Documentos de Académico
Documentos de Profesional
Documentos de Cultura
Table of contents
Grünenthal is in motion. These few words summarize our company’s development in 2009
quite well. Due to the market trends and developments in the industry we have decided
that only fundamental change extending to all areas of the company will form the basis
for the long-term future success of our company. Following Grünenthal’s intensive inter-
nationalization, we have summarized our strategy as “Success through Focus”. Part of the
accompanying change is that we want to be more open than in the past and communicate
with greater intensity and transparency. Thus, we have summarized the most important
corporate results from the past year of 2009 in this report and are providing a brief outlook
on the ongoing business year of 2010 at the same time.
We at the Grünenthal Group set ourselves an ambitious goal in 2009: We want to be
the global innovation leader in pain management within the next few years. We laid out
the prime measures which we want to take to reach this goal at the beginning of 2009 in a
10-Points Plan containing short-term, medium-term and long-term measures. This plan is the
framework which we used to make all corporate decisions. By implementing this plan, we
will be creating the basis for greater strategic measures by promoting operational excellence
in all core processes as well as the continued development of our corporate culture.
We can already tell today that we are extremely well positioned and equipped to
sustainably redeem our claim as a leader in the foreseeable future. We have maintained our
course in a tough economic climate and made consistent progress in Grünenthal’s focus on
pain therapy. This has paid off for the company. We have a successful business year to look
back on and can look ahead into the future with optimism. What is this confidence based on?
Grünenthal is strong in the two areas which make up a successful R&D focused pharmaceuti-
cal corporation: profitability and innovation. This enabled us to grow our revenues as well
as increase our profitability in all central divisions in the previous year, and our strategy of
focusing on pain management is resulting in an excellent, effective product portfolio and
a full research and development pipeline. This gives us the room we need to maneuver in
order to continue to grow in a highly competitive and ever more heavily regulated market
and remain independent as a family-owned company.
The benefits of this independence are enormous: We can apply a more long-term
view and lead the research and development projects which we are confident in to fruition.
Today, Grünenthal is one of just five R&D focused pharmaceutical companies with corporate
headquarters in Germany. But the market conditions have become more difficult: slower
overall market growth, declining profits due to heavy price pressure, a generics market which
is becoming stronger and a sinking number of newly approved pharmaceutical products
with increasing expenses at the same time as well as uncertain, shifting general political
conditions. All of this requires us to be more flexible, to be prepared to change and to have
the determination to win.
Foreword | 5
What does this specifically mean for Grünenthal? Our task is to develop and market innova-
tions which address a significant medical need for our patients. “True” innovations which
contribute to making medical treatment more effective and successful. We firmly believe
that we will be most successful at this in the pain market at present: Our active substance
tapentadol, which was already introduced in the US in 2009, will make a decisive contribution
towards markedly improving the treatment of moderate to severe pain.
We thus assume responsibility for our patients. But we also have a feeling of obligation
towards the society in which we operate. This is why Grünenthal has created the position of
Vice President Global Sustainability and Chief Compliance Officer, who reports directly to the
CEO. This is also due to the importance we put on the topic of thalidomide: thalidomide is
and remains part of our company’s history, and constructive dialog as well as the creation
of projects to improve the living situation of those affected are anchored in our values.
Our products in the field of pain are the linchpin of our plans for the future. But they are
not the only cornerstones of our strategy. We will be developing a comprehensive strategy
which will enable us to sustainably gain ground against our competitors and have future
success as an independent German R&D focused pharmaceutical corporation, and we are
pressing ahead with these deliberations – with the following key points:
Our shareholders, Supervisory Board and the Grünenthal Management firmly believe that
the company is exceptionally well-equipped to create a successful future for itself. In the
process, our employees are and remain the backbone of our company. Your knowledge,
dedication and enthusiasm for Grünenthal – even in these changing times – will continue
to be crucial for the company’s success. For this reason, we strive to create the best overall
conditions for our employees to assume responsibility, participate and be part of the success.
With this in mind, we invite all of those interested in Grünenthal to become more closely
involved in our company and contact us. We look forward to interaction and dialog with you.
Q 1st QUARTER
1
Spain: Award for Innovative Pain Expert JANUARY
Our Transtec® pain patch was praised as being one of the most innovative medications in
the last 25 years with the Spanish award “Premio Especial Edimsa 25 Aniversario”.
APRIL
Q
2nd QUARTER
2
Application for the Approval of Tapentadol in the EU
Grünenthal filed the application for the EU approval of the new substance tapentadol for
acute and chronic pain. Tapentadol is a product of Grünenthal’s research.
JULy
Q
3rd QUARTER
3
USA: Introduction of Nucynta®
The new substance tapentadol, resulting from Grünenthal’s research, has been marketed in
the USA by partner corporation Johnson&Johnson under the brand name Nucynta® since
July 2009.
Q 4th QUARTER
4
New Opening of the Corporate Centre OCTOBER
In October, the Grünenthal Group’s Corporate Executive Board moved into the modernized
management floor at the Corporate Centre in Aachen-Eilendorf. The Corporate Executive
Board can now work together much more closely, as befits a culture of transparency, short
routes and quick decisions.
