Harrow Health

Last updated

Harrow Health, Inc.
FormerlyImprimis Pharmaceuticals ( - Jan 2019)
Company type Public
Nasdaq:  HROW
Russell Microcap Index component
Industry Pharmaceutical Industry
Founded2012;12 years ago (2012) [1]
Headquarters
Nashville, Tennessee
,
United States
Number of locations
1 (Nashville, TN)
Key people
  • Mark L. Baum (CEO)
  • Andrew R. Boll (CFO)
Products Pharmaceuticals
Subsidiaries
  • ImprimisRx
  • Eton Pharmaceuticals
  • Surface Pharmaceuticals
  • Melt Pharmaceuticals
  • Visionology.com
Website www.harrow.com   OOjs UI icon edit-ltr-progressive.svg

Harrow Health, Inc., formerly known as Imprimis Pharmaceuticals, is a publicly traded pharmaceutical company based in Nashville, Tennessee.

Contents

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, [2] and Eton is now a publicly traded company. In 2017, Harrow started Surface Pharmaceuticals, hiring Dr. Kamran Hosseini [3] to be its chief executive officer. Surface was funded with a $20 million Series A financing [4] with Flying L Partners leading the round. In 2018, Harrow started Melt Pharmaceuticals and announced an $11 million Series A financing. [5]

In 2019, Harrow hired founder and former CEO of Doxy.me, Drew Livingston, as its Chief Innovation Officer. [6] 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 is Mark L. Baum, a lawyer by training. [7] Baum has been working in the HIV-related pharmacy field since 1999. [7] Baum has been an advocate for drug pricing and patient advocacy, debating former US congressman James Greenwood on this issue [8] at the Oxford Union debating society. In 2016, Baum authored a monograph on drug pricing and has written about pharmaceutical market monopolies in The Wall Street Journal . [9] [10]

Harrow, through its ImprimisRx subsidiary, has sought to create competition for drugs that companies have monopolies through regulatory or other means by marketing new formulations as a compounding pharmacy. 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. [11]

In 2015, the company gained international attention when it compounded a pyrimethamine and leucovorin combination formulation which it argued may offer a low-cost, US$1 per pill, [12] "alternative" to Daraprim, a medication which gained public attention after its price in the United States was increased by over 5,000 percent by Martin Shkreli and Turing Pharmaceuticals. [7] [13] In December 2015, Express Scripts accepted the company's product into its formulary. [14]

In 2016, it introduced a lower cost version of tiopronin, and was said to have been working on a version of Mylan's EpiPen. [15] The EpiPen competitor's price target was US$100 for a pair of injectors. [16]

In October 2015, Anthony Principi, a former United States Secretary of Veterans Affairs, was elected to the company's board of directors. [17] [18]

ImprimisRx compounding business

Through its compounding subsidiary ImprimisRx, the company was the first pharmaceutical compounding company to make cGMP ophthalmic eye drops and other sterile compounded products available at a national scale through its FDA-registered outsourcing facility.

ImprimisRx's primary business is that of compounding drugs; that is, combining or altering the formulation of existing drugs to market them to specific populations. As of 2015, the company's business model was driven by development and sale of inexpensive alternatives to off-patent medicines where there was previously only a single manufacturer who could therefore charge outsize prices. [1]

In August 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. [19]

As of 2020, Imprimis operated two pharmaceutical production and distribution facilities, both of which are located in Ledgewood, New Jersey. The company has licenses to operate federally, through the US DEA, and through state pharmacy boards in all 50 of the United States. [7]

Litigation

In 2017, after launching a $49 per month low-cost compounded cyclosporine-A formulation as a potential competitor to Restasis and a glaucoma eye drop program called Simple Drops, [20] the company, alongside Sinceres, became the target of a suit from Allergan for claims connected to supposed false and misleading marketing statements. [21]

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." [22]

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. [17] [23]

After a jury trial, Harrow (then Imprimis Pharmaceuticals) was ordered to pay $0 for disgorgement of profit and $48,500 for lost profit, despite Allergan having sought $60 million. [24]

Related Research Articles

<span class="mw-page-title-main">Generic drug</span> Pharmaceutical equivalent to a brand-name product

A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.

