Khaled Elrefae – General Manager MEA, Ipsen

Ipsen’s general manager for Middle East and Africa (MEA), Khaled Elrefae, highlights the French firm’s expanding footprint in the region, the fundamentals that make MEA a growth driver for Ipsen, and the opportunities for further growth from its oncology, rare disease and neuroscience portfolios. In addition, Elrefae discusses the changing dynamics in the Saudi market, including improvements to the registration and procurement systems.

 

Saudi Arabia is one of the fastest growing markets within the MEA region. The Saudi government is taking bold decisions to transform the healthcare system and providing pharmaceutical companies with fantastic opportunities to join this transformational journey

PharmaBoardroom last interviewed you in 2019, just after Ipsen opened its legal entity in the United Arab Emirates (UAE). What have been the highlights of the company in the region since then?

As part of its expansion strategy, Ipsen has been looking to expand its footprint in MEA and so far has successfully managed to adapt its business model in a number of the region’s most important countries. Most notably, we have been developing partnerships with key distributors in Saudi Arabia, Egypt, and the GCC countries.

With an established scientific office in Dubai, UAE, we are now planning to open another one in the Kingdom of Saudi Arabia during 2022. This is all part of our geographical expansion strategy, bringing us closer to all the relevant stakeholders and enabling the organisation to better serve patients. Our leadership team perceives this region as a growth driver for the company. IQVIA statistics show that MEA is one of the fastest growing regions globally and will continue to be so.

The new scientific office in Saudi Arabia will allow us to enable timely access for our well differentiated and innovative medicines in the country and foster cooperation with key stakeholders such as the Ministry of Health (MoH) and Saudi FDA, as well as other private sector firms. Moreover, it will help us build in-house capabilities and attract the best local talent.

 

Ipsen has been undergoing a transformation in the past couple of years, with a new CEO in place and several M&A deals struck. Against this backdrop, how are the company’s MEA operations evolving?

Ipsen’s vision is to be a leading global mid-size biopharmaceutical company, focusing on innovative, transformative medicines in oncology, rare disease, and neuroscience to serve patients and society.

Interestingly, the company’s transformation coincides with the one occurring across the entire pharma industry and in MEA. Our team in the region is passionately translating its everyday efforts into valuable outcomes for patients and society and our top priority is bringing the full potential of our innovative medicines to patients through timely and sustainable access.

The second key priority is building on our valuable pipeline; for which the launch of our oncology drug Cabometyx® across the region is a good example. The third priority is to identify efficiencies that can help us invest in different ways and continue growing, while the final priority is to foster a culture of collaboration both internally and with other external stakeholders.

There are great opportunities opening up in this region and big unmet medical needs, including the rising incidence of cancer and awareness of screening. Governments, particularly in the GCC countries, are making huge efforts to invest in diagnosis and introduce the industry’s latest life-saving innovations. We are seeing a growing embrace of innovation and a clear shift towards targeted therapies, immuno-oncology and biotherapeutics which is being coupled with improvements in the regulatory landscape, thereby providing faster access to these treatments.

 

How does the Kingdom of Saudi Arabia fit into your regional strategy?

Saudi Arabia is one of the fastest growing markets within the MEA region. The Saudi government is taking bold decisions to transform the healthcare system and providing pharmaceutical companies with fantastic opportunities to join this transformational journey.

In recent years, Saudi Arabia has established new cancer centres, improved its screening programs, and fostered greater public awareness of risk factors in terms of cancer and obesity. A good example of their efforts is the creation of early screening units with third parties.

When it comes to the regulatory environment, the Saudi FDA has transformed the way in which companies apply for the registration of new, innovative medicines by providing an electronic registration system and putting in place a fast-track path for life-saving therapies and orphan drugs.

In light of that, Ipsen – as part of its global geographical expansion strategy – is planning to have a more robust footprint in Saudi Arabia by opening up a Scientific Office in the country.