Co m pany Po r tr ai t 2 0 09
12 | Grünenthal Group 2009
Grünenthal’s Strategic and Grünenthal is an R&D focused international medium-sized family-owned company in the
Operational Direction pharmaceutical industry. Our core competence is pain management with a clear focus on
the treatment of moderate to severe pain, with the goal of becoming the global preferred
pain partner for patients, health-care-professionals and payors. We seek to assist patients
worldwide in leading a self-determined life. Additional fields of therapy complete our portfo-
lio in individual countries and regions. At the beginning of 2009, we developed a 10-Points
Plan to sustainably increase our competitiveness containing short, medium and long-term
measures. The immediate measures already implemented at the beginning of 2009 included
the establishment of customer, competition and public-oriented key performance indica-
tors, a new working structure and a global goals and objectives system. In the short term,
a positive corporate image will be promoted by means of integrated, proactive corporate
communication, which expands on the global compliance structure and maximizes the
success of our global brands. For the medium term, we seek to achieve the sustainable
improvement of our cost of goods and subsequently gross margins, a more efficient and
streamlined administration as well as a global program for offering and marketing our new
pain reliever with the substance tapentadol. At the end of 2009, we also began with the
development of a corporate strategy for Grünenthal as a long-term measure. In the scope
of the new business distribution, all activities were allocated to four divisions, for which the
respective targets and key figures are defined and agreed upon.
The Global Commercial Operations (GCO) Division comprises the central, corporation-wide
management of the marketing and distribution activities in the countries where Grünenthal
is represented by organizations of its own.
The Research, Development, Regulatory Affairs, Patenting, Portfolio Management and
Development, and Business Development & Licenses are bundled in the Global Products
(GP) Division.
The corporation manages all production, quality, supply chain, procurement and service
activities centrally in the Global Operations (GO) Division.
The General & Administration (G&A) Division encompasses all managerial and ad-ministrative
functions.
On the product level, we are focusing on our global brands and their corporate-wide market-
ing. In addition to the pain relievers Tramal®, Zaldiar®, Transtec® and Versatis®, our global
brands also include the oral contraceptive Belara® as well as Colistin / Colistin CF, which has
been successfully administered in cystic fibrosis treatment for several years.
Annual Review 2009 | Company Portrait
Jahresrückblick | Market and Business
2009 | Unternehmensporträt Development
| Produktion | Core
| Produktportfolio Brands 2009
| Lagebericht | Research und Entwicklung |
& Development
| Forschung 13
Production Mitarbeiter / Personalpolitik
| Grünenthal | Unternehmerische
as EmployerVerantwortung
| Corporate| Responsibility
Meilensteine der Firmengeschichte
| Outlook
Harald F. Stock, PhD. (second from left), is Chief Executive Officer (CEO) of the Grünenthal Corporate
Group. Wolfgang Becker (third from left) is in charge of the marketing and sales activities Excecutive Board
worldwide. Stefan Genten (r.), CFO&COO, manages Global Finance, Global Controlling,
Corporate Legal, Global IT, Global Industrial Operations and Global Supply Chain Manage-
ment. Prof. Eric-Paul Pâques, PhD. (l.), is responsible for the Global Products division, i.e.
for the worldwide product portfolio, i.e. Research and Development as well as Worldwide
Alliances and Partnering.
Grünenthal was founded by Hermann Wirtz in 1946. As of 2009, it is privately owned by 20 Corporate Governance
shareholders. The company is run by a Corporate Executive Board of four, which is headed by
the CEO of the Grünenthal Group. The Supervisory Board ensures the corporate governance
of the Grünenthal Group.
Shareholders
elect
Supervisory Board
Management
14 | Grünenthal Group 2009
Grünenthal began with international activities very early on. Our company was already ex-
porting antibiotics to Belgium and the Netherlands only three years after being founded. The
initial representative offices abroad were established starting in the 1950s in such countries
as Switzerland and Spain. We have continuously pushed ahead with internationalizing our
company ever since our first affiliate was established in Peru in 1968. Today, Grünenthal
is represented with affiliates in 35 countries and has production sites in six countries. Our
products are available in over 100 countries and approximately 4,900 employees work for
Grünenthal worldwide. But the people working in Germany are international as well: The
2,000 employees based in Germany come from 34 different nations. Grünenthal has been a
member of the Charter of Diversity of German Companies since 2009, and is thus dedicated
to cultural diversity, integration and equal opportunities for all of its employees.
While the highest turnover internationally through the distribution of our products was
made in Germany in 2009, just over 80 % of our revenue was made by our European and
Latin American affiliates.
Success • We have increased our income before taxes by more than 50 % in comparison with
2008.
• In spite of the constantly increasing competitive pressure, our employees have succeeded
in continuing to grow sales in 2009 as well. Nearly all of our national organizations in
our core business “pain” have grown faster than their respective markets.
• We have optimized our global product and project portfolio in 2009 through more than
20 partnerships and strategic agreements.
Annual Review 2009 | Company Portr ait | Market and Business Trends | Core Brands | Research & Development | 15
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
Our employees are the key to our success. We put great value on respectful and open interac-
tion with one another. Our five leadership principles are not meant to be just words, but
should be familiar to and lived out by every employee. The Priority Principle, the Transparency
Principle, the Delegation Principle, the Clear Accountability Principle and the Joint Ownership
Principle stand for the principles which should characterize and have a positive influence on
our daily work with one another.
• With tapentadol, we have developed an innovative new pain reliever which, thanks to Innovation
its unique pharmacological profile with two mechanisms of action, is the first member
of the new pharmacological class MOR-NRI.
• In 2009, we invested 18 % of our revenues (157 Mio €) into research and development.
• 22 European and 16 US patents awarded underscore our efforts to secure the product
flow through innovations from our own research and development.
Around 60 years ago, Grünenthal was the first West German company to produce and
distribute penicillin. A few years later, Tramal®, the world’s most prescribed centrally active
pain reliever with just one active substance, was introduced on the market. The development
and introduction of Transtec®, one of the first pain patches, was successfully carried out in
2001. Grünenthal searches for innovative ways to relieve pain better, more effectively and
with fewer side-effects. To accomplish this, we invested 18 % of our sales into our own
research and development in 2009. An example for Grünenthal’s innovative research is the
development of a Tamper Resistant Formulation (TRF), a new form of tablet which heavily
restricts manipulation and makes the medication considerably more difficult to abuse thanks
to its high mechanical stability and poor solubility.
16 | Grünenthal Group 2009
Grünenthal Affiliates
Australia
Austria
Belgium
Bosnia-Herzegovina
Chile
Colombia
Croatia
Czech Republic
Denmark
Ecuador
Finland
France
Germany
Ireland
Italy
Liechtenstein
Mexico
Netherlands
Norway
Panama
Peru
Poland
Portugal
Russia
Slovakia
Slovenia
Spain
Sweden
Switzerland
Turkey
Ukraine Grünenthal
United Kingdom affiliates
USA
Venezuela
Partner countries
Annual Review 2009 | Company Portr ait | Market and Business Trends | Core Brands | Research & Development | 17
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
18 | Grünenthal Group 2009
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 19
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
Business Development
Group Figures in Mio € 2009 2008
Rest of World 31 25
Versatis® 28 17
Belara® 78 75
Colistin / Colistin CF 24 20
Our business year 2009 was characterized by a renewed upturn in growth of 17.3 Mio € or
2.0 % as compared to the previous year and an improvement of 36.2 Mio € in our results
compared to the previous year.
Continued positive developments in sales were thus made in spite of consistently rising
competitive pressure. In the process, Europe continued to be the most significant market
with a total share of turnover of 80.2 %. The American market generated 86.9 % of the
proportion of turnover made outside of Europe, which amounted to 19.8 %.
Products Within Global Commercial Operations, our time-tested product Tramal® suffered worldwide
losses of 8.8 %, while our combination product Zaldiar® enjoyed growth of 15.7 % and our
buprenorphine pain patches Transtec® and Norspan® made gains totaling 4.3 %. Our pain
patch Versatis®, which was offered to the public the previous year, also contributed to the
positive development in turnover with an increase of 60.4 % of the previous year’s revenues.
In total, our buprenorphine pain patches generated a share of 14.3 % of the operating
turnover, followed by Zaldiar® with 12.7 % and Tramal® with 12.5 %.
We reached 8.6 % of our revenues with our product Belara®, thus achieving 3.6 % growth
as compared to the previous year.
The share of our global brands thus amounts to 61.5 % of turnover in pharmaceuticals and
54.1 % of the operating revenue.
In the remaining business segments, whose products are predominately distributed locally or
regionally, such as anti-infectives and gastroenterological agents, we succeeded in recording
an increase in turnover of 3.3 % over the previous year despite mounting competitive pressure
from generics, further legislative cost reduction measures in healthcare in individual countries
and having adjusted our advertising expenditures based on our portfolio optimization.
Countries The German domestic market contributed to the largest share of Grünenthal’s sales in 2009
with 155.2 Mio €, which corresponds to approximately 20 % of our total revenues.
The other European markets which were important to Grünenthal included the region of
Iberia (Spain and Portugal) with sales of 156.7 Mio €, the region of Southern Europe (Italy,
Switzerland and Austria) with sales of 118.3 Mio € and France, where Grünenthal and its
partners achieved sales of 114.6 Mio €.
Grünenthal’s result in the United Kingdom was also pleasing: we reached 22.7 Mio € and
achieved growth of 30 %.
In the region of Central and South America, Grünenthal brought in revenues of 113.0 Mio €
and an equally satisfying growth of 8.9 %.
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 23
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
Development in the Scandinavian countries was also strong in 2009: We launched our
commercial activities in Denmark and Sweden. In Sweden and Belgium, we received approval
for our product Versatis®.
In our core business, the analgesic market, growth in Grünenthal’s pain product range Market Shares
(including partner business) came in slightly above that of the defined pain market with an
evolution index1 of 102. In the process, Grünenthal succeeded in establishing itself among
the top five pain product suppliers in the countries with Grünenthal companies (above all
in Europe) with a market share of 11 %.
In the course of the past year, market leadership was achieved in Spain and the Czech
Republic, in addition to the existing market-leading positions in Belgium, Poland and Slo-
venia. The leap to the level of the top three suppliers was made for the first time in the
United Kingdom.
