Novo Nordisk
Novo Nordisk manufactures and markets pharmaceutical products and services. Created in 1989 through a merger of two Danish companies dating back to the 1920s, it has become one of the world's leading companies in diabetes care, where Novo Nordisk pursues research into pulmonary delivery systems; other companies, such as Medtronic, have expanded into insulin pump systems. Novo Nordisk also commands large sectors of the markets in haemostasis management, growth hormone therapy and hormone replacement therapy. They are beginning research in the areas of autoimmune and chronic inflammatory diseases, using novel technologies such as translational immunology and monoclonal antibodies [2]
With headquarters in Denmark, Novo Nordisk has international production facilities in seven countries, with affiliates or offices in 76 countries. Novo Nordisk employs approximately 29,000 people globally (as of Q4 2009), and markets its products in 179 countries.
Novo Nordisk is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA).[3]
Novo Nordisk has been ranked 25 among 100 Best companies to work for 2010 by Fortune.[4]
Collaborative Research
Toxicogenomics
In addition to internal research and development activities Novo Nordisk is also involved in publicly funded collaborative research projects, with other industrial and academic partners. One example in the area of non-clinical safety assessment is the InnoMed PredTox.[5][6] The company is expanding its activities in joint research projects within the framework of the Innovative Medicines Initiative of EFPIA and the European Commission.[7]
Diabetes
Novo Nordisk founded the World Diabetes foundation[8] to save the lives of those affected by diabetes in developing countries and were instrumental in achieving a UN resolution to fight diabetes, making diabetes the only other disease alongside HIV / AIDS to have a commitment to combat at a UN level.
Additional Research
Inflammation
Novo Nordisk is committed to the development of immunotherapies to combat chronic inflammatory diseases including rheumatoid arthritis, lupus, inflammatory bowel disease, and psoriatic arthritis. [9] A new Seattle-based branch was opened as of September 2009 with the goal of applying Novo Nordisk’s strong background in the field of proteins to inflammation research. [10] Crohn’s disease, for example, is an inflammatory bowel disease that Novo Nordisk is attempting to target with NN8555, an Anti-NKG2D monoclonal antibody that targets natural killer cells. [11] NN8555 is currently undergoing phase II clinical trials. [12]
Translationial Immunology
Translational immunology is a new technology that involves testing a drug candidate ex vivo within human tissue samples before the drug enters into human trials. This process allows researchers to directly assess human immune responses. [13] Not all of the data found in mouse models can be directly translated to humans. Because of this, translational immunology is used by Novo Nordisk as an extra step in ensuring the safety and efficacy of their candidate drugs prior to entering phase one clinical trials. [14]
Novo Nordisk currently is conducting pre-clinical trials using translational immunology technology which have resulted in promising results. The pre-clinical trials are studying a novel drug for the treatment of rheumatoid arthritis. The drug works as an inhibitory receptor, down-regulating the immune response. Three studies were conducted looking at Interleukin-6 (IL-6) levels, osteoclasts levels, and synoviocyte levels, all of which are part of the immune response causing rheumatoid arthritis. The studies were conducted in tissue and synovial fluid cultures. In the cultures with the new therapeutic agent the samples were free of osteoclasts, IL-6, and synoviocytes proving the immune response was down-regulated. [15] The results from the current pre-clinical trials confirm that this new drug technology provides the extra step needed before human trials to assure the drug is an adequate candidate.
Pharmaceutical Brands
Levemir
Levemir is the company brand name for insulin detemir [recombinant DNA origin]. It is a long-acting insulin analog with a subsitited Lys-(N-tetra decanoyl) for B28, the 28th amino acid on the B chain of insulin. It is a soluble insulin analog for injection.[16] Levemir is used to treat adult patients with diabetes for the control of high blood sugar.[17]
NovoLog/NovoRapid
NovoLog is the company brand name for insulin aspart, a rapid-acting soluble insulin for injection. It has a substituted aspartic acid for proline on B28 .[16]
NovoLog Mix 70/30
Novolog mix is a 70% insulin aspart protamine suspension and 30% insulin aspart for injection.[16]
Novolin R
Novolin R is the company brand name for regular insulin.
