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Intarcia Therapeutics, Inc.
Company typePrivate
Industrypharmaceutical industry Pharmaceutical
FoundedHayward, California, United States (1995 (1995))
Headquarters
Boston
,
United States
Key people
Kurt C. Graves (Chairman, President and CEO)
ProductsITCA 650
Medici Drug Delivery System
Websiteintarcia.com

Intarcia Therapeutics is an American biopharmaceutical company based in Boston, MA and incorporated under the laws of Delaware.[1][2] The company engages in research and development for the prevention and treatment of chronic disorders and infectious diseases, including diabetes, obesity and HIV.[3][4] Its Medici product, which has not yet been approved by the FDA, is a matchstick-sized device that is inserted under the skin and delivers medicine over the course of six or 12 months, with the intention of improving dosage consistency and patient compliance.[5][6]

History[edit]

It Intarcia was founded in 1995 under the name "BioMedicines" and changed to its present name in 2004.[1] In 2013, Intarcia relocated its headquarters to Boston, keeping its manufacturing facility in Hayward, CA. In addition to Boston and Hayward, Intarcia also has a location in Research Triangle Park, North Carolina, where it discovers and develops peptides for its drug delivery system.[7]

In 2005, the executive leadership of Intarcia was largely vested in two people, Karling Leung and James Ahlers, President/CEO/Director and Vice President/CFO/Finance & Operations Officer, respectively.[8] By 2012, Kurt Graves had replaced Karling Leung as President and CEO. Kurt Graves has been with Intarcia since joined the company in August 2010, first serving as Executive Chairman before becoming President and CEO in April 2012.[9][10] Intarcia acquired biotechnology company Phoundry Pharmaceuticals, based in Research Triangle Park, North Carolina, in 2015.[11]

Research and development[edit]

In May 2016, the company announced that it had completed Phase 3 clinical trials for its GLP-1 product.[12] As of 2016, Intarcia is engaged in development of claims the product, referred to as ITCA 650, is a "potential once-a-year type 2 diabetes treatment". Referred to as ITCA 650, tThe therapeutic consists of exenatide delivered via its Medici Drug Delivery System,[13][6] "a drug delivery platform that stabilizes and delivers therapeutic proteins and peptides".[1] The Medici system is a drug pump the approximate size of a matchstick that is injected underneath the patient's skin. Because the product would only require replacement every six or 12 months, it would be intended to improve patient compliance in addition to dosage consistency.[5][6]

In November 2017, the FDA rejected the product for approval, citing manufacturing issues.[14] In December 2018, the company said it was intending to re-submit its application with the FDA.[15][16]

As of 2017, the company is developing an HIV prevention and treatment product that would also use the Medici delivery technology,[4] with investment from the Bill & Melinda Gates Foundation.[17]

Investors[edit]

In November 2012, Intarcia received $210M in preferred stock and debt financing from, The Baupost Group, Farallon Capital Management, New Enterprise Associates, New Leaf Venture Partners and Venrock Associates. [18] Other Investors investors include Greenspring Associates,[19] Alta Partners and Granite Venture Partners.

In April 2014, Intarcia secured an additional $200M in financing. RA Capital led the round and was joined by new and existing investors.[7] In April 2015, the company raised $225M in exchange for 1.5% of future global net sales of ITCA 650.[6] In May 2016, Intarcia secured an additional $75M in financing to scale-up manufacturing and inventory in anticipation of ITCA 650s global launch.[20] In September 2016, Intarcia raised an additional $215M in equity financing to prepare for the commercial launch of ITCA 650 in late 2017 and additional pipeline programs.[21]

In December 2016, Intarcia received a $140M investment from the Bill & Melinda Gates Foundation to support development of HIV treatment and prevention technology.[17] The company raised another $200M in September 2017.[22]

Notes[edit]

  1. ^ a b c "Company Overview of Intarcia Therapeutics, Inc.", Bloomberg Businessweek, retrieved November 15, 2012
  2. ^ Exhibit 4.1, SEC, retrieved November 15, 2012
  3. ^ Stevenson, Abigail (14 May 2015). "The holy grail of treating disease: Intarcia". CNBC. Retrieved 22 July 2019.
  4. ^ a b Vanian, Jonathan (2 May 2017). "How a Tiny, Implantable Drug Could Prevent HIV". Fortune. Retrieved 22 July 2019.
  5. ^ a b "Intarcia Medici, a Tiny Implantable Pump for Drug Delivery". Medgadget. 9 June 2016. Retrieved 23 July 2019.
  6. ^ a b c d Winslow, Ron (April 28, 2015). "Startup Intarcia Raises $225 Million" – via www.wsj.com.
  7. ^ a b "Investors pump $200M into Intarcia's PhIII for once-yearly diabetes therapy". www.fiercebiotech.com.
  8. ^ "INTARCIA THERAPEUTICS, INC.", AMENDMENT NO. 1 TO FORM S-1, SEC, March 18, 2005, retrieved November 15, 2012
  9. ^ Ron Leuty (November 15, 2012), "Intarcia raises $210M as it pushes once-a-year diabetes treatment into Phase III, moves HQ to Boston area", San Francisco Business Times, retrieved November 15, 2012
  10. ^ "Stocks". Bloomberg.com.
  11. ^ "Intarcia Therapeutics Acquires Phoundry Pharmaceuticals". The Wall Street Journal. 24 September 2015. Retrieved 22 July 2019.
  12. ^ Primack, Dan (6 May 2016). "Diabetes 'Unicorn' Intarcia Hits Major Milestone". Fortune. Retrieved 22 July 2019.
  13. ^ "Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus", ClinicalTrials.gov, May 1, 2012, retrieved November 15, 2012
  14. ^ Stendahl, Max (12 December 2018). "FDA warned Intarcia about manufacturing issues before drug rejection". Boston Business Journal. Retrieved 22 July 2019.
  15. ^ "Intarcia Provides 2019 Corporate Update". Intarcia Therapeutics (Press release). 18 December 2018. Retrieved 23 July 2019. In 2018, Intarcia has made significant progress towards the resubmission of its New Drug Application (NDA) for ITCA 650, the company's lead investigational therapy for the treatment of type 2 diabetes (T2D), which it expects to file with the FDA in mid-2019.
  16. ^ DeAngelis, Allison (19 December 2018). "Diabetes unicorn Intarcia delays timing of FDA re-submission". Boston Business Journal. Retrieved 23 July 2019.
  17. ^ a b Winslow, Ron (29 December 2016). "Gates Foundation to Invest Up to $140 Million in HIV Prevention Device". The Wall Street Journal. Retrieved 22 July 2019.
  18. ^ "Intarcia raises $210M as it pushes once-a-year diabetes treatment into Phase III, moves HQ to Boston area". BizJournals. November 15, 2012. Retrieved November 7, 2013.
  19. ^ "Direct Investments". Greenspring Associates. November 7, 2013. Retrieved November 7, 2013.
  20. ^ "Intarcia raises $75M, touts final data as it preps to launch once-yearly diabetes drug implant". www.fiercebiotech.com.
  21. ^ "Diabetes 'Unicorn' Raises Final VC Round Before IPO". Fortune.
  22. ^ "Intarcia Therapeutics' Series E Round". CB Insights. 15 September 2016. Retrieved 23 July 2019.

External links[edit]

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