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» IN THIS ISSUE
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IN FOCUS |
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Guy Villax, CEO, gives
us his view of Hovione |
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FDA inspection to five new
product lines |
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New R&D Laboratories |
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Staff exchanges promote knowledge and
synergies between sites |
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HOVIONE GROUP |
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{ HQ } News from
Loures |
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{ NJ } News from New
Jersey |
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{ HM } News from Macau |
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» IN FOCUS
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Guy Villax, CEO, gives us his view of Hovione |
 The
Hovione Group closes its accounts on March 31st, how was 2004?
Hovione closed the year with sales of USD82m, a growth of 8% compared to
2003 – with an EBITDA of USD16m – a modest financial performance due to the
weakness of the Dollar. However, compared to our six main competitors in
Europe, whose sales volume in fine chemicals declined 14% on average, we
worked very well. In terms of new product development and patents it was a
very good year – there was an increase of 35% (from 17 to 23) in the number
of projects under development.
How much does Hovione invest in R&D?
In 2005 we will invest USD12.7m in R&D, that is a total of 15% of the
foreseen sales value. In Portugal we will mobilize a total of 102 people and
in Princeton we have 36 people in our Technology Transfer Centre (TTC).
And what results have you achieved?
We are working on 30 development projects – the pharma multinational
companies and the Biotechs look to Hovione for technical competence and
industrial know-how. For the new molecules of those innovative companies, we
develop processes, produce small quantities for clinical trials and take
care of the documentation necessary for registration of the active
ingredient with the health authorities. This work constitutes 20% of the
business volume and will, in time, ensure the growth of the industrial
activity. The fact that we are involved in the development of three of the
19 new drugs to be approved by FDA and launched in the North American market
within the next 12 months, clearly reflects our commitment and success in
this market segment.
How does one build a scientifically
based industrial business in Portugal that succeeds in the most advanced
markets?
First one needs to work very hard to establish a good name, build skills,
give evidence of know-how and make very long-term technological choices. We
may not be known in Portugal since we do not sell directly to the public,
but within the industry, worldwide, we enjoy a very good reputation and an
excellent name. Secondly, one must keep to a clear strategy: serving
demanding customers in highly regulated markets, as well as possessing good
management in a variety of skills: chemists, engineers, pharmacists,
microbiologists, biologists – we all have to be technicians and managers, be
creative as well as concerned with financial results. We must pay constant
attention to service, quality, and communication with customers – always
studying competition, trying to understand the market and keeping an eye on
future technologies.
Who are those people you describe, who
are so versatile?
The people who work at Hovione are certainly very unusual as they obtain
results that most multinational companies in this field do not achieve. The
technicians that come out of our universities are undoubtedly very good. We
have excellent brainpower in all areas and very competent and committed
people. Dedication to the company, team spirit, willingness to improve, and
our commitment to training, explain this success.
Who are your clients?
Around 100 companies in 40 countries. In the generic segment most of the
largest companies in the most demanding markets are our clients. In the
Innovative Client segment, six of the biggest multinational companies and
two of the four biggest Biotechs are also our customers. We have a high
quality client portfolio and in 45 years of operation we have had only one
unpaid invoice…
|
What about Hovione abroad?
In Macao we have 130 people – it has been a fantastic story of hard
work and many successes. We began by transforming Chinese raw materials
in order to supply Japanese and American clients. In the 90’s we started
transferring know-how to Chinese factories – handpicked – to perform the
intermediate steps of our products and bridged a connection with
American clients and FDA demands. In competitive terms it is an
advantage that none of our competitors can offer in such a concrete way
because none of them has 20 years experience in China. In other words,
Hovione went global long before the word had the meaning it has today.
What are the results of the
Technology Transfer Centre in the US?
In this first half of 2005, the TTC doubled its sales in relation to
the same period last year – we sold USD3.5m and have reached breakeven .
However, the benefits from this presence in the USA are much more
extensive, not only in terms of image but also in showing our commitment
to the American market and level of service and support to Biotech
companies. With the TTC we were able to produce the first kilos of
active ingredients for clinical trials of many companies which had
always been reluctant to order R&D services outside the USA. Thanks to
the atmosphere of trust and professionalism that we have demonstrated,
these companies have allowed their projects to be transferred to the
Loures and Macao plants.
Who works at TTC?
