KV Pharmaceutical
St. Louis, Missouri, U.S. | |
---|---|
Key people | Greg Divis, CEO |
Website | www.kvpharmaceutical.com |
KV Pharmaceutical Company (KV) was an American
Background
KV was founded by Bob Keith and Victor Hermelin in 1942 who ran the company until 1975, when he was replaced by his son Marc.[2] Marc Hermelin was ousted in 2008 when a Food and Drug Administration (FDA) inspection took place. The following year KV, convicted of felony charges for the "making, marketing, and distribution of adulterated and unapproved drugs", was shut down by the FDA.[3] After a proxy fight, Marc Hermelin returned to the company's board.[2] Between 2008 and 2010, KV lost three-quarters of its workforce, down to 350.[2] KV was reapproved for manufacturing drugs in 2010, while its Ethex manufacturing subsidiary was sold.[4]
Rather than developing new molecular entities, KV researches different modes of drug delivery. It developed bioadhesive drug delivery where molecules adhere to wet sites such as a mucosa (for example Clindesse), and is investigating quick-dissolving and controlled-release drug venues.[citation needed]
Makena pricing controversy
In February 2011, the FDA granted approval to KV for "Makena" (
The pricing policy of KV was heavily criticized as it substantially increased medication cost and removed less expensive alternatives.[4] KV indicated that the cost of taking care of a premature birth at about $51,000 justified the cost of the medication, and that a system would be in place to enable patients without means to obtain it.[4] Thus, expenses would essentially fall on the public sector and insurance carriers. A number of physician organizations have opposed the pricing policy of the company[6] as did the March of Dimes that supported the arrival of Makena.[7] The FDA commissioner, Margaret Hamburg, said that the agency was not in a position to influence pricing. Concerned about price gouging, two sSenators, Amy Klobuchar (D-Minn.) and Sherrod Brown (D-Ohio), indicated that they planned to initiate hearings with the Federal Trade Commission about KV's conduct.[7] The controversy spawned protests like the "Shame on You KV Pharmaceutical and CEO Greg Divis" Facebook page.[8]
By the end of March 2011, the FDA announced that pharmacies compounding the drug independently would not face legal reprisal, thus enabling the price of the drug to remain in the $10–20 range.[9] After this announcement, K-V's stock dropped by more than 60% on March 30, 2011,[citation needed] and the company cut the price of Makena to $690 per dose.[10]
Bankruptcy and acquisition
KV Pharmaceutical filed a petition for protection under
The company emerged from bankruptcy in 2013 with less debt and a $375 million recapitalization, including cancellation of its previous preferred and common stock. Senior secured notes were paid in cash and general unsecured creditors received a pro rata share of $10.25 million. Convertible subordinated noteholders received 7 percent of KV's new common shares in addition to shares purchased through the rights offering or direct purchase of shares.[citation needed]
The company changed its name to Lumara Health, Inc. in May 2014 and, in September 2014, announced that it was being acquired by two different buyers in deals valued at $757 million.
Products
Ther-Rx Corporation
- Gynazole-1 (butoconazole nitrate vaginal cream, 2%)
- Clindesse (clindamycin phosphate vaginal cream, 2%)
- Evamist (estradiol transdermal spray)
- Makena (Hydroxyprogesteronecaproate) (after March 14, 2011)
Nesher Pharmaceuticals
- Potassium ChlorideExtended-Release Capsules, USP
References
- ^ "KV Pharmaceutical web site". Archived from the original on July 13, 2011. Retrieved March 10, 2011.
- ^ a b c Jim Doyle (September 11, 2010). "FDA gives green light to KV drug manufacturing". St. Louis Today. Retrieved January 23, 2024.
- ^ "FDA Takes Action Against KV Pharmaceutical Company, Company Making, Marketing and Distributing Adulterated and Unapproved Drugs" (Press release). Food and Drug Administration. March 2, 2009. Archived from the original on July 10, 2009. Retrieved January 23, 2024.
- ^ a b c d e Jim Doyle (March 10, 2011). "KV boosts prenatal drug price 100-fold". St. Louis Post-Dispatch. Retrieved March 10, 2011.
- ^ "FDA approves drug to reduce risk of preterm birth in at-risk pregnant women" (Press release). Food and Drug Administration. February 4, 2011. Archived from the original on August 5, 2011. Retrieved January 23, 2024.
- ^ "Letter by Physicians' organizations to Ther-Rx Corp" (PDF). Archived from the original (PDF) on July 25, 2011. Retrieved March 12, 2011.
- ^ a b Doyle, Jim (March 23, 2011). "Backlash builds over KV's 'outlandish' price for prenatal drug". St.Louis Post-Dispatch. Retrieved March 24, 2011.
- ^ "Shame on You KV Pharmaceutical and CEO Greg Divis", Facebook
- ^ "Bill 101: A gift we never expected". Macleans. Retrieved March 30, 2011.[dead link]
- ^ "Price of preterm birth medicine cut". Boston Globe. Associated Press. April 2, 2011. Archived from the original on February 25, 2012. Retrieved January 23, 2024.
- ^ Leonard, Mike (August 29, 2019). "AMAG Pharma Hit With $50 Million Earnout Suit Over Lumara Merger". Bloomberg Law. Retrieved December 18, 2020.
- ^ Mueller, Angela (September 29, 2014). "Former KV Pharmaceutical to be acquired". St Louis Business Journal. Retrieved December 18, 2020.