Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. is an American publicly traded generics and specialty pharmaceutical company. The company is headquartered in Bridgewater, New Jersey.[2]

Amneal Pharmaceuticals
Public
Traded asNYSE: AMRX (Class A)
Russell 2000 Component
Founded1995 (1995)
Founders
  • Chirag Patel, Ph.D.
  • Chintu Patel, Ph.D.
Headquarters
Bridgewater, New Jersey
Number of locations
Manufacturing plants in Branchburg, East Hanover and Piscataway, NJ; Brookhaven and Hauppauge, NY, Hayward, CA, India and Ireland
ProductsGeneric and specialty pharmaceuticals
Revenue $US $1.8 billion (2017)
Number of employees
>6,000 [1]
Divisions
  • Generics
  • Specialty Pharma
Websiteamneal.com

History

Amneal before 2017 merger

In 2007, the company acquired five divested drugs from Mylan which they were forced to sell as part of their acquisition of the generics unit of Merck KGaA.[3] At this time, the company was noted as being a private company based in Paterson, New Jersey.[3]

In 2011, the company's president and chief executive officer were, respectively, Chirag Patel and Chintu Patel.[4]

Impax before 2017 merger

The company's predecessor entity, privately held Impax Pharmaceuticals, Inc., was founded in 1995. Publicly traded Global Pharmaceutical Corporation and Impax Pharmaceuticals, Inc. completed a reverse merger, forming Impax Laboratories, Inc. on December 14, 1999.[5]

In March 2015, Impax completed its acquisition of Tower Holdings, Inc. (including operating subsidiaries CorePharma LLC and Amedra Pharmaceuticals LLC including its Adrenaclick epinephrine autoinjector), and Lineage Therapeutics Inc. In connection with the closing of the acquisition, Impax reshaped the operating and reporting structure of its two divisions into Impax Generics and Impax Specialty Pharma.[6][7]

In June 2016, the company acquired 15 marketed generics, as well as three others which are close to market, for $586 million from Teva Pharmaceutical Industries.[8][9]

Formation of Amneal Pharmaceuticals Inc.

In October 2017, Impax, led by Paul Bisaro, and Amneal Pharmaceuticals LLC announced their intent to merge in an all stock transaction, creating the fifth largest United States generics company, with more than 300 products in their portfolio, with an expected value of US$6.4 billion.[10] As part of the deal Impax shareholders would own 25% of the new merged entity, with the other 75% going to Amneal's shareholders.[10] At the time of the merger, Amneal was headquartered in Bridgewater, New Jersey.[11] The merged entity would be called Amneal Pharmaceuticals, Inc.[10] In April 2018, the FTC approved the merger, which it described as having a value of US$1.45 billion, and required the companies to divest several marketed products and development projects as a condition of the approval.[12] The merger was completed in May 2018, with shares of IMPX ceasing trading on NASDAQ on May 4 and shares of AMRX commencing trading on the NYSE on May 7.[13]

Operations

Impax Generics includes the company's legacy Global Pharmaceuticals business as well as the acquired CorePharma and Lineage Therapeutics businesses. Impax Specialty Pharma includes the legacy Impax Pharmaceuticals business as well as the acquired Amedra Pharmaceuticals business.[14]

Impax's Generics Division focuses on a broad range of therapeutic areas, including products having technically challenging drug-delivery mechanisms or unique product formulations. In addition to developing solid oral dosage products, the company's portfolio includes alternative dosage form products, primarily through alliance and collaboration agreements with third parties.[6]

The company's Specialty Pharma Division is focused on the development and promotion, through the company's specialty sales force, of proprietary branded pharmaceutical products for the treatment of Central Nervous System disorders and other select specialty segments.[6]

The Impax Specialty Pharma Division has developed one branded pharmaceutical product, RYTARY (IPX066), an extended release oral capsule formulation of carbidopa-levodopa for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication, which was approved by the FDA on January 7, 2015.[15]

Regulatory and litigation

Impax and DAVA Pharmaceuticals engaged in a legal dispute with Purdue Pharma over the patents and production of time-released oxycodone (OxyContin) until reaching an agreement in April 2007.[16] Another dispute with Endo Pharmaceuticals and Penwest Pharmaceuticals concluded with Impax gaining the right to begin producing extended-release oxymorphone through its Global Pharmaceuticals division as of 2013.[17][18]