Prescription drug list prices in the United States continually are among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the American health care reform debate of 2009, and received renewed attention in 2015. One major reason for high prescription drug prices in the United States relative to other countries is the inability of government-granted monopolies in the American health care sector to use their bargaining power to negotiate lower prices, and the American payer ends up subsidizing the world's R&D spending on drugs.

Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company based in Hyderabad. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited. Dr. Reddy manufactures and markets a wide range of pharmaceuticals in India and overseas. The company produces over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology.

Bausch Health Companies Inc. is an American-Canadian multinational specialty pharmaceutical company based in Laval, Quebec, Canada. It develops, manufactures and markets pharmaceutical products and branded generic drugs, primarily for skin diseases, gastrointestinal disorders, eye health and neurology. Bausch Health owns Bausch & Lomb, a supplier of eye health products. Bausch Health's business model is primarily focused on acquiring small pharmaceutical companies and then sharply increasing the prices of the drugs these companies sell.

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 executive offices in Hatfield, Hertfordshire, UK and a "Global Center" in Canonsburg, Pennsylvania, US.

<span class="mw-page-title-main">Allergan, Inc.</span> Former American conglomerate

Allergan, Inc. was an American global pharmaceutical company focused on eye care, neurosciences, medical dermatology, medical aesthetics, breast enhancement, obesity intervention and urologics. Allergan, Inc. was formed in 1948, incorporated in 1950 and became a public company in 1970. It ceased operation in 2015 when it was acquired by Irish-based Actavis plc, who then renamed the group as Allergan plc.

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

Pyrimethamine, sold under the brand name Daraprim among others, is a medication used with leucovorin to treat the parasitic diseases toxoplasmosis and cystoisosporiasis. It is also used with dapsone as a second-line option to prevent Pneumocystis jiroveci pneumonia in people with HIV/AIDS. It was previously used for malaria but is no longer recommended due to resistance. Pyrimethamine is taken by mouth.

Dorzolamide/timolol, sold under the brand name Cosopt among others, is a medication used to treat high pressure inside the eye including glaucoma. It is a combination of dorzolamide hydrochloride and timolol maleate. It may be used when a beta blocker, like timolol, is not sufficient alone. It is used as an eye drop.

<span class="mw-page-title-main">Teva Pharmaceuticals</span> Israeli pharmaceutical company

Teva Pharmaceutical Industries Ltd. is an Israeli multinational pharmaceutical company. Teva specializes primarily in generic drugs, but other business interests include branded-drugs, active pharmaceutical ingredients (API's) and, to a lesser extent, contract manufacturing services and an out-licensing platform.

<span class="mw-page-title-main">Actavis</span> Global pharmaceutical company

Actavis Generics is a global pharmaceutical company focused on acquiring, developing, manufacturing and marketing branded pharmaceuticals, generic and over-the-counter medicines, and biologic products. Actavis has a commercial presence across approximately 100 countries. The company has global headquarters in Dublin, Ireland and administrative headquarters in Parsippany-Troy Hills, New Jersey, United States.

<span class="mw-page-title-main">Trospium chloride</span> Chemical compound

Trospium chloride is a muscarinic antagonist used to treat overactive bladder. It has side effects typical of this class of drugs, namely dry mouth, stomach upset, and constipation; these side effects cause problems with people taking their medicine as directed. However it doesn't cause central nervous system side effects like some other muscarinic antagonists. It is in pregnancy category C and is excreted in breast milk.

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

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) marketed in the US as an ophthalmic solution by ISTA Pharmaceuticals for short-term, local use. Prolensa and Bromday are the once-daily formulation of bromfenac, while Xibrom was approved for twice-daily administration. In the European Union, the brand name is Yellox. Bromfenac is indicated for the treatment of ocular inflammation and pain after cataract surgery.

