AstraZeneca
AstraZeneca PLC, is a large Anglo-Swedish pharmaceutical company formed on 6 April 1999 by the merger of Swedish Astra AB and British Zeneca Group PLC. Zeneca was part of Imperial Chemical Industries prior to a demerger in 1993. AstraZeneca develops, manufactures, and sells pharmaceuticals to treat disorders in the gastrointestinal, cardiac and vascular, neurological and psychiatric, infection, respiratory, pathological inflammation and oncology areas.
Sales in 2003 totalled $18.8 billion, with a profit before tax of $4.2 billion. Total R&D spending was $3.5 billion. The corporate headquarters are in London, England, the research and development (R&D) headquarters are in Södertälje, Sweden. Major R&D centres are located on three continents in the United States, United Kingdom, Sweden, and India.
Bristol-Myers Squibb a world wide collaboration to develop and commercialize two investigational drugs (Saxagliptin and Dapagliflozin) beginning from 2007. * Abbott Laboratories in relation to Crestor® and TriCor®, commencing in 2006 and extending to at least 2009.
Astex. Announced 2005. For discovery, development and commercialisation of novel small molecule inhibitors of Protein Kinase B for use as anti-cancer agents.
Avanir. Announced 2005. For research and licensing in the area of Reverse Cholesterol Transport (RCT) enhancing compounds for the treatment of cardiovascular disease.
Diamond Member of the Pennsylvania Bio commerce organization.
Schering AG. Announced 2005. For research and licensing in the area of Selective Glucocorticoid Receptor Agonists (SEGRAs).
AstraZeneca is the major sponsor for Breast Cancer Awareness Month which focuses on "early detection and treatment" but does little to address prevention[citation needed]. AstraZeneca is also a leading producer of breast cancer treatment drugs like Tamoxifen, Arimidex and Faslodex.
Possible long term health effects of elevated prolactin levels amongst women taking anti-psychotic drug medication
Anti-psychotic medications can cause a significant increase in a woman's prolactin levels. Pharmaceuticals and Endocrinology. Prolactin is a hormone in breast milk. [[Prolactin]http://en.wikipedia.org/wiki/Prolactin] The long-term effects of elevated prolactin levels are unknown, thus it is one of the factors that may lead a female patient to be cautious in deciding whether or not, for her, the benefits of anti-psychotic medications outweigh the possible negative consequences.
Seroquel is a drug manufactured by Astrazeneca in the neuroscience group. It is used to treat psychiatric symptoms that are often classified as "schizophrenia" (psychiatrists and insurance companies use the current Diagnostic Statistical Manual to choose a diagnosis that best describes the mental disorder that the person is experiencing).
Gastrointestinal
Entocort (budesonide)
Losec/Prilosec (omeprazole)
Nexium (esomeprazole) (purified stereoisomer of Losec)
Cardiovascular
Atacand (candesartan)
Crestor (rosuvastatin) (2003 launch)
Exanta (2004 launch; not approved in the United States)
Imdur
Inderal
Lexxel
Logimax
Nif-Ten
Plendil
Ramace (ramipril)
Seloken ZOK/Toprol-XL (#1 beta blocker by sales globally in 2004)
Tenoretic
Tenormin (atenolol)
Unimax
Zestoretic
Zestril
Respiratory and Inflammation
Accolate
Bambec
Bricanyl
Oxis
Pulmicort
Rhinocort
Symbicort
Oncology
Arimidex
Casodex
Faslodex
Iressa
Nolvadex
Tomudex
Tamoxifen
Zoladex
in development
Zactima (Phase III clinical trial - Press release)
Neuroscience
Heminevrin
Mysoline (handed over to Acorus Therapeutics Ltd. in July of 2004)
Seroquel (quetiapine)
Vivalan
Zomig
Anaesthetics
Carbocaine
Citanest
Diprivan
EMLA (mixture of Lidocaine and Prilocaine)
Marcaine/Sensorcaine
Naropin
Xylocaine
Xyloproct (mixture of Lidocaine and Hydrocortisone)
Infection
Apatef/Cefotan
Paludrine
Foscavir
Lexinor
Merrem/Meronem
AstraZeneca's annual report identifies Seroquel as one of its 5 key growth products. The global sales of Seroquel in 2005-2006 increased 24% to 3.4 billion dollars. AstraZeneca claims that Seroquel is the market leading anti-psychotic drug in the United States.
