Genpharm is a Dubai-based regional company providing market access and marketing solutions for rare disease products in the MENA region. Co-Founders Karim Smaira and Kamel Ghammachi provide insights into the rare disease space in the region, explain how the company is positioning itself in the gene therapy arena and why innovative treatments are bound for success in the GCC countries. Moreover, they reveal the challenges of starting their own company in the MENA pharmaceutical industry.
Change should be part of our daily life. Genpharm has been always centred around being an agile and dynamic organization
Can you introduce Genpharm and explain the evolution of the company after its inception in 2012?
Karim Smaira (KS): We are proud to say that after seven years, we have lived up to the initial mission and vision that we had established when we started the organisation in 2012, the vision of being the partner of choice in particular for rare disease companies that want to expand into the MENA region. We have come a long way both in terms of portfolio and strategy. Last year we launched Genpharm 2.0, redefining the objectives of the company for the next stage and introducing a refreshed brand identity. We are now a mid-size organization with more than 40 people and have built a strong footprint in some disease areas like neuromuscular disease, genetic diseases, metabolic diseases, ophthalmological rare disease, plus women’s health. From a commercial point of view, we have reached profitability a couple of years ago and are looking at the next steps of growth. As a result of this, we have set up a company Genpharm Ireland, to acquire and in-license products in the niche areas where we have expertise.
What have been some of the lessons you have learned after seven years of Genpharm?
Kamel Ghammachi (KG): Something that we both learned from our days working at multinational companies, is that there is no place for complacency; The environment is very dynamic. You always need to keep an eye outside the organization to be ahead of the curve. Change should be part of our daily life. Genpharm has been always centred around being an agile and dynamic organization.
What are the main services you provide to the global pharma industry wanting to enter the MENA region?
KS: We are structured like any other specialty pharmaceutical company. Our partners do not necessarily possess the resources or know-how to expand into the MENA region. We bring a thorough expertise of the region. Hence, the first role we play is an educational one because there is, in particular for rare disease companies, a steep learning curve. They are not aware that due to some of the tribal aspects of our societies such as the high rate of consanguinity, we do have a higher prevalence and incidence of rare diseases, particularly in inherited diseases. The challenge is to convince people that, although the Middle East represents only two percent of the global pharmaceutical sales, the growth is substantial, one of the highest in emerging markets with significant upside.
In addition, our markets have matured from a regulatory standpoint and the gaps have been closed with other markets. Regulations related to fast-track approval, international referencing models for pricing as well as outcome-based reimbursement are some of the critical developments introduced in recent years. The FDA and EMA are recognized as the benchmarks in terms of drug approvals so the region does not require regulatory trials for approved products. All of this information goes needs to be communicated properly to generate interests in our markets. We also need to explain our business model and why the risk for our potential partners is minimal. We do the upfront investment in building the team and in deploying across the region to generate disease awareness and identify the patients that require the treatment. We also handle the logistics and supply to the markets, making us a one-stop-shop for our partners.
However, a lot is still to be done. When we talk to the medical community or the health authorities, we have seen that there is disappointment in the perception of the region as only a commercial opportunity. There is very little research or participation from the region in clinical trials. We have started engaging with our partners on that front; this would greatly help the local healthcare systems because it would build local expertise and patients would have the opportunity to participate in clinical trials. It would also accelerate the regulatory pathway post-approval. The discussion is generating some and companies started asking us about the selected hospitals or centres from the region and how Genpharm can help in this regard.
How does Genpharm approach partnerships?
KS: During our first four years as an organization, we were building a brand and a reliable reputation. During the last three years, we have seen that most of our new partners have come through referrals. That is very encouraging because it means that we are doing something that our partners appreciate. Genpharm has established itself as the partner of choice in rare disease in the region. Our business model depends on our capacity to adapt and react to what companies want; some might want to begin with regulatory work, others only with market access or identifying patients, others clinical trials, big pharma companies might already have distributors and don’t need Genpharm to intervene in the distribution channel. We can provide a tailored service.
How much potential do you foresee in the region for innovative and expensive products like gene therapy?
KG: While it is still in its early stages, we are proud to be the first company to bring gene therapy into the Middle East. We see a big potential in the space. We established the Genpharm name in the field and will continue to focus on it.
Innovative products will probably succeed in the region because of the willingness to do fast approvals. Most of the diseases we are tackling are degenerative, and most of them are pediatric, so the early you treat them, the better the prognostic. Anything that will support fast access will benefit the patients. It is important to say that the UAE is one of the fastest markets to register products after the United States; it speaks to the maturity of the healthcare system.
What are the best-performing countries for Genpharm?
KG: The GCC countries are definitively driving our growth because they have matured and have proper funding, at least for their nationals.
What does Genpharm 2.0 mean in terms of strategy?
KS:. Genpharm 2.0 is about projecting ourselves into the future in line with the coming changes in the area of rare diseases. We tell our people that rare disease is a very peculiar field and we must deliver on everything we promise. We changed our vision to be in line with our ambition in gene therapy and is now “Bringing cures to MENA patients.” Cure is the key word because, as we move to gene therapy, we are not only treating the symptoms but the underlying cause of the disease itself. Genpharm 2.0 is also about living daily the passion we have for what we do. Continuing to put patients first, because everything we do in rare disease is about the patients and their families. It is quite motivating for our employees to earn a living while having a positive impact on someone. This alone should be very motivating for anyone that is thinking of joining Genpharm or building a career with us.
After all the consolidation going on in the industry, is it something of interest to you?
KS: We are not working with the intention of being acquired but you never really know what the future holds. We feel that there is a lot of interest in rare disease and not everybody will be successful. If the market will be able to accommodate a large number of players remains to be seen. Are we open to the idea? We are open to any business proposition that makes sense, but the intention is not to deliver on our objectives. We want to continue growing the business organically because there is still a lot of potential; most of the products we have are still in the launch phase and we have new products coming soon. If a collaboration leads to a faster growth and helps us achieve our objectives faster will definitely look at it seriously.
What would your advice be to a young entrepreneur willing to leave a comfortable job?
KS: Have a plan, don’t listen to naysayers and make sure that you have patience. Things never go as planned so they should not get discouraged. They should celebrate every milestone and use the small wins as fuel until the next ones. Any entrepreneur should be ready to work for no income for the first few years. The primary focus should be to build a solid foundation and make sure that the business model is scalable and can sustain shocks.
KG: You have to have passion and believe in what you are doing in order to succeed. Another important lesson we have learned is the importance of being nimble and dynamic, not over-analyzing everything to the point of paralysis; small companies cannot afford to be paralyzed. I also agree that you should not listen to naysayers, these are very numerous, unfortunately. You should use these doubters to motivate yourself and not let them discourage you.