Inosan Biopharma General Manager Juan Lopez de Silanes outlines the Mexican family company’s recent milestones, including an impressive internationalisation push in the Middle East & Africa Region, how demand for antivenom products is evolving in emerging markets, and why knowledge transfer and inter-stakeholder collaboration is key for the firm’s future success.

 

Could you please start by introducing Inosan Biopharma? What have been the main milestones of the company in recent years?

I am the third generation of my family to have worked in the pharmaceutical industry. My grandfather was Antonio de Silanes, who founded Laboratorio Silanes, one of the biggest Mexican manufacturers, more than 70 years ago. My father was also part of the family business and was in charge of a group of companies specialized in antivenom products for snakebites and scorpion stings.

After the North American Free Trade Agreement (NAFTA) was signed between the USA, Canada, and Mexico in 1994, many Mexican companies changed their lines of business and my father decided to focus even more on antivenoms. I have always been around the industry but wanted to branch out on my own as an entrepreneur. I first created a consulting company and then, in 2007, my father and I started our own company focused on antivenoms and antitoxins.

We saw an opportunity to develop products for the Middle East and African markets from which Sanofi was about to move out. By 2012, we had a production plant in place and were ready to begin commercial operations. Nowadays, we are present in more than 30 countries between Africa, Middle East, Europe and North America. Our main products are for the Sub-Saharan region of Africa, which we call PAN-AFRICA, but we also have products for snakebites in North Africa and for scorpion stings in the Middle East.

We have developed different products for every region because snakes, scorpions and spiders are different in every place. Our vision is for no-one to suffer or die as a consequence of animal envenoming.

 

What was your internationalisation strategy when entering the African, Middle East, and European Markets?

Upon entering a new market I like to figure out things by myself on the ground. In Europe we started operations in Spain where we have an office in Madrid. We also now have an office in Paris with a commercial team and regional regulatory affairs specialist. When we enter a region, we are building the ecosystem and developing the market. We start by talking to the regulatory agencies and local key opinion leaders and then finding a local partner. We have received great support from the Mexican embassies in those countries who have helped us to connect to the key actors.

We have to adapt to individual countries and gain a better understanding of the landscape. The WHO has now recognised snakebites as a neglected tropical disease. Countries have a better understanding of the problem of animal envenoming and its consequences thanks to the WHO’s guidelines and it has become somewhat easier to connect with local ecosystems. The African and Middle East markets are growing fast because the needs there are important and were previously not well covered. For example, Sanofi’s product covered only a small fraction of the needed treatments per year (about 80,000 vials), but now we are producing more than double the amount on a yearly basis. It has been challenging to enter this area, but we have learnt a lot.

 

Inosan Biopharma has a truly international scope, where do you see growth coming from?

There are only a few producers of antivenom around the world. We have developed a very specific technology to produce a complex product but easy to use. Before, it was really difficult to fit different antivenoms in only one vial, to use as treatment for different types of snakes. With our product we are able to fit treatment for each region category 1 species in only one vial.

For example, in Africa, with one product we can cover 24 different species, Sanofi’s product was only showing the coverage of four, so this represents a big jump in the technology. Now we are manufacturing products in Mexico and very soon in Spain within the highest GMP standards, which makes the product more expensive, but since we have improved efficiency (and efficacy), this has allowed us to bring the cost down to sell in Africa at a competitive price.

Africa was a good place to start, because our complex products are needed there. Therefore, on one side we have the Middle East and Africa which are large markets where we are growing little by little. On the other side we have much smaller markets but higher value in Europe and the US, and we are working to develop that segment. It is easier to manufacture the product, but the regulatory framework is more complex.

Another interesting market, which is bigger than we thought, is armies. We are currently selling to the US, French, and other first world armies, who have troops in the Africa or Middle East region. We are also planning to go into the South American market with a specific product for them, in the same way that we have specific product for South Africa. We are also in discussion to work on a product for Asia.

Finally, we have other products in the pipeline for which we have already seen growth: antitoxins. One of them is almost ready and was well received by the WHO and the CDC in Europe and the US. We need to have a comprehensive understanding of the demand, because it is more costly to produce. The product still needs to go through the regulatory process, but we are really looking forward to its release.

 

As a Mexican company, producing in Mexico, but exporting more than 80 percent of your production, what is the importance of Mexico for Inosan? What makes Inosan different from other Mexican companies going abroad?

When we set up the company, the Mexican market was well covered by other Mexican companies. That is why we decided not to start our sales here. Through the years we have seen that our Mexican competitors were not able to supply the demand, so we decided to set up here. Unfortunately, the COFEPRIS approval process has been slow, so we are still waiting for the Mexican registration.

Mexico is an interesting place thanks to its culture. Mexicans are creative and like to develop new things; as do we with our technology. We are facing challenges and to tackle them we are always trying to find innovative solutions. This creative approach sets us apart.

Also, we are a global company with Mexican roots and leadership, but selling all of our products abroad, with affiliates in Spain, France, and the US. In most companies, the headquarters are in Europe or the US and they open an affiliate in Mexico. For us it is the opposite. We have managed to bring our cultural skillset and integrated it with some learnings from Europe. Our multicultural team, with its mix of countries and cultures, and with Mexican leadership is our asset and uniqueness.

It has also been a challenge for us to say that a company from Mexico with Mexican leadership is now one of the world leaders in the antivenoms market.

 

How are you making Inosan the partner of choice for multiple stakeholders in multiple countries? How do you transfer your knowledge and education to them?

We are always looking to connect with the authorities, experts, and local partners in order to explain our products and for them to have a better understanding of how they work and how they should be used. It is important to meet with the health professionals who will be the ones using our products more often. They have helped us to understand which products they need to use and what kind of antivenoms they specifically need, because snakes are different in every region.

Training is also a very important part of our job and we have developed a comprehensive training program. For example, in Togo, where an European foundation invested in more than 8,000 antivenoms, asked us to help with training on their use. We went to a rural area of the country where the health centres are small and usually not well equipped to train health professionals on how to use our products. We are currently working with an American foundation (Asclepius Snakebite Foundation) which did an amazing job in bringing equipment to Guinea and Sierra Leone for patients who received a bad bite in the countryside without access to antivenom.

In Mexico, we received a grant from CONACYT to work together in this field. Mexico is a big market where we have more than 300,000 scorpion stings per year, and only 50 percent of the demand is being manufactured. For snakebites, only 30 percent of the demand is being supplied. In Mexico more than 300,000 patients need to be treated for either snake and spider bites or scorpion stings, which makes it a very promising market for us

Partnerships are key. We first worked with the biotechnology centre of UNAM in Mexico, then with the University of Arizona, with the WHO, and The African Society of Venimology. Our partnerships allow us to go to many places, get feedback, learn, and make sure that our products can help the population there.

 

Looking forward, where do you want to see the company in the next few years?

We are committed to our mission of bringing lifesaving products to the population. Our main task is to continue to raise awareness in the markets where our products are needed. We will keep working in Africa and the Middle East. We are aiming to bring products to Asia, where there is a lack of good antivenoms with a good safety profile. Finally, we are aiming to continue growing in Europe and the US, which will help us to bring more funds to our other operations and truly become the global leader in antivenoms.