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K-V Pharmaceutical Company, a specialty branded pharmaceutical company with a primary focus in the area of women's healthcare, announced on Friday that the United States Bankruptcy Court for the Southern District of New York has approved the firm's settlement agreement with Hologic Inc.
K-V Pharma is selling the unit to fully focus on women's health, which is in line with its transition to a branded speciality pharmaceutical company.
Louis-based K-V had attempted to stop pharmacists from formulating such treatments by warning them that they would be violating the law if they compounded Makena-like products.
They quadrupled their K-V take when they started clearcutting in the 1960s.
The Complaint charges K-V Pharmaceutical and certain of the Company's executive officers with violations of federal securities laws.
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.
Under the company's Consent Decree, successful FDA inspections of its quality systems, processes and facilities are expected to be required before K-V is permitted to resume manufacturing and shipment of particular products.
The Complaint alleges that, during the Class Period, K-V and certain of the Company's executive officers issued false and/or misleading statements concerning the Company's business and financial prospects.
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.
Following this news, K-V Pharmaceutical's A-series stock dropped $1.
The investigation focuses on whether certain individuals violated federal securities laws by, among other things, failing to disclose that: (1) the Company had inaccurately claimed that the Food and Drug Administration (the "FDA") was granting K-V the exclusive distribution rights over "Makena," a drug used to prevent miscarriages; (2) the FDA would not be enforcing K-V's rights by preventing the Company's competitors from distributing generic formulations of the drug; and (3) the drug's $1,500 price would reduce the availability of Makena to low-income and other at-risk groups.