News from Nordisk
`
`At the beginning of the 1960s, Hagedorn
`
`received a visit from a specialist in children's
`diseases, Professor Henning Andersen. In
`
`Rising sales
`Sales of Nanormon® rose rapidly through
`
`the 1970s and 1980s. Most of the output
`
`his work, Professor Andersen had seen
`the unhappy consequences of growth
`
`was exported, and Nordisk became one
`of the world's largest manufacturers and
`
`disturbances in children. He therefore
`asked Hagedorn to begin manufacturing
`
`exporters of human growth hormone. One
`reason for this success was that Nordisk
`
`human growth hormone, which was used
`for treating short stature due to growth
`
`had developed new methods of purification
`which improved the purity of the growth
`
`hormone insufficiency. It was a good
`
`hormone.
`
`suggestion, because Nordisk's experience
`
`in purifying insulin could also be used to
`extract and purify growth hormone.
`
`Together with doctors at the Steno
`Memorial Hospital, Nordisk also investigated
`
`Production begins
`
`how often patients should take the growth
`
`hormone. Normally, patients were given
`
`Growth hormone was extracted from
`the human pituitary, a pea-sized gland at
`
`a specific dose of growth hormone every
`other day, but the company's researchers
`
`the base of the brain . Following a strict
`
`discovered that growth was far better when
`
`the growth hormone was taken every day.
`
`procedure, Hagedorn and his employees
`began collecting pituitary glands from
`the pathology departments of several
`
`hospitals. The glands were frozen and taken
`
`to Nordisk for extraction of the hormone .
`
`In 1966, Professor Andersen treated the
`first patients with the growth hormone
`Nanormon®, which was made by Nordisk.
`
`The results were good, and in 1973,
`Nanormon® was approved by the health
`
`authorities in Denmark.
`
`Sanofi Exhibit 2137.035
`Mylan v. Sanofi
`IPR2018-01675
`
`Nanormon"' was Nordisk's first human
`growth hormone.
`
`2 Norditropin®.
`
`3 Norditropin® is made by fermenting
`genetically engineered microorganisms.
`
`34
`
`NOVO NORDISK HISTORY
`
`

`

`
`
`Sanofi Exhibit 2137.036
`Sanofi Exhibit 2137.036
`Mylan v. Sanofi
`Mylan v. Sanofi
`IPR2018-01675
`lPR2018-01675
`
`

`

`Genetic engineering
`
`When children of short stature due to
`growth hormone insufficiency were treated
`with Nanormon®, they achieved normal or
`almost normal height. However, difficulties
`
`in obtaining sufficient human pituitary
`glands made it impossible to treat all the
`
`In 1990, Norditropin® was approved for
`
`the treatment of Turner syndrome, and in
`1995 it was marketed for the treatment
`
`of children of short stature due to chronic
`renal insufficiency. In 1989, the company
`launched Nordiject®, a pen device with
`
`which patients could inject themselves with
`
`children needing the growth hormone.
`
`growth hormone.
`
`Therefore, in 1982, Nordisk began
`
`Plasma products
`
`manufacturing human growth hormone
`
`In the 1970s, at the request of the Danish
`
`by means of genetically engineered
`microorganisms. This meant that enough
`
`health authorities, Nordisk launched a
`number of products made from plasma
`
`growth hormone could now be produced
`
`of human blood. The reason for the
`
`to treat all children suffering from growth
`
`hormone insufficiency. The first treatments
`with Nordisk's new, genetically engineered
`
`authorities' request was that the World
`Health Organization (WHO) had asked all
`countries to become self-sufficient with
`
`regard to blood products.
`
`growth hormone, which was given the
`name Norditropin®, took place in 1985, and
`
`by 1988 the product had been approved in
`most European countries and in Japan .
`
`At the end of the 1980s, researchers at
`Nordisk began to study whether Norditropin®
`
`could be used to treat other diseases,
`
`including Turner syndrome, stunted growth
`
`in children due to chronic renal insufficiency,
`and growth hormone deficiency in adults.
`
`A few of Nordisk's laboratory and production
`buildings in Gentofte, circa 1987.