NovoSeven
NovoSeven is a recombinant factor VII. It is a vitamin K-dependent gycosylated serine protease proenzyme. It is used in the treatment of hemophilia in cases of bleeding episodes or prevention of bleeding in surgical intervention. NovoSeven is intended for intravenous bolus injection.[18]
Norditropin
Norditropin is a brand name for somatropin, a polypeptide hormone of recombinant DNA origin. It contains the identical sequence of 191 amino acids in naturally occurring pituitary human growth hormone (hGH).
Victoza
Main article:
Liraglutide
Logo
The Novo Nordisk logo since the year after the company’s foundation is the Apis bull, one of the sacred animals of ancient Egypt. The Apis bull was worshipped as the incarnation of Ptah, creator of the universe, city god of Memphis and the patron deity of craftsmen. The logo is a stylised reproduction of an Egyptian statuette dating from circa 664–323 BC. It is richly ornamented with symbols representing, among other things, the eternal dualities of life, day and night, life and death. The choice of the logo follows an old European chemist's tradition of identifying pharmacies by an animal symbol.
Unite for Diabetes
Novo Nordisk have sponsored the International Diabetes Federation's Unite for Diabetes campaign — one of many campaigns that helped to successfully pass UN Resolution 61/225, making November 14 World Diabetes Day.[19]
The company has also launched the Novo Nordisk Changing Diabetes World Tour — a truck that folds out into an educational and awareness-developing bus. The vehicle was launched in Copenhagen in September 2005 and has visited Europe, Africa, Australia, Asia, the Indian subcontinent and the United States. The bus journey culminated in being stationed in New York City for the inaugural World Diabetes Day on November 14, 2007.[20]
Victoza controversy
In 2010 Novo Nordisk breached the ABPIs code of conduct by failing to provide information about side-effects of Victoza and by promoting Victoza prior to being granted market authorization.[21]
Timeline
Novo Nordisk was created in 1989 through a merger between two Danish companies – Novo Industri A/S and Nordisk Gentofte A/S.
- 1923 Nordisk Insulinlaboratorium (later Nordisk Gentofte) founded by Hans Christian Hagedorn.[22]
- 1925 Novo Terapeutisk Laboratorium (later Novo Industri) founded.
- 1932 Nordisk Insulinlaboratorium founds the Steno Memorial Hospital.
- 1938 Novo founds Hvidøre Diabetes Sanatorium.
- 1941 Novo launches its first enzyme, trypsin, extracted from the pancreas of animals and used for bating leather before tanning.
- 1946 Nordisk develops isophane insulin, branded as Neutral Protamine Haegdorn or NPH insulin, a neutral insulin with prolonged action.
- 1947 Penicillin Novo is launched – Novo's first product to be manufactured through fermentation.
- 1953 Lente – a long-acting insulin zinc suspension – is launched.
- 1963 Alcalase – Novo's first detergent enzyme produced by fermentation.
- 1973 Nordisk Gentofte markets Nanormon growth hormone for the treatment of growth hormone insufficiency. The growth hormone is extracted from human pituitary glands.
- 1973 Monocomponent (MC) insulin is introduced – the purest insulin available at the time.
- 1974 Novo's B shares are quoted on the Copenhagen Stock Exchange.
- 1977 Trisequens – sequential combined oral hormone replacement therapy (HRT) for peri-menopausal women – is marketed.
- 1977 Novo enters the U.S. insulin market, but based on market share data, the company was a very marginal player.
- 1978 In an effort to alleviate its product and quality problems in the U.S. insulin market, E.R. Squibb & Sons contracts with Novo. Novo becomes the single bulk supplier of insulin for Squibb.
- 1981 Novo becomes the first company in Scandinavia to be quoted on the New York Stock Exchange.
- 1982 Novo enters into a 50/50 U.S. joint venture with E.R. Squibb & Sons, known as Squibb-Novo, based in Princeton, NJ. Squibb-Novo became the distributor for Novo insulin sold in the U.S. market, with Novo focused on producing insulin, and Squibb focused on distributing and selling the product. The joint venture is able to significantly increase Novo's U.S. market share.
- 1982 'Human' Monocomponent insulin is launched in the U.S. – the world's first insulin preparation which is structurally identical to human insulin. It is extracted from the pancreas of pigs and converted to human insulin chemically.
- 1983 Novo Industri A/S enters a joint venture with Canada's Connaught Laboratories, considered to be the birthplace of insulin. Under the terms of the agreement, Novo agreed to manufacture insulin in Canada for distribution by Connaught. Novo Laboratories Ltd. agreed to lease, modernize and operate Connaught's insulin production facilities. Another subsidiary company, Connaught-Novo, was jointly owned by both parent companies. Connought Laboratories was privatized by the Mulroney government in 1985.
- 1985 NovoPen – an injection system similar in appearance to a fountain pen, with replaceable insulin cartridges – is launched.
- 1987 Novo starts production of biosynthetic human insulin with the help of genetically engineered yeast cells using recombinant DNA technology.
- 1988 Nordisk Gentofte markets Norditropin genetically engineered human growth hormone.
- 1989 Novo Industri A/S and Nordisk Gentofte A/S merge to become Novo Nordisk A/S, the world's leading producer of insulin.
- 1989 Following the merger of Novo and Nordisk, and the merger of Bristol-Myers and E.R. Squibb & Sons in the U.S., the Squibb-Novo joint venture in the U.S. market was dissolved. Novo purchased Squibb's 50% share and all rights to the joint U.S. diabetes care business.
- 1989 NovoLet – the world's first prefilled insulin syringe – is marketed.
- 1992 The Steno Memorial Hospital and Hvidøre Hospital merge to form the Steno Diabetes Center.
- 1994 Novo Nordisk Canada Inc. and Connaught Laboratories Ltd. announced a distribution agreement, which replaced their joint venture which was known as Connaught Novo Nordisk Inc. Under the terms of the agreement, Connaught received a financial consideration and a percentage fee for distribution services related to Novo Nordisk Canada's diabetes care products. Connaught continued to distribute Novo Nordisk Canada's diabetes products in Canada and Bermuda.
- 1996 NovoSeven – for the treatment of haemophilia patients with inhibitor reaction – is launched.
- 1998 NovoNorm/Prandin, a new oral treatment for type 2 diabetes, is launched in the US and a number of European countries.
- 1998 Activelle – the first low-dose continuous combined oral HRT for post-menopausal women – is introduced.
- 1999 Novo Nordisk publishes its first social report.
- 1999 Christian Karsten Hansen and Jan Møller Mikkelsen leave Novo Nordisk to found Profound Pharma A/S which is acquired by Maxygen in 2000.
- 1999 Innovo, the world's first insulin doser with a built-in electronic memory, is launched in Europe.
- 1999 Novorapid (Novolog in the U.S.) – a rapid-acting insulin analogue – is marketed.
- 1999 Norditropin SimpleXx – the world’s first liquid growth hormone in a dedicated pen system – is launched.
- 2000 Novofem, a low-dose sequential combined oral HRT, is marketed in Germany. Two years later it is launched in several other European countries.
- 2000 Novo Nordisk is split into three separate companies operating under the umbrella of the Novo Group: Novo Nordisk A/S, Novozymes A/S and Novo A/S.
- 2001 InnoLet – the first insulin delivery system specially designed to suit the needs of insulin users with poor eyesight and reduced dexterity – is launched.
- 2001 InDuo – the world's first combined blood glucose monitor and insulin injection system – is introduced.
- 2001 NovoRapid/Novolog FlexPen and Insulatard (NPH) FlexPen are marketed. FlexPen is a new disposable, prefilled insulin pen dosage device.
