Editor's Note:

In June of 2018, Luye Pharma announced the completion of acquisition of AstraZeneca’s Seroquel and Seroquel XR in 51 countries and regions, both teams then entered into transition period for product transfer in different countries. Further to transferring the market authorization of Seroquel products in the UK from October 2020, a new packaging livery for Seroquel and Seroquel XR has recently made its debut in the UK market with Luye Pharma’s company logo, which is a symbolic milestone. This month, we invited one of the leaders of the project, Mr. Bruno Delie, General Manager of Luye Pharma (Switzerland) to share the story behind this new packaging livery.
 

Bruno Delie-General Manager of Luye Pharma (Switzerland)

Bruno Delie has more than 20 years of experience in the global pharmaceutical business. Prior to being appointed General Manager of Luye Pharma in Switzerland, he was a board member and executive VP at Ethypharm. There, he was responsible for international development and the company’s transition to a specialty pharma model. Before joining Ethypharm, Bruno Delie acquired wide-ranging experience in corporate and business development as well as international sales and marketing. He has also worked in various licensing and sales management roles for a number of European, American, and Asian companies.

Q：  Thank you for taking this interview, and congratulations on the successful debut of Seroquel’s new packaging livery in U.K. We were all very excited to hear that news. To start with, could you please give us a brief instruction about your roles and responsibilities during the process, and share the background story of this packaging change project?

Bruno: My role at Luye Pharma is to manage and develop the business operation in Europe, Middle East, and Africa, also known as the EMEA region. Our target is to become a specialty pharmaceutical company in many European countries, either with our own sales organization in some key countries, or strong partnership with key CNS players for other countries. We want to become visible as CNS specialty pharmaceutical company in Europe, as well as some Middle East and African countries, like GCC, that’s the roadmap in the next 5 years from now. For other products, which are not CNS will continue to go with license-in and partners. For example, the biosimilar from Boan, as soon as we bring this product in Europe, we will find partners. 

Why do we focus on CNS? Because we are developing products, which are addressing the secondary care market. We are not addressing the primary care market, because for that you will need a huge sales organization. Our products are focusing on schizophrenia, bipolar disorder, Parkinson’s disease, which are targeting specialists, like neurologists and psychiatrists. For that, you need a very specialized sales organization, which can remain very small. This is something which is affordable for Luye’s strategy in Europe to set up from greenfield in some markets as I say. Or eventually to buy some small organization and to develop our own direct sales organization. 

Seroquel is probably one of the first steps for that roadmap, because we've got opportunity acquire Seroquel right for many countries. This is the reason why we have decided to market by our own in UK, which is the first market today where we have the first packaging Seroquel with Luye livery because it was the first country where we change. It's very simple, it doesn't change the sales in UK, but it's a very key milestone for Luye, because this is the first market where instead of having AstraZeneca on the pack, we see Luye Pharma becomes visible in Europe as a company marketing product, it's a symbolic and important milestone. 

We have also decided to set up our own organization in Gulf countries-GCC. Why GCC and why not other countries? Because in GCC the sales of Seroquel are still good. And there are countries where we have sales organization restarting the promotion of Seroquel, we see the sales increasing again. Thanks to the sales organization that we have in place. 

UK was not the first market where we switch from AZ to Luye for the marketing approval of Seroquel. In many countries, marketing approval already switched from AZ to Luye. But UK is the first country where right after this transfer of marketing approval, we also change the product itself and the packaging to totally move the product to Luye, Seroquel today in UK is 100% a Luye product. It's on the market and distributed to patients and community with Luye’s flagship. It's the first milestone, and our plan is to launch further products in UK, including Rivastigmine Multi-day， and then of course we are preparing to launch any of the products coming from the pipeline. Same for GCC countries, we have Seroquel and preparing to launch Rivastigmine MD as well as other products from our own pipeline.

New packaging livery with Luye Pharma's logo

Q: What about the market feedback when they see the first Luye logo? 

Bruno: The fact is that when it comes to the market itself, there is no big change. Why? Because, when you look at a pharmaceutical product as a patient, you look at the name of the products, like Seroquel or Lipusu, but you do not look really at the name of the company. Professionals like doctors and all the professional stakeholders know very well as a company. 

The change of Luye doesn't change the market a lot, because it is a very established market. We were able to avoid any loss, any changes or turbulence during that switch. Everything was well managed; the transition was done in a very smooth manner, so there is no real change, and that's exactly what we want. But for the professional community this is a real change, because they start to see Luye Pharma as a new pharmaceutical company marketing product in UK. We have more and more interactions with the authority which is called MHRA in the UK. We have more interactions with all the stakeholders in the distribution of products, because we have set up a very strong distribution channel with wholesalers. We have some strong commercial contracts with chain of pharmacies. It's a first step in UK. Thanks to the preparation with Seroquel, we will be ready to go with the second and the third product as soon as we can.

Q: That’s good to hear, and hope rest of the products can have smooth progress. How about our internal team? Were they excited to see this new packaging livery?

Bruno: For the time in UK this is still a very tiny organization. We are still having a lot of people acting through service agreement, and they are not FT at the present. Why? Because with the Seroquel itself, it didn't justify to set up a full organization. We need to get more products then to be ready to get our own FT. For the time being, we have a very tiny organization with a commercial director, which acts through a service agreement, we do have the support from PV, Miesbach. We also have the support from the supply chain with Luye, which is Man Chow currently based in UK. Man does help a lot during the transition process. There were some technical issues at the beginning, as usual. Man Chow was able to go to the wholesalers himself to help and to support. It is very good to have Man in UK at that time, otherwise I think it would have been a bit of problems.

