In Focus: Towards Equitable Access to Biologic Medicines in the Middle East & Africa: The Story of MiGenTra, a Minapharm Company

Welcome to the inaugural edition of the In Focus series by AIMS International. We begin with a fascinating story: Minapharm Group’s MiGenTra’s efforts to ensure equitable access to biologic medicines in the Middle East and Africa, a landscape brimming with potential yet facing distinct challenges.

___

In the ever-evolving landscape of the life sciences industry, the Middle East and Africa (MEA) region holds a wealth of untapped potential, along with unique challenges. 

In this comprehensive interview, we delve into the insights and experiences of Frederic Bouvier, Vice President Corporate & Business Development at MiGenTra, and Dina Soliman, Director of Strategic Operations & Business Development at Minapharm Pharmaceuticals, both companies being part of the Minapharm Group. We will also explore how AIMS International has supported them throughout the journey.

Could you help us understand how you see the status of healthcare in MEA, what makes this region an attractive proposition for companies in the life sciences industry, and what hurdles remain?

Frederic: The MEA region has long been overlooked by global pharmaceutical players: this is particularly true for Africa. We believe there are three main reasons for this situation.

First, there’s the issue of insufficient healthcare coverage coupled with low-income populations. This creates a challenging situation where companies struggle to price their products in a way that is both affordable for patients and profitable for them.

Second, the lack of healthcare infrastructure, particularly in countries with high rates of rural population. This in turns leads to late or no diagnosis, and the inability to supply and dispense drugs to patients.

Last, the absence of regulatory harmonisation when it comes to reviewing and approving medicines, resulting in highly fragmented markets, hard to navigate.

But here’s the thing – we believe we have the right ingredients to overcome these hurdles and are uniquely positioned to benefit from MEA’s largely untapped market opportunity.

We understand that access to biologic medicines remains a challenge in MEA. Could you walk us through the root cause of this situation?

Frederic: Contrary to drugs, which are typically manufactured through chemical synthesis, biologic medicines (also called biologics) are produced using living systems such as microorganisms or plant or animal cells, and are very large molecules. By way of example, while a molecule of aspirin has an average mass of about 180 Da, a biologic such as a monoclonal antibody has an average mass of about 150,000 Da.

Producing these biologics requires highly skilled personnel, and complex and lengthy manufacturing steps.

As a result, selling prices are high to very high, and most patients in MEA cannot afford this class of medicine. While 80% of patients in North America and Europe can access or afford biologic medicines, there is a stark contrast in Africa, with less than 20%.

Minapharm embarked on its biotechnology journey over two decades ago, arguably a courageous move then. What was the vision, and what successes have you achieved?

Dina: Minapharm was established in 1958 as the first privately owned company in Egypt with a mission to provide innovative medicines in an affordable way.

As an early recognizer of the global shift in the healthcare industry towards large, complex molecules, Minapharm adopted an evolutionary vision and embarked on biotechnology in the 90’s, defying the region’s industry norms. It started with a strategic joint venture with Rhein-Biotech, Germany (now Dynavax Europe), followed by the acquisition of ProBioGen AG, the Berlin-based cellular engineering expert specialist and global provider of intelligent proprietary technologies.

In 2001, Minapharm established Egypt’s first biopharmaceutical manufacturing facilities and R&D platform to develop and manufacture therapeutic recombinant proteins from the cell line all the way to the finished product, allowing a significant cost reduction. Our first recombinant protein launched in 2005 demonstrated an unprecedented price erosion model in the market and led to a six-fold price reduction of its imported competitors to catalyse Egypt’s Hepatitis C eradication programme. This same model was replicated upon the launch of the next therapeutic proteins on the market, transforming healthcare for patients in Egypt.

Capitalising on this strong foundation, Minapharm strengthened its presence across the region, where access to advanced medicines is an everyday burden due to their high prices. 

In 2021, Minapharm and ProBioGen AG incorporated MiGenTra GmbH to elevate access to innovative complex immunotherapies for millions of patients in Africa and the Middle East.

