Country Manager Giovanna Labbate talks how Gedeon Richter aims to become the point of reference for women’s health in Italy, the successful launch of ESMYA, and the establishment of the affiliate five years ago.

The Gedeon Richter Italy affiliate was established in 2011. What was the rationale behind starting this affiliate what has driven its growth so far?

We started in 2011 with only one product, the Belara contraceptive. Our true success however has come from the dynamism and enthusiasm that we have put into all the functions of the company in order to build it. The most important thing that we have in Italy is the empowerment and knowledge of our people. In Italy we started by researching the market. The idea behind setting up the Gedeon Richter affiliate in Italy was to launch a mature product that another company had previously withdrawn. While generally this strategy might not necessarily be perceived as ideal, I saw a lot of opportunities as in Italy it is challenging to get funding for the development of a new product.

It is strategic headquarters’ decision to initially concentrate our efforts on women’s health. I decided to focus on our knowledge and experience in this specific sectors. First off, our medical director was a gynecologist. Second, when I added up the combined number of years of experience that our staff had in gynecology across all departments – regulatory, sales, and market access – it came out to more than 220 years! It was important for me to have people with backgrounds in gynecology to better understand how we can introduce new products we receive from headquarters in Italy.

When we interact with gynecologists we need to understand that this interaction takes place on more than one level: they are essentially general practitioners for women from adolescence to maternity and through to menopause. Thus, we knew from headquarters that we would be introducing products for all these stages; it was just a matter of timing.

My objective from the start was to launch a new product every year, either through generic products from headquarters, an originator product or a partnership with a local Italian company.

We were able to launch several contraceptives such as the Drospirenone family and Sibilla. Therefore we moved from one to five products in two years. In the meantime there were questions about the launch of ESMYA, which proved difficult with AIFA, the Italian pharmaceutical regulatory body. We eventually launched it in September 2014 as an innovative product and our first one to be reimbursed in Italy.

The turning point was with ESYMA because it was proof that we were a completely different company. It is the most innovative product in the gynecology field –a product that addresses the cure for fibroids. Launching this product certainly helped the identity of the company and gave doctors a strong degree of confidence in our portfolio.

How did the doctors receive ESYMA?

During the launch of ESMYA we engaged in a lot of explaining and education. In Italy we refer to our sales representatives by a term that literally translates to “people who inform on science.” We train them very hard to talk to the doctors, because such an innovative product naturally comes with a lot of questions. Thus, you have to be able to clearly explain the significance of the product in their technical language. They accepted it very well and there is room for improvement considering the potential in being a breakthrough therapy for Fibroids.

What other pipeline products are you developing and preparing to launch?

We have a three pillar strategy – contraceptives, fibroids and what we call in Italy the business opportunity of “all other products” such as food supplements, antibiotics and hormone replacement therapy (HRT).

We just launched (in the 2nd week of January) a new innovative contraceptive called Enciela – a patch formulation with low dose hormone (Lisvy in all other countries)

We are in the middle of the negotiation for the ESMYA Long Term Intermittent use and we were able to launch Lenzetto – a new product for HRT symptoms. In addition, we have biosimilars, which is another innovation that we can bring to Italy.

Contraceptive products and services very much rely on the image of the OBGYN and the connection that you have with them. How do you make sure that Gedeon Richter is their preferred partner?

Through our market research we have a stronger knowledge than many of our competitors. We reached the point at which the sales reps can talk to doctors in the same language.

We offer not only the basic information to the doctor but also very accommodating services to help them overcome market access constraints. We give doctors help in terms of market access and how they can move forward to be sure they will maintain their patients.

A lot of big pharma companies fled the area of women’s health in the late 2000s. Meanwhile, Gedeon Richter has invested massively in the field such as with ESMYA, bringing an innovative product to the market. How do you want Gedeon Richter to be perceived in Italy?

The feedback that I get from the market is that previously Schering (now Bayer), Organon (now MSD) and Wyeth (now Pfizer) were the reference points for the gynecology field. However, either their women’s health portfolios have completely disappeared or their investments are ongoing but their portfolios are not perfectly in line with the needs of patients today. Thus, we are being told that Gedeon Richter represents today what big pharma used to represent 10-20 years ago. They now turn to us to be that new reference point.

The doctors appreciate that we are innovative not only because we launch innovative products such as ESMYA, but also the way that we are flexible in managing our contraceptives portfolio.

We are still the point of reference for gynecologists all over Italy, but I think that we will only continue to grow stronger as demonstrated by our launch of ESMYA.

Having successfully set up the Italian affiliate for Gedeon Richter from scratch, what advice can you give to future country managers?

When I developed the company I always referred to the DNA of Gedeon Richter during my hiring interviews. The most important DNA components are flexibility, entrepreneurship and the openness to be actors of change. All people in this company have these characteristics and I strongly believe in my team.

Change management is very important – to be as strong and flexible as possible. You have to understand the little signals that you get from the market and to be open enough to change your idea or approach depending on the constantly changing environment. Flexibility will allow you to change in order to find niche products that can suit the market.

One of the reasons why I wanted to join the company was to start from scratch. We are a different kind of company. We are neither a pure generics company nor a pure originator. We are a mix of both.

What would be the story that you would like to tell about Gedeon Richter in Italy in three to five years?

I would like to say that we are a company thinking of sales and revenues. Despite our double-digit growth we are a small company. Nevertheless, I believe that we have strong potential to be medium big company. The most important thing is to be the reference point for the gynecology business in Italy. In three years we will have established ESMYA, not just for the short-term but more importantly for the long-term. We already have established and will continue to grow our contraceptives portfolio. Further, we established and will continue to grow our HRT and biosimilars portfolio for gynecology. To sum up, I want Gedeon Richter to be the point of reference for women’s health.

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