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Amphastar Pharmaceuticals[edit]

From Wikipedia, the free encyclopedia

Amphastar Pharmaceuticals Inc.
Company typePublic
Nasdaq: AMPH
IndustryPharmaceutical Industry, Biotechnology, Generic drug
HeadquartersRancho Cucamonga, California, U.S.
Key people
Jack Yongfeng Zhang, PhD
(Co-Founder, CEO, CSO)
Mary Ziping Luo, PhD
(Co-Founder and COO)
ProductsEnoxaparin Sodium,
Medroxyprogesterone Acetate,
Naloxone,
Phytonadione,
Primatene Mist,
Cosyntropin,
Hyaluronidase, etc.
RevenueIncrease US $294.66 million (2018) [1]
Increase US $115.60 million (2018)
Decrease US $5.73 million (2018)
Total assetsIncrease US $513.56 million (2018)
Total equityIncrease US $332.43 million (2018)
Number of employees
2,078 (December 2018) [2]
Websitewww.amphastar.com

Amphastar Pharmaceuticals Inc. is a publicly traded, American multinational specialty pharmaceutical company, focused on biotechnology and generics.[3] Amphastar was established in 1996 and is headquartered and incorporated in Rancho Cucamonga, California as a Delaware corporation in July 2004.[4] Amphastar's membership in notable exchange-traded funds (ETF's) include:[5] [6]

Amphastar engages in the research, development, manufacture, marketing, and commercialization of technically challenging and proprietary injectable, inhalation, and intranasal pharmaceutical products.[7]

The company operates through finished pharmaceutical products, and active pharmaceutical ingredients (or API) products segments.[7] The finished pharmaceutical products segment manufactures, markets, and distributes enoxaparin, cortrosyn, amphadase (hyaluronidase), naloxone, lidocaine jelly, as well as various other critical and non-critical care drugs.[8] The active pharmaceutical ingredients products segment manufactures and distributes recombinant human insulin and porcine insulin.[8]

Currently, the company operates manufacturing and drug development research facilities in the following locations:[8][9]

History[edit]

The word Amphastar is a portmanteau of the company's stated goals to be a "recognized American pharmaceutical star."[10] The company's chief executive officer and chief science officer is co-founder, Jack Yongfeng Zhang, PhD, followed by chief operations officer and co-founder, Mary Ziping Luo, PhD. The company, initially incorporated as Aegis Pharmaceutical Inc. in 1996, was renamed to Amphastar Pharmaceuticals Inc. in 1997.[11][12]

In June 2014, Amphastar went public with an IPO of $64 million.[13][14] The financial institutions listed as Amphastar's joint book-runners at the time of the company's IPO include:[14]

In addition to the investment banks previously mentioned, the company currently maintains analyst coverage with:[15]

Development History[edit]

Development Timeline[edit]

  • 1996 – Aegis Pharmaceutical Inc.[16]
  • 1997 – Renamed to Amphastar Pharmaceuticals Inc.[17]
  • 1998 – International Medication Systems, Limited (IMS) Inc[18]
  • 1999 – New Drug Research Center[19]
  • 2003 – Armstrong Pharmaceuticals[20]
  • 2009 – Nanjing Puyan Pharmaceutical Technology Co. Ltd. (NPPT), renamed Amphastar Nanjing Pharmaceuticals (ANP)[21]
  • 2014 – Merck Insulin Active Pharmaceutical Ingredient unit, renamed Amphastar France Pharmaceuticals (AFP)[22]


Primatene Mist's reintroduction featured on the NASDAQ MarketSite

Historical Timeline[edit]


Aegis Pharmaceutical Inc.
(Founded in 1996; renamed to Amphastar Pharmaceuticals Inc. in 1997)

International Medication Systems, Limited (IMS) Inc
(Acq. in 1998 from Medeva PLC)

New Drug Research Center
(Est. in 1999)

Armstrong Pharmaceuticals
(Acq. in 2003. from Andrx Pharmaceuticals Inc., rights acquired for Albuterol CFC MDI )

Trademark for Cortrosyn (cosyntropin)
(Acq. in 2003 from Oganon USA Inc.)

Generic version of Primatene Mist, (Epinephrine mist)
(Acq. in 2004 from Alpharma USPD Inc.)

