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Alkermes plc

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Alkermes, Inc.
Company typePublic Nasdaq: ALKS
IndustryBiotechnology
Headquarters
Dublin[1]
,
Ireland
Key people
Richard Pops, CEO
RevenueIncrease US$187 Million[2]
Decrease US$-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 (NASDAQ: ALKS) is a global biopharmaceutical company with expertise in central nervous system (CNS) diseases and a broad portfolio of products and technologies. The company is the result of a merger in September 2011 between Alkermes, Inc. and Elan Drug Technologies (EDT), a drug formulation and manufacturing unit of Elan.[3] Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland, Gainesville, Georgia and Wilmington, Ohio.[4]

Products & Technologies

Alkermes plc has more than 20 commercial drug products and clinical candidates that address CNS disorders such as addiction, schizophrenia and depression. Among these, five products are primary to the company: Risperdal Consta, Invega Sustenna, Ampyra, Vivitrol and Bydureon.[5] Risperdal Consta (risperidone Long-Acting Injection) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar 1 disorder.[6] As the first long-acting formulation of an atypical antipsychotic approved by the FDA, Risperdal Consta is administered once every two weeks.[7]

Also a long-acting injectable medication, Invega Sustenna (paliperidone palmitate) is used for the treatment of schizophrenia. It is the first once-monthly, long-acting, injectable atypical antipsychotic approved in the U.S. for this use.[8] Invega Sustenna is commercialized under the name Xeplion in the European Union.[9]

Ampyra (dalfampridine) is a twice-daily controlled release tablet approved by the FDA to improve walking in patients with multiple sclerosis (MS). It is the first drug approved to improve walking in MS patients, as other currently approved MS drugs are indicated to decrease relapse rates or in some cases to prevent accumulation of disability.[10] In all markets outside of the U.S. the drug is branded as Fampyra. In May 2011, Fampyra received conditional approval from the European Commission.[11]

Vivitrol (naltrexone for extended-release injectable suspension) is the only non-addictive, once-monthly medication for both alcohol and opioid dependence. Designed for once-monthly dosing, Vivitrol eliminates the daily need for patients to medicate.[12]

Partnerships

Alkermes is partnering with Amylin Pharmaceuticals, Inc. and Eli Lilly and Company to develop Bydureon (exenatide extended-release injectable suspension), an extended-release formulation of the same active ingredient in Byetta. Administered twice-daily, Byetta is a first-in-class injectable medication for the treatment of type 2 diabetes.[13] The companies submitted a New Drug Application (NDA) for Bydureon to the FDA on May 5, 2009, and if approved, Bydureon could be the first once-weekly therapy for the treatment of type 2 diabetes.[14] On June 21, 2011, Bydureon received marketing authorization in the European Union.[15]

[16] Risperdal Consta (risperidone Long-Acting Injection) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar 1 disorder.[17]

References

  1. ^ Robert Weisman (10 May 2011). "Alkermes to buy Irish drug maker". Retrieved 13 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  2. ^ "Alkermes (ALKS) Quarterly Report". 2011. Retrieved 13 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  3. ^ "Alkermes Reels In Elan's Drug Technology Business". 9 May 2011. Retrieved 13 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  4. ^ Robert Weisman (10 May 2011). "Alkermes to buy Irish drug maker". Retrieved 13 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  5. ^ Luke Timmerman (09 May 2011). "Alkermes Acquires Elan Drug Manufacturing Unit for $960M". Retrieved 19 October 2011. {{cite web}}: Check date values in: |date= (help); Unknown parameter |publication= ignored (help)
  6. ^ Laurie Barclay (27 May 2009). "FDA Approvals: Risperdal Consta and Cimzia". Retrieved 19 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  7. ^ Megan J Ehret, PharmD (November 2004). "Long-Acting Injectable Risperidone". Retrieved 19 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  8. ^ Cole Petrochko (5 August 2009). "FDA Okays First Monthly Antipsychotic Drug". Retrieved 19 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  9. ^ Matt Jarzemsky (9 March 2001). "Johnson & Johnson Gets European Approval For Schizophrenia Shot". Retrieved 19 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  10. ^ Susan Jeffrey (27 January 2010). "FDA Approves Dalfampridine to Improve Walking in Multiple Sclerosis". Retrieved 13 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  11. ^ Toni Clarke (20 May 2011). "UPDATE 3-Europe backs Acorda, Biogen drug in change of tack". Reuters.com. Retrieved 13 October 2011.
  12. ^ Rita Rubin (13 October 2010). "FDA OKs Vivitrol to treat heroin, narcotic addictions". Retrieved 13 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  13. ^ "Amylin trades higher on diabetes drug promise". 8 July 2011. Retrieved 13 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  14. ^ Ransdell Pierson and Lewis Krauskopf (5 May 2009). "Lilly, Amylin seek OK for weekly Byetta". Retrieved 13 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  15. ^ Howard Lovy (22 June 2011). "Europe's Bydureon approval is victory for Alkermes". Retrieved 13 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  16. ^ "Risperdal Consta Approved for Bipolar". 18 May 2009. Retrieved 13 October 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
  17. ^ Y. Waknine (27 May 2009). "FDA Approvals: Risperdal Consta and Cimzia". Retrieved October 19, 2011. {{cite web}}: Unknown parameter |publication= ignored (help)
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