`
`2 Blood products were manufactured from
`plasma of human blood.
`
`3 Optimising the fermentation process during
`the manufacture of growth hormone.
`
`4 Nordiject® enabled patients to inject
`themselves easily and almost painlessly
`with growth hormone.
`
`5 A nurse explains how to use Nordiject®.
`
`36
`
`NOVO NORDISK HISTORY
`
`Sanofi Exhibit 2137.037
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`NOVO NORDISK HISTORY
`
`37
`
`Sanofi Exhibit 2137.038
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`The haemophilia lawsuit
`Like a number of other countries in Europe
`and elsewhere, Denmark has had its
`'haemophilia lawsuit': in 1987, the Danish
`Haemophilia Society brought a civil action
`against the Ministry of the Interior, the
`National Board of Health and Nordisk.
`The Haemophilia Society alleged that a
`number of Danes with haemophilia had
`been infected with the HIV virus after using
`haemophilia medicine from Nordisk. The
`High Court ruled in 1995 that it had not
`been proven that haemophilia patients had
`been infected by blood products from Novo
`Nordisk. Therefore, it gave judgment in
`favour of the defendant.
`
`Albumin and haemophilia medications
`The first plasma product introduced by
`Nordisk was albumin . It was used to treat
`patients who had suffered loss of fluid
`in connection with, for example, a traffic
`accident or an operation. The company
`also began production of the haemophilia
`medications factor VIII and factor IX. The
`blood of people with haemophilia lacks the
`ability to coagulate, but when treated with
`the factor products, coagulation is almost
`normal . During the 1980s, Nordisk supplied
`blood products to a large part of the Danish
`market.
`
`New products developed
`Nordisk followed up with a number of new
`and improved blood products. In 1988, the
`company developed Nordimmun®, which
`was given to people with a reduced capacity
`for producing antibodies; in 1991, it was
`launched in Denmark by Novo Nordisk,
`and within two years it had conquered
`half the Danish market. Before long, the
`product was also marketed in other parts of
`Europe. In 1988, Nordisk began developing
`Nordiate®, a new, double virus-inactivated
`factor VIII product which was almost 10
`times purer than earlier factor VIII products.
`It was marketed in Denmark by Novo
`Nordisk in 1995.
`
`Sanofi Exhibit 2137.039
`Mylan v. Sanofi
`IPR2018-01675
`
`1 Blood plasma products from Nordisk.
`
`2 Fermentation tank for the production
`of growth hormone.
`
`3 Blood plasma production.
`
`38
`
`NOVO NORDISK HISTORY
`
`

`

`
`
`Sanofi Exhibit 2137.040
`Sanofi Exhibit 2137.040
`Mylan v. Sanofi
`Mylan v. Sanofi
`IPR2018-01675
`lPR2018-01675
`
`

`

`A dynamic merger
`
`A lot had happened since that modest start
`in the 1920s. By the end of the 1980s,
`Nordisk had become the world's third(cid:173)
`
`largest insulin manufacturer and one of the
`world's largest manufacturers and exporters
`of human growth hormone.
`
`Novo had become the world's second(cid:173)
`largest manufacturer of insulin and the
`world's largest manufacturer of industrial
`enzymes. Both companies exported more
`than 90% of their production and both had
`subsidiaries and information offices in many
`countries around the world.
`
`Novo Nordisk A/S
`In January 1989 came the news that
`Nordisk Gentofte A/Sand Novo lndustri
`A/S* were joining forces under the name
`
`of Novo Nordisk A/S, giving Denmark
`the honour of having the world's leading
`manufacturer of insulin. The decision to
`merge was made because cooperation
`between the two companies' strong
`research units would increase the possibility
`of developing new products within
`diabetes treatment and allow intensified
`research in other areas. Moreover, the
`two together would have the size and
`strength to improve their competitiveness
`on international markets. Having competed
`with each other for more than 60 years, the
`two companies could now concentrate their
`combined forces on conquering the world
`markets.
`
`Novo Nordisk's logo, as it looked after
`the merger in 1989.