Repros Therapeutics Inc. (Nasdaq: RPRX), was a US-based development stage biopharmaceutical company headquartered in The Woodlands, Texas. Founded in 1987 as Zonagen, it focused on the development of oral small molecule drugs to address major unmet medical needs in male and female health. Joseph S. Podolski was the CEO of this company.

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.

<span class="mw-page-title-main">Martin Shkreli</span> American financial investor and businessman (born 1983)

Martin Shkreli is an American investor and businessman. He was convicted of financial crimes for which he was sentenced to seven years in federal prison, being released on parole after roughly six and a half years in 2022, and was fined over 70 million dollars. Shkreli is the co-founder of the hedge funds Elea Capital, MSMB Capital Management, and MSMB Healthcare, the co-founder and former CEO of pharmaceutical firms Retrophin and Turing Pharmaceuticals, and the former CEO of start-up software company Gödel Systems, which he founded in August 2016.

AbbVie Inc. is an American pharmaceutical company headquartered in North Chicago, Illinois. It is ranked sixth on the list of largest biomedical companies by revenue. In 2023, the company's seat in Forbes Global 2000 was 74, and rank 89 on the 2024 list. The company's primary product is Humira (adalimumab), administered via injection. It is approved to treat autoimmune diseases including rheumatoid arthritis, Crohn's disease, plaque psoriasis, and ulcerative colitis.

<span class="mw-page-title-main">NovaBay Pharmaceuticals</span> Biopharmaceutical company

NovaBay Pharmaceuticals, Inc. is an Emeryville, California based clinical-stage biopharmaceutical company, focused on developing novel, fast-acting, synthetic anti-infectives compounds. These compounds are designed to mimic the body's defense system against infection. The company is currently focused on products for the eye care market. Major products include Avenova, cleared by FDA for lid and lash cleansing as part of a regimen for Blepharitis. and NeutroPhase, used in treatment of Necrotizing Fasciitis

<span class="mw-page-title-main">Vyera Pharmaceuticals</span> Pharmaceutical company

Vyera 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.

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. The company is the maker of Botox.

Relief Therapeutics is a Swiss biopharmaceutical company based in Geneva. The company focuses on developing drugs for serious diseases with few or no existing treatment options. Its lead compound, RLF-100, is a synthetic form of a natural peptide that protects the lung. The company was incorporated as Relief Therapeutics Holdings AG (RFLB.S) and listed on the SIX Swiss Exchange in 2016.