Late Stage Clinical Trial Results re: Controversial Seroquel Drug Expected January 2008
AstraZeneca is currently testing various uses for Seroquel, its best selling anti-psychotic drug.
Nexium, the trade name for esomeprazole, is the successor to Prilosec (containing omeprazole). Commentators have taken issue with its development being an example of a company attempting to "evergreen" its drug patents. In this practice, a company might not be able to maintain a product's price and market share in the face of competition after the expiry of its patent protection, and therefore tries to find a new, patentable medication in the same field, which would ensure maximum profitability and market share for the company if marketed properly.
In this specific case, esomeprazole is a single stereoisomer of omeprazole and based upon available evidence there seems to be little difference between the two in dose-related response. Omeprazole is a very successful medication , but its patent protection expired in 2001. AZ, as owners of the lucrative Losec patent, sought to extend domination of the PPI market with Nexium and consequently marketed it as the successor to the original drug. Though identical in biological action[citation needed], the new drug could be patented, thus achieving an "evergreen" patent protection of the product and maintaining market share. This practice is criticised because it involves high costs for either individual patients and public healthcare systems, as well as potentially immoral, aggressive marketing to doctors in order to prevent them from prescribing generics.
On 16th of August, 2007, Marcia Angell, former editor-in-chief of the New England Journal of Medicine and Harvard Medical School lecturer in social medicine, alleged in the German magazine "Stern" that AstraZeneca's scientists had doctored their research on the drug's efficiency:
Instead of using presumably comparable doses [of each drug], the company's scientists used Nexium in higher dosages. They compared 20 and 40mg Nexium with 20mg Prilosec. With the cards having been marked in that way, Nexium looked like an improvement- which however was only small and shown in only two of the three studies.
Nexium is also alleged by the authors to be "the top of the list" of medications which are marketed by pharmaceutical companies directly to doctors, who receive gifts of money and/or goods when they prescribe the medication in question. As a reason for the company's behaviour, it is alleged that the German public healthcare system spends an additional €99 million per annum on Nexium as compared to using Omeprazole, which however would be less profitable for the company as its patent protection has expired.
According to The New Yorker, Nexium has "become a symbol of everything that is wrong with the pharmaceutical industry".
Chloroquine and Paludrine were marketed with diminutive vague health warnings inside the boxes. Rather than specifying "depression", Zeneca used the term "changes in mood". Also "panic attacks and anxiety" were not mentioned, only "fits and seizures", in effect hiding information about mental effects, as it was more widely reported. As a result of these understatements, thousands of people went on holiday carrying up to 365 days dosage of these drugs, without any understanding that if they were experiencing black moods after a couple of months, the medication should be discontinued.
Confronted by allegations in a May 13, 1996, Business Week cover story, of widespread sexual harassment and other abuses at its Astra USA Inc. subsidiary, the company suspended three top executives and launched an internal probe.
On June 26, the parent company announced that it had fired Astra USA President and CEO Lars Bildman without severance pay. Carl-Gustav Johansson, an Astra executive vice-president, says the investigation found that Bildman had "exhibited inappropriate behavior at company functions" and had "abused his power."
Astra USA agreed to pay $9.85 million to settle a suit brought by at least 79 women and one man against the company. The suit accused Astra's former president and other executives of pressuring female employees for sex and replacing older workers with younger, more attractive women. It was the biggest sexual harassment settlement ever obtained by the United States Equal Employment Opportunity Commission.
