Mathieu Fitoussi, Country Manager, Servier, Poland
“Innovation is about bringing new chemical compounds on the market; but it is also, and sometimes even more, to continue the therapeutic development of the drugs which are already there” comments Servier Poland’s country manager. He even adds: “we believe that it is not because a drug has lost patent protection that there is nothing to discover about it.”
Servier is part of the exclusive group of international companies which decided to enter Poland in the early 1990’s. Could you share with us that story and how the company has been performing over time?
Servier has been in Poland for the past 21 years and is among the first important pharmaceutical companies to enter Poland.
Servier has decided to implement from the start the highest quality in its promotion and medical information and has set the standards of the market. For this reason, Servier has been market leader for many years in the segment of prescribed medicine. It positioned Poland as a very important subsidiary for Servier, and Poland is still today top ten in the Servier League.
Since 2008, a few events have weakened our position. The most important one was the result of the harmonization process which took place during four years after Poland joined the EU in 2004. During this period we lost the marketing authorization of three products (Detralex, Bioparox and Eurespal syrup) which represented a significant share of our turnover.
Thankfully this part is behind us. We have still a leader position in cardiology, diabetes, and we are very proud of the new heart failure indication of Procoralan which is now available for Polish patients.
What were your main responsibilities when you joined as Country Manager in March 2011?
One of my duties has been to rebuild a trustworthy relation between all employees, Servier and the authorities. This is always challenging as trust demands time.
Also, shortly after my arrival the new Reimbursement Act was introduced (in January 2012) and this new act, as you know, had a strong negative impact on the whole pharmaceutical market. Therefore, 2012 was a difficult year for us.
In 2013 we have managed to come back to growth, even if very limited and today, despite the significant price decrease that we are facing (from January this year), the situation is more stable and more predictable.
The market is divided into three parts: prescription reimbursed segment, prescription non-reimbursed segment and finally OTC.
We are mostly present in the reimbursed segment; thus we have to diversify; and in the near future, we believe that the prescription non-reimbursed and OTC segments represent the best opportunities.
Therefore, we are working on some projects to diversify our offering in Poland. Nonetheless these initiatives take time.
Could you specify which drugs you have in your pipeline for 2014 and how close you are to getting them approved on the reimbursement list?
One of our drugs (Procoralan for chronic heart failure) has joined the reimbursement list in January of 2014 and this is extremely important for a limited number of Polish patients who can now be treated according to the European Guidelines for Heart Failure.
It is a very significant therapeutic progress, which also shows that Polish Authorities are taking steps to allow REAL innovation to get access.
We also just received from AOTM (Health Technology Assessment Agency) a positive recommendation for Valdoxan (antidepressant) and this means that we hope to have fruitful discussion soon with the commission.
Again, this drug is not a “blockbuster” as it should be taken by a relatively small number of patients, but for those, it can change life for better. It is a key milestone for us in 2014.
While the company is strongly associated with the French market, 90% of its medicines are today prescribed internationally, and this figure continues to grow. Given the group’s international expansion, what does the Polish affiliate represent for the group?
Europe in general does not show very promising prospects of economic growth. Poland sets apart in Europe with some promising macro-economic forecast. Still, the pharma market growth should be relatively limited in the next years.
However, public spending for drugs in Poland is far behind that of other European countries, including those with similar GDP per capita. Hence, if Poland decides to catch up and make more innovative drugs accessible, it will be for the benefit of all, and patients first.
But whatever happens, Poland will remain very important for Servier. We are committed to Poland and we will keep investing in this country which has given us so many rewards over the years.
Servier invests 25 percent of its revenues in R&D and this is much higher than the global average which is around 14-16 percent. Why does Servier invest more on global level than other companies?
Servier is a relatively small foundation, especially in comparison to large companies in the pharma industry. This entails that we need to have a certain level of investments to sustain research programs which can lead to success.
Jacques Servier had a true desire to participate in medical progress through research and discovery. This philosophy still structures the decisions of the company.
Investing in research is always a bet. Risks are very high indeed, considering the billions invested to develop new molecules which sometimes do not reach market.
Innovation is about bringing new chemical compounds on the market; but it is also, and sometime even more, to continue the therapeutic development of the drugs which are already there.
The real definition of innovation should be related to “a NEW answer to an unmet medical need”. Sometimes, it requires a new chemical Entity; but often it requires a well-designed clinical development, even with an existing medicine, even if not patent protected anymore. This is what we do. We fight for therapeutic innovation.
We did bring pure innovation on the market recently, for example with Procoralan and with Valdoxan. In both case: New Chemical Entity (NCE), 1st of their class, targeting new receptors and bringing new therapeutic answers.
But we also continue to develop our current drugs and work to bring new evidences which are expected by doctors and patients alike.
This makes us different: we believe that it is not because a drug has lost patent protection that there is nothing to discover about it. Some of the most important therapeutic progresses are related to late clinical development that we have made, even if our drugs were close to patent expiry or if the patent had already expired.
Also one of Servier’s 19 International Center for Therapeutic Research is located in Poland. Could you talk about the importance of this centre?
Our International Center for Therapeutic Research (ICTR) is a hub for Poland and the CEE region. Poland is participating to all important clinical programs. Again, sometimes with new compounds and sometimes with relatively older compounds, we think that some answers are expected by doctors. We have studies on going in diabetes, cardiology, oncology, and also in some orphan diseases.
Servier Poland according to IMS is in 10th place, which is a great recognition of the company’s performance in Poland. Can you tell us how your manufacturing capabilities will help Servier Poland remain a strong player in the Polish pharma industry?
98 percent of the drugs that we sell in Poland are manufactured in Anpharm, a production and manufacturing site close to Warsaw, in Bialolenka. This is unique.
Anpharm employs close to 200 people and also exports a significant share of its production. Indeed, our exports to Baltic countries, Russia, Central and Eastern Europe and France represent about 40 percent of Anpharm production.
Anpharm was the first production site in Poland to receive the European GMP certificate. The Anpharm site indeed is evidence of is our commitment to Poland and a clear sign that we are here for the long run.
In price and reimbursement discussion with authorities, we know of course that the first criteria is about medical value, safety, quality of drugs.
But we know that Anpharm as such, as well as the recognised quality of its production and people and the traceability of our Active Principles are key elements to consider.
This value is recognised by Polish Authorities as investments in Poland and EU in general are considered by law as criteria’s for price negotiations.
After 12 years working for Servier, you were appointed in March 2011 at the head of one of its important subsidiaries. How do you feel about this great opportunity and the responsibilities?
With higher responsibilities come more challenges. Adrenalin is necessary to achieve great things. And I have to say that I did not miss challenges here in Poland.
The main one though I believe is nether external, it is internal and it is about establishing relation of trust between all of us and by that building a team dedicated to making our Polish business a marvelous one.
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