KV Pharmaceutical

Last updated

KV Pharmaceutical Company
NYSE:  KVA
NYSE:  KVB
Industry Pharmaceuticals
Founded1942
FounderBob Keith and Victor Hermelin
Headquarters St. Louis, Missouri, U.S.
Key people
Greg Divis, CEO
Website www.kvpharmaceutical.com

KV Pharmaceutical Company (KV) was an American drug company that brought generic and non-branded pharmaceutical products to the market. Headquartered in St. Louis, Missouri, it had 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. [1]

Contents

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" (hydroxyprogesterone caproate or OHPC) 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. [5] For many years, however, OHPC had been available and used by obstetricians "off label". Before the release of Makena, the drug was compounded by pharmacies for $15, or less, per injection. Typically 15 to 20 injections are given over a treatment course, costing a total of $225 to $300. [4] 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. [4]

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 Chapter 11 of the Bankruptcy Act on August 4, 2012, in the U.S. Bankruptcy Court for the Southern District of New York in Manhattan. The petition listed the company’s assets as $237 million and its debts as $728 million. The filing came on the same day that the company failed to make a $95 million payment it owed to Hologic Inc., KV's partner in developing Makena. The bankruptcy followed a long string of troubles for KV involving oversize morphine tablets, a criminal prosecution and the barring of KV's former chairman, Marc Hermelin, from doing business with federal health programs.[ citation needed ]

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. AMAG Pharmaceuticals, based in Waltham, Massachusetts, acquired Lumara Health for $675 million in cash and stock, [11] and, in a separate transaction, Perrigo Co. of Dublin, Ireland, acquired Lumara Health's women's health care business, including the Clindesse Vaginal Cream, Gynazole-1 and Evamist products, for $82 million. [12] The AMAG Pharmaceuticals acquisition included the Makena product. Lumara Health now operates as a division of AMAG Pharmaceuticals.

Products

Ther-Rx Corporation

Nesher Pharmaceuticals

Related Research Articles

<span class="mw-page-title-main">Oxymorphone</span> Opioid analgesic drug

Oxymorphone is a highly potent opioid analgesic indicated for treatment of severe pain. Pain relief after injection begins after about 5–10 minutes, after oral administration it begins after about 30 minutes, and lasts about 3–4 hours for immediate-release tablets and 12 hours for extended-release tablets. The elimination half-life of oxymorphone is much faster intravenously, and as such, the drug is most commonly used orally. Like oxycodone, which metabolizes to oxymorphone, oxymorphone has a high potential to be abused.

Leiner Health Products was a company based in Carson, California, and was one of America's largest manufacturers of vitamins, minerals, herbal nutritional supplements, and generic medications. It was founded in 1973, and was owned by North Castle Partners, a private investment firm from Connecticut.

Maternal use of androgens or high doses of certain weakly androgenic synthetic progestogens (progestins) structurally related to testosterone can masculinize (virilize) the vulva of a female fetus during susceptible times in pregnancy.

Forest Laboratories was a company in the pharmaceutical industry incorporated in Delaware, with its principal office in New York City. It was known for licensing European pharmaceuticals for sale in the United States. On July 1, 2014, the company was acquired by Actavis.

<span class="mw-page-title-main">Regeneron Pharmaceuticals</span> American biotechnology company

Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York. The company was founded in 1988. Originally focused on neurotrophic factors and their regenerative capabilities, giving rise to its name, the company then branched out into the study of both cytokine and tyrosine kinase receptors, which gave rise to their first product, which is a VEGF-trap.

Endo International plc is an American Irish-domiciled generics and specialty branded pharmaceutical company that generated over 93% of its 2017 sales from the U.S. healthcare system. While Endo's management, operations, and customers are almost exclusively U.S.–based, in 2013 Endo executed a corporate tax inversion to Ireland to avoid U.S. corporate taxes on their U.S. drug sales, and to avail of Ireland's corporate tax system.

<span class="mw-page-title-main">Gestonorone caproate</span> Chemical compound

Gestonorone caproate, also known as gestronol hexanoate or norhydroxyprogesterone caproate and sold under the brand names Depostat and Primostat, is a progestin medication which is used in the treatment of enlarged prostate and cancer of the endometrium. It is given by injection into muscle typically once a week.

<span class="mw-page-title-main">Hydroxyprogesterone caproate</span> Medication

Hydroxyprogesterone caproate, sold under the brand names Proluton and Makena among others, is a medication used to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. In March 2023, the manufacturer, Covis Pharma, agreed to withdraw the drug from the US market. The approvals of Makena and its generics were withdrawn by the US Food and Drug Administration (FDA) in April 2023.

<span class="mw-page-title-main">Mallinckrodt</span> Irish domiciled pharmaceutical

Mallinckrodt Pharmaceuticals is an American-Irish domiciled manufacturer of specialty pharmaceuticals, generic drugs and imaging agents. In 2017, it generated 90% of its sales from the U.S. healthcare system. While Mallinckrodt is headquartered in Ireland for tax purposes, its operational headquarters are in the U.S. Mallinckrodt's 2013 tax inversion to Ireland drew controversy when it was shown Acthar was Medicaid's most expensive drug.

<span class="mw-page-title-main">Norethisterone enanthate</span> Chemical compound

Norethisterone enanthate (NETE), also known as norethindrone enanthate, is a form of hormonal birth control which is used to prevent pregnancy in women. It is used both as a form of progestogen-only injectable birth control and in combined injectable birth control formulations. It may be used following childbirth, miscarriage, or abortion. The failure rate per year in preventing pregnancy for the progestogen-only formulation is 2 per 100 women. Each dose of this form lasts two months with only up to two doses typically recommended.

