Alkermes (company)

Summary

Alkermes plc
TypePublic
Nasdaq: ALKS
Russell 1000 Component
IndustryBiotechnology
Founded1987
FounderMichael Wall
Headquarters,
Key people
Richard Pops, CEO
RevenueIncrease US$1 billion (2018)[2]
Decrease US$-42.9 Million
Decrease US$-39.6 Million
Total assetsDecrease US$452 Million
Total equityDecrease US$392 Million
Number of employees
1200
Websitewww.alkermes.com

Alkermes plc is a biopharmaceutical company that focuses on central nervous system (CNS) diseases such as such as schizophrenia, depression, addiction and multiple sclerosis. The company was founded in 1987 by Michael Wall.[3] In September 2011 Alkermes, Inc. merged with Elan Drug Technologies (EDT), the former drug formulation and manufacturing division of Élan Corporation, plc.[4] The company is headquartered in Dublin, and has an R&D center in Waltham, Massachusetts, and manufacturing facilities in Athlone, Ireland, and Wilmington, Ohio.[1]

Products

Alkermes has more than 20 commercial drug products and candidates that address serious and chronic diseases, such as addiction, schizophrenia, diabetes and depression. Among these products, five are primary to the company: risperidone long-acting Injection (generic for Risperdal Consta) for schizophrenia and bipolar 1 disorder,[5][6] paliperidone palmitate (generic for Invega Sustenna in the U.S., Xeplion in Europe) for schizophrenia,[7][8] 4-aminopyridine (generic for Ampyra in the U.S., Fampyra in Europe) to improve walking in patients with multiple sclerosis,[9][10] naltrexone for extended-release injectable suspension (generic for Vivitrol) for alcohol and opioid dependence,[11][12] and exenatide extended-release for injectable suspension (generic for Bydureon) for the treatment of type 2 diabetes. Bydureon is a once-weekly, extended-release form of the drug, exenatide (Byetta), and was developed through a partnership between Amylin Pharmaceuticals, Alkermes and Eli Lilly. It is approved in Europe and the U.S.[13]

Buprenorphine/samidorphan (ALKS-5461), a κ-opioid receptor antagonist, was under development by Alkermes for treatment-resistant depression.[14] In 2019, the FDA rejected Alkermes' New Drug Application for ALKS-5461, citing insufficient evidence of efficacy.[15]

Olanzapine/samidorphan (ALKS-3831) is an atypical antipsychotic and opioid modulator combination intended for the treatment of schizophrenia and bipolar mania; the addition of samidorphan is intended to reduce the risk of weight gain associated with olanzapine.[16][17] In June 2021, ALKS-3831 was accepted under the brand name Lybalvi for use in schizophrenia and bipolar disorder, in the latter as both an acute treatment for mania and mixed episodes as well as a maintenance therapy alone or in combination with lithium or valproate.[18]

References

  1. ^ a b Robert Weisman (10 May 2011). "Alkermes to buy Irish drug maker". Boston Globe.
  2. ^ "Alkermes (ALKS) Quarterly Report". WikiInvest. 2011. Retrieved 13 October 2011.
  3. ^ "Alkermes And Richard Pops — The Evolution Of A Company And Its Leader". LifeScienceLeader.com. 1 May 2019. Retrieved 21 June 2019.
  4. ^ "Alkermes Reels In Elan's Drug Technology Business". Forbes.com. 9 May 2011. Retrieved 13 October 2011.
  5. ^ Zacks Equity Research, “Positive Data on Risperdal Consta Archived 2012-04-26 at the Wayback Machine,” Yahoo! Finance, March 29, 2011.
  6. ^ John M. Grohol, “Risperdal Consta Approved for Bipolar,” PsychCentral.com, May 18, 2009.
  7. ^ Cole Petrochko, “FDA Okays First Monthly Antipsychotic Drug,” MedPage Today, August 5, 2009.
  8. ^ Matt Jarzemsky, “Johnson & Johnson Gets European Approval For Schizophrenia Shot,” The Wall Street Journal, March 9, 2011.
  9. ^ Susan Jeffrey, “FDA Approves Dalfampridine to Improve Walking in Multiple Sclerosis,” Medscape Medical News, January 22, 2010.
  10. ^ Toni Clarke, “Europe backs Acorda, Biogen drug in change of tack,” Reuters, May 20, 2011.
  11. ^ Miranda Hitti, “FDA OKs New Drug to Treat Alcoholism Archived 2010-10-13 at the Wayback Machine,” WebMD, April 14, 2006.
  12. ^ Rita Rubin, “FDA OKs Vivitrol to treat heroin, narcotic addictions,” USA Today, October 13, 2010.
  13. ^ Denise Mann, "Weekly Shot Gets FDA Nod for Type 2 Diabetes," WebMD, January 27, 2012
  14. ^ Harrison, Charlotte (2013). "Trial watch: Opioid receptor blocker shows promise in Phase II depression trial". Nature Reviews Drug Discovery. 12 (6): 415. doi:10.1038/nrd4028. ISSN 1474-1776. PMID 23722336. S2CID 250460.
  15. ^ "FDA rejects Alkermes' depression drug ALKS 5461". FierceBiotech. Retrieved 2021-08-04.
  16. ^ Maric NP, Jovicic MJ, Mihaljevic M, Miljevic C (2016). "Improving Current Treatments for Schizophrenia". Drug Development Research. 77 (7): 357–367. doi:10.1002/ddr.21337. PMID 27633376. S2CID 205750190.
  17. ^ Fellner C (2017). "New Schizophrenia Treatments Address Unmet Clinical Needs". P T. 42 (2): 130–134. PMC 5265239. PMID 28163559.
  18. ^ "FDA Approves Lybalvi (olanzapine and samidorphan) for the Treatment of Schizophrenia and Bipolar I Disorder". Drugs.com. Retrieved 2021-08-05.