Ever since the scandal erupted over compounding pharmacies and a national outbreak of fungal meningitis, KV Pharmaceuticals has been telling the FDA ‘we told you so.’ Now, the drugmaker, which landed in bankruptcy after a pricing controversy over its Makena treatment for premature births caused a ruckus and dramatically slashed sales, is finally experiencing a degree of vindication.
For months, KV has been complaining about the quality of some compounded versions of Makena (back story). Specifically, KV has pointed to the troubles at the New England Compounding Center, which was blamed for 741 cases of meningitis, including 55 deaths, and subsequently recalled all of its products, including hydrxyprogesterone caproate, or 17P, which is a compounded version of Makena (see this and this).
In the wake of the outbreak, KV has aggressively and successfully pushed Makena as a safe alternative. “They’ve been in doctors’ faces a lot more about the possible harm of compounded medications,” Armando Fuentes, a perinatologist at Children’s Hospital Central California, tells The Wall Street Journal. “They’ve really ratcheted up their marketing.”
Quarterly shipments of Makena vials reached 8,410 in this year’s first quarter, up from less than 2,000 a year earlier. And Makena revenue rose to $29 million in the first quarter, an increase of 123 percent over the third quarter in 2012, which was before the meningitis outbreak and the controversy over the safety of compounded medicines erupted.
As we have reported previously, Makena was projected to become a big moneymaker after the FDA approved the treatment in early 2011 under the Orphan Drug Act. Shortly afterwards, though, both the KV and the agency came under fire because the price was set at $1,500, compared with $10 to $20 a week for compounded versions of a medication that has been used for decades (back stories here and here).
In response, the FDA took the unusual step of deciding not to prevent compounders from compounding. Normally, the FDA would have banned the sale of older, unapproved drugs. The agency decision not to pursue enforcement actions against compounders, unless there was a safety issue, signaled White House concern about publicity over cost since a federal agency had allowed a monopoly to develop.
KV later attempted to convince the FDA that some compounded versions contained unsafe ingredients, but the agency rejected its contentions (look here). The drugmaker, meanwhile, lower its Makena pricing last summer, but that proved insufficient and blamed agency moves for its deteriorating financial situation (see this).
KV, in fact, unsuccessfully filed a lawsuit that claimed the FDA abdicated its responsibility to prevent some compounding pharmacies from selling versions of Makena (back story). That lawsuit is now being appealed (back story here and you can read the recent FDA response to the appeal here).
The drugmaker, meanwhile, is also pursuing another legal strategy: reminding physicians of the potential for malpractice risks associated with prescribing compounded versions: “For some physicians,” Arnold Cohen, who chairs maternal-fetal medicine at Einstein Medical Center in Philadelphia, tells the Journal, “it has resulted in a change of prescribing patterns.”
The upshot? KV prospects appear brighter for the first time in more than two years. Last week, a group of senior bondholders raised an offer to take control of the bankrupt drugmaker in after an investor increased their own proposal a few days earlier.
STORY ENDS HERE
premature baby pic thx to cesar rincon on flickr