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Maypharm Life Sciences: Licensing niche generics & value added healthcare products for Latin American markets

Maypharm Life Sciences: Licensing niche generics & value added healthcare products for Latin American markets

Sameer Kolhe , President, Maypharm Life Sciences


Question: Recently in the Indian Pharma circle, Maypharm's name is associated with the Brazilian market. What is the background?

Answer: Gladly, it seems that we are on the right track. Building a perception around this takes time, especially in a fiercely competitive industry like pharmaceuticals. Before I talk about it, I would like to thank you for having this conversation with me. It is indeed a pleasure to share my thoughts with such an esteemed publication.

Starting up in 2017, we chose a tough market like Brazil as our first target, based on our core Philosophy on the ‘field of play’ having ‘nicheness’ weather it is Market, Molecule or Model. The Indian Pharmaceutical companies for almost a decade decade or more have preferred to stay away from Brazil as a market, especially on the finished dosage forms side, due to the complex nature of the country’s regulatory and legislative structure. More importantly, there was never a quick business available in Brazil until and unless companies had a focussed approach starting with a specific portfolio for this market. We believed that we had a deeper understanding on the regulations and appropriate resources to tap on the opportunities presented by the market and capability to enter in Brazil with a focussed approach. We offered this capability as a service provider to start with, helping companies to enter Brazil in the right way, especially to those companies which had the vision to build long term presence in this market. Some big names trusted us and within the first 2 years we had more than 7 manufacturing sites associated with us, giving us that momentum needed to invest on our own portfolio. A journey had started and one of the outcomes that we expected was exactly as your question, building a credible association between ‘Maypharm’ for ‘Brazil’.

Backed up by some long-term service agreements, proof of concept now proven with successful filings / GMP approvals to our manufacturing partners via us, we approached for and received a round of funding in 2019. The investment is intended for building our own portfolio, primarily for the Brazilian territory & some other carefully selected markets to which we can extrapolate the assets we are developing for Brazil.

Since then, in last 3 years we have built a robust pipeline of almost 35 products, now at various stages from, being registered to just signed for development. Although the major focus is on prescription products, we also have a portfolio of some interesting over-the-counter products filed which provides us quicker access to the market and a scope to build a brand around Maypharm in Brazil. With a subsidiary company established in Brazil, fully operation since January 2021, we are well equipped to leapfrog into the next phase in Brazil.

Question: What are the biggest hits and misses as far as Brazil is concerned till now for Maypharm?

Answer: Undoubtedly, Brazil is a highly challenging market, and we have some hits and misses to our likings or not. The pandemic since 2020 meant that we started with our portfolio development during the COVID times and had to swim against the stream, till date.

So, some hits will be - having managed to receive Marketing Authorizations for 2 complex medicinal products, in the Injectable dose form, in a year’s time, is surely unheard of in Brazil. ANVISA GMP approvals to more than 10 manufacturing facilities in India via us. Establishing a fully operational subsidiary company in Brazil with importation status for functional food and OTC products is another hit that we will be proud of. During COVID 19, we could support the country by importing some lifesaving hospital medicines, via special import permits granted by ANVISA. These achievements have kept us motivated to set and chase more aggressive goals for ourselves.

Misses – we could have done much more in the pandemic related emergency importation opportunity, which could have given us higher revenues, when the opportunity existed. At the same time, some of the complex projects we are working on have not seen approvals yet. Growing the team has been a challenge, driven by the pandemic, and resources at the right time could have avoided some missed last year. These are teething issues of any start-ups and we will manage to overcome these soon.

Question: Can you provide some insights into the typical cost involved in registration of a product in Brazil and how Maypharm is funding so many product registrations?