Astra USA admitted that it allowed a hostile environment—including requests for sexual favors, replacing older female employees with younger women, and pressuring women into having sex. Bildman reportedly demanded that "eight hours of work be followed by eight hours of drinking and partying." In addition to firing Bildman and other top officials, Astra USA agreed to a sexual harassment policy and took action against 30 employees and Astra customers who had taken part in the harassment. Current USA CEO, Ivan Rowley apologized:
On February 4, 1998, Astra USA sued Bildman, seeking $15 million for defrauding the company. The sum included $2.3 million in company funds he allegedly used to fix up three of his homes, plus money the company paid as the result of the EEOC investigation. Astra's lawsuit alleged Bildman sexually harassed and intimidated employees, used company funds for yachts and prostitutes, destroyed documents and records, and concocted "tales of conspiracy involving ex-KGB agents and competitors … in a last-ditch effort to distract attention from the real wrongdoer, Bildman himself."
Sales in 2003 totalled $18.8 billion, with a profit before tax of $4.2 billion. Total R&D spending was $3.5 billion. The corporate headquarters are in London, England, the research and development (R&D) headquarters are in Södertälje, Sweden. Major R&D centres are located on three continents in the United States, United Kingdom, Sweden, and India.
Corporate governance
Current members of the board of directors of AstraZeneca are: Peter Bonfield, David Brennan, John Buchanan, Jane Henney, Michele Hooper, Joe Jimenez, Tom McKillop, Håkan Mogren, Erna Möller, Bridget Ogilvie, John Patterson, Louis Schweitzer, Jonathan Symonds, and Marcus Wallenberg.
Founded as Atlas Powder Company in 1912 as a result of divestment of DuPont businesses, later changed its name and purchased The Stuart Company (which it renamed Stuart Pharmaceuticals), and was eventually acquired by Imperial Chemical Industries (ICI).
Founded in 1913 near Stockholm, Sweden, incorporated as Astra USA in 1947, formed a joint venture with Merck in the 1990s, and eventually became Astra Pharmaceuticals, LP.
Imperial Chemical Industries (ICI) / Zeneca
Founded in 1926 in the United Kingdom, established a research organization in 1967 in Stamford, Connecticut, and then a year later a business unit called ICI Americas, which acquired Atlas Chemical Industries in 1972 and moved the United States headquarters to the Fairfax campus and the Stuart Pharmaceuticals Division to offices in Concord Plaza in Wilmington, Delaware]. Changed its bioscience businesses name to Zeneca Inc in 1992, keeping the ICI branding on its chemical businesses, and then a year later demerged into two separate and independent companies.
Founded as The Stuart Company in 1941 in Pasadena, California, by Arthur Hanisch, manufactured and marketed a number of innovative pharmaceutical products (including liquid multivitamin, chewable vitamin tablets, capsule-shaped tablets, effervescent laxatives, and instant liquid vitamin mix), purchased by Atlas Chemical Industries.
Merger and acquisition activity
AstraZeneca has, following a collaborative relationship begun in 2004, commenced the acquisition of Cambridge Antibody Technology (CAT). The company is currently in the final stages of exercising compulsory acquisition options against outstanding CAT shares. On April 23, 2007 it was announced MedImmune and AstraZeneca entered into a definitive agreement under which AstraZeneca intends to acquire MedImmune in an all cash transaction at $58 per share, or about $15.2 billion.
Collaborations and alliances
Bristol-Myers Squibb a world wide collaboration to develop and commercialize two investigational drugs (Saxagliptin and Dapagliflozin) beginning from 2007. * Abbott Laboratories in relation to Crestor® and TriCor®, commencing in 2006 and extending to at least 2009.
Astex. Announced 2005. For discovery, development and commercialisation of novel small molecule inhibitors of Protein Kinase B for use as anti-cancer agents.
Avanir. Announced 2005. For research and licensing in the area of Reverse Cholesterol Transport (RCT) enhancing compounds for the treatment of cardiovascular disease.
Diamond Member of the Pennsylvania Bio commerce organization.
Schering AG. Announced 2005. For research and licensing in the area of Selective Glucocorticoid Receptor Agonists (SEGRAs).
Diversity
AstraZeneca is one of the 100 Best Companies for Working Mothers in 2004 according to Working Mothers magazine.
