KV Pharma's launch last week of generics marketing subsidiary Nesher Pharmaceuticals shows just how far a consent decree can reach. Nesher, led by Mark Hartman, will spearhead the company's back-to-market strategy. A recent FDA OK for the company to resume some product manufacturing and sales follows a 2008 GMP violation-induced shutdown of a plant near St. Louis.
"We remain focused on returning additional generic products to the market," the company says in a statement that runs about 2,400 words--that's gargantuan by press release standards.
The unusual length results from a list of caveats that remain part of the company's lexicon with investors, lawyers and regulators as it travels the GMP comeback trail. Operations now run within the bounds of the consent decree that halted production and shipment of all KV products, ultimately leading to the shutdown of subsidiary ETHEX and the sale of its Particle Dynamics unit to raise cash to stay in business.
First on the list of caveats is "the ability to continue as a going concern." There are 38 others, seven of which relate directly to the FDA consent decree. The remainder relate indirectly to the consent decree as well; they involve the company's financial wreckage as well as pending lawsuits.
- here's the KV release