`
`2 The two chief executives in Novo Nordisk:
`Henry Brenn um (left) from Nordisk and Mads
`0vlisen from Novo. In 1990, Henry Brennum
`died and Mads 0vlisen became president
`and CEO.
`
`3 The merger made the two companies
`considerably more competitive.
`
`40
`
`NOVO NORDISK HISTORY
`
`* With effect from January 1976, the
`parent company Novo Terapeutisk
`Laboratorium A/S was amalgamated with
`its subsidiary under the name of Novo
`lndustri A/S.
`
`Sanofi Exhibit 2137.041
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`Sanofi Exhibit 2137.042
`Sanofi Exhibit 2137.042
`Mylan v. Sanofi
`Mylan v. Sanofi
`IPR2018-01675
`lPR2018-01675
`
`

`

`The Novo Nordisk Foundation
`
`Until the merger, the board of the Nordisk
`Insulin Foundation consisted of 12
`scientists from the Scandinavian countries,
`
`and August Krogh was its first chairman.
`
`The Novo Foundation
`In 1951, Harald and Thorvald Pedersen
`established the Novo Foundation . At
`
`the time, Novo was enjoying a period
`of rapid growth, and the foundation
`was meant to ensure Novo's future as
`
`an independent Danish company. The
`
`Pedersen brothers also decided that
`
`the foundation should provide financial
`support for scientific, humanitarian and
`
`social causes. Over the years, medical
`
`research in Denmark has benefited greatly
`from the Novo Foundation, the Nordisk
`Insulin Foundation and their present-day
`successor - the Novo Nordisk Foundation.
`
`The merger in 1989 also brought the
`
`establishment of the Novo Nordisk
`Foundation - an independent institution
`
`whose objectives were to create a solid
`basis for the operation of Novo Nordisk
`
`and to support scientific, humanitarian
`and social causes.
`
`The Foundation owns all Novo Nordisk's
`
`A shares and thus has the majority vote
`
`at general meetings. This ensures that
`
`Novo Nordisk will remain an independent
`company in Danish hands.
`
`The funds distributed by the Foundation
`
`come from interest, capital gains and
`dividends on the Foundation's shares in
`
`Novo Nordisk. The Foundation is headed
`
`by a board of directors which is not
`involved in the day-to-day management of
`the company.
`
`Nordisk Insulin Foundation
`
`The Novo Nordisk Foundation was not
`the first foundation in Novo Nordisk's
`
`history, however. In 1926, Krogh and
`
`Hagedorn established Nordisk Insulin
`Foundation to provide financial support
`for scientific purposes. The foundation's
`
`funds consisted of a portion of Nordisk
`
`lnsulinlaboratorium's profits plus the
`return on the foundation's equity capital.
`
`The Novo Nordisk Foundation's flagship
`is the Novo Nordisk Prize. Professor Jan
`Fahrenkrug (left), DMSc, chairman of the
`Novo Nordisk Foundation's Prize Committee,
`presents the Novo Nordisk Prize 2009 to
`Professor S0ren Nielsen, MD, CEO.
`
`2 Nordisk Insulin Foundation was established
`in 1926.
`
`3 The Novo Foundation was established in 1951 .
`
`4 The Novo Nordisk Foundation was established
`in 1989 by a merger of Nordisk Insulin
`Foundation and the Novo Foundation.
`
`42
`
`NOVO NORDISK HISTORY
`
`Sanofi Exhibit 2137.043
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`NORDISK INSULINF,OND
`
`0 PRETTET 1 g151
`
`NOVO NORDISK HISTORY
`
`43
`
`Sanofi Exhibit 2137.044
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`A global challenge
`
`According to an estimate by the
`International Diabetes Federation (IDF),
`there were approximately 285 million
`
`adults with diabetes in the world in 2009.
`IDF further estimates that the number
`will increase to 435 million worldwide
`before the year 2030 . Thus, as one of the
`
`most costly diseases in human as well as
`economic terms, diabetes is growing into
`
`one of the world's biggest health problems.
`
`Especially in the developing world, where
`
`the rise in the number of people with
`type 2 diabetes has reached epidemic
`
`500 million Danish kroner over the following
`
`10 years. The World Diabetes Foundation is
`a modern continuation of the Novo Nordisk
`
`Foundation's tradition for supporting
`humanitarian and scientific work.
