Specialty Drugs: A Priority for Local Giant

Q: What is the strategy behind the double digit growth for Landsteiner Scientific?

A: In 2014 we started exporting to some countries in Central America, such as Guatemala and El Salvador, which are very close to Mexico and eager to have our medications. Before that, Landsteiner was only focused on the local market. COFEPRIS has signed several recognition agreements in the region, and we are capitalizing on that to consolidate our export business. We are working with nine countries in Central and South America, as well as the Caribbean. Also, we are finishing a new manufacturing site in Toluca, State of Mexico, where some of our operations started in October 2015, giving us the chance to produce and process many more drugs. We are going to transfer all of our production lines to this new site while our current facility will undergo some renovations to exclusively use it to manufacture high-specialty products requiring separate facilities. High-specialty drugs and biotechnology are a priority area for Landsteiner and we want to cover ophthalmology, oncology and hormonal products.

Q: What are your latest developments in areas such as genomic medicine and oncology?

A: We have different projects with a subsidiary of Landsteiner in Spain that is fully dedicated to genomic medicine research. It has three research lines including obesity, colon cancer and Alzheimer’s disease. Colon cancer is one of the most common types of cancer in the US, while in Mexico prostate cancer is highly prevalent among men. Alzheimer’s is still underdiagnosed in Mexico and being highly difficult to treat, our researchers have identified candidate molecules for drug development. We expect to have the authorization for preclinical studies of two potential obesity drugs this year. Next year we will conduct clinical studies in Mexico. Spain has good infrastructure and expertise in genomics. There is a huge database for the Caucasian population in this Spanish center and we want to know if their findings also apply to Mexico through our genomics division.

Q: How can companies capitalize on the opportunity the new regulation for biosimilars is bringing?

A: We were involved in the development of the new regulations for these products in Mexico as the government got fully involved in discussions with academia and the industry to develop a world-class normativity. Clear regulations and guidelines were essential to ensuring quality, safety and efficacy of all biotechnology products, whether innovative or biosimilar. This was not properly established before and regulators argue that patient safety was in jeopardy. The new regulation will therefore segregate between large and small companies according to their ability to comply with new requirements, arguably resulting in a decreasing number of companies commercializing biocomparables.

Q: How do you foresee the competitive landscape of the biopharmaceutical business?

A: International players have long been interested in entering the Mexican market and now that having a manufacturing plant in the country is no longer a requirement to commercialize pharmaceutical products, obtaining product registration in the country is much more accessible. Nevertheless, public institutions are the main buyers of high-specialty drugs and to be allowed to participate in a tender companies have to demonstrate that 70 percent of the added value activities of a product were done in Mexico. Producers not located in Mexico have to find a way to demonstrate this national integration through partnerships with local players for either manufacturing, clinical development, marketing, distribution or commercialization.

Q: What do you want to achieve in 2016?

A: Landsteiner has had a broad line of products so it can provide physicians with alternatives for whatever need. This has helped us to get a position within the healthcare system but now we want to specialize in certain areas. We want to organize our pipeline per therapeutic lines including obesity, cancer, ophthalmology, anemia and so on. We are aiming to grow in biotechnology and in other products, such as new combinations and we want to strengthen our presence in the private market.