Amphastar Pharmaceuticals becomes a Delaware corporation
(Est. 2004)

Exclusive rights to Primatene Mist trademark and assets
(Acq. 2008 from Wyeth Consumer Healthcare Division)

Nanjing Puyan Pharmaceutical Technology Co. Ltd. (NPPT)
(Acq. in 2009, renamed Amphastar Nanjing Pharmaceuticals Co. Ltd., or ANP)

FDA issues final ruling requiring to phase out Primatene Mist CFC by the end of 2011
(Ruling made in 2009)

Generic of Lovenox (enoxaparin sodium) for injection approved
(ANDA in 2011)

Primatene Mist CFC discontinued
(Effective after December 31, 2011)

Merck insulin active pharmaceutical ingredient unit
(Acq. in 2014)

Merck insulin active pharmaceutical ingredient unit
(Acq. in 2014 and renamed Amphastar France Pharmaceuticals, or AFP)

Amphastar Pharmaceuticals Inc. files for IPO
(IPO of $64 Million in 2014)

Primatene Mist is reintroduced, HFA formulation for Over-the-Counter
(FDA approval in 2018)

Amphastar Pharmaceuticals Inc.[23]


Notable Products[edit]

Primatene® Mist[edit]

Acquired in 2007 from Wyeth Consumer Healthcare, Amphastar currently manufactures and commercializes Primatene Mist, currently the only FDA approved, over-the-counter epinephrine inhaler for the temporary relief of mild symptoms of intermittent asthma.[24]

Discontinuation of Primatene® Mist[edit]

The over-the-counter medication, which was available since the early 1960's, was taken off pharmacy shelves in December 2011 as part of US implementation of the 1989 Montreal Protocol and Clean Air Act of 1990 because it used chlorofluorcarbon (CFC) propellants.[25][26]

The FDA first began public discussion about the use of CFCs for epinephrine inhalers in January 2006. The FDA finalized the phase-out date for using CFCs in these inhalers and notified the public in November 2008.[26]

Despite this transition, opposition to the FDA's decision was notable, with some remarks including:

Physicians and patients are questioning the wisdom of the ban, which will have an insignificant effect on ozone but a measurable impact on wallets: the reformulated brand-name alternatives can be three times as expensive, raising the cost to about $40 per inhaler. The issue is even more disconcerting considering that asthma disproportionately affects the poor and that, according to recent surveys, an estimated 20 percent of asthma patients are uninsured.

Scientific American, 2008 [27]

The decision to make the change was political, not medical or scientific.

Professor Leslie Hendeles, Pharm.D
University of Florida, Co-author of "Withdrawal of Albuterol Inhalers Containing Chlorofluorocarbon Propellants"
The New England Journal of Medicine, explaining the withdrawal and transition. [27][28]

Boxed label indicating Primatene Mist with CFC will no longer be sold after December 31, 2011.

At least one member of the FDA advisory committee, Nicholas J. Gross of the Stritch School of Medicine of Loyola University Chicago, has publicly regretted the decision, recanting his support and requesting that the ban be pushed back until 2010, when the first patent expires.[27]

During this period, many manufacturers were in the transition period in changing their inhalers to replace CFCs with a propellant called hydrofluoroalkane (HFA). For instance, albuterol HFA inhalers can be used in the same way as epinephrine CFC inhalers. [26]

Purchasing any inhaler with CFC propellants after Dec. 31 2011 was not made possible after FDA compliance with the Montreal Protocol and Clean Air Act. At the time, there was no over-the-counter or prescription epinephrine inhaler made without CFCs.[26]

Reintroduction of Primatene® Mist[edit]

Seven years later, in 2018, the FDA approved the new version of the OTC asthma inhaler with a built-in spray indicator and a metal canister. The older version had a glass canister instead with no built-in spray indicator.[29] The new OTC product contains hydrofluoroalkane (HFA) propellants, which are permitted under current international and U.S. law.[29] Prescription-only inhalers that use different medications, such as albuterol and levalbuterol, also use HFAs as propellants.[29]

The new version is approved for use in adults and children 12 years of age and older.[30] It is not known if the product works or is safe in children younger than 12 years. By contrast, the old version was approved for ages 4 and older.[30] FDA analysis of the data, including new information that was developed since Primatene Mist was previously on the market, shows that there are no serious safety concerns when Primatene Mist is used as directed.[30]