Grünenthal comes in at fifth place in a worldwide ranking in the sub-market of centrally-
active analgesics (high and low-level opioids) with a market share of 4.1 % (2008: 6th
place). In Europe, Grünenthal succeeded in defending its position in the top three with a
market share of 13 %.
1
The evolution index compares the growth of a market participant or sub-segment with the growth of the
market in which it operates. An evolution index of over 100 indicates above-average growth of the market
participant or sub-segment, while an index below 100 indicates below-average growth.
24 | Grünenthal Group 2009
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Br ands | Research & Development | 25
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
Co r e br ands 2 0 0 9
26 | Grünenthal Group 2009
Nearly 20 % of the European population suffers from chronic pain, which constitutes an
enormous burden for the persons affected and their families.
Grünenthal specializes in pain treatment and seeks to improve the quality of life of
those affected by providing effective and reliable analgesics. Grünenthal is distinguished
by its intensive search for innovative ways to relieve pain better, more effectively and with
fewer side-effects.
We are passionate about globally being the preferred partner in pain management for
patients, health-care-professionals and payors. Grünenthal’s portfolio comprises a great
number of highly effective treatment options for chronic as well as acute pain conditions.
It offers solutions for all forms of pain intensity with mechanisms of action which are either
topical (i.e. affecting a particular part of the body) or systemic, meaning that they are
distributed throughout the body (see diagram below). In addition to our comprehensive pain
portfolio, we were also successful in the oral contraceptives segment in 2009. Our products
are available in more than 100 countries.
SYSTEMIC TOPICAL
3
PAIN INTENSITY
2
1
ACUTE CHRONIC CHRONIC
Tramal®
In 1977, Grünenthal set a milestone in pain treatment with the introduction of Tramal®
(tramadol hydrochloride). Tramal® is a centrally active analgesic for treating moderately
severe to severe pain. Today, Tramal® and medications based on tramadol rank among the
most frequently used weak opioid analgesics of the monosubstances measured in patient
treatment days, cumulatively amounting to 10 billion in more than 100 countries. This
consistently becomes apparent in treatment recommendations of national and international
professional associations.
Zaldiar®
Zaldiar® is made up of the non-opioid paracetamol and the weak opioid tramadol, thus
combining two well-known and proven analgesic active substances. It is indicated for the
treatment of moderately severe to severe pain.
Versatis®
Versatis® is an active substance patch with 5 % lidocaine for treating neuropathic pains
affecting defined areas after herpes zoster infections (“shingles”).
NORSPAN
®
Norspan®
Norspan® is a 7-day patch containing the active substance buprenorphine. It is used for the
treatment of moderate, non-malignant pain.
NORSPAN
®
Belara®
Belara® is an oral contraceptive and has been on the market for over 10 years. Today, it is
distributed in about 40 countries worldwide.
• Oral contraceptive
• Market introduction: 1999
• Sales 2009: 78 Mio €
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Br ands | Research & Development | 29
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
30 | Grünenthal Group 2009
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 31
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
Grünenthal is one of the last five research-oriented pharmaceutical corporations with head-
quarters based in Germany which sustainably invests in research and development. These
investments amounted to 18 % of revenues in 2009. Grünenthal’s research and development
strategy concentrates on select fields of therapy and state-of-the-art technologies. We focus
on the intensive search for new ways to treat pain better, more effectively and with fewer
side-effects than before.
Clinical Drug
Preclinical R&D
Development Approval
acute nociceptive
chronic nociceptive
chronic neuropathic
mixed pain
Grünenthal's Research Our Research & Development Centre is located at headquarters in Aachen (Germany).
& Development Centre Approximately 650 employees are working here in the R&D area (incl. Preclinical R&D,
Clinical Development, Regulatory Affairs, Drug Safety and other support units). R&D work
is mainly focused on chemical, preclinical and clinical science, and operations in the field of
analgesics.
Preclinical Research and Our preclinical research and development continued to concentrate its activities in 2009
Development on profiling molecules with both opioid and non-opioid mechanisms of action for the core
indication of pain. Efforts to bring the first substance from a new generation of NCEs (new
chemical entities) to clinical trial had already proven successful in 2008. This step was carried
forward in 2009 with a second substance from the same class of NCEs.
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 33
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
Clinical Development The results for chronic, non-malignant pain and acute pain in the clinical development for
the NCE development project tapentadol with all required documents were incorporated
in the dossier for the European submission, leading to successful submissions in Europe for
both of these indications in April 2009. Two additional NCE-substances from the series of
a new NCE-generation are currently undergoing clinical trials: The first substance is in the
clinical development phase IIa with the goal of the so-called “proof of concept” for proving
the disease-specific effect in patients, while the second substance of this new generation is
currently going through its initial application in humans.
Approval, Patents Submissions for our new pain product Palexia® were initiated in April 2009; in total, 122 ap-
and Licenses proval applications were submitted in 38 countries. In the USA, our partner Johnson&Johnson
has already placed the corresponding active substance tapentadol for the indication of acute
pain on the market under the brand name Nucynta® in June 2009, and the initial approval
for acute pain treatment was granted in Chile in December 2009. 29 approval procedures
were initiated in 2009 for our pain patch Versatis® in various European countries as well
as the Near East; the European approval procedure was already completed successfully in
14 countries as early as December of 2009, meaning that 35 countries are now covered.
