Interview of the Week: Francisco Kuri Breña, New Developments Director at Landsteiner Scientific
Q: What is the strategy behind the double digit growth exhibited by 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. Currently, 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 past October 1st, giving us the chance to produce and process much more drugs. We are going to move all of our production lines to this new site while our current facility will undergo some renovations in order to exclusively use it to manufacture high specialty products, which require separate facilities. High-specialty drugs and biotechnology are a priority area for Landsteiner, and we want to cover ophthalmology, oncology, and hormonal products.
Q: Landsteiner is well known for collaborating with academia in different cutting-edge fields such as genomic medicine and oncology, what are your latest developments in these areas?
A: We actually 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, which is a big issue in Mexico, 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. On the other hand, Alzheimer’s is still underdiagnosed in Mexico, and it is highly difficult to treat, and our researchers have identified candidate molecules for drug development. Firstly, hits are identified, which are molecules that have a therapeutic potential, afterward they become leads that are further analyzed through extensive preclinical and clinical studies. We expect to have the authorization for preclinical studies of two potential obesity drugs this year, and next year we will conduct clinical studies in Mexico. Spain has good infrastructure and expertise in genomics, with a huge database for Caucasian population, but we want to know if their findings also apply to Mexico through our genomics division.
Q: Setting up the regulatory framework for biopharmaceuticals in Mexico was key to supporting this industry, what do you think is the next step to capitalize on this huge business opportunity?
A: We were involved in the development of the new regulations for these products in Mexico, and the government implemented a triple helix model in which government, academia, and the industry collaborated to develop a world class normativity. Having clear regulations and guidelines was 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 therefore segregates between large and small companies according to their ability to comply with new requirements, and this will result in a decreasing number of companies commercializing biocomparables. At this point there are probably five companies that are capable of maintaining their manufacturing and commercial operations in total compliance with the biotechnology normativity. While generics need bioequivalence studies, the development of biosimilars is much more sophisticated. The new norm states that clinical studies performed in Mexico are a requirement for biosimilars to be approved in the country. In addition, there are some third party authorized laboratories providing biosimilar characterization services, and we are working with the UNAM Biotechnology Institute to do our physicochemical studies. Clinical studies are necessary in Mexico because there are some genetic variants among the population that could lead to products having lower efficiency than in other places of the world.
The company has six biosimilars in the market, covering conditions such as neutropenia, anemia, multiple sclerosis, and diabetes- We have more of them in our pipeline despite the development of a biosimilar being a long process, including characterization, clinical trials, biocomparability studies, plus the regular pharmaceutical development of every drug. It takes two years to develop a biosimilar from the API, and phase III clinical trials can be really complicated to conduct depending on the disease, yet some others are easier such as anemia, in which the population is easy to identify, data can be easily collected, and trials are short. Other diseases require longer clinical trials to evaluate efficacy, and the trial can go on for one or two years.
Q:What will the biosimilars’ industry look like in the next couple of years, and how are you planning to compete against new and current players expanding their activities in this market?
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, registering new products in the country is much more accessible. Nevertheless, public institutions are the main buyers of high specialty drugs, and in order to be allowed to participate in a tender, companies have to demonstrate that 70% of the added value activities of a product were done in Mexico. Therefore, producers that are 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. On the other hand, imported products can definitely be sold in the private market, but due to high prices and a low penetration level of private insurance services, the private market for high specialty drugs is almost non-existent.
We are determined to maintain a leadership position.
Q: What do you want to achieve in 2016?
A: We will continue with a strong and aggressive development plan, supported by our ambitious pipeline. Landsteiner has had a very 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 be specialized 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 sstrengthening our presence in the private market. Seguro Popular was created to provide universal coverage, but catastrophic diseases are not fully covered yet. We want to go in line with them and guarantee people’s access to our drugs. Moreover, we do not want to stay behind, and we are committed to investing in R&D.
This is an excerpt of an interview to be published in Mexico Health Review 2016 – to nominate your company for an interview please contact Marta Aguilar email@example.com
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