At present we have 36 people working at TTC; a third are scientists
with 20 to 30 years experience in large multinational companies, a third
are young graduates and another third are people transferred from Loures
or Macao.
What about cultural issues?
The Americans have their own very strong business culture and therefore
one of our main concerns is to ensure that, if we learn from them what
they do best, we must also bring in the Hovione culture, which to a
great extent explains our success. |
What is Hovione’s present strategy?
We want to increase in value rather than in volume, by serving clients that
demand more service, reliability and technical capability and by investing
more in innovation and technology. In this way we are migrating to more
complex products and services, with higher quality attributes. For example,
with our new technology in particle design, we are entering into
pre-formulation, a highly specialized area which bridges the gap between API
chemistry and pharmaceutical formulation. This technical capability has
given rise to much interest and demand, and has proven very successful with
our customers.
How do you see the future?
With optimism! We certainly need to improve our productivity and become
better managers. It is vital that we develop skills such as leadership,
autonomy, delegation, communication… We are still dealing with the shift of
a company that only supplied products to a company that now organizes itself
by projects and sells services of great complexity and highly specialized
know-how. But I am confident that we are in the right direction!
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FDA inspection to five new
product lines |
 The
Hovione plant in Loures was inspected in September, for the ninth time
since 1982, by the North American health authority Food and Drug
Administration (FDA). The inspection, which lasted six days, focused on
five active substances, two of which relate to new medicines and the
other three to new generic formulas. Such an inspection is undoubtedly
an indication of sales growth – five new products to be added to the 17
we already have! An increase of 30%! Eleven items were registered on
Form 483. The inspection, which was the most thorough ever carried out,
provided valuable lessons. To be noted:
- Whenever parameters are defined,
values adopted or decisions taken, the reasoning that led to those
choices must be registered – the “what’s the rationale” always being
demanded by Thomas Arista.
- Everything that’s done must be
documented by a detailed procedure. i.e. how to load and unload a
vacuum chamber tray. Many new Operating Instructions (Ifs) will have
to be issued.
- The GMP documentation must be
concise, clear and thorough, both in substance and in form, and the
documentation trail must add up. i.e. if a procedure mentions a
validation protocol and a validation report, then a Master Validation
Plan must not be issued after a Report.
- It is important to be humble and use
simple words to convey what to our mind is clear. When difficult words
and complex explanations are used and thought to be clever, the wrong
idea is conveyed and this is not the way to handle an inspector of
Thomas Arista’s calibre…
We thank all those who directly or
indirectly participated in this inspection.
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During the past two years, building 2 has
undergone renovation work to its installations and is now a building
totally dedicated to Research and Development (R&D). Between July and
September, the Chemistry Labs on the 4th floor have been refurbished and
divided into two separate areas:
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An area with room for eight scientists,
promoting the exchange of ideas and sharing of experiences, which is
important to the process development work.
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A laboratory area equipped with eleven
fume hoods designed to carry out experimental work in a safe way.
R&D Labs
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» HOVIONE GLOBAL
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Staff exchanges promote
knowledge and synergies between sites |
 The
TTC site in New Jersey has contributed to an active and rich exchange of
people from Hovione between its plants in Loures, Macao and New Jersey. In
fact, a third of the people presently at TTC came from Loures or Macao.
Seven are from Portugal and four from Macao. This rotation of people is not
only culturally enriching but positively contributes to the exchange of
expertise, experience and knowledge. While the American scientists at the
TTC (several of whom with many years of experience in pharma multinationals)
have been passing on their scientific and management knowledge to the young
Portuguese and Asian on transfer at the TTC, the latter bring to their
American colleagues our company’s culture which greatly explains our success.
Hovione actively promotes this exchange
which it considers both personally and professionally beneficial. Besides
these exchanges with the TTC, other protocols have been established and
signed with Hovione Macao and Hovione LLC in NJ, for technical and
professional training. We have, consequently, been regularly receiving
colleagues from Macao for periods ranging from one to three months; from New
Jersey, we’ve already welcomed two colleagues for periods of up to 18 months.
This training has become a valuable addition to their professional
performance and development. We must not forget the many colleagues who,
throughout the years, have provided occasional support and training at these
three sites, both in projects and in technology transfer. We thank them for
their availability and commitment, which has, undoubtedly been an important
contribution to Hovione’s multi-cultural integration.
