Imprimis Pharmaceuticals
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Harrow Health, formerly known as Imprimis Pharmaceuticals, is a
publicly traded A public company is a company whose ownership is organized via shares of stock which are intended to be freely traded on a stock exchange or in over-the-counter markets. A public (publicly traded) company can be listed on a stock exchange (list ...
pharmaceutical company The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate sympto ...
() based in
Nashville, TN Nashville is the capital city of the U.S. state of Tennessee and the county seat, seat of Davidson County, Tennessee, Davidson County. With a population of 689,447 at the 2020 United States census, 2020 U.S. census, Nashville is the List of muni ...
. Since 2014, Harrow has started six healthcare businesses, including ImprimisRx, an ophthalmic-focused pharmaceutical company. In 2017, Harrow started and funded Eton Pharmaceuticals with a $20 million Series A financing, and Eton is now a publicly traded company. In 2017, Harrow started Surface Pharmaceuticals, hiring Dr. Kamran Hosseini to be its chief executive officer. Surface was funded with a $20 million Series A financing with Flying L Partners leading the round. In 2018, Harrow started Melt Pharmaceuticals and announced an $11 Series A financing. In 2019, Harrow hired founder and former CEO of Doxy.me, Drew Livingston, as its Chief Innovation Officer. Livingston is the senior executive of Harrow's Visionology.com telemedicine subsidiary.


Administration and drug pricing advocacy

The company's founder and
chief executive officer A chief executive officer (CEO), also known as a central executive officer (CEO), chief administrator officer (CAO) or just chief executive (CE), is one of a number of corporate executives charged with the management of an organization especially ...
is Mark L. Baum, a lawyer by training. Baum has been working in the
HIV The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...
-related pharmacy field since 1999. Baum has been an advocate for drug pricing and patient advocacy, debating former US congressman James Greenwood on this issue at the
Oxford Union The Oxford Union Society, commonly referred to simply as the Oxford Union, is a debating society in the city of Oxford England, whose membership is drawn primarily from the University of Oxford. Founded in 1823, it is one of Britain's oldest ...
debating society. In 2016, Baum authored a monograph on drug pricing and has written about pharmaceutical market monopolies in ''
The Wall Street Journal ''The Wall Street Journal'' is an American business-focused, international daily newspaper based in New York City, with international editions also available in Chinese and Japanese. The ''Journal'', along with its Asian editions, is published ...
''. Harrow, through its ImprimisRx subsidiary, has sought to serve American patients and create competition for drugs that companies have monopolies through regulatory or other means by marketing new
formulations Formulation is a term used in various senses in various applications, both the material and the abstract or formal. Its fundamental meaning is the putting together of components in appropriate relationships or structures, according to a formul ...
as a
compounding pharmacy In the field of pharmacy, compounding (performed in compounding pharmacies) is preparation of a custom formulation of a medication to fit a unique need of a patient that cannot be met with commercially available products. This may be done for me ...
. This strategy would allow patient access to certain lower cost medication provided, among other conditions, a patient's physician believed such a formulation was best suited for a patient's needs. In 2015, the company gained international attention when it compounded a
pyrimethamine Pyrimethamine, sold under the brand name Daraprim among others, is a medication used with leucovorin (leucovorin is used to decrease side effects of pyrimethamine; it does not have intrinsic anti-parasitic activity) to treat the parasitic disea ...
and
leucovorin Folinic acid, also known as leucovorin, is a medication used to decrease the toxic effects of methotrexate and pyrimethamine. It is also used in combination with 5-fluorouracil to treat colorectal cancer and pancreatic cancer, may be used to tr ...
combination formulation which it argued may offer a low-cost, per pill, "alternative" to
Daraprim Pyrimethamine, sold under the brand name Daraprim among others, is a medication used with leucovorin (leucovorin is used to decrease side effects of pyrimethamine; it does not have intrinsic anti-parasitic activity) to treat the parasitic disea ...
, a medication which gained public attention after its price in the United States was increased by over 5,000 percent by
Martin Shkreli Martin Shkreli (; born March 17, 1983) is an American former hedge fund manager. Shkreli is the co-founder of the hedge funds Elea Capital, MSMB Capital Management, and MSMB Healthcare; the co-founder and former chief executive officer (CEO) of ...
and
Turing Pharmaceuticals Vyera Pharmaceuticals (formerly Turing Pharmaceuticals) is a pharmaceutical company incorporated in Zug, Switzerland, with offices in New York City. The company started to do business in the US as Vyera Pharmaceuticals in September 2017. The com ...
. In December 2015,
Express Scripts Express Scripts Holding Company is a pharmacy benefit management (PBM) organization. In 2017 it was the 22nd-largest company in the United States by total revenue as well as the largest pharmacy benefit management (PBM) organization in the United ...
accepted the company's product into its formulary. In 2016, it introduced a lower cost version of
tiopronin Tiopronin, sold under the brand name Thiola, is a medication used to control the rate of cystine precipitation and excretion in the disease cystinuria. Due to the rarity of the disorder, tiopronin falls under the classification of an orphan drug ...
, and was said to have been working on a version of
Mylan Mylan N.V. was a global generic and specialty pharmaceuticals company. In November 2020, Mylan merged with Upjohn, Pfizer's off-patent medicine division, to form Viatris. Previously, the company was domiciled in the Netherlands, with principal e ...
's
EpiPen An epinephrine autoinjector (or adrenaline autoinjector, also known by the trademark EpiPen) is a medical device for injecting a measured dose or doses of epinephrine (adrenaline) by means of autoinjector technology. It is most often used for t ...
. The EpiPen competitor's price target was for a pair of injectors. In October 2015,
Anthony Principi Anthony Joseph Principi (born April 16, 1944) is the former United States Secretary of Veterans Affairs. He was appointed by President George W. Bush on January 23, 2001, and resigned on January 26, 2005. He Chaired the 2005 Defense Base Closur ...
, a former
United States Secretary of Veterans Affairs The United States secretary of veterans affairs is the head of the United States Department of Veterans Affairs, the department concerned with veterans' benefits, health care, and national veterans' memorials and cemeteries. The secretary is a me ...
, was elected to the company's
board of directors A board of directors (commonly referred simply as the board) is an executive committee that jointly supervises the activities of an organization, which can be either a for-profit or a nonprofit organization such as a business, nonprofit organiz ...
.