`
`Haemophilia
`
`Access to care and treatment is also a
`
`problem for people with haemophilia in
`the developing world, where 75% of the
`global haemophilia community resides.
`
`Many lack diagnosis and adequate care,
`
`as haemophilia is not a healthcare priority
`
`proportions, there is a need for concerted
`
`in these countries .
`
`action to defeat diabetes. That is why Novo
`
`Nordisk in 2001 launched a number of
`initiatives that aim to improve diabetes care
`
`in developing countries. These initiatives,
`known as LEAD (Leadership in Education
`
`and Access to Diabetes care), are based
`on cooperation with international NGOs
`(nongovernmental organisations), local
`
`authorities and diabetes associations.
`
`World Diabetes Foundation
`
`The most prominent of the LEAD initiatives
`
`is the World Diabetes Foundation, an
`independent foundation whose purpose is
`to support projects to improve diabetes care
`
`in developing countries. The foundation
`
`was established by Novo Nordisk, and the
`company committed itself to a donation of
`
`Novo Nordisk Haemophilia Foundation
`To address this need and move haemophilia
`higher up on the global agenda, Novo
`Nordisk launched a new initiative in 2005
`called the Novo Nordisk Haemophilia
`Foundation (NNHF). The NNHF works with
`the haemophilia community, authorities
`and other relevant partners and funds
`
`development programmes that include
`
`patient education and training of healthcare
`professionals as well as diagnostic
`facilities and registries . Funding consists
`of donations from the Novo Nordisk
`
`Haemophilia Foundation.
`
`Aleksey Evstratov lives in Russia and has
`type 1 diabetes.
`
`2 A diabetes clinic in Tanzania.
`
`3 In 2001, Novo Nordisk established the
`World Diabetes Foundation with the aim of
`supporting projects to improve diabetes care
`in developing countries.
`
`4 In 2005, the Novo Nordisk Haemophilia
`Foundation was established with the
`purpose of supporting projects which
`contribute to improving haemophilia
`care in developing countries.
`
`5 Lu Zhongqian from China, pictured here
`with his parents, is one of the people
`with haemophilia to benefit from the first
`sucessfully completed project in China
`supported by the Novo Nordisk Haemophilia
`Foundation.
`
`44
`
`NOVO NORDISK HISTORY
`
`Sanofi Exhibit 2137.045
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`WORLD DIABETES FOUNDATION,
`
`0
`
`NOVO NORDISK
`HAEMOP'HILIA
`FOUNDATION
`
`NOVO NORDISK HISTORY
`
`45
`
`Sanofi Exhibit 2137.046
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Sustainable development
`
`0
`
`In 1974, the first environmental protection
`
`and followed up on the company's efforts
`
`act was passed in Denmark, and in
`1975, Novo established an independent
`
`to live up to its social responsibility towards
`employees, patients, communities and
`
`environmental unit whose tasks included
`measuring waste water, noise and smell
`
`other stakeholders. In 2002, Novo Nordisk
`signed the United Nations Global Compact,
`
`I
`
`I
`
`' -
`
`In 1994, Novo Nordisk published its first
`environmental report; in 1995, the company
`received an award for best green accounting
`in Europe.
`
`from production . In 1992, the UN held an
`environmental conference in Rio de Janeiro.
`
`For Novo Nordisk, this conference was an
`inspiration that further strengthened the
`
`company's direction towards sustainable
`
`development.
`
`Environmental reporting
`
`In 1993, Novo Nordisk was the first
`
`company in Denmark, and one of the first
`
`in the world, to prepare an environmental
`report describing its resource consumption,
`
`promoting good corporate principles within
`human rights, labour, environment and
`anti-corruption. In 2006, Novo Nordisk
`
`joined the WWF's Climate Savers initiative,
`committing itself to reducing CO2 emissions
`by 10% by 2014 compared to 2004, despite
`
`significant projected growth in production .
`
`The Triple Bottom Line
`In 2004, Novo Nordisk's Articles of
`
`Association were amended to specify that
`
`the company will "strive to conduct its
`
`emissions and use of experimental animals.