In March 2011 several wholesale lots of the company's 200 mg fenofibrate capsules were recalled due to metal contamination and variable dose weight.[19][20] Impax announced the resolution of its May 2011 FDA warning letter for its Hayward, CA facility on September 8, 2015.[21]

References
  1. https://www.amneal.com/about/our-story/amneal-at-a-glance/
  2. "Amneal at-a-glance". Amneal Pharmaceuticals. Retrieved July 26, 2019.
  3. Sabatini, Patricia (September 28, 2007). "Drug maker selling assets to win OK for deal". Business. Pittsburgh Post-Gazette. Retrieved June 23, 2018 – via Newspapers.com (Publisher Extra).
  4. Perrault, Mike (November 16, 2011). "LinkedIn duo lauded as top entrepreneurs". Business. The Desert Sun. Palm Springs, California. p. A15. Retrieved June 23, 2018 – via Newspapers.com (Publisher Extra).
  5. "Impax Laboratories Inc. - Investor Relations - Investor FAQ".
  6. "Impax 2014 Annual Report" (PDF). Archived from the original (PDF) on October 23, 2015. Retrieved October 20, 2015.
  7. Impax March 10, 2015 Press Release: Impax Completes Acquisition Of Tower Holdings, Inc. And Lineage Therapeutics Inc. Archived August 27, 2016, at the Wayback Machine
  8. "Impax Buys Generic Product Portfolio from Teva, Allergan for $586M - GEN News Highlights - GEN".
  9. "Teva sells castoffs to Impax for $586M as clock ticks on Allergan deal - FiercePharma".
  10. Helfand, Carly (October 17, 2017). "Bisaro steers Impax to $6.4B Amneal merger, creating fifth-largest U.S. generics company". FiercePharma. Newton, Massachusetts: Questex. Retrieved June 23, 2018.
  11. Loyd, Linda (October 18, 2017). "Impax, Amneal merge". Briefcase. The Philadelphia Inquirer. p. A12. Retrieved June 23, 2018 – via Newspapers.com (Publisher Extra).
  12. "Press release: FTC Requires Generic Drug Marketers Amneal Pharmaceuticals LLC and Impax Laboratories Inc. to Divest Rights to 10 Generic Medications as Condition of Merger". FTC. April 27, 2018.
  13. "Press release: Amneal and Impax Complete Business Combination - NASDAQ.com". Amneal via PRNewswire via NASDAQ. May 7, 2018.
  14. "Impax Completes Acquisition Of Tower Holdings, Inc. And Lineage Therapeutics Inc" (Press release). Hayward, California: Impax Laboratories, Inc. March 10, 2015. Archived from the original on October 26, 2015. Retrieved October 20, 2015.
  15. "Impax Pharmaceuticals Announce FDA Approval of RYTARY (Carbidopa and Levodopa) Extended-Release Capsules for the Treatment of Parkinson's disease" (Press release). Hayward, California: Impax Laboratories, Inc. January 8, 2015. Archived from the original on October 22, 2015. Retrieved October 20, 2015.
  16. "Purdue Pharma L.P. Announces Agreement to End OxyContin® Patent Lawsuit with IMPAX Laboratories" (Press release). Purdue Pharma. April 2, 2007. Archived from the original on July 22, 2010. Retrieved April 29, 2013.
  17. "Impax Labs. Introduces Oxymorphone Hydrochloride Extended-Release Tablets". RTTNews. January 4, 2013. Archived from the original on January 10, 2013. Retrieved February 15, 2014.
  18. Larson, Erik (April 2, 2007). "Purdue, Impax Settle Oxycontin Litigation". Law360. LexisNexis. Retrieved February 15, 2014.(registration required)
  19. "Warning Letter". Inspections, Compliance, Enforcement, and Criminal Investigations. Food and Drug Administration. May 31, 2011. Archived from the original on December 23, 2011. Retrieved February 15, 2014.
  20. Miller, George (June 7, 2011). "Impax reveals warning letter related to drug recall Read more: Impax reveals warning letter related to drug recall". FiercePharma Manufacturing. Questex Media Group. Archived from the original on February 15, 2014. Retrieved February 15, 2014.
  21. "Impax Announces Resolution of FDA Warning Letter Related to its Hayward Manufacturing Facility" (Press release). Hayward, California: Impax Laboratories, Inc. September 8, 2015. Retrieved May 18, 2019.
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