Answer: It is a good question. It needs to be answered in terms of tangible and intangible costs involved. Brazil happens to be one of the most expensive countries when you consider pharmaceutical product registration process. Of course, the regulatory requirements vary based on the nature of the product, dosage forms, status of the product’s development, regulatory status of the API, product being official in any pharmacopoeia or not, etc. We can conder a scenario of a product already being completely ‘ready to file’ for markets like the US or Europe and understand the costs and timelines needed to file and register these into Brazil. Despite a product being completely ‘ready to file’ for the US / EU markets, we are still looking at minimum 1 year to filing the product with ANVISA and another 1 year or more to get it registered. Additional investment into such a product is around US$ 150,000 to US$ 180,000, assuming it’s a dosage form which needs human Bio-equivalence studies to be submitted. For hospital products (Injectable dose forms) the investments are lower as it doesn’t need any Bioequivalence studies to be performed.

But, for Brazil everything percolates down the analytical requirements, which can take months of efforts in the QC to generating the data needed to file the product.

As a company, for our initial portfolio, we have stayed away from products which require bioequivalence studies to be performed, reducing the overall capital investment needed upfront significantly. Also, we are working with partners in the market, who have part sponsored some of expensive projects, giving us flexibility to expand our reach and portfolio. As an organisation, we are well funded to increase our portfolio to 40 to 50 products in next 3 to 4 years. I believe we are on track for the target we have set for ourselves.

Question: So, can you elaborate more on the service model which you offer for Brazil to foreign companies? Also, how do you manage to avoid any conflict of interest with your own projects?

Answer: Sure. Entering Brazil with products, needs super-efficient soft and hard infrastructure both. The hard infrastructure includes an entity in Brazil, QC Lab to hold the Marketing Authorization, etc. and the soft infrastructure would mean the regulatory knowhow, project management, network in Brazil to distribute the products, etc. Over a period of almost 5 years, we have built a robust platform to introduce any type of product in Brazil, end to end. We have a strong team of professionals working on critical aspects like project management, regulatory affairs, and technical support, located both in India and in Brazil. We have cultivated trusted network of service providers promptly supporting us in sourcing of samples, standards, PE studies in Brazil, BE studies, material movement and other key activities. Through our connections with the local Marketing companies & distributors we make sure that we achieve optimum market penetration for the commercial supplies. With a local entity in Brazil for better co-ordination we are well placed to cater to the early stage needs of pharmaceutical companies trying to enter in Brazil.

While providing services, we ensure that we don’t provide services for the products on which we are working on our own. This avoids any kind of conflict of interest. We are keen to facilitate entry of niche, technology driven products in Brazil through our service model.

Question: Do you intend to operate in any other markets apart from Brazil? Please elaborate on current status and plans.

Answer: Naturally, we are looking at multiple opportunities to grow and monetize the assets outside Brazil. We are focused on emerging markets with high population in need of better healthcare products. The idea is to introduce niche and technology driven products to consumers from these countries at affordable prices. With this vision, we are expanding in Mexico, Central America, Peru & Columbia. We have multiple products under registration in these markets. We expect the commercial activity to start in FY 22-23 in all these markets. Meanwhile, we have also launched products in the Indian market, but stuck to health and wellness as a strategy, yet they will be based on niche drug delivery platforms. We expect to have a robust portfolio of almost 30 products in India by the next year.

It is an interesting mix of products and territories you are working on. What is the Philosophy driving this strategy? How do you plan to execute it?

The Philosophy was always to be meticulous and enter high entry barrier ‘Markets’, with an interesting ‘Molecule’ (portfolio) and innovative business ‘Model’. This philosophy needs a start-up mindset and culture to thrive, and we aspire to remain a start-up cultured company even when we grow, rather than becomes a rigidly process-oriented company. Sounds contrary to the ‘Pharma’ norms as, everything is about process, but I am only referring to a cultural mindset within the organization to being a start-up like, which will keep us young and agile.

Hopefully we meet and discuss similar topics again in 2 years where I emphasize more on execution retrospectively. That will be a big achievement for us.

Articles about interviews | February - 13 - 2022



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