Pharmaceutical fraud involves activities that result in false claims to insurers or programs such as Medicare in the United States or equivalent state programs for financial gain to a pharmaceutical company. There are several different schemes used to defraud the health care system which are particular to the pharmaceutical industry. These include: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs. Examples of fraud cases include the GlaxoSmithKline $3 billion settlement, Pfizer $2.3 billion settlement, and Merck $650 million settlement. Damages from fraud can be recovered by use of the False Claims Act, most commonly under the qui tam provisions which rewards an individual for being a "whistleblower", or relator (law).

<span class="mw-page-title-main">Estradiol dipropionate</span> Chemical compound

Estradiol dipropionate (EDP), sold under the brand names Agofollin, Di-Ovocylin, and Progynon DP among others, is an estrogen medication which has been used in hormone therapy for menopausal symptoms and low estrogen levels in women and in the treatment of gynecological disorders. It has also been used in feminizing hormone therapy for transgender women and in the treatment of prostate cancer in men. Although widely used in the past, estradiol dipropionate has largely been discontinued and is mostly no longer available today. It appears to remain in use only in Japan, Macedonia, and Australia. Estradiol dipropionate is given by injection into muscle at intervals ranging from once or twice a week to once every week and a half to two weeks.

AMAG Pharmaceuticals, Inc. is an American pharmaceutical company developing products that treat iron deficiency anemia (IDA) in adult patients. The company was a publicly traded company listed on NASDAQ under the symbol "AMAG" until November 2020 when it was acquired by Covis Pharma.

<span class="mw-page-title-main">Hydroxyprogesterone acetate</span> Chemical compound

Hydroxyprogesterone acetate (OHPA), sold under the brand name Prodox, is an orally active progestin related to hydroxyprogesterone caproate (OHPC) which has been used in clinical and veterinary medicine. It has reportedly also been used in birth control pills.

<span class="mw-page-title-main">Hydroxyprogesterone heptanoate</span> Chemical compound

Hydroxyprogesterone heptanoate (OHPH), also known as hydroxyprogesterone enanthate (OHPE) and sold under the brand names H.O.P., Lutogil A.P., and Lutogyl A.P. among others, is a progestin medication used for progestogenic indications. It has been formulated both alone and in together with estrogens, androgens/anabolic steroids, and other progestogens in several combination preparations. OHPH is given by injection into muscle at regular intervals.

<span class="mw-page-title-main">Estradiol valerate/hydroxyprogesterone caproate</span> Pharmaceutical combination

Estradiol valerate/hydroxyprogesterone caproate (EV/OHPC), sold under the brand names Gravibinon and Injectable No. 1 among others, is a combined estrogen and progestogen medication which is used in the treatment of threatened miscarriage and other indications and as a form of combined injectable birth control to prevent pregnancy. It contains estradiol valerate (EV), an estrogen, and hydroxyprogesterone caproate (OHPC), a progestin. The medication is given by injection into muscle once a day to once a month depending on the indication.

<span class="mw-page-title-main">Estradiol benzoate/hydroxyprogesterone caproate</span> Combination drug

Estradiol benzoate/hydroxyprogesterone caproate (EB/OHPC), sold under the brand name Primosiston among others, is a combined estrogen and progestogen medication which is used to treat gynecological disorders and habitual abortion. It contains estradiol benzoate (EB), an estrogen, and hydroxyprogesterone caproate (OHPC), a progestin. The medication is given by injection into muscle.

<span class="mw-page-title-main">Estradiol cypionate/hydroxyprogesterone caproate</span> Combination drug

Estradiol cypionate/hydroxyprogesterone caproate (EC/OHPC), sold under the brand name Sinbios, is a combination medication of estradiol cypionate (EC), an estrogen, and hydroxyprogesterone caproate (OHPC), a progestin, which was reportedly used as a combined injectable contraceptive in women in the early 1970s. It contained 5 mg EC and 250 mg OHPC in oil solution, was provided in the form of 1 mL ampoules, and was administered by intramuscular injection at regular intervals. The medication was manufactured by the pharmaceutical company Mavi in Mexico.

References

  1. ↑ "KV Pharmaceutical web site". Archived from the original on July 13, 2011. Retrieved March 10, 2011.
  2. 1 2 3 Jim Doyle (September 11, 2010). "FDA gives green light to KV drug manufacturing". St. Louis Today. Retrieved January 23, 2024.
  3. ↑ "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.
  4. 1 2 3 4 5 Jim Doyle (March 10, 2011). "KV boosts prenatal drug price 100-fold". St. Louis Post-Dispatch. Retrieved March 10, 2011.
  5. ↑ "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.
  6. ↑ "Letter by Physicians' organizations to Ther-Rx Corp" (PDF). Archived from the original (PDF) on July 25, 2011. Retrieved March 12, 2011.
  7. 1 2 Doyle, Jim (March 23, 2011). "Backlash builds over KV's 'outlandish' price for prenatal drug". St.Louis Post-Dispatch. Retrieved March 24, 2011.
  8. ↑ "Shame on You KV Pharmaceutical and CEO Greg Divis", Facebook
  9. ↑ "Bill 101: A gift we never expected". Macleans. Retrieved March 30, 2011.[ dead link ]
  10. ↑ "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.
  11. ↑ Leonard, Mike (August 29, 2019). "AMAG Pharma Hit With $50 Million Earnout Suit Over Lumara Merger". Bloomberg Law. Retrieved December 18, 2020.
  12. ↑ Mueller, Angela (September 29, 2014). "Former KV Pharmaceutical to be acquired". St Louis Business Journal. Retrieved December 18, 2020.


This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.