Furthermore, new approval procedures for two pain relievers, two contraceptives and for
our product Microser® have been started in three European and 17 other countries. 16 new
approvals were achieved for a new formulation of our combination product Zaldiar® as an
effervescent tablet under the brand name Zaldiar® effervescent. In 2009 overall, 21 new
approvals for our products were received from authorities in Europe. There were also 18
new approvals from the regions Eastern Europe, Central and South America, Africa and the
Near East.
22 European and 16 US patents awarded underscore our efforts to ensure a steady
product flow through innovations from our own research and development.
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 35
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
In addition to our own product development and marketing, we have also taken the op-
portunity to optimize our global project and product portfolio in 2009 through partnerships
and other strategic agreements. We have a total of 20 new agreements to look back on, the
most important of which are:
We have reached an agreement with Labopharm Europe Limited that Grünenthal will take
on the marketing of this further development of the product Zaldiar® in select European
countries.
Tapentadol
µ / NA
2 mechanisms of action
in 1 active substance
A new centrally active analgesic is in the pain pipeline in the form of tapentadol, Grünenthal’s
newest innovation. Thanks to its unique pharmacological profile with two mechanisms
of action, tapentadol is the first member of the planned new pharmacological class
MOR-NRI: It combines µ-opioid agonism (MOR) with noradrenaline reuptake inhibition (NRI)
of the classic opioids, such as oxycodone or morphine, and other centrally active analgesics.
Pre-clinical studies indicate that both mechanisms contribute to tapentadol’s analgesic effect.
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 37
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
Developmental Phases
2004 Partnership with Johnson&Johnson for joint development in the field of acute pain
2009 Submission for EU approval conducted by Grünenthal (April) for acute and chronic pain.
Marketing of tapentadol as Nucynta® in the USA by Johnson&Johnson (July)
38 | Grünenthal Group 2009
Tapentadol
acute pain
acute USA
Tapentadol
acute pain
acute EU
Tapentadol
chronic pain
chronic USA
Tapentadol
chronic pain
chronic EU
acute &
Tapentadol LCM
chronic pain
chronic non-
Axomadol
malignant pain
chronic
Axomadol
neuropathic pain
acute &
NCE 1
chronic pain
acute &
NCE 2
chronic pain
chronic
NCE 3
neuropathic pain
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 39
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
Grünenthal’s global clinical development concentrates on providing new options for treating Our Pipeline –
pain. This should largely be accomplished by the innovative clinical development of new the Engine of
medications (NCEs) originating from Grünenthal’s own preclinical research. In addition, state- Value Creation
of-the-art new treatments (NTEs) and application technologies for established substances
are being developed to expand the portfolio. In Grünenthal’s view, a balanced pipeline is the
engine of value creation. There are currently numerous active substances and combinations
of active substances in various stages of development.
40 | Grünenthal Group 2009
Größte Grünenthal Niederlassung mit einem Umsatz von 155,2 €€ war der Geschäftsbereich
Deutschland, der ungefähr für 20 % unseres Gesamtumsatzes durch den Vertrieb von
Arzneimitteln steht.
Die wichtigen Märkte für Grünenthal in Europa waren darüber hinaus die Region Iberia
(Spanien und Portugal) mit einem Umsatz von 156,7 €, die Region Südeuropa (Italien,
Schweiz und Österreich) mit einem Umsatz von 118,3 € und Frankreich, wo Grünenthal
inklusive Partner einen Umsatz von 114,6 € erzielen konnten.
Erfreulich war auch das Ergebnis von Grünenthal in Großbritannien, wo wir 22,7€€ umsetzen
konnten und ein Wachstum von 30% erreichen konnten.
In der Region Zentral und Südamerika erzielte Grünenthal Umsätze von 113,0 €€ und einem
ebenfalls erfreulichen Wachstum von 8,9%.
Im Laufe des vergangenen Jahres konnte neben den bereits bestehenden marktführenden
Positionen in Belgien, Polen und Slowenien auch die Marktfüherschaft in Spanien und Ts-
chechien erreicht werden. In Großbritannien wurde erstmals der Sprung unter die Top 3
Anbieter geschafft.
Insbesondere in den nordischen Ländern verlief die Entwicklung 2009 sehr erfreulich: In
Dänemark und Schweden starteten wir mit unseren kommerziellen Aktivitäten. In Schweden
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 41
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
bekamen wir die Zulassung für unser Präparat Versatis. Das Gleiche gilt für Belgien.
Auch für die Zukunft sehen wir im Indikationsgebiet Schmerz erhebliche Wachstumspoten-
ziale und wollen diese heben. Wichtige Indikatoren Przeigen
o ducti o n 2dieser
die Berechtigung 0 0 9Pläne:
Tramadol aus unserer eigenen Forschung wurde 1977 zunächst in Deutschland als Tramal
eingeführt. Mittlerweile ist es weltweit erhältlich, Grünenthal’s
erzielt mehr als 2 Mrd.Operations”
“Global Patientenbehand-
(production) are distinguished
by safety, reliability,
lungstage und ist damit das meistverordnete zentralwirksame quality,
Analgetikum customer-orientation and efficiency.