References

  1. 1 2 Johnson, Linda A. (23 October 2015). "Drug compounder offers cheap version of costly Turing drug". Santa Maria Times. Vol. 134, no. 185. Santa Maria, California: Lee Enterprises. Associated Press. p. B4 – via Newspapers.com.
  2. ↑ Inc, Imprimis Pharmaceuticals, Inc; Eton Pharmaceuticals. "Eton Pharmaceuticals Announces $20 Million Series A Financing". www.prnewswire.com. Retrieved 17 August 2020.{{cite web}}: |last= has generic name (help)CS1 maint: multiple names: authors list (link)
  3. ↑ Inc, Imprimis Pharmaceuticals. "Imprimis Launches Surface Pharmaceuticals Subsidiary". www.prnewswire.com. Retrieved 17 August 2020.{{cite web}}: |last= has generic name (help)
  4. ↑ Inc, Imprimis Pharmaceuticals. "Surface Pharmaceuticals, Inc. Announces $20 Million Series A Financing from Flying L Partners". www.prnewswire.com. Retrieved 17 August 2020.{{cite web}}: |last= has generic name (help)
  5. ↑ Inc, Harrow Health (5 February 2019). "Harrow Health Announces $11 Million Series A Financing for Melt Pharmaceuticals Subsidiary". GlobeNewswire News Room. Retrieved 17 August 2020.{{cite web}}: |last= has generic name (help)
  6. ↑ "Harrow hires chief innovation officer". Nashville Post. Retrieved 17 August 2020.
  7. 1 2 3 4 Kroll, David (23 October 2015). "Imprimis' Fight Against Martin Shkreli Is Part of a Larger Battle". Forbes. Forbes Publishing Group.
  8. ↑ "Big Pharma Prioritises Profits Over Patients | Mark Baum | Oxford Union - YouTube". www.youtube.com. Retrieved 17 August 2020.
  9. ↑ Baum, Mark L. (26 January 2016). "A New Prescription for Lower Drug Prices". Wall Street Journal. ISSN   0099-9660 . Retrieved 17 August 2020.
  10. ↑ Baum, Mark L. (5 April 2017). "How FDA Rules Made a $15 Drug Cost $400". Wall Street Journal. ISSN   0099-9660 . Retrieved 17 August 2020.
  11. ↑ Staff (25 March 2016). "Imprimis Pharmaceuticals pushes the definition of pharmaceutical manufacturing". Pharmaceutical Commerce. New York, New York: Healthcare Commerce Media Corporation.
  12. ↑ Luttrell, Regina; Ward, Jamie (2018). "Advocacy". A Practical Guide to Ethics in Public Relations. Rowman & Littlefield. p. 60. ISBN   9781442272736 – via Google Books. While Turing is a glaring example of corporate greed, Imprimis plays the role of public health advocate and de facto public hero.
  13. ↑ Bomey, Nathan (23 October 2015). "Drug company attempts $1 alternative to Daraprim". USA TODAY. Gannett. Retrieved 4 January 2016.
  14. ↑ Murphy, Tom (2 December 2015). "Low-cost alternative to Turing drug offered". The Citizens' Voice. Wilkes-Barre, Pennsylvania: Times-Shamrock. Associated Press. p. A4 – via Newspapers.com.
  15. ↑ Elvidge, Suzanne (29 September 2016). "Imprimis shuts down Texas plant, axes 8% of jobs". BioPharma Dive. Industry Dive.
  16. ↑ Johnson, Linda A.; Murphy, Tom (26 August 2016). "Mylan boosts patient programs, doesn't budge on EpiPen price". The Santa Fe New Mexican. Vol. 167, no. 238. Santa Fe, New Mexico. Associated Press. p. A8 – via Newspapers.com.
  17. 1 2 Raymond, Nate (16 January 2018). "Imprimis receives FDA warning over eye medication advertising". Reuters. Archived from the original on 17 January 2018.
  18. ↑ Staff (1 October 2015). "People". Genetic Engineering & Biotechnology News (Paper). Vol. 35, no. 17. p. 49. Imprimis Pharmaceuticals elected Anthony J. Principi to its board of directors
  19. ↑ Inc, EyePoint Pharmaceuticals (4 August 2020). "EyePoint Pharmaceuticals and Harrow Health's ImprimisRx Announce U.S. Commercial Alliance for DEXYCU®". GlobeNewswire News Room. Retrieved 17 August 2020.{{cite web}}: |last= has generic name (help)
  20. ↑ "Imprimis Pharmaceuticals Launches Simple Drops Combination Glaucoma Drops". Eyewire News. Retrieved 17 August 2020.
  21. ↑ Silverman, Ed (31 January 2018). "FDA stepping between drug makers, compounders". The Boston Globe. Vol. 293, no. 31. Boston, Massachusetts: Boston Globe Media. p. B11 – via Newspapers.com.
  22. ↑ Inc, Imprimis Pharmaceuticals. "Imprimis Releases Statement Regarding Allergan Lawsuit". www.prnewswire.com. Retrieved 17 August 2020.{{cite web}}: |last= has generic name (help)
  23. ↑ Porter, Steven E. Jr. (21 December 2017). "Imprimis Pharmaceuticals - 540678 - 12/21/2017". Warning Letters. FDA.
  24. ↑ "Allergan wins lawsuit against Imprimis, but jury awards only $48,500". www.healio.com. Retrieved 17 August 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.