`
`activities in a financially, environmentally
`
`The report was published in 1994. Since
`then, Novo Nordisk has set new targets
`every year for its environmental performance.
`
`and socially responsible way". This
`reinforced the company's commitment to
`the principles of the so-called Triple Bottom
`
`Targets include more efficient use of
`
`Line. Since then, environmental and social
`
`resources and minimising the use of animals
`
`performance has been presented in the
`
`annual report alongside financial results.
`
`2 The principle of the Triple Bottom Line.
`
`3 Since 2007, the company's energy savings have
`been earmarked to buy electricity from DONG
`Energy's offshore wind farm in the North Sea.
`
`for research. Environmental reporting helps
`maintain a focus on continuous improvement
`
`and creates transparency about impacts
`
`and goals .
`
`4 Organic waste is reused as fertiliser.
`
`Social reporting
`
`5 Novo Nordisk works continuously to improve
`conditions for experimental animals.
`
`In 1999, Novo Nordisk published its first
`
`report on social responsibility, covering
`activities in 1998. The report set targets
`
`46
`
`NOVO NORDISK HISTORY
`
`Sanofi Exhibit 2137.047
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Financially and
`economically responsible
`
`Socially
`responsible
`
`Environmentally
`responsible
`
`NOVO NORDISK HISTORY
`
`47
`
`Sanofi Exhibit 2137.048
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Business strategy
`
`In 1994, Novo Nordisk implemented a new
`
`increased performance in turnover and
`
`business strategy to ensure progress in a
`
`rapidly changing and ever more competitive
`
`world. Focus was on the two core business
`areas, Health Care and Enzyme Business,
`while other areas such as Ferrosan (dietary
`
`supplements and other over-the-counter
`
`market share in the years approaching the
`new millennium. By 2001, sales in the five(cid:173)
`
`year period up to that year had doubled.
`
`Markets grew in Europe, the US and Japan.
`The same trends held in other, less well(cid:173)
`
`products) and Plant Protection (biological
`
`developed markets in Eastern Europe, Asia
`
`plant protection) were divested.
`
`and Latin America. As turnover increased,
`
`The plan for Health Care was to develop
`
`the diabetes care business to encompass
`a broader portfolio of products and
`
`services that offer patients and healthcare
`
`professionals better treatment solutions.
`
`At the same time, efforts were made to
`reinforce growth hormone therapy and
`hormone replacement therapy (HRT) with
`new indications and introduction into new
`
`markets.
`
`The best in its markets
`
`In 1996, this focused business strategy
`
`the company needed increasingly larger
`and more modern production facilities,
`
`as well as more employees. Thus Novo
`
`Nordisk embarked in 2001 on the biggest
`
`investment programme in the history of the
`company.
`
`Increased globalisation
`
`The company became increasingly
`globalised in the following years. In the
`
`first decade of the new millennium, Novo
`
`Nordisk invested in large new production
`
`plants in Brazil and China and a sizeable
`expansion of the organisation outside
`
`was followed up by a reorganisation of
`the staff and service functions, and the
`
`Denmark. In 2007, for the first time, more
`than half of Novo Nordisk's workforce was
`
`management strategy was adapted a year
`
`later. Procedures and activities that did not
`
`add substantial value to Novo Nordisk were
`dropped, and the resources thus liberated
`
`were used for development and marketing.
`
`employed outside Danish borders. Strong
`focus on the company's core competences
`
`combined with willingness to invest in
`
`markets with long-term growth potential
`are cornerstones of Novo Nordisk's future
`
`This change process produced results and
`
`business strategy.
`
`helped fuel Novo Nordisk's significantly
`
`In 1997, a new plant in Koriyama, Japan,
`was inaugurated.
`
`2 In 2000, Novo Nordisk inaugurated a 16,000
`m' facility in Hiller0d, Denmark, for the
`production of the Novolet"' prefilled insulin
`pen. Two years later, the foundation stone
`was laid for a new NovoSeven"' factory.
`
`3 In 2007, Novo Nordisk's insulin production
`plant in Montes Claros, Brazil, was expanded,
`and production at the site increased fivefold.
