Bloomberg News

KV Jumps as Doctors Say Makena Differs From Low-Cost Drugs

October 13, 2011

(Updates with company’s comment in the seventh paragraph.)

Oct. 13 (Bloomberg) -- KV Pharmaceutical Co., maker of the Makena drug to prevent premature births, rose 27 percent after a doctors’ group said the medicine isn’t identical to lower-cost compounds.

Doctors should be free to choose the version they want, the American College of Obstetricians and Gynecologists said in a statement today. Previous statements by the group, which criticized pricing for Makena, “may have been taken out of context” by insurers “and used to interfere with physician’s judgment,” the college said.

Two U.S. Senators criticized KV Pharmaceutical in March after reports the Bridgeton, Missouri-based drugmaker planned to charge $1,500 for an injection of Makena, compared with the $10 to $20 that compounded versions typically cost. The company’s shares slid 21 percent on March 30 after the Food and Drug Administration said pharmacists were free to provide the less- expensive versions.

“This announcement strengthens KV’s argument that doctors should provide the FDA-approved product, Makena, and shouldn’t replace it with the much cheaper compounding pharmacy drug,” said Kevin Kedra, a Gabelli & Co. analyst in Rye, New York, in a telephone interview. “This won’t stop compounding pharmacies, but it lends a strong voice of support to Makena.”

KV Pharmaceutical rose to $1.65 at 4 p.m., for its biggest increase since Aug. 11.

Marketing Rights

In February, the company became the first to win FDA approval for a type of hydroxyprogesterone caproate, or 17P, to prevent preterm labor and received seven years of marketing exclusivity. The FDA for years has allowed pharmacists to mix versions of the treatment for patients’ needs at the request of their doctors.

Insurer coverage has “been influenced by a belief that unapproved compounded 17P formulations are the same as Makena,” KV Pharmaceutical said in a statement today. “These policies should be modified to ensure that clinically-indicated patients have unencumbered access to FDA-approved Makena” as doctors see fit, the company said.

A second doctors’ group, the Society for Maternal-Fetal Medicine joined the obstetricians’ group in today’s statement. Both are based in Washington.

KV Pharmaceutical cut Makena’s list price to $690 per shot and offered rebates to further lower the cost, the company said on April 1.

The two doctors’ groups, in a statement that day, called the reduction a “woefully inadequate response.”

“Although there are clear benefits to having an FDA- approved version of 17P, there is no evidence that Makena is more effective or safer than the currently used compounded version,” the physicians said.

--With assistance from Molly Peterson in Washington. Editors: Bruce Rule, Angela Zimm

To contact the reporter on this story: Alex Nussbaum in New York anussbaum1@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


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