FDA Center for Drug Evaluation and Research (CDER) Director Janet Woodcock


FDA Commissioner Scott Gottlieb
FDA Statement on Approval of OTC Primatene Mist to Treat Mild Asthma
November 08, 2018

We’ve made expanding access to OTC products a high priority and have worked on new legislative and policy proposals to promote access to safe and effective OTC drugs. Yesterday the FDA approved a new version of Primatene Mist, the only OTC metered-dose inhaler. This product has been the subject of past and current interest by patients and providers...When Primatene Mist came off the market during the CFC phase out, many people objected to the removal of the product. Among those were patients with mild asthma who had been using the product successfully. There was also concern for underserved populations who had no other access to asthma treatment.[24]

FDA Commissioner Scott Gottlieb, MD
Center for Drug Evaluation and Research Director Janet Woodcock, MD


Naloxone[edit]

One of its products is naloxone, an injectable generic drug that treats opioid overdose, and the company was criticized when it doubled the price of the drug from around $20 to $40 in 2015 during the opioid epidemic.

In February 2017, the FDA rejected the company's application to market a device that delivers naloxone intranasally.

Enoxaparin Sodium[edit]

Ball-and-stick model of enoxaparin sodium molecule.

The company manufactures and markets enoxaparin sodium, an anticoagulant medication (blood thinner) used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) including during pregnancy, following certain types of surgery, patients with acute coronary syndrome (ACS), patients at risk to heart attacks, and patients using kidney dialysis machines.[31]

Enoxaparin is a low molecular weight version of heparin, produced by breaking the heparin polysaccharide into smaller pieces.[32] The diversity of heparin molecules (varying in size between 5,000 and 40,000 daltons), stems from the biosynthetic pathway used to produce the molecule. Enoxaparin is likewise comprised of molecules of different molecular weights.[32]

This molecular diversity makes it more difficult for a generic manufacturer of enoxaparin to establish that its product has the same ingredients as the originator product, Lovenox.[32] The Hatch-Waxman Act requires, among other things, that an application for abbreviated approval of a generic drug shall contain information to show that the active ingredient of the generic drug is the same as that of the listed originator drug.[32]

Enoxaparin Sodium Approval and Litigation[edit]

In September 2011, Momenta Pharmaceuticals, Inc., and Sandoz Inc., the generic division of Novartis, two days after Amphastar received approval for its generic enoxaparin product, Momenta and Sandoz sued Amphastar in alleged patent infringement of two patents related to testing methods for batch release of enoxaparin.[33]

In July 2017, a Massachusetts federal jury invalidated a Momenta patent, freeing Amphastar from the threat of almost $1 billion in damages.[34]

In March 2018, the company won a patent infringement lawsuit brought against it by Momenta Pharmaceuticals and Sandoz Inc.

In June 2019, partners Momenta and Sandoz have agreed to pay $59.9 million to Amphastar to resolve yearslong antitrust and patent disputes. Momenta and Sandoz previously sued Amphastar on patent infringement claims, but Amphastar counter sued with an antitrust suit against the partners.[35]

Key People[edit]

Jack Yongfeng Zhang, PhD[edit]

Amphastar co-founder, Jack Yongfeng Zhang's co-authored research (from 1991-1992) with Rudolph A. Marcus, recipient of the Nobel Prize in Chemistry in 1992. See Scientific Publications and Works Attributed.

Jack Yongfeng Zhang, Ph.D. co-founded Amphastar Pharmaceuticals in 1996 and has served as the company's Chief Executive Officer and a member of the company's board of directors since its inception.[36]

Dr Zhang served as the company's President from 1996 until June 2013. Dr. Zhang has also served as the company's Chief Scientific Officer since 2005. Dr. Zhang co-founded Applied Physics & Chemistry Laboratories, Inc., or APCL, a full service chemical analytical laboratory, in May 1989, where he held the position of President until October 2002.[36]

Dr. Zhang is named as the inventor on several U.S. and foreign patents. He received a Ph.D. in chemistry from the State University of New York at Stony Brook and was a Post Doctoral Research Associate at the California Institute of Technology.[36]

Notable Contributions[edit]

Jack Yongfeng Zhang's published work includes research with Rudolph A. Marcus, who earned the Nobel Prize in Chemistry in 1992 during Zhang's tenure as a post-doctoral research associate at the California Institute of Technology in Pasadena, CA.[37] Rudolph Marcus earned the Nobel Prize in Chemistry for "for his contributions to the theory of electron transfer reactions in chemical systems" and is known for the Marcus Theory of Electron Transfer.[38]

Mary Zi Ping Luo, PhD[edit]

Mary Zi Ping Leo holds the position of Chief Operating Officer with Amphastar Pharmaceuticals and is co-founder. Dr. Luo is a professor emerita of chemistry at California State Polytechnic University, Pomona , serving as professor from 1989 to 2007,[39] and is named as the inventor on several U.S. and foreign patents. Dr. Luo received a Ph.D. in chemistry from Princeton University and was a Post Doctoral Research Associate at the California Institute of Technology.[36]

Notable Contributions[edit]

Mary Ziping Luo authored, A Generation Lost: China Under the Cultural Revolution, where Luo recalls her life in China during the Cultural Revolution describing how, with the secret help of Chinese intellectuals, she was able to obtain an education and eventually escape.[40]

Book Reviews for A Generation Lost: China Under the Cultural Revolution

Notable remarks include:


As the Cultural Revolution overtook China in 1966, Luo's parents were branded anti-revolutionaries. She watched Red Guards drag her father through the streets to be kicked and spat upon; he died after 12 years of house arrest. Her mother was sent to a labor camp, where she died in 1979. In deceptively simple prose, Luo, a physical chemist at California Polytechnic, describes her family's agony, how she cared for her three siblings in Shanghai and narrowly avoided forcible relocation to the countryside. Cast mainly in the form of letters to a professor in China, her autobiography is a cry from the heart, a tragic family drama that mirrors the dislocation of a generation.

Publisher's Weekly, 1990

China during the Cultural Revolution was a place of almost unimaginable cruelty, especially for intellectuals. The child of intellectuals whom the Communists had branded as enemies, Luo Zi-Ping grew up during China's time of troubles in the late 1960s and 1970s. Her memoir of this period, written in the form of letters to a fellow Chinese professor, reveals her as a woman of uncommon courage and remarkable strength of character. While caring for her invalid father and toiling in a workshop, she managed to teach herself several foreign languages as well as the natural sciences. When things improved, she went to Princeton for graduate study and now teaches at Cal Tech. This reflective and, at times, even lyrical memoir reminds readers that family devotion and human decency can triumph even over barbarism.

Steven I. Levine, Duke University, Durham, N.C.

References[edit]