(Monosubstanz).
Dank der sehr erfreulichen Geschäftsentwicklung Our production sites in
im Indikationsgebiet six countries
Schmerz konnte were
die merged under uniform
Eigenkapitalquote von 47% im Jahr 2008 auf 52% global management
im Jahr in 2009.
2009 gesteigert werden.
In 2009, we also developed a global production strategy
Als langfristig denkendes und handelndes Unternehmen which supports Grünenthal’s
im Familienbesitz consistent
verfolgen focus on its core business
eine
Strategie, unser Wachstum vor allem über unsereofeigenen pain byForschungs-
concentratingundonEntwicklung-
the strategically significant compo-
sanstrengungen zu sichern. Wir haben daher den nents Anteilof
fürthe
F&Evalue
mit chain.
knappWe 19% began
Anteilimplementing
am these plans at
Konzernumsatz konstant auf hohem Niveau gehalten. the end of 2009; they are to be completed by 2012.
The newly established project organization “Transfer & Strat-
Die Umsatzrendite hat sich von 3% im Jahr 2008 egy” auf 8%willim Jahr 2009
ensure fast verdreifacht.
systematic and expedited product and technol-
ogy transfer between R&D and Production as well as between the
individual Grünenthal sites and contract manufacturers.
Our quality organization ensures uniform, comprehensive,
complete and professional compliance management on a world-
wide level according to GMP (Good Manufacturing Practices)
standards, which ranges from audits and supplier qualification,
lot approvals, storage and shipping to delivery to the patients.
The backbone of the production network is made up of
the sites in Germany, Switzerland and Italy, which encompass
the entire value chain from the active substances and tablets to
the final packaging, and which are equipped with the facilities
necessary to take on products from R&D.
Global Supply Chain links Global Operations with Marketing
and Distribution and ensures supply to our patients as well as the
smooth flow of our product offerings.
42 | Grünenthal Group 2009
Location Germany: 20 high-performance packaging lines occupy 6,000 m2 at the packaging centre. Nearly all of
Grünenthal GmbH the pharmaceuticals which Grünenthal distributes are packaged here. It is directly connected
to the distribution center and the high-bay warehouse. These have special methods of storing
and shipping products which fall under the Narcotics Act. This is Grünenthal’s competence
center for packaging and distribution, and Grünenthal is the first company in Europe to
have a high-bay warehouse approved for narcotics. Furthermore, active substances (such
as tapentadol, codeine, betahistine), which are used for Grünenthal’s own products, are
manufactured on two production lines. The picture is rounded off by production lines for
manufacturing sterile ampoules and liquid forms as well as pharmaceutical products with
agents such as antibiotics and low-dosage hormones. The production facility is certified in
accordance with EN ISO 14001 and OHSAS 18001.
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 43
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
With an area of 50,000 m2, the Italian production facility in Orrigio (near Milan) is one of Location Italy:
the most modern pharmaceutical plants. The focus of the Italian production is on solid Grünenthal Farmaceutici
pharmaceutical forms for oral administration. The plant also has a facility for the production Formenti S.p.A.
of oral solutions. The production facility is certified in accordance with EN ISO 9001:2008.
The site offers a broad range of services, including pharmaceutical development, pro-
duction (manufacturing and packaging), quality organization, material procurement and
storage.
The pharmaceutical development has a flexible and qualified organization for all activities
related to such things as pre-formulation studies, formulation development, analytical
developments, validation activities, stability studies and production for clinical studies.
44 | Grünenthal Group 2009
Location Spain: Medinsa focuses nearly exclusively on the development and production of pharmaceuticals
Medinsa (Laboratorios for other pharmaceutical companies. Medinsa enjoys an excellent reputation among its
Medicamentos customers for being customer-oriented, reliable and competent. With its state-of-the-art
Internacionales, S.A.) equipment, Medinsa offers a comprehensive range of services, starting with pharmaceutical
formulations and analytical development and running to the provision of clinical studies, scale
enlargements and manufacturing according to production standards, including all requested
logistic and qualitative services. In addition to tablets and capsules, its core competence is
the manufacturing of powder, granulates, pellets and micro-tablets as well as pharmaceutical
development for partners.
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 45
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
Grünenthal Pharma AG is the competence centre for the manufacture of semi-solid Location Switzerland:
pharmaceuticals within the Grünenthal network. Grünenthal Pharma AG
Ointments, creams, gels, lotions and suppositories are manufactured in this OHSAS
18001 and ISO 14001 certified production facilitiy. It is equipped with separate rooms
for handling antibiotics and hormones. The computer-aided weighing systems and the
scanners and barcode-controlled processes are SAP-supported and Part 11-compliant. This
makes it possible to develop and produce pharmaceuticals with a great number of active
substances such as hormones, antibiotics, antimycotics and vitamins for the world market.
Our customers can select the services they desire from the entire supply chain, starting with
procurement and running all the way to market introduction.
Grünenthal produces the active substance tramadol in a production facility built specifically Proto Chemicals AG
for this purpose at Proto Chemicals AG in Mitlödi, Switzerland. It combines a modern
active substance production facility with long-term experience and great expertise with
tramadol. Proto Chemicals AG is accredited by the FDA as well as Swiss Medic and certified
in accordance with ISO 14001 and OHSAS 18001.
Proto Chemicals AG is the leading supplier of the active ingredient tramadol worldwide.
The great number of customers includes leading pharmaceutical corporations offering
generic and original products.
The leading position in the market regarding customer orientation, service, quality and
reliability of delivery is demonstrated for example by the fact that Johnson&Johnson has
honored Proto Chemicals AG as its first API supplier with the Golden Supplier Award three
times in a row.
46 | Grünenthal Group 2009
Location Mexico: The Mexican production facility manufactures capsules and drops exclusively for the local
Grünenthal de México market. Together with the quality organization and analytical laboratory, it also ensures the
S.A. de C.V. high standards in quality and service which Grünenthal is known for worldwide.
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 47
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
Tecnandina S.A. is the largest and most modern production facility for solid and semi-solid Location Ecuador:
pharmaceuticals in Ecuador. It is Grünenthal’s central production facility, the pharmaceutical Tecnandina S.A
development centre and the logistics hub in Latin America. Tecnandina is recognized as the
preferred contract manufacturer and logistics supplier, and its customers include global
corporations. With an area of 50,000 m2, the plant to the north of Quito guarantees the
high standards of quality which Grünenthal is known for with its modern production and
packaging facilities.
48 | Grünenthal Group 2009
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 49
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
Grünenthal as Employer
Dedicated and competent employees are among the most
important factors for the sustainable success of our company.
In order to ensure this success, we must be able to rely on our
employees’ innovation capacity and challenge them – but also
support them in equal measure. Which is why every employee
at Grünenthal has the opportunity to make use of his or her full
potential and continue to develop as his or her abilities allow.
At the end of 2008, about 2,000 employees were working at
the Grünenthal Group in Germany and approximately 4,900
were employed worldwide.
50 | Grünenthal Group 2009
Advanced Training The competence of our employees is the basis of our success. For that reason, we at Grünen-
thal view the continued development of our employees as an investment and we promote
their talents. We offer about 70 different internal training sessions each year to enhance
our employees’ qualifications: specialized, product and language training courses as well as
seminars focusing on behavioral training, project management, PC training and management
training.
We realize this philosophy within a modern, architectural face in our Corporate Centre in
Aachen-Eilendorf, which houses our advanced training centre. It offers training laboratories,
a technical school, a training workshop, six classrooms for apprentices, 18 seminar rooms
as well as two computer training rooms.
In the development of our new talents, deployment to our affiliates in other countries
plays an increasingly important part. It is our goal to make our international business activity
come alive for trainees and participants in student programs and to integrate this experience
as an added value into the training of our young employees.
In 2009, a management program for our international managers was established for the
first time. It deals with the principles of professional management at Grünenthal, combines
face-to-face teaching and internet-based learning, and concludes with a transfer phase in
one’s own professional everyday life as a manager.
Apprenticeships Since its establishment in 1946, Grünenthal has enabled 1,700 apprentices to make a well-
founded and practice-based entry into professional life. More than half of our chemistry
and biology laboratory technicians currently active in the research and quality organizations,
as well as more than three quarters of the chemical technicians working in production
were trained at Grünenthal. In 2009, Grünenthal has hired about 30 apprentices in seven
skilled professions: chemical technician, chemistry laboratory technician, biology laboratory
technician, industrial businessman/woman, businessman/woman for office communication,
IT specialist in system integration and IT businessman/woman. Approximately 90 people are
currently completing their training at Grünenthal. Once the examination has been completed
successfully, we take on all apprentices for at least six months. Grünenthal also promotes
education in natural sciences at other companies in the region within the scope of contract
training agreements. Grünenthal is one of the largest private trainers in the Aachen area.
On the Way to a Grünenthal seeks to improve continuously and would like to learn from its employees’
“Great Place to Work” feedback. Which is why we launched a worldwide employee survey in cooperation with the
Great Place to Work® institute in 2009: How satisfied are our employees with their tasks at
Grünenthal? How about the confidence in their supervisors and management? How good
is the work atmosphere in the teams? Going forward, we will ask our employees to take
a survey annually, so that we can continuously improve and turn Grünenthal into a “Great
Place to Work”. With this approach, we simultaneously promote a culture of open feedback
in the company.
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 51
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
Engagement in Grünenthal established the Grünenthal Foundation for Palliative Medicine as early as 1998.
Palliative Medicine It is dedicated to the needs of people with incurable illnesses and a limited life expectancy.
The foundation promotes science and research in palliative medicine through the Chair
of Palliative Medicine at Aachen University. It supports the care of the severely ill and dying.
The goal is to maintain the quality of life and dignity of those affected during the last phase
of their lives.
Change Pain® In 2009, Grünenthal started an international initiative called CHANGE PAIN® which aims
to enhance the understanding of the needs of patients with severe chronic pain and to
develop solutions to improve pain management. Initiated by Grünenthal and endorsed by
the European Federation of the IASP® Chapters (EFIC), the initiative involves pain experts
from across Europe. The international Advisory Board is chaired by Professor Giustino Var-
rassi, MD, President of the EFIC, and Dr. Gerhard H. H. Müller-Schwefe, MD, President of
the German Pain Association (DGS). Key objectives of CHANGE PAIN® are to generate a
better understanding of physicians‘ and patients‘ perspectives, publish the results of research
projects and communicate findings in scientific publications, as well as to increase knowledge
of pain physiology to facilitate individual treatment decisions.