ImprimisRx compounding business

Through its compounding subsidiary ImprimisRx, the company was the first pharmaceutical
compounding In the field of pharmacy, compounding (performed in compounding pharmacies) is preparation of a custom formulation of a medication to fit a unique need of a patient that cannot be met with commercially available products. This may be done for me ...
company to make cGMP ophthalmic
eye drop Eye drops or eyedrops are liquid drops applied directly to the surface of the eye usually in small amounts such as a single drop or a few drops. Eye drops usually contain saline to match the salinity of the eye. Drops containing only saline ...
s and other sterile compounded products available at a national scale through its FDA-registered outsourcing facility. ImprimisRx's primary business is that of
compounding In the field of pharmacy, compounding (performed in compounding pharmacies) is preparation of a custom formulation of a medication to fit a unique need of a patient that cannot be met with commercially available products. This may be done for me ...
drugs; that is, combining or altering the
formulation Formulation is a term used in various senses in various applications, both the material and the abstract or formal. Its fundamental meaning is the putting together of components in appropriate relationships or structures, according to a formul ...
of existing drugs to market them to specific populations. As of 2015, the company's
business model A business model describes how an organization creates, delivers, and captures value,''Business Model Generation'', Alexander Osterwalder, Yves Pigneur, Alan Smith, and 470 practitioners from 45 countries, self-published, 2010 in economic, social, ...
was driven by development and sale of inexpensive alternatives to generic medicines which were made by a single manufacturer and which price had been substantially increased to increase return-on-investment. In August of 2020, ImprimisRx announced that it was expanding its business beyond compounded drugs and that through a partnership with EyePoint Pharmaceuticals, it would begin to sell Dexycu, an FDA-approved steroid product. As of 2020, Imprimis operated two pharmaceutical production and distribution facilities, both of which are located in
Ledgewood, New Jersey Ledgewood is an unincorporated community located within Roxbury Township in Morris County, New Jersey. It was historically known as Drakesville after Abraham Drake, originally from Piscataway, New Jersey, who operated a mill and tavern here in th ...
. The company has licenses to operate federally, through the US
DEA The Drug Enforcement Administration (DEA; ) is a United States federal law enforcement agency under the U.S. Department of Justice tasked with combating drug trafficking and distribution within the U.S. It is the lead agency for domestic en ...
, and through state pharmacy boards in all 50 of the United States.


Litigation

In 2017, after launching a $49 per month low-cost compounded cyclosporine-A formulation as a potential competitor to
Restasis Ciclosporin, also spelled cyclosporine and cyclosporin, is a calcineurin inhibitor, used as an immunosuppressant medication. It is a natural product. It is taken orally or intravenously for rheumatoid arthritis, psoriasis, Crohn's disease, ...
and a glaucoma eye drop program called Simple Drops, the company, alongside Sinceres, became the target of a suit from
Allergan Allergan plc is an American, Irish-domiciled pharmaceutical company that acquires, develops, manufactures and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. ...
for claims connected to supposed false and misleading marketing statements. The company responded, calling Allergan a "professional litigant" and stating, "Allergan, one of the most powerful Big Pharma companies in the world, has filed this lawsuit against one of the smallest pharmaceutical companies in the world, to snuff out any competition to its high drug price strategies. Allergan, a true Goliath, is bent on ensuring that Americans continue to pay the highest possible prices for its drugs." During the lawsuit, it was revealed that Allergan engaged in significant lobbying to FDA, state boards of pharmacy, and other federal and state agencies to complain about ImprimisRx. In December 2017, ImprimisRx received a warning letter from the FDA, relaying the agency's determination that the marketing of some of the company's eye drops contained false or misleading claims about efficacy and risks, allegedly in violation of
federal law Federal law is the body of law created by the federal government of a country. A federal government is formed when a group of political units, such as states or provinces join in a federation, delegating their individual sovereignty and many po ...
. After a multi-day jury trial in Santa Ana, California and after Allergan spent an estimated $20 million in legal fees, Harrow (then Imprimis Pharmaceuticals) was successful in defending itself against the $60 billion market capitalization Allergan. After requesting more than $60 million in damages, the jury returned a verdict of $0 for disgorgement of profit and $48,500 for lost profit.


References


External links

* {{authority control, state=expanded Pharmaceutical companies of the United States Companies based in Nashville, Tennessee Health care companies based in Tennessee Companies listed on the Nasdaq