 

How has Saudi Arabia’s improved regulatory system translated into tangible results for Ipsen?

We started to engage in discussions with the Saudi FDA back in 2018 with the objective of introducing Ipsen’s full portfolio in the country. So far, we have managed to successfully register Cabometyx®, Dysport® (botulinum toxin type A), Somatuline® Autogel and Diphereline® (triptorelin) products’ range.

The company is in a fantastic position because it offers great medicines in three main therapeutic areas. The first is oncology, where our brands cover almost 11 indications; the second is neuroscience through our Dysport® brand, and the third is rare disease, where we have Increlex® and some other upcoming medicines.

Cabometyx® is a good example of Ipsen leveraging fast-track registration opportunities; it has US FDA and EMA approval and addresses clear unmet medical needs.

 

Does Ipsen already enjoy a good level of recognition from healthcare practitioners (HCPs) in Saudi?

Being present in the country provides us with a great opportunity to increase collaboration and awareness of our innovation capability. Our plan is to build more local capabilities and the establishment of a Scientific Office should contribute to that mission.

By having a clear understanding of the patient journey – from diagnosis to treatment and follow up – we were able to put in place key initiatives to work closely with HCPs and raise the level of awareness.

Launching during the COVID-19 pandemic was challenging, but it boosted the digital transformation, which maintained the connection with HCPs and patients

 

How do you perceive the enhanced role of NUPCO in the public procurement process affecting Ipsen’s operations in Saudi Arabia?

NUPCO is definitively a great initiative and a key part of Saudi Arabia’s market transformation. Having a unified body for procurement will make the process more transparent and streamline access to medicines across the country.

Ipsen is working closely with NUPCO through its local distributor in Saudi Arabia to ensure that our medicines are accessible to all of the country’s key public and private institutions.

 

How would you characterise Ipsen’s process of choosing distributors and what characteristics do you look for in a local partner?

Ipsen mandates that all internal stakeholders be involved in the selection of local distributors. All our departments – from quality to legal, business ethics and compliance, regulatory, pharmacovigilance, and commercial – have their own criteria.

With a well-defined profile in mind, we engage with interested distributors following internal due diligence. At the end, as a cross-functional team, we discuss and agree on a partner.

Our aim is to select the partner that can add the most value to patients by being reliable and having a strong supply chain system. Due to the geographical characteristics of Saudi Arabia, it is important that your local partner can reach patients in both urban and rural areas.

 

Saudi Arabia’s Vision 2030 promises to be truly game-changing for the country’s healthcare system and for patients. What do you see as Ipsen’s role within this system-wide transformation?

Through Vision 2030, Saudi Arabia is looking to transform its healthcare system and Ipsen has put in place a strategy that aligns with that goal, investing in establishing a Scientific Office, providing timely access to our innovative therapies, and hiring local Saudi talent. The establishment of the Scientific Office in particular is a big first step and we will continue exploring localization opportunities that align with both the country’s vision as well as the company’s long-term strategy.

There is a trend of privatization of healthcare provision in Saudi Arabia, which is also an opportunity for us to make sure that our medicines are accessible to all patients, regardless of the institution they seek them from. Another trend is a move towards a value-based system; we have observed discussions about health economics, and it is our responsibility to make sure that the right local and global data are readily available to decision makers.

Moreover, there is a big opportunity to increase the level of clinical research being done in Saudi Arabia since the country has already established the infrastructure needed. From our side, we are building in-house medical capabilities so that Saudi Arabia can be part of our global clinical trial programs.

 

Is there a final message you would like to share with PharmaBoardroom’s audience?

I would like to underline the fact that Ipsen is fully committed to bringing innovation for patients in our three therapeutic areas of oncology, neuroscience, and rare disease. Ipsen is uniquely positioned as a biopharmaceutical company focusing on specialty care that is willing to work closely with all stakeholders in the region.


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