`
`4 The groundbreaking ceremony for Novo
`Nordisk's new plant in Tianjin, China, took
`place on 7 November 2008.
`
`48
`
`NOVO NORDISK HISTORY
`
`Sanofi Exhibit 2137.049
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`NOVO NORDISK HISTORY
`
`49
`
`Sanofi Exhibit 2137.050
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`A unique product
`
`In 1996, after more than a decade of
`
`Growth hormone therapy
`
`development, Novo Nordisk marketed
`NovoSeven® - a unique product to help
`
`people with haemophilia who are not
`responsive to traditional medications.
`NovoSeven® is a recombinant coagulation
`
`factor (rFVlla) that promotes safe and
`
`effective blood coagulation in patients
`with inhibitors to factors VIII or IX. The
`use of NovoSeven® increased significantly
`
`following introduction in the US in 1999.
`
`In 2004, NovoSeven® was approved for
`
`treatment of congenital factor VII deficiency
`and Glanzmann's thrombasthenia. In the
`
`Novo Nordisk is a leading manufacturer
`in the field of human growth hormone.
`In 1999, the company marketed Norditropin®
`SimpleXx®, the world's first liquid growth
`
`hormone. This user-friendly profile was
`further simplified in 2003, when the
`
`product was launched in the prefilled
`NordiFlex® pen. Norditropin® is approved
`
`for treatment of growth hormone
`
`deficiency in children and adults, Turner
`syndrome, SGA (Small for Gestational
`Age), chronic renal disease, Noonan
`
`syndrome and skeletal dysplasia.
`
`US, approval was also granted in 2005 for
`
`use in surgery on people with haemophilia,
`
`Hormone replacement therapy (HRT)
`Novo Nordisk is also one of the world's
`
`and in 2006 for treatment of acquired
`
`haemophilia. Meanwhile, Novo Nordisk
`also began to develop improved treatment
`options for general haemophilia and new
`versions of the NovoSeven® molecule .
`
`Other new products
`
`Novo Nordisk also introduced new products
`within the company's other focus areas -
`growth hormone and HRT - around the
`turn of the millennium.
`
`largest manufacturers of hormone
`replacement therapy (HRT) products and
`offers a range of low- and ultra-low-dose
`medicines to treat menopausal symptoms .
`The low-dose combination HRT products
`Activelle® and Novofem® were introduced
`
`in 1998 and 2000, respectively, followed
`by ultra-low-dose Eviana® in 2007. Most
`recently, ultra-low-dose Vagifem® 10 mcg
`
`was introduced in 2010 for the local
`treatment of vaginal atrophy.
`
`0
`
`NovoSeven® means increased life expectancy
`and improved quality of life for people with
`haemophilia.
`
`2 Ulla Hedner, researcher at Novo Nordisk
`and professor at the University of Lund in
`Sweden, conceived the idea that led to the
`development of NovoSeven®.
`
`3 In 1983, Ulla Hedner and Walter Kisiel
`published their first findings on the treatment
`of haemophilia patients with factor VIia in
`Journal of Clinical Investigation.
`
`4 Six-year-old Patrick Moll from Germany
`has growth hormone deficiency.
`
`5 Norditropin NordiFlex®.
`
`50
`
`NOVO NORDISK HISTORY
`
`Sanofi Exhibit 2137.051
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

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`ll ~ morhlli■ :\ Po1hr11t~ ....-nJ, llh;l1-TI1N luhU,1ton
`
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`_ " •. ..__ • ..,.__<II
`
`,_ , ,1 i - ,11 __ ... _ " ' __
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`0
`
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`-·~--i,..~-- -··- .
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`
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`,:,
`
`C!
`
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`NOVO NORDISK HISTORY
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`51
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`Sanofi Exhibit 2137.052
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`A broad selection of products for
`the effective treatment of diabetes
`
`0
`
`In 1998, the results of what was then
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`diabetes - without the weight gain often
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`the world's largest diabetes study, the
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`associated with insulin treatment. With
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`United Kingdom Prospective Diabetes
`Study (UKPDS), were published. The
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`study confirmed the need for improved
`blood glucose control - in line with Novo
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`these new products, Novo Nordisk became
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`the first company in the world with a full
`portfolio of modern insulins.