Free Medicines for Lower Income families in the USA
AstraZeneca's Patient Assistance Program provides access to AstraZeneca medicines for low income Americans by providing the medicines for free to eligible patients
Although these free medicines are sorely needed and surely appreciated by the percentage of low income families who receive them, one wonders how the cost of this initiative compares to other "promotional" activities that pharmaceutical companies undertake to promote their drugs, such as providing free samples to physicians, publishing full page colour ads in medical journals, and other "administration/marketing/sales" type economic activities.
Although these free medicines are sorely needed and surely appreciated by the percentage of low income families who receive them, one wonders how the cost of this initiative compares to other "promotional" activities that pharmaceutical companies undertake to promote their drugs, such as providing free samples to physicians, publishing full page colour ads in medical journals, and other "administration/marketing/sales" type economic activities.
The Cost of Drug Promotion
A free, peer-reviewed article published online in Winter 2007 Study of US pharmaceutical industry suggests that in the U.S., pharmaceutical companies spend more money on drug marketing than they do on research and development ("R&D"). Companies claim that developing drugs from the research stage to the clinical trials stage before the drug is finally ready to receive approval by a country as safe for use by the general public, but this new research suggests that it is marketing costs, not drug development costs, that consume the majority of the company profits. Pharmaceutical companies are much more profitable than companies in any other industry.
AstraZeneca is the major sponsor for Breast Cancer Awareness Month which focuses on "early detection and treatment" but does little to address prevention[citation needed]. AstraZeneca is also a leading producer of breast cancer treatment drugs like Tamoxifen, Arimidex and Faslodex.
Possible long term health effects of elevated prolactin levels amongst women taking anti-psychotic drug medication
Anti-psychotic medications can cause a significant increase in a woman's prolactin levels. Pharmaceuticals and Endocrinology. Prolactin is a hormone in breast milk. [[Prolactin]http://en.wikipedia.org/wiki/Prolactin] The long-term effects of elevated prolactin levels are unknown, thus it is one of the factors that may lead a female patient to be cautious in deciding whether or not, for her, the benefits of anti-psychotic medications outweigh the possible negative consequences.
Seroquel is a drug manufactured by Astrazeneca in the neuroscience group. It is used to treat psychiatric symptoms that are often classified as "schizophrenia" (psychiatrists and insurance companies use the current Diagnostic Statistical Manual to choose a diagnosis that best describes the mental disorder that the person is experiencing).
AstraZeneca specialises in prescription medicines to fight disease in the several therapeutic areas. Year-on sales information can be found through AstraZeneca annual reports. The following is a list of key products as found on the AstraZeneca UK website, retrieved 2005-03-27. Generic drug names are given in brackets following the brand name.
This list is incomplete; you can help by expanding it.
This list is incomplete; you can help by expanding it.
Gastrointestinal
Entocort (budesonide)
Losec/Prilosec (omeprazole)
Nexium (esomeprazole) (purified stereoisomer of Losec)
Cardiovascular
Atacand (candesartan)
Crestor (rosuvastatin) (2003 launch)
Exanta (2004 launch; not approved in the United States)
Imdur
Inderal
Lexxel
Logimax
Nif-Ten
Plendil
Ramace (ramipril)
Seloken ZOK/Toprol-XL (#1 beta blocker by sales globally in 2004)
Tenoretic
Tenormin (atenolol)
Unimax
Zestoretic
Zestril
Respiratory and Inflammation
Accolate
Bambec
Bricanyl
Oxis
Pulmicort
Rhinocort
Symbicort
Oncology
Arimidex
Casodex
Faslodex
Iressa
Nolvadex
Tomudex
Tamoxifen
Zoladex
in development
Zactima (Phase III clinical trial - Press release)
Neuroscience
Heminevrin
Mysoline (handed over to Acorus Therapeutics Ltd. in July of 2004)
Seroquel (quetiapine)
Vivalan
Zomig
Anaesthetics
Carbocaine
Citanest
Diprivan
EMLA (mixture of Lidocaine and Prilocaine)
Marcaine/Sensorcaine
Naropin
Xylocaine
Xyloproct (mixture of Lidocaine and Hydrocortisone)
Infection
Apatef/Cefotan
Paludrine
Foscavir
Lexinor
Merrem/Meronem
Controversies
Class Action Lawsuits in Canada and US re: Seroquel. Adverse effects of Atypical Antipsychotic
In the US, there were multiple product liability cases alleging personal injury, namely, that Seroquel caused people to develop diabetes.