- 2001 Novo Nordisk acquires the controlling interest in the Brazilian pharmaceutical company Biobrás, the dominant insulin manufacturer in Brazil.
- 2002 NovoMix 30 FlexPen and NovoMix Penfill are introduced. NovoMix 30 is a dual-release insulin analogue.
- 2004 Levemir – a long-acting insulin analogue – is launched.
- 2005 Novo Nordisk announced that the company had moved into a leadership position in the U.S. insulin market for the first time ever based on the most recent data on total insulin volume.[23]
- 2008 Novo Nordisk Canada Inc. was named one of Greater Toronto's Top Employers by Mediacorp Canada Inc. in October, which was announced by the Toronto Star newspaper.[24]
- 2009 Novo Nordisk was named as an ethical leader of international business by think-tank Ethisphere.[25]
- 2009 Novo Nordisk agrees to pay a $9 Million fine in connection with the payment of $1.4 million in kickbacks through the United Nations Oil-for-food Program.[26]
- 2010 Victoza - the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes is approved for distribution in the US.[27]
- 2010 Novo Nordisk pulls medicine from Greece due to price cuts triggered by the financial crisis in the country. The act caused uproar among diabetics and relatives.[28]
- 2010 Novo Nordisk agreed to pay $25 million to the US government for illegally promoting its haemostasis management drug, NovoSeven.[29]
- 2011 The Association of the British Pharmaceutical Industry reprimands Novo Nordisk for poor management due to breaching industry codes concerning various promotional efforts for its Victoza diabetes medicine.[30]
See also
References
- ^ a b c d e f "Annual Report 2010". Novo Nordisk. http://annualreport.novonordisk.com/web-media/pdfs/Novo-Nordisk-AR-2010-en.pdf. Retrieved 6 February 2011.
- ^ “Biopharmaceutical Research Unit,” Novo Nordisk Corporation, accessed November 29, 2011, http://www.novonordisk.com/science/organisation/bru.asp
- ^ "The Pharmaceutical Industry in Figures - 2008 Edition". European Federation of Pharmaceutical Industries and Associations (EFPIA). pp. 49. http://www.efpia.eu/content/default.asp?PageID=559&DocID=4883. Retrieved 2008-08-25.
- ^ Money.CNN.com
- ^ Mattes WB (2008). "Public consortium efforts in toxicogenomics". Methods in Molecular Biology. Methods in Molecular Biology™ 460: 221–38. doi:10.1007/978-1-60327-048-9_11. ISBN 978-1-58829-638-2. PMID 18449490.
- ^ "InnoMed PredTox Member Organizations". http://www.innomed-predtox.com/consortium/members/. Retrieved 2008-08-25.
- ^ Innovative Medicines Initiative. "IMI Call Topics 2008". IMI-GB-018v2-24042008-CallTopics.pdf. European Commission. http://imi.europa.eu/docs/calls01_en.zip. Retrieved 2008-08-25.
- ^ "World Diabetes Foundation website". http://www.worlddiabetesfoundation.org/composite-75.htm. Retrieved 2008-08-25.
- ^ “Inflammation,” Novo Nordisk Corporation, accessed November 29, 2011, http://www.novonordisk.com/science/partnering/inflammation.asp.
- ^ “Novo Nordisk opens new research center in Seattle,” Novo Nordisk press release, September 18, 2009, on Novo Nordisk website, http://www.levemir.dk/press/news/news.asp?sNewsTypeGUID=&lMonth=0&lYear=2009&sLanguageCode=en-GB&sSearchText=&sShowNewsItemGUID=7947ef3e-9199-4c47-b4eb-ef7c77923429&sShowLanguageCode=en-GB, accessed November 2011.
