KV Pharmaceutical
Encyclopedia
KV Pharmaceutical Company (KV) is an American drug company that brings generic and non-branded pharmaceutical products to the market. Headquartered in St. Louis, Missouri
, it has research and manufacturing facilities, as well as marketing and sales operations, the latter activities conducted through its subsidiaries, Ther-Rx Corporation and Nesher Pharmaceuticals Inc.
(FDA). After a proxy fight, M. Hermelin returned to the company's board. Between 2008 and 2010, KV lost three-quarters of its workforce, down to 350. KV was reapproved for manufacturing drugs in 2010, while its Ethex manufacturing subsidiary was sold.
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 (example Clindesse), and is investigating quick-dissolving and controlled-release drug venues.
(FDA) granted approval to KV for "Makena" (17-hydroxyprogesterone caproate
or 17OHPC) for the prevention of premature birth
in women with a single fetus of less than 37 weeks gestation who had at least one previous preterm birth. For many years, however, 17OHPC had been available and used by obstetricians "off label". Prior to the release of Makena, the drug was made available by pharmacies that compounded the agent for $15 or less per injection (typically 15 to 20 injections are given over a treatment course). With the FDA approval of Makena as an orphan drug
, KV received the exclusive right to sell the drug for seven years. KV boosted its price by a factor of 100, to $1,500 per injection, or about $25,000 per treatment.
The pricing policy of KV was heavily criticized as it substantially increased medication cost and removed less expensive alternatives. KV indicated that the cost of taking care of a premature birth is about $51,000 justifying the cost of the medication, further, a system would be in place to enable patients without means to obtain the medication. 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 as did the March of Dimes
that supported the arrival of Makena. The FDA commissioner Margaret Hamburg stated that the agency was not in a position to influence pricing. Concerned about price gouging
, two Senators, Amy Klobuchar
(D-Minn.) and Sherrod Brown
(D-Ohio) indicated that they plan to initiate hearings with the Federal Trade Commission
about KV's conduct.
By the end of March the FDA announced that pharmacies compounding the drug independently will not face legal reprisal, thus enabling the price of the drug to remain in the $10-20 range. After this announcement, K-V's stock dropped by more than 60% on March 30, 2011, and the company cut the price of Makena to $690 per dose.
St. Louis, Missouri
St. Louis is an independent city on the eastern border of Missouri, United States. With a population of 319,294, it was the 58th-largest U.S. city at the 2010 U.S. Census. The Greater St...
, it has research and manufacturing facilities, as well as marketing and sales operations, the latter activities conducted through its subsidiaries, Ther-Rx Corporation and Nesher Pharmaceuticals Inc.
Background
KV was founded by Victor Hermelin in 1942 who ran the company until 1975, when he was replaced by his son Marc. Marc Hermelin was ousted in 2008 when an 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 Food and Drug AdministrationFood and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA). After a proxy fight, M. Hermelin returned to the company's board. Between 2008 and 2010, KV lost three-quarters of its workforce, down to 350. KV was reapproved for manufacturing drugs in 2010, while its Ethex manufacturing subsidiary was sold.
Rather than developing new molecular entities, KV researches different modes of drug delivery
Drug delivery
Drug delivery is the method or process of administering a pharmaceutical compound to achieve a therapeutic effect in humans or animals. Drug delivery technologies modify drug release profile, absorption, distribution and elimination for the benefit of improving product efficacy and safety, as well...
. It developed bioadhesive drug delivery where molecules adhere to wet sites such as a mucosa (example Clindesse), and is investigating quick-dissolving and controlled-release drug venues.
Makena pricing controversy
In February 2011, U.S. Food and Drug AdministrationFood and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) granted approval to KV for "Makena" (17-hydroxyprogesterone caproate
17-Hydroxyprogesterone caproate
17α-Hydroxyprogesterone caproate is a synthetic steroid hormone that is similar to medroxyprogesterone acetate and megestrol acetate. It is an ester derivative of 17α-hydroxyprogesterone formed from caproic acid ....
or 17OHPC) for the prevention of premature birth
Premature birth
In humans preterm birth refers to the birth of a baby of less than 37 weeks gestational age. The cause for preterm birth is in many situations elusive and unknown; many factors appear to be associated with the development of preterm birth, making the reduction of preterm birth a challenging...
in women with a single fetus of less than 37 weeks gestation who had at least one previous preterm birth. For many years, however, 17OHPC had been available and used by obstetricians "off label". Prior to the release of Makena, the drug was made available by pharmacies that compounded the agent for $15 or less per injection (typically 15 to 20 injections are given over a treatment course). With the FDA approval of Makena as an orphan drug
Orphan drug
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease...
, KV received the exclusive right to sell the drug for seven years. KV boosted its price by a factor of 100, to $1,500 per injection, or about $25,000 per treatment.
The pricing policy of KV was heavily criticized as it substantially increased medication cost and removed less expensive alternatives. KV indicated that the cost of taking care of a premature birth is about $51,000 justifying the cost of the medication, further, a system would be in place to enable patients without means to obtain the medication. 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 as did the March of Dimes
March of Dimes
The March of Dimes Foundation is a United States nonprofit organization that works to improve the health of mothers and babies.-Organization:...
that supported the arrival of Makena. The FDA commissioner Margaret Hamburg stated that the agency was not in a position to influence pricing. Concerned about price gouging
Price gouging
Price gouging is a pejorative term referring to a situation in which a seller prices goods or commodities much higher than is considered reasonable or fair. In precise, legal usage, it is the name of a crime that applies in some of the United States during civil emergencies...
, two Senators, Amy Klobuchar
Amy Klobuchar
Amy Jean Klobuchar is the senior United States Senator from Minnesota. She is a member of the Minnesota Democratic-Farmer-Labor Party, an affiliate of the Democratic Party...
(D-Minn.) and Sherrod Brown
Sherrod Brown
Sherrod Campbell Brown is the senior United States Senator from Ohio and a member of the Democratic Party. Before his election to the U.S. Senate, he was a member of the United States House of Representatives, representing Ohio's 13th congressional district from 1993 to 2007...
(D-Ohio) indicated that they plan to initiate hearings with the Federal Trade Commission
Federal Trade Commission
The Federal Trade Commission is an independent agency of the United States government, established in 1914 by the Federal Trade Commission Act...
about KV's conduct.
By the end of March the FDA announced that pharmacies compounding the drug independently will not face legal reprisal, thus enabling the price of the drug to remain in the $10-20 range. After this announcement, K-V's stock dropped by more than 60% on March 30, 2011, and the company cut the price of Makena to $690 per dose.
Ther-Rx Corporation
- Gynazole-1 (butoconazoleButoconazoleButoconazole is an imidazole antifungal used in gynecology....
nitrate vaginal creame, 2%) - Clindesse (clindamycinClindamycinClindamycin rINN is a lincosamide antibiotic. It is usually used to treat infections with anaerobic bacteria but can also be used to treat some protozoal diseases, such as malaria...
phosphate vaginal creame, 2%) - Evamist (estradiolEstradiolEstradiol is a sex hormone. Estradiol is abbreviated E2 as it has 2 hydroxyl groups in its molecular structure. Estrone has 1 and estriol has 3 . Estradiol is about 10 times as potent as estrone and about 80 times as potent as estriol in its estrogenic effect...
transdermal spray) - Makena (17-Hydroxyprogesterone17-Hydroxyprogesterone17-Hydroxyprogesterone is a C-21 steroid hormone produced during the synthesis of glucocorticoids and sex steroids.As a hormone, 17OHP also interacts with the progesterone receptor.-Production:...
caproate) (after 3/14/2011)