Seroquel is an anti-psychotic drug that is used to treat schizophrenia. In the US, Seroquel has also been approved to treat bi-polar disorder.
According to AstraZeneca, global sales of Seroquel in the year 2005-2006 amounted to 3,416 million dollars.
In the US, there were multiple product liability cases alleging personal injury, namely, that Seroquel caused people to develop diabetes.
Seroquel is an anti-psychotic drug that is used to treat schizophrenia. In the US, Seroquel has also been approved to treat bi-polar disorder.
According to AstraZeneca, global sales of Seroquel in the year 2005-2006 amounted to 3,416 million dollars.
AstraZeneca's annual report identifies Seroquel as one of its 5 key growth products. The global sales of Seroquel in 2005-2006 increased 24% to 3.4 billion dollars. AstraZeneca claims that Seroquel is the market leading anti-psychotic drug in the United States.
Late Stage Clinical Trial Results re: Controversial Seroquel Drug Expected January 2008
AstraZeneca is currently testing various uses for Seroquel, its best selling anti-psychotic drug.
Given the amount of personal injury complaints about the drug, and the recent approval of Seroquel for bipolar disorder in the U.S., the company may be seeking approval for Seroquel to be used to treat other psychiatric conditions, such as depression and general anxiety disorder.
Note as well that a new sustained release form of the drug was announced at a conference in Madrid in March 2007. At the time the new drug was discussed, it had not been approved for sale by any health regulatory body in any country. See Canada Newswire announcement below:
Note as well that a new sustained release form of the drug was announced at a conference in Madrid in March 2007. At the time the new drug was discussed, it had not been approved for sale by any health regulatory body in any country. See Canada Newswire announcement below:
Late Stage Trial Failures
AstraZeneca has experienced an extraordinary run of failures of drugs in late-stage clinical trials. These include Galida for diabetes, Exanta to prevent thrombosis, NXY-059 for acute ischemic stroke, and AGI-1067 for prevention of atherosclerosis. With patents expiring on older drugs, this threatens future revenue growth.
MedImmune Takeover
After this long run of failed late-stage clinical trials, in April of 2007 AstraZeneca bought vaccine maker MedImmune, paying $15.2 billion primarily for its drug development pipeline. Analysts have criticized this take-over, claiming that AstraZeneca paid too much.
Nexium
Nexium, the trade name for esomeprazole, is the successor to Prilosec (containing omeprazole). Commentators have taken issue with its development being an example of a company attempting to "evergreen" its drug patents. In this practice, a company might not be able to maintain a product's price and market share in the face of competition after the expiry of its patent protection, and therefore tries to find a new, patentable medication in the same field, which would ensure maximum profitability and market share for the company if marketed properly.
In this specific case, esomeprazole is a single stereoisomer of omeprazole and based upon available evidence there seems to be little difference between the two in dose-related response. Omeprazole is a very successful medication , but its patent protection expired in 2001. AZ, as owners of the lucrative Losec patent, sought to extend domination of the PPI market with Nexium and consequently marketed it as the successor to the original drug. Though identical in biological action[citation needed], the new drug could be patented, thus achieving an "evergreen" patent protection of the product and maintaining market share. This practice is criticised because it involves high costs for either individual patients and public healthcare systems, as well as potentially immoral, aggressive marketing to doctors in order to prevent them from prescribing generics.
On 16th of August, 2007, Marcia Angell, former editor-in-chief of the New England Journal of Medicine and Harvard Medical School lecturer in social medicine, alleged in the German magazine "Stern" that AstraZeneca's scientists had doctored their research on the drug's efficiency:
Instead of using presumably comparable doses [of each drug], the company's scientists used Nexium in higher dosages. They compared 20 and 40mg Nexium with 20mg Prilosec. With the cards having been marked in that way, Nexium looked like an improvement- which however was only small and shown in only two of the three studies.