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`Nordisk's strategy within diabetes care.
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`Delivery systems
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`Modern insulins
`With the so-called modern insulins (insulin
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`Several advanced delivery systems were
`launched along with the new insulin
`products. In 2001, for example, lnnolet®
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`analogues), a new milestone in insulin
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`was launched for insulin users with poor
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`therapy was reached. Modern insulins are a
`tailored form of human insulin in which the
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`insulin molecule has been altered at specific
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`eyesight or reduced manual dexterity.
`The same year, Novo Nordisk introduced
`FlexPen®, a new prefilled pen.
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`sites so as to alter the onset and duration
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`of action of the insulin. The rapid-acting
`modern insulin NovoRapid® was marketed
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`A new kind of treatment
`With the introduction in 2009 of Victoza®
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`in Europe in 1999 and in the US and Japan
`two years later. NovoRapid® provides better
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`control of mealtime blood glucose levels as
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`well as the opportunity for a more flexible
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`lifestyle, because injections can be taken
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`on the European market, Novo Nordisk
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`moved into a new kind of treatment of
`type 2 diabetes. Victoza® is a once-daily
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`dosed human Glucagon-Like Peptide-1
`(GLP-1) analogue developed for the
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`immediately before or after a meal . On
`the basis of NovoRapid®, Novo Nordisk
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`treatment of adults with type 2 diabetes .
`Victoza® works by stimulating insulin
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`developed an insulin product with both a
`rapid-acting and a long-acting component,
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`secretion only when blood sugar levels
`are too high. Victoza® provides improved
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`also known as a dual-release modern insulin.
`The first dual-release product, NovoMix®
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`30, was launched in 2002. Two years later,
`the long-acting, once-daily modern insulin
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`blood sugar control and other benefits,
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`including weight loss, blood pressure
`reduction and improvement of beta-cell
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`function. Impairment in beta-cell function
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`Levemir® was launched. Levemir® covers the
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`need for basal insulin of most people with
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`is an important indicator of disease
`progression.
`
`I r.;;;MALet
`I~
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`1 lnnolet®.
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`2 Zouheira Harrabi of Tunisia has type 1
`diabetes.
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`3 Levemir® FlexPen®, Novo Rapid® FlexPen®
`and NovoMix® 30 FlexPen®.
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`4 Victoza® pen.
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`52
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`NOVO NORDISK HISTORY
`
`Sanofi Exhibit 2137.053
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`0
`
`NOVO NORDISK HISTORY
`
`53
`
`Sanofi Exhibit 2137.054
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Engagement and values
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`As Novo grew and expanded, the need
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`arose at the beginning of the 1970s for a
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`that linked specific goals to long-range
`strategies for Novo Nordisk's global
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`more specific statement of the ideals that
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`development. In this vision, Novo Nordisk
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`had characterised the company since its
`beginnings. The purpose of this was to
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`engage employees and managers in the
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`declared its intention of being the best in
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`its business areas while at the same time
`being a challenging workplace with four
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`common cause of making Novo a global
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`values: ambitious, responsible, honest
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`leader while still upholding its historical
`ideals.
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`and open. In their daily work, every Novo
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`Nordisk employee was to strive towards the
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`realisation of both the vision and the values .
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`Mission statement and vision
`Novo's first mission statement was
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`Employee shares
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`unveiled in 1974, the same year the
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`In the decades after the release of the
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`company's B shares were listed on the
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`Copenhagen Stock Exchange. The mission
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`mission statement and later of Vision 21,
`a number of supporting activities were
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`it expressed was to be an independent
`company working to meet society's need
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`for medicine and industrial processes. In
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`addition, Novo aspired to base its activities
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`on a high, ethical foundation in an open
`and communicative environment.
`
`The mission statement was regularly
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`developed to motivate and train employees.
`
`For example, in 1974- the same year Novo
`was publicly listed and presented its mission
`statement - employees were given the
`
`chance to become part-owners of their
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`company by purchasing employee shares
`at a favourable price . The following year,
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`updated and revised, but the basic ideals
`remained the same .
