AstraZeneca

About AstraZeneca

AstraZeneca (AZ) is an international pharmaceutical manufacturer based in the UK. As currently constituted, AZ the result of over 100 years of pharmaceutical company mergers and is the 10^th largest pharma company in the world. In part, due to COVID-19 vaccine revenue, AZ annual revenue has risen 40% over 2 years and is estimated at $37 billion annually.

The company is focused in certain therapeutic areas including:

• Cardiovascular disease
• Renal disease
• Metabolic disorders
• Immunology
• Respiratory disorders
• Cancer
• Biopharmaceuticals
• Rare diseases
• Other diseases areas

AstraZeneca has had a number of blockbuster medications including:

• Crestor (rosuvastatin)
• Farxiga (dapagliflozin)
• Onglyza (saxagliptin)
• Zestril (lisinopril)
• Byetta and Bydureon (exenatide)
• Seroquel (quetiapine)
• Zomig (zolmitriptan)
• Prilosec (omeprazole)
• Nexium (esomeprazole)
• Pulmicort (budesonide), Symbicort (budesonide/formoterol)
• Tagrisso (osimertinib)

AstraZeneca History

Astra AB was founded in Sweden in 1913 as an international group focused on gastrointestinal, respiratory, cardiovascular and pain control products. Separately, four British companies, all established between 1870 and 1919, underwent a merger in 1926 to become ICI (Imperial Chemical Industries).

In 1993, ICI split off its chemical and pharmaceutical business, producing Zeneca, a London-based bioscience and pharmaceutical company focused on central nervous system, heart, and anesthesia–as well as special chemicals and healthcare provision.

In 1999, Astra and Zeneca group merged to form AstraZeneca plc (AZ) with headquarters in London, UK and established U.S. headquarters in Wilmington, Delaware. In 2005, AZ acquired UK biotech company, KuDOS, followed by the acquisition of Cambridge Antibody Technology in 2006. Additional acquisitions would follow with Arrow Therapeutics (2007), Medimmune (2007), Novexel Corp. (2010), Guangdong BeiKang Pharmaceutical Company (2011), Ardea Biosciences (2012).

Also, in 2012, AZ and Bristol-Myers Squibb formed a joint venture to acquire Amylin Pharmaceuticals, a diabetes-focused company. In 2013, the company announced a corporate restructuring, moving headquarters to Cambridge, UK and focusing on Respiratory, Inflammation & Autoimmune disorders, Cardiovascular & Metabolic diseases, and Oncology, and later the same year, acquired oncology biotech firm, Spirogen.

In 2014, AstraZeneca rejected an offer from pharma giant Pfizer to purchase the company, which would have resulted in the largest worldwide pharma company and the biggest takeover of a British company by a foreign firm. The purchase was widely panned in the UK.

AstraZeneca, in 2015, partnered with Actavis for its respiratory medications, with Orca Pharmaceuticals for development of autoimmune treatments, with Daiichi Sankyo to commercialize naloxegol, and with Celgene for cancer treatments. They also sold off rights to a number of drugs but acquired rights to others including immunotherapy, cancer treatment and respiratory medications.

In 2018, the company announced that they would spin off several experimental drugs into a new biotech-focused company, Viela Bio but would again work with Daiichi Sankyo in new oncology drugs. The same year, AZ purchased 8% of the US-based biopharmaceutical and immunology company, Moderna.

By 2020, the company had proposed or agreed to a number of joint projects and had rejected others including a preliminary discussion with Gilead Sciences which was scrapped due to ongoing development projects including the COVID-19 vaccine and treatment plans.

In December 2020, the UK approved emergency use of the Oxford-AstraZeneca COVID-19 vaccine, which was later approved in the EU, US, India, and other countries but by March 2021, some countries began suspending the use of the vaccine over reports of thromboembolic events. The vaccine was later reinstated and was approved under the name Vaxzevria.

 AstraZeneca Products

AstraZeneca is currently focused on pharmaceutical products in therapeutic areas of oncology, biopharmaceuticals, immunology, cardiovascular and metabolic diseases, respiratory and inflammatory disorders, and rare diseases.

AstraZeneca has had a number of popular blockbuster medications which have resulted in $billions in revenue for the company including:

• Crestor (rosuvastatin)
• Farxiga (dapagliflozin)
• Onglyza (saxagliptin)
• Zestril (lisinopril)
• Byetta and Bydureon (exenatide)
• Seroquel (quetiapine)
• Zomig (zolmitriptan)
• Prilosec (omeprazole) and Nexium (esomeprazole)
• Pulmicort (budesonide) and Symbicort (budesonide/formoterol)

Newer medications, including the AstraZeneca-Oxford COVID-19 vaccine, Vaxzevria, led to a revenue increase of 40% over 2 years, bringing annual sales to an estimated $37 billion in 2021.

AstraZeneca Lawsuits

AstraZeneca has faced a number of medical liability and class action lawsuits for drug injuries and other issues involving AZ medications such as Prilosec and Nexium. The company has also faced accusations of improper or illegal marketing activities, including lawsuits by the U.S. Department of Justice for marketing of Byetta, Seroquel, and Crestor.

Prilosec and Nexium Lawsuits

Proton pump inhibitor (PPI) medications, Prilosec (omeprazole) and Nexium (esomeprazole), along with a similar drug, Prevacid have been widely used in both prescription and over-the-counter formulations to treat peptic ulcer disease and gastroesophageal reflux.

The drugs may also have caused thousands of injuries including birth defects, heart attacks, kidney failure, cancer and bone fractures. The U.S. Food and Drug Administration (FDA) has issued multiple warnings about the use of PPIs, particularly in long-term use or use not monitored buy a physician.

PPIs were approved as over-the-counter (OTC) medications because they were believed to be safe enough for use without a doctor’s prescription. Safety concerns about Nexium, Prilosec and other PPI use have continued to occur but the medications are still in use, both as prescriptions and over-the-counter. AstraZeneca may be facing 13,000 kidney damage lawsuits, which may begin going to trial in October 2022 and lawsuits for other medical conditions may still be under consideration.

Separately, the company was accused of improper practice in manipulating consumers when Prilosec’s patent was set to expire. Nexium was introduced at nearly the same time, and the company was accused of manipulative marketing, improperly encouraging patients to switch to Nexium. AstraZeneca ultimately paid $20 million in 2015 to settle a class-action lawsuit for improper marketing.

Byetta and Bydureon Lawsuits

Byetta (exenatide) is an incretin mimetic that was discovered and is formulated from an enzyme found in the saliva of the Gila Monster and is used as a daily injection to treat Type 2 diabetes. It was developed by Eli Lilly and later sold to Amylin Pharmaceuticals, who was acquired by AstraZeneca. Bydureon is a longer acting form of exenatide.

The companies involved in Byetta and Bydureon manufacturing and marketing, Eli Lilly, Amylin and AstraZeneca were accused of misleading the public and healthcare providers about the safety of Byetta which has been linked to pancreatitis, pancreatic cancer, and other disorders.

AstraZeneca, Amylin and Eli Lilly have all been named in a number of drug injury lawsuits regarding Byetta and Bydureon. Lawsuits which were consolidated into multidistrict litigation were dismissed, however the dismissal was overturned, and the cases may still be pending in federal, state and local courts.

Seroquel and Crestor Lawsuits

In 2010, AstraZeneca paid about $520 million to settle a lawsuit with the U.S. Department of Justice (DOJ) for improper marketing. They were accused of promoting Seroquel (quetiapine) for “off-label” use, for uses that have not been approved by the FDA. The company has spent about $1.9 billion to defend and settle Seroquel lawsuits with federal, state, and local agencies due to illegal marketing and improper use of kickback payments.

Similar charges were made against AstraZeneca regarding Crestor (rosuvastatin). The company reportedly paid $110 million to settle whistleblower lawsuits in Texas for improper actions involving the Texas Medicaid system and paid $355 million to settle Medicare fraud accusations of Zoladex.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.