Nexium is also alleged by the authors to be "the top of the list" of medications which are marketed by pharmaceutical companies directly to doctors, who receive gifts of money and/or goods when they prescribe the medication in question. As a reason for the company's behaviour, it is alleged that the German public healthcare system spends an additional €99 million per annum on Nexium as compared to using Omeprazole, which however would be less profitable for the company as its patent protection has expired.
According to The New Yorker, Nexium has "become a symbol of everything that is wrong with the pharmaceutical industry".
Chloroquine and Paludrine were marketed with diminutive vague health warnings inside the boxes. Rather than specifying "depression", Zeneca used the term "changes in mood". Also "panic attacks and anxiety" were not mentioned, only "fits and seizures", in effect hiding information about mental effects, as it was more widely reported. As a result of these understatements, thousands of people went on holiday carrying up to 365 days dosage of these drugs, without any understanding that if they were experiencing black moods after a couple of months, the medication should be discontinued.
In 1998 the University of Edinburgh department of tropical medicine conducted a study on over 100 gap year students that had been abroad. It found that 31.8% of them that had taken the antiprophylactics for over three months complained of depression compared to 12.4% of students that had taken a holiday but not taken Chloroquine or Paludrine at all. Neither Zeneca nor the NHS replied to the findings of the study. The conclusion of the study was that Chloroquine and Paludrine cause a slow and gradual depression, and that the NHS were widely prescribing double dosages of the drug without any health warnings.
Confronted by allegations in a May 13, 1996, Business Week cover story, of widespread sexual harassment and other abuses at its Astra USA Inc. subsidiary, the company suspended three top executives and launched an internal probe.
On June 26, the parent company announced that it had fired Astra USA President and CEO Lars Bildman without severance pay. Carl-Gustav Johansson, an Astra executive vice-president, says the investigation found that Bildman had "exhibited inappropriate behavior at company functions" and had "abused his power."
He was also accused of misappropriation of funds, diverting them for personal expenses such as "lavish trips" and "extensive renovations for his home." Another suspended executive, George Roadman, was also fired, while a third, Edward Aarons, resigned. A senior executive in Sweden, Anders Lonner, was asked to resign for failing to report the misconduct to superiors, Astra says.
Astra USA agreed to pay $9.85 million to settle a suit brought by at least 79 women and one man against the company. The suit accused Astra's former president and other executives of pressuring female employees for sex and replacing older workers with younger, more attractive women. It was the biggest sexual harassment settlement ever obtained by the United States Equal Employment Opportunity Commission.
Astra USA admitted that it allowed a hostile environment—including requests for sexual favors, replacing older female employees with younger women, and pressuring women into having sex. Bildman reportedly demanded that "eight hours of work be followed by eight hours of drinking and partying." In addition to firing Bildman and other top officials, Astra USA agreed to a sexual harassment policy and took action against 30 employees and Astra customers who had taken part in the harassment. Current USA CEO, Ivan Rowley apologized:
“ As a company, we are ashamed of the unacceptable behavior that took place. … To each person that has been harmed and who has suffered because of that behavior, I offer our apologies. ”
On February 4, 1998, Astra USA sued Bildman, seeking $15 million for defrauding the company. The sum included $2.3 million in company funds he allegedly used to fix up three of his homes, plus money the company paid as the result of the EEOC investigation. Astra's lawsuit alleged Bildman sexually harassed and intimidated employees, used company funds for yachts and prostitutes, destroyed documents and records, and concocted "tales of conspiracy involving ex-KGB agents and competitors … in a last-ditch effort to distract attention from the real wrongdoer, Bildman himself."
Bildman had already plead guilty in U.S. District Court for failing to report more than $1 million in income on his tax returns; in addition, several female co-workers filed personal sexual-harassment lawsuits.
Source : http://www.wikipedia.org/
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