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= Amphastar Pharmaceuticals = From Wikipedia, the free encyclopedia

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


 * NASDAQ Biotechnology Index - IBB
 * S&P 600 Component - IJT, IJR, IJS
 * Russell 2000 Index - IWM, IWO
 * Invesco Dynamic Pharmaceuticals - PJP, PBE, PSYCH

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

The company operates through finished pharmaceutical products, and active pharmaceutical ingredients (or API) products segments. 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. The active pharmaceutical ingredients products segment manufactures and distributes recombinant human insulin and porcine insulin.

Currently, the company operates manufacturing and drug development research facilities in the following locations:


 * Rancho Cucamonga, California - Amphastar Pharmaceuticals
 * Chino, California - New Drug Research Center (NDRC)
 * South El Monte, California - International Medication Systems (IMS)
 * Canton, Massachusetts - Armstrong Pharmaceuticals
 * Éragny-sur-Epte, France - Amphastar France Pharmaceuticals (AFP)
 * Nanjing, China - Amphastar Nanjing Pharmaceuticals (ANP)

History
The word Amphastar is a portmanteau of the company's stated goals to be a "recognized  Am erican  pha rmaceutical  star ." 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.

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


 * Jefferies Group LLC.
 * Bank of Montreal Capital Markets (BMO)
 * Piper Jefferies (now renamed to Piper Sandle r)
 * Needham & Company (Co-Manager)

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


 * Wells Fargo Securities
 * Raymond James Financial

Development Timeline

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



Primatene® Mist
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.

Discontinuation of Primatene® Mist
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.

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.

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

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.

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.

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.

Reintroduction of Primatene® Mist
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. The new OTC product contains hydrofluoroalkane (HFA) propellants, which are permitted under current international and U.S. law. Prescription-only inhalers that use different medications, such as albuterol and levalbuterol, also use HFAs as propellants.

The new version is approved for use in adults and children 12 years of age and older. 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. 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.



Naloxone
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
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.

Enoxaparin is a low molecular weight version of heparin, produced by breaking the heparin polysaccharide into smaller pieces. 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.

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. 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.

Enoxaparin Sodium Approval and Litigation
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.

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

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.

Jack Yongfeng Zhang, PhD
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.

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.

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.

Notable Contributions
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. 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.

Mary Zi Ping Luo, PhD
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, 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.

Notable Contributions
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.

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


 * The New York Times
 * The Washington Post

Notable remarks include: