KV Pharmaceutical Co. (KV/A) gained the most in nine months after U.S. regulators said they are investigating pharmacies’ low-cost versions of the company’s drug to prevent premature births for potency and impurities.
KV rose 91 percent to $1.71 at the close in New York, the biggest single-day increase since Feb. 4 when the drug, marketed as Makena, was approved.
Pharmacies make, or compound, their own versions of Bridgeton, Missouri-based KV’s drug. The Food and Drug Administration tends to allow compounding pharmacists to operate outside the normal rules at its discretion, the agency said in a March 30 statement on Makena.
After the drug was approved, the agency allowed compounding pharmacies to continue providing the low-cost version, also known as 17-P.
“FDA has begun its own sampling and analysis of compounded hydroxprogesterone caproate products” and the active ingredients “used to make them,” the agency said today in a statement.
The investigation is based on information from KV on the potency and purity of samples of the bulk active ingredient and compounded finished products, the FDA said.
KV hired Fuld & Co. based in Cambridge, Massachusetts, to acquire samples of hydroxyprogesterone caproate -- the active ingredient in compounded versions of the drug -- from suppliers and finished products from compounding pharmacies, according to testing data provided to the FDA by the company. The 10 active ingredient samples were obtained from Chinese suppliers and the finished product came from 30 different pharmacies in 15 states.
Testing determined eight of 10 active ingredient samples and 16 of 30 finished product vials failed to meet FDA standards for unknown impurities. One of 10 active ingredient samples and five of 30 finished product vials failed FDA potency standards, according to the data supplied by KV.
One of the active ingredient samples was found to be glucose rather than hydroxyprogesterone caproate, KV said.
“I know people in almost every medical center when they are using the formulated preparation,” said Baha Sibai, professor of clinical obstetrics and gynecology at the University of Cincinnati. “No one has ever shown this medication is unsafe.”
David Miller, executive director of the International Academy of Compounding Pharmacists, criticized the FDA’s move and said he may do a separate analysis of compounded products.
“The agency is taking a knee-jerk response to allegations from KV Pharmaceuticals,” Miller said by telephone.
He said he has not seen KV’s data. The pharmacy organization may contract with an academic institution to conduct its own study of 17-P, Miller said.
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