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Staff on transfer to and
from the TTC |
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| FROM LOURES TO NEW
JERSEY: |
- António Mendes Santos, Director
of Operations, since November 2001
- Graça Flores, Director of
Compliance, since November de 2001
- Pedro Ruben Pires, QC Development
Specialist, since March 2004
- Dirce Macário, QA Manager, since
May 2004
- Filipe Tomás, Process Engineer,
since August 2004
- Marco Marques, Process Engineer
Trainee, since April 2005
- Carla Vozone, Business
Development Manager, since July 2005
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| FROM MACAO TO NEW JERSEY:
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- Jeffrey Ng, QC Lab. Manager,
since July 2002
- Jimmy Asilo, Lead Process
Technician, since May 2004
- Jun Asilo, Process Technician,
since August 2005
- Karen Chan, since June 2005
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FROM NEW JERSEY TO LOURES: |
- Scott Miller, Director of
Technology, from April to December 2001
- Anthony diSanti, since September
2005 for 18 months
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| RETURNED TO LOURES:
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- Mário Caetano after 3 years at
TTC as Facilities Engineer
- Vitória Segismundo after 3years
at TTC as Process Engineer
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» HOVIONE GROUP
DCS Surveillance
New Automation warning system
 DCS
Surveillance is a computer program for the surveillance and alert of
automation systems that has recently been developed at Hovione. The
program supervises various systems at the Loures plant, sending messages
to users at certain hours of the day or when an equipment shows certain
needs (i.e. lack of a solvent in stock), allowing the operators to act
in conformity. This program allows for an increase in productivity as it
replaces routine tasks and, at the same time, transmits information more
timely and with greater accuracy.
ISO14001 in its final phase of implementation
October
has marked the start of the final phase of implementation of ISO14001 in
order to obtain the environmental certification for the Loures plant.
ISO14001 is an international standard containing various requisites that
enable the establishment, implementation and maintenance of an
environmental management system, based on continuous improvement. This
phase will last six months and every employee will be directly or
indirectly involved. Meanwhile you may refer to our Management System
Manual on Hovione new HSE internal website (hse.hovione.com), and send
your questions and suggestions.
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ADVANTAGES OF ISO14001 |
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Elimination or
reduction of risks for all the interested parties
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Better cooperation and
transparency between the authorities and Hovione
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The possibility of
demonstrating to clients and the neighbouring community Hovione’s
conformity and commitment.
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Greater efficiency and
cost reduction
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Better image and
competitive advantage.
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Hovione Loures –
6th Open Day
September 24th, 2005
 Hovione organized on 24th
September its 6th Open Day under the theme “Chemistry in Everyday Life”.
We welcomed 300 visitors, among families, neighbours, official
entities and suppliers. The areas which best represent the company’s
activity were visited: production, laboratories, control room,
warehouses and design room. Environment protection was also on the
agenda with a tour of the recycling areas. However, chemical
experiments and safety demonstrations proved to be the most successful
activities. We thank the colleagues who collaborated in the
organization of this event as well as the Dêsso Blues Gang for
livening up the party that ended the day.
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{ NJ }
News from New Jersey |
TTC doubles its
sales volume
In its 3rd year of
operation, the Technology Transfer Center (TTC) in New Jersey, USA,
doubled its sales in the first semester of the current fiscal year,
compared to the same period of the previous year. Sales have reached
USD4.8m in the first semester, placing the TTC at breakeven point.
The TTC has showed a growth of 200% in the first three years. It was
a hard process as its start-up coincided with the worst phase of the
cycle, but we were able to differentiate ourselves in the US market
and today TTC boasts a customer portfolio that is the envy of any
competitor: the best companies, the most promising projects. Thanks
to our presence in the US and to our marketing efforts, the number
of new process development contracts has increased by 35% in a year,
from 17 to 23. In the first seven months of this fiscal year alone,
we won eight new clients – a record growth since the start of the
custom synthesis business 15 years ago. The TTC is, at the moment,
developing seven projects and has successfully transferred two
projects for industrial production, one to the Loures plant and one
to the Macao plant.
Michael Humora
promoted to General Manager of the TTC
 Michael
has a Ph.D in Chemistry by the Northeastern University, and has
worked for 25 years in the pharmaceutical industry, at Bristol-Myers
Squibb and Johnson and Johnson. He’s been at the TTC since April
2004 as Team Leader in the R&D area. He has, until now, been working
closely with NJ and Macao members with the IR01 campaign and its
transfer to HM. He was involved in many of the TTC projects
including IR02, BN03, AI01, GM05, NS01 and NS02. On July 1st, 2005
he was promoted to General Manager of the TTC Business Unit. Dave
Hoffman remains President of Hovione’s operations in the US. We
congratulate Michael for this promotion and wish him the greatest
success in this new challenge.