`
`Novo celebrated its 50th anniversary with
`
`a gift of employee shares to everyone. In so
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`The company's first vision, Novo Nordisk
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`Vision 21, was launched in 1994 as a
`further development of the mission
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`doing, Novo wanted to thank employees for
`their efforts and strengthen their interest
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`in the company. Every few years since then,
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`employee shares have been offered for sale
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`statement. It was worded in a way
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`on attractive terms.
`
`Sanofi Exhibit 2137.055
`Mylan v. Sanofi
`IPR2018-01675
`
`Employee shares were offered by Novo as
`early as 1974.
`
`2 Novo Nordisk's Vision 21 was presented to
`employees in a colourful paperboard form
`that could be folded into a stand-up figure
`and placed on a desk or table. The figure
`became affectionately known as 'the milk
`carton'.
`
`54
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`NOVO NORDISK HISTORY
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`

`

`NOVO NORDISK HISTORY
`
`55
`
`Sanofi Exhibit 2137.056
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`0
`
`Education and training
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`To help employees live up to the requirements
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`that came with the company's growth and
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`In 1985, the company introduced the Novo
`Interview programme. All salaried personnel
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`development, Novo placed an increasing
`focus on education during the 1970s. A great
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`participated in the programme, in which
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`employees met with their managers once a
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`many courses were held on such topics as
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`language, financial management, leadership,
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`year to discuss job-related efforts, plans and
`wishes. After the merger with Nordisk and up
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`teamwork, safety and technical subjects.
`In 1982, a new training centre opened in
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`to the present day, conversations of this type
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`remain a regular part of the professional life
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`Bagsvaerd, and by the mid-1980s some
`
`of many employees .
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`3,000 employees a year were participating
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`in coursework at the centre.
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`Facilitators
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`In 1997, Novo Nordisk established a corps
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`After the merger with Nordisk in 1989,
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`employee training became an important
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`of internal consultants called facilitators.
`The job of these very experienced managers
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`means to integrate the two company cultures
`and ensure that everyone worked according
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`was to evaluate the extent to which the
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`company operated in accordance with its
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`to the same basic mindset. By now, Novo
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`Nordisk could offer a portfolio of qualifying
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`courses that grew proportionately with the
`company's expansion both in and outside of
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`Denmark. Individual units and affiliates were
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`free to develop training according to their
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`own needs; headquarters supported these
`efforts, ensured a common set of values
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`and created a common approach to the
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`development of talented leaders.
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`values. By gathering data and through
`interviews, especially with employees,
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`facilitators determined whether company
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`values and management philosophies were
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`fully observed in daily work, or whether
`improvement was needed .
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`Today, facilitators run audits against the
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`code of conduct called the Novo Nordisk
`Way (formerly the Novo Nordisk Way
`
`of Management). Through this unique
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`Today, employee development grounded in
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`approach, facilitators help maintain the
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`the values of the company is still highly valued
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`as a way of retaining talented, engaged
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`company's strong culture and approach
`to responsible business.
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`people.
`
`Participants in the Lighthouse leadership
`programme gain new insights at the Great
`Wall of China in 2006.
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`2 Novo Nordisk recruits and trains gifted
`students from around the world through
`its Graduate Programme.
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`3 The Novo Nordisk facilitator team in 2007.
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`4 In May 2011, the Novo Nordisk Centre of
`Learning opened at the historic Favrholm
`Manor near Hiller0d, Denmark.
`
`56
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`NOVO NORDISK HISTORY
`
`Sanofi Exhibit 2137.057
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`NOVO NORDISK HISTORY
`
`57
`
`Sanofi Exhibit 2137.058
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`The Novo Group - one company
`becomes many
`
`Novo Nordisk celebrated a new chapter
`in its history on 13 November 2000. At
`an extraordinary general meeting, the
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`company's two core businesses, Health
`Care and Enzyme Business, became
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`independent legal entities .
`
`The name Novo Nordisk A/S was carried on
`by the former Health Care, while Enzyme
`
`Business took the name Novozymes A/S .
`
`The holding company Novo A/S was
`
`established at the same time to manage the
`fu