Harrow Health, Inc.
FormerlyImprimis Pharmaceuticals ( - Jan 2019)
TypePublic
Nasdaq: HROW
Russell Microcap Index component
IndustryPharmaceutical Industry
Founded2012 (2012)[1]
Headquarters
Nashville, TN
,
United States
Number of locations
1 (Nashville, TN)
Key people
  • Mark L. Baum (CEO)
  • Andrew R. Boll (CFO)
ProductsPharmaceuticals
Subsidiaries
  • ImprimisRx
  • Eton Pharmaceuticals
  • Surface Pharmaceuticals
  • Melt Pharmaceuticals
  • Visionology.com
Websitewww.harrow.com Edit this on Wikidata

Harrow Health, formerly known as Imprimis Pharmaceuticals, is a publicly traded pharmaceutical company (Nasdaq: HROW) based in Nashville, TN.

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]

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.
  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.
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