In GCC this will be different, we have people dedicated to Luye. They are not our own FTE for the time being, there are FTE from our local partners and distributors. But there are 100 % dedicated to Luye for the promotion of Seroquel. Probably next year with the preparation of Rivastigmine MD, we will open our business office in GCC. 

Q: After we finish this first step in UK, what is our next strategic planning for Seroquel in EMEA countries? What is our plan for the overall CNS product pipeline in the global market?

Bruno: For Seroquel in the Middle East and Africa, I think we've done what we wanted to do. In GCC we have the organization and distribution in place. Now we are preparing the transfer the same as for UK, the transfer of the marketing approval and the packaging to Luye name, this year and next year starting in Saudi Arabia. For the other countries we will continue to go with partners and to go with licensing because the other market does not justify to change and to market by our own when it comes to Europe. The next step is to secure the pipeline. We have clearly selected the products that we want to develop for Europe. We have clear pipeline of product under development or focusing CNS, which are either coming from patch, or coming from corporate project like long-acting injectables. 

Next is to prepare our sales organization in the countries where we want to go. This is where either we will have the opportunity to acquire a small sales organization in one country, like Italy or Spain, for example, if we cannot do that, then we would probably set up from scratch, the same way we have done in UK for Seroquel. We will do that with the target, which is 2023. Because 2023 is the first product from the pipeline ready to be marketed, we should be ready for that time. We will focus on key markets in Europe, for other European markets we will continue to go with strategic partners. They will market the product on our behalf.

Q: What is the biggest Challenge during the process of the whole project? 

Bruno: Actually, the overall project was managed by Janet and the supply team. I think the main challenge was to be ready on track when it comes to the timelines. Because to make the change of packaging, first you need to transfer the MA from AZ to Luye, which was the first challenge. Then the second challenge was to make all the appropriate variation in the dossier to change all the information related to packaging information relating to SMPC. When you market a product, you need also to provide a very strong PV and medical information support. Medical information is about doctors or prescribers when they have information and they want to get an information on the product on the Seroquel. PV is about any side effect, any misuse of the product by the patient. All those needed to be settled and to be put in place in order to be able to switch from AZ to Luye, it's not only a question of packaging itself. Packaging itself was probably the easiest step, but it was everything around that. Luye is fully responsible for the distribution of the product in UK. To do that, we need to put in place all the appropriate organization and support in order to fulfill and to comply with the pharmaceutical requests in Europe, which are the same as almost worldwide. We put in place all that, and the challenge was to be sure that all those will be achieved and ready on time. Otherwise, we will face some delay in launch and potentially to get some shortage, because of course, the old product with AZ was not available anymore, so we need to be ready right on time, and it has been well-managed by the team, which was involving different people from different responsibilities: supply, material, purchasing, PV, medical information, regulatory. All the people were working as a team to be able to be sure that product will be ready on time. It was an interdisciplinary project involving people from different disciplines, from different field of activities, and they need to work altogether that is the reason why project management is important. In that case, the project manager is a key person and we have Janet act as a project manager, she's pretty good for that.

It's a good example of successful management of the project, when we change in the first country, where we were able to move from AZ to Luye for the marketing approval, packaging, distribution, etc. with a successful team. There are thousands of issues during the process, and therefore you need to get a strong team really involved and to solve all the problems, because there is no issue, there is only solution, as I said.

Q: Talking about Rivastigmine MD patch, we know that currently it is in the final registration phase of marketing approval in Europe. And can you share with us your expectation on this product?

Bruno: For Rivastigmine MD, we are expecting it in a couple of weeks. Then we have one step more, which is to get in each national country for registration. So maybe it will take 1 or 2 months more to get the MA in France, Italy, Spain, and others. After that, we will prepare the launch with our partners due to limit of time and organization, but we will market ourselves in UK obviously because we have the organization, As I told you, our target is to be ready for 2023, we have entered into an agreement with Italfarmaco for exclusive commercial right in 4 European countries, and there will be more partners in the future. In the second half of this year, we need to negotiate the price with the authorities. The launch is expected to be in Q1 of 2022.

Packaging livery of Rivastigmine MD

 

Q: What do you think the biggest take away during this process, that can be useful to all of us that to be applied in future projects or future work?

Bruno: I think what we need is to have a clear target, which is the first key. People need to share the same objective, the same target. It's easy to say, but it's not. How can you be sure that all people understand what you want to do? It's a question of communication. You need always to repeat again and again what you want to do, where you want to go, so that people will understand that we need to go to that direction. That's a target as the first step, and as soon as people understand that, they have appropriate target, then it's a question of motivation, to make people motivated and continue to be happy to do that. Because on a daily business, there are always issues, problem that you need to solve step by step. But if you continue to share that target, if you continue to be fully motivated, things are doing very well and going very well.

The other is project management, which is the key to success. You need to have a lead in the project to give the phasing, continuously to support and push people, otherwise it's difficult to reach a target on time. It proves that Luye is absolutely able to do that. We have very good people within the organization, very motivated people. We need to give a clear target and direction to the people, when they understand that, then everything is okay to go.