CHANGE PAIN® is committed to improve patient outcomes by providing solutions for
healthcare professionals for daily practice. PAIN EDUCATION is a new educational program
focusing on the insights resulting from the discussions of the CHANGE PAIN group. The
PAIN EDUCATION program continuously provides healthcare professionals with up-to-date
scientific know-how on chronic pain – to strengthen the expertise and support better out-
comes in pain management by educating on a modern mechanism-orientated treatment
approach. Healthcare professionals can acquire CME (continuous medical education) points
by participating in the online learning modules.
EFIC Grünenthal Grant Since 2004, Grünenthal has been supporting young scientists in realizing innovative clinical
Pain Research Prize and experimental pain research projects in cooperation with the European Federation of
Chapters of the International Association for the Study of Pain (EFIC). The EFIC Grünenthal
Grant (E-G-G) is one of the most highly endowed research prizes in the field of pain with
a total sum of 200,000 €.
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 55
Production | Grünenthal as Employer | Corpor ate Responsibilit y | Outlook
Grünenthal has been donating pharmaceuticals for many years to people who could be Aid for the Needy in the
helped by our products, but do not have access to them. Form of Pharmaceutical
People also need highly effective medicinal products in the event of natural disasters Donations
and crises in remote areas of the world. For that reason, we support the non-profit organiza-
tion “action medeor”, a leading expert in handling pharmaceutical donations.
We deliver our pharmaceuticals directly to “action medeor”. There, they are kept in
interim storage, equipped with packaging inserts in English, French or Spanish and sent
with all of the necessary documents to the country where they are required.
Our cooperation with “action medeor” allows us to maintain the WHO guidelines for
pharmaceutical donors and contribute to “Good Drugs Donation Practice (GDDP)”.
The safety and health of our customers, employees and neighbors, as well as the protection Consistent Environmental
of the environment are of great importance to Grünenthal. For that reason, constant and Labor Protection
improvement of workplace safety and environmental protection are a matter of course
for Grünenthal. Grünenthal has established a global labor protection and environmental
management system to accomplish this. The safety of our patients, neighbors and employees
thus takes first priority for Grünenthal. We reduce raw material consumption, prevent waste
and save energy and water by continuously improving our work methods and processes. By
introducing this system, the company is facing challenges which exceed the legal provisions
for industrial environmental protection. Our locations in Germany and Switzerland were
presented with an environmental and labor protection certificate in accordance with the
standards ISO 14001 and OHSAS 18001 for all activities. We are also making efforts to
receive this certification for other locations. In addition, we have been participating in the
“Responsible Care” initiative of the interest group for the chemical industry for many years.
56 | Grünenthal Group 2009
O u t l o o k
Annual Review 2009 | Company Portrait | Market and Business Trends | Core Brands | Research & Development | 57
Production | Grünenthal as Employer | Corporate Responsibility | Outlook
In 2010 and the years to follow, we will be continuing down the trail we’ve blazed in 2009.
To us, “Success through Focus” also means the conviction that there will always be a market
for innovations targeted at patient benefit, even in times of health reforms and increasing
price pressure. We will thus continue to work on our focus and put patients’ needs in the
centre of our considerations. With this claim, we have taken the optimism and energy from
the preceding business year with us into 2010. The first quarter and the first month of the
second quarter confirm to us that we will be successful in the continuation of our guiding
concept, “Success through Focus”. We have grown considerably faster than the market from
January 2010 to May 2010 with a rate of over 11 %. This confirms our market-oriented and
focused innovation strategy, which is being implemented further in the second half of the
year with the direct offering of Palexia®. Preparations for it are going full steam ahead, and
the positive signals from the USA, where the active substance tapentadol is already being
distributed by our partner Johnson&Johnson, are a promising sign for the introduction in
Europe.
One of the pillars for our long-term success is the strategic orientation of our existing
product portfolio towards the treatment of moderate to severe pain. We therefore launched
a portfolio optimization in 2010 and thus sold the long-unpromoted antibiotics business
at the beginning of the year. The sale of the dermatology segment, which we commenced
in 2009, was then completed in the second quarter. The already initiated process of Grü-
nenthal’s complete strategic orientation towards sustainable success will be brought to a
preliminary conclusion with the initial results in the summer of 2010.
Grünenthal is in motion. That requires a great deal of flexibility and dedication from all
of our employees. Therefore, we have implemented various processes within the company
so that our colleagues will be familiar with and understand Grünenthal’s direction and the
individual steps on the way. Another part of these processes will be the second worldwide
employee survey, which we will be conducting in cooperation with the Great Place to Work®
institute.
We are certain that we will have to keep sustainability in mind in everything we do.
Economic success provides the best conditions to accomplish this. Our independence as
a family-owned company will create the basis for this. In this way, we have the necessary
prerequisites for ensuring the best care for our patients, being an esteemed partner in the
healthcare system and offering our employees interesting and challenging jobs.