MiGenTra was incorporated in mid-2021 as a new addition to the Minapharm Group. What are the mission and vision of this young company and its unique selling points?

Frederic: At MiGenTra, we believe that healthcare is a human right: it is encrypted deep into our DNA. No one on this planet should be denied access to lifesaving biological medicines for cost reasons. Unfortunately, this is a situation faced by most patients in Africa.

We want to change this situation; we want to transform healthcare on the continent by developing and commercialising high quality biological medicines at affordable cost.

To achieve our goal, we are progressing a portfolio of 6 biosimilar candidates (ie. biologics highly similar other already approved biologics, also called ‘reference medicines’) by leveraging the capabilities and expertise available within the Minapharm Group: world class cell-line development at ProBioGen AG, in Berlin, coupled with state-of-the-art process development and low-cost manufacturing at Minapharm Pharmaceuticals.

To meet the needs of patients in MEA, we are enriching this portfolio by licensing-in carefully selected biosimilar products, complementary to ours. In November 2022, Minapharm and MiGenTra signed with Dubai-based Bioventure an exclusive licence agreement for the commercialization of multiple biosimilar candidates developed and manufactured by Alvotech, a world leader in the development and manufacture of biosimilar medicines, for 19 countries in MEA.

We will be filing our first two biosimilars in key markets in the very near future: Bonosome, a teriparatide product biosimilar to Forteo/Forsteo developed in-house by Minapharm Pharmaceuticals, and ustekinumab, a biosimilar candidate to Stelara, the first product from our alliance with Bioventure/Alvotech.

So, stay tuned for further announcements.

Entering new markets comes with many challenges. Can you explain how MiGenTra plans to establish its footprint in the MEA region? And then, how will it grow its geographic reach?

Frederic: To start with, MiGenTra is already deeply rooted in Africa, thanks to the export strategy Minapharm initiated a few years ago. So the low hanging fruit will be, no doubt, to leverage at the maximum this unique network.

In parallel, we are actively working on establishing new export routes to five promising countries in Africa—Morocco, Algeria, Kenya, Ghana, and Nigeria—and four countries in the Middle East—Iraq, Jordan, Lebanon, and Yemen—by partnering with local champions.

There is no one size fits all approach when it comes to partnering deals. While in some cases simple distribution agreements may suffice, in some others we may need to contemplate more complex agreements, e.g., to localise part(s) of manufacturing and ensure optimal market access. Thus, flexibility is key, and our approach will be tailored to the needs and specificities of each country.

In the long run, we will pursue aggressive geographic expansion by, for example, turning certain countries into regional hubs able to service neighbouring ones.

Within the next 5 years, our ambition is to have our products available to ca. 70% of the population living in the region.

Talent is a key asset in any industry, more so in life sciences. In the highly competitive MEA region, how has MiGenTra approached talent acquisition and strategies to build a skilled workforce that supports their growth and innovation in the life sciences sector?

Frederic: As we mapped out all necessary resources and functions, we quickly came to realise that some activities could not and should not be driven from Berlin, where MiGenTra’s headquarters are.

For example, profiles combining a solid understanding of biologics together with a proven track record of building and managing sales organisations in the MEA region were absolutely key in delivering on our ambition: talents hard to identify from Europe. This is how AIMS came into play.

Dina: AIMS quickly recognised MiGenTra’s unique requirements and tailored their search strategy, with results exceeding our expectations. Because of their experience in the life sciences sector, they were able to cater to our unique needs. Their approach combined speed, precision, and an understanding of our strategic goals.

To delve deeper into MiGenTra’s work and their vision for the future, visit their official website

______

This interview is the first edition of our In Focus series.

In Focus is more than just a collection of stories; it’s a celebration of success, collaboration, and leadership.

In Focus is designed to highlight the extraordinary journeys we have taken with our valued clients. It is a tribute to the powerful collaborations that have driven success in various markets and fostered innovation and growth around the world. Each edition of the series will include insights from some of the most influential leaders we have had the pleasure of working with across a wide range of industries.