business objective remains for K-V to maximize the value of our genetics business in alignment with our long-term strategy."
The reduction in the company's workforce is part of its efforts to manage cash and financial resources while it continues working with the US Food and Drug Administration (FDA) to return its products to market, K-V Pharmaceutical said.