  1. ^ "Annual Report, Form 10-K 2018". California Secretary of State. 15 March 2019. Retrieved 9 January 2020.{{cite web}}: CS1 maint: url-status (link)
  2. ^ "Page 25, Annual Report, Form 10-K 2018". California Secretary of State. 15 March 2019. Retrieved 9 January 2020.{{cite web}}: CS1 maint: url-status (link)
  3. ^ "About Us | AMPHASTAR". www.amphastar.com. Retrieved 2020-01-22.
  4. ^ "Certificate of Merger of Amphastar Pharmaceuticals Inc., a California Corporation, into Amphastar Pharmaceuticals Inc., a Delaware corporation". California Secretary of State. Retrieved 9 January 2020.{{cite web}}: CS1 maint: url-status (link)
  5. ^ GmbH, finanzen net. "Amphastar Pharmaceuticals Company Profile | Markets Insider". markets.businessinsider.com. Retrieved 2020-01-22.
  6. ^ "AMPH". ETF.com. 2019-02-25. Retrieved 2020-02-07.
  7. ^ a b "AMPH". www.nasdaq.com. Retrieved 2020-01-21.
  8. ^ a b c "SEC Filings, Form 10k for FY 2018". SEC - EDGAR.{{cite web}}: CS1 maint: url-status (link)
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  10. ^ "CEO Message". Amphastar Pharmaceuticals Inc. Retrieved 9 January 2020.{{cite web}}: CS1 maint: url-status (link)
  11. ^ "Articles of Incorporation". California Secretary of State. 29 February 1996. Retrieved 9 January 2020.{{cite web}}: CS1 maint: url-status (link)
  12. ^ "Certificate of Amendment of Articles of Incorporation". California Secretary of State. 15 April 1997. Retrieved 9 January 2020.{{cite web}}: CS1 maint: url-status (link)
  13. ^ "Amphastar Pharmaceuticals Announces Exercise of Over-Allotment Option". MarketWatch. Retrieved 2020-01-18.
  14. ^ a b "Amphastar Pharmaceuticals Debuts In IPO - socaltech.com". www.socaltech.com. Retrieved 2020-01-21.
  15. ^ "Analyst Coverage". Amphastar Pharmaceuticals, Inc. Retrieved 2020-02-05.
  16. ^ "Articles of Incorporation". California Secretary of State. 29 February 1996. Retrieved 9 January 2020.{{cite web}}: CS1 maint: url-status (link)
  17. ^ "Certificate of Amendment of Articles of Incorporation". California Secretary of State. 15 April 1997. Retrieved 9 January 2020.{{cite web}}: CS1 maint: url-status (link)
  18. ^ "f10k_032515.htm". www.sec.gov. Retrieved 2020-02-14.
  19. ^ "f10k_032515.htm". www.sec.gov. Retrieved 2020-02-14.
  20. ^ "Armstrong Pharmaceuticals Inc. Registration".{{cite web}}: CS1 maint: url-status (link)
  21. ^ "f10k_032515.htm". www.sec.gov. Retrieved 2020-02-14.
  22. ^ "f10k_032515.htm". www.sec.gov. Retrieved 2020-02-14.
  23. ^ http://www.amphastar.com/history.html
  24. ^ a b Commissioner, Office of the (2019-09-11). "FDA statement on approval of OTC Primatene Mist to treat mild asthma". FDA. Retrieved 2020-01-21.
  25. ^ GmbH, finanzen net. "The Return Of OTC Asthma Inhaler Primatene Mist | Markets Insider". markets.businessinsider.com. Retrieved 2020-01-21.
  26. ^ a b c d Commissioner, Office of the. "Consumer Updates - Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011". wayback.archive-it.org. Retrieved 2020-01-22.
  27. ^ a b c Harrison, Emily (2008-08-01). "Unlikely Victims of Banning CFCs--Asthma Sufferers". Scientific American. Retrieved 2020-01-22.{{cite web}}: CS1 maint: url-status (link)
  28. ^ Hendeles, Leslie; Colice, Gene L.; Meyer, Robert J. (2007-03-29). "Withdrawal of Albuterol Inhalers Containing Chlorofluorocarbon Propellants". New England Journal of Medicine. 356 (13): 1344–1351. doi:10.1056/NEJMra050380. ISSN 0028-4793. PMID 17392304.
  29. ^ a b c Research, Center for Drug Evaluation and (2019-12-20). "CDER Conversation: Safely Using the Newly Available OTC Asthma Inhaler Primatene Mist". FDA.
  30. ^ a b c "A Primer on the Newly-Approved OTC Asthma Inhaler". Pharmacy Times. Retrieved 2020-01-22.
  31. ^ "Enoxaparin Sodium Monograph for Professionals". Drugs.com. Retrieved 2020-02-13.
  32. ^ a b c d "The `Safe Harbor' May Be Safer than Expected—Or Maybe Not:The Conflict Created by Momenta Pharmaceuticals v. Amphastar Pharmaceuticals". news.bloomberglaw.com. Retrieved 2020-02-13.
  33. ^ "amph_Current_Folio_10K". www.sec.gov. Retrieved 2020-02-13.
  34. ^ "Dodging $938M in damages, Amphastar prevails in Momenta, Sandoz patent fight". FiercePharma. Retrieved 2020-02-14.
  35. ^ "Amphastar squeezes partners Momenta, Sandoz for $60M in Lovenox settlement". FiercePharma. Retrieved 2020-02-14.
  36. ^ a b c d "amph_Current_Folio_Proxy". www.sec.gov. Retrieved 2020-01-21.
  37. ^ Yongfeng Zhang and R. A. Marcus. "Intramolecular dynamics. II. Artificial intelligence search evaluation function and treatment of resonance centers for large systems" (PDF). California Institute of Technology.{{cite web}}: CS1 maint: url-status (link)
  38. ^ "The Nobel Prize in Chemistry 1992". NobelPrize.org. Retrieved 2020-01-21.
  39. ^ "California Polytechnic University, Pomona, Emeriti Faculty".{{cite web}}: CS1 maint: url-status (link)
  40. ^ Feldman, Gayle (1990-03-11). "Sage from Mao in the Angel Cave". The New York Times. ISSN 0362-4331. Retrieved 2020-01-21.

External Links[edit]

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