- ^ “Novo Nordisk and Innate Pharma swap product rights,” Novo Nordisk press release, October 6, 2008, on Novo Nordisk website, http://www.novonordisk.com/press/news/news.asp?sNewsTypeGUID=&lMonth=&lYear=&sLanguageCode=&sSearchText=Anti-NKG2D&sShowNewsItemGUID=45cadd39-2d8c-4d42-9db0-ac81d01824cd&sShowLanguageCode=en-GB, accessed November 2011.
- ^ “Anti-NKG2D,” Novo Nordisk Corporation, accessed November 29, 2011, http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=9.
- ^ Ueno, Hideki, Hawrylowicz, Catherine M., Banchereau, “Immunological intervention in human diseases,” Journal of Translational Medicine (2007): accessed November 23, 2011, doi:10.1186/1479-5876-5-59.
- ^ C. M. Dayan and D. C. Wraith, “Preparing for first-in-man studies: the challenges for translational immunology post-TGN1412.” Clinical and Experimental Immunology 151 (2007): 231-234. Accessed November 22, 2011. doi:10.1111/j.1365-2249.2007.03559.x
- ^ Spee, Pieter, “Drug development based on patient studies ex vivo” Lecture, Novo Nordisk, Måløv, Denmark, Oct 19, 2011.
- ^ a b c “Insulin” Beals JM, DeFilippis MR, Kovach PM, Pharmaceutical Biotechnology
- ^ "Patient Information Sheet, Insulin Detemir [rDNA origin Injection (marketed as Levemir)"]. Archived from the original on 25 January 2008. http://web.archive.org/web/20080125131920/http://www.fda.gov/CDER/consumerinfo/druginfo/Levemir.htm.
- ^ “Recombinant Coagulation Factors and Thrombolytic Agents” Modi N, Pharmaceutical Biotechnology
- ^ Wordldiabetesday.org
- ^ Diabetesbus.novonordisk.com
- ^ "Novo Nordisk Limited, Eli Lilly and Company Limited, GrĂĽnenthal Ltd and Napp Pharmaceuticals Limited named in advertisements". Prescription Medicines Code of Practice Authority (PMCPA). http://www.pmcpa.org.uk/?q=node/878. Retrieved 2011-02-07.
- ^ Deckert T (August 2007). "Hans Christian Hagedorn (1888–1971)" (in Danish). Ugeskrift for Laeger 169 (35): 2883. PMID 17877991.
- ^ Novo Nordisk
- ^ "Reasons for Selection, 2009 Greater Toronto's Top Employers Competition". http://www.eluta.ca/top-employer-novo-nordisk-canada.
- ^ "Ethical leadership title to Novo companies". http://www.cphpost.dk/business/business/45461-ethical-leadership-title-to-novo-companies.html.
- ^ "Novo Nordisk Agrees to Pay $9 Million Fine in Connection with Payment of $1.4 Million in Kickbacks Through the United Nations Oil-for-food Program". justice.gov. The United States Department of Justice. May 11, 2009. http://www.justice.gov/opa/pr/2009/May/09-crm-461.html. Retrieved 21 October 2011.
- ^ "Novo Nordisk's Victoza(R) Receives FDA Approval for Adults With Type 2 Diabetes". http://pr-usa.net/index.php?option=com_content&task=view&id=323297&Itemid=96.
- ^ "Insulin giant pulls medicine from Greece over price cut". BBC News. 2010-05-29. http://www.bbc.co.uk/news/10189367.
- ^ "Danish Pharmaceutical Novo Nordisk to Pay $25 Million to Resolve Allegations of Off-Label Promotion of Novoseven". Justice.gov. The United States Department of Justice. June 10, 2010. http://www.justice.gov/opa/pr/2011/June/11-civ-764.html. Retrieved 21 October 2011.
- ^ Silverman, Ed (March 30th, 2011). "Novo Nordisk Reprimanded For Poor Management". Pharmalot.com. UBM Canon Pharmaceutical Media Group. http://www.pharmalot.com/2011/03/novo-nordisk-reprimanded-for-poor-management/. Retrieved 21 October 2011.
External links