New Technology implemented at the TTC
Highly Active
Pharmaceutical Ingredients (HAPI) Laboratory
 One
of the TTC’s labs has been recently equipped with a technology
destined to handle “highly active pharmaceutical ingredients” –
these drugs differ from conventional drugs as they produce
pharmacological effects in extremely small doses, usually in the
order of micrograms/kg (a million times smaller than the gram). Due
to this extremely high pharmacological effect any handling requires
specific care and represents an engineering challenge. The TTC has,
at the moment, a contract for the development of a HAPI, presently
in Phase III. Since these drugs are produced in very small
quantities due to their high potency and because there is sufficient
capacity and technology at the TTC for its commercial production,
there will be no need to transfer the project to the industrial
plants. The facility therefore anticipates an FDA inspection for the
manufacture of this compound.
| What is the
TTC’s activity? |
- R&D – develops new chemical
synthesis processes for new active pharmaceutical ingredients.
- Pilot production of these active
ingredients and preparation of small quantities for clinical
trials.
- Transfer of processes, when
ready for scale-up, to Hovione plants in Loures and Macao, for
industrialization and production at industrial level.
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2005 Dragon Boat
Race
Our team has, once more, entered the 2005 International Dragon Boat
Race, which took place in June in Macao. The team assembled in 2003
with members from various areas, provides interaction between the
Company and the Macao society. |
| The results of the team have been improving throughout these last
three years. Times obtained: |
- 2003 – 2:18’66”; in the small dragon boats race the Hovione team
reached 1st place on Final C.
- 2004 – 2:14’45”
- 2005 – 2:13’86”
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| Congratulations!
|
Safety and GMP
Week 2005
With the purpose of
improving our workers’ perception of Safety and GMP, this event is
organized every year and internal and external lecturers are invited.
The subjects dealt with, this year, were health, safety and work
environment. Since the health issue was one of the concerns of
workers, we invited Dr. Sam, Occupational Health Doctor, who talked
about “Hypertension”. A guided tour of the industrial area,
including a brief description of the manufacturing process, was
organized following interest shown by employees of the
administrative department. Some of them have been working in Hovione
Macao for over ten years but never had the chance to visit the
industrial area.
After receiving a few days of training, people were required to sit
for an examination in order to consolidate their knowledge gained
during the Safety and GMP week 2005.
Fire Drill
 During the Safety and GMP Week 2005 a fire drill was carried out in
which Macao firemen and all workers were involved. This drill was
organized not only to test the efficiency of the fire brigades but
also to test our capacity to handle critical situations. In order to
prepare a possible emergency evacuation, we have been carrying out
since November 2004 evacuation drills in all areas as detailed on
the distribution map.
Beside the fire drill, Hovione Macao also had its first spillage
drill during the Safety and GMP Week 2005, in commitment to
environmental protection
Spillage Drill
Leakage of mother liquors
from the 8000l reactor was simulated in order to test and ensure
that the existing equipment at the plant is adequate and efficient
for this type of situation. With these regular simulation tests we
mean to raise employees’ awareness, both to the costs involved in
solvent leakages and to the preservation of the environment.
Hovione Macao –
2005 Open Day
 Last
year’s Open Day only attracted 51 visitors of which mostly were
employees´ families. Therefore, in 2005 we increased our
communication of the event by sending out more invitations to
neighbours, the community and to the Macao society which resulted in
145 visitors. Students from the local community were particularly
curious of our activity and showed special interest in chemical
reactions. We also welcomed the visit of 23 directors and
entrepreneurs from the Macao Industrial Association. The Open Day
was a success and it is with great pleasure that we see this
initiative contributing in a significant way to the improvement of
relations between Hovione and the neighbouring community.
|
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Editorship: Isabel Pina, Sofia
Villax • With the collaboration of:
Guy Villax (DG); Luisa Paulo (CM);
João Bandarra (QUI);
Ana Ferreira (RH); Paulo Baião (DGF); Jorge Costa
(AU); Dave Hoffman and Lavinia Emery (NJ); Luis Gomes
(HM) |
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