Mauricio Mendieta
General Manager
Laboratorios Alfasigma
View from the Top

Certainty Needed to Spur Investment for Drug Development

Wed, 03/13/2019 - 10:22

Q: How has the company progressed in its goals to boost its presence in women’s healthcare and consolidate a business unit focused on biosimilars?
A: Three years ago, there were three players in the women’s health segment and now there are 12. That is aggressive growth. It is very important to define what we want to be as a company. We want to be a pharmaceutical that provides specialized treatments in the area of gynecology. Gedeon Richter works with 6,000 gynecologists across the country. Our competitors’ coverage ranges from 6,500 to 120,000 doctors. Our differentiator is that 90 percent of our doctors are gynecologists and not a mixture of different specializations.
Our goal is clear. We will continue expanding our portfolio, introducing added-value products and working with specialized doctors. In the private sector, the goal is to consolidate a presence in all therapeutic areas of women’s health. In the public sector, we are focused on contraception and introducing the uterine fibroid treatment Esmya. Overall, we have 10 products pertaining to women’s health and will launch two more this year.
Q: What is the difference between public and private sector clients?
A: These involve very distinct mechanisms. The private market follows supply and demand. With respect to the government, there are two scenarios. One is to operate in a therapeutic area that is already established. The other is to launch something that is entirely new in the market. In this second scenario, we need to convince the government that the treatment will be beneficial. This can take time: we have been working with the government for over a year to get Esmya introduced. Today in Mexico, women with a uterine fibroid condition receive treatment with medication while waiting for surgery. The waiting time for an operation is often five months. We had to make clear to the government that we are not offering a medication but a treatment of a whole other class. We can offer a product that is not only better but reduces the need for surgery by 40 percent. We are reorienting the entire model of treating symptomatic uterine fibroids in Mexico.
Q: What opportunities exist to make Mexico a clinical research hub and what business opportunities would result if that becomes a reality?
A: Thirteen percent of our global sales returns every year is invested in R&D. In Europe, we have three biotechnology plants. In Mexico, R&D is not our immediate priority due to bureaucratic hurdles. At CONACYT, researchers are driven by the number of publications they produce. There are other institutes that are dedicating efforts to development but approval processes are slow. Ten years ago, 50 percent of the investment in research was tax deductible. That is no longer the case. We certainly see potential in Mexico as a research and innovation location for us but industrywide, there needs to be more support.
Q: How is the political climate impacting the sector?
A: The reality is that there is a great deal of uncertainty related to investing in Mexico. There is uncertainty about López Obrador. I think the administration has good intentions but it does not have the necessary background or expertise. Economic growth in 2019 was projected last year to be 2.5 percent, now that has been lowered to 1.3 percent, or even lower. In the pharmaceutical industry, growth below 3 percent can be debilitating. The growth basically comes with the rise of prices and units, not due to investments. if you look at Latin America, 80 percent of the market for women’s health is in Mexico. If you look at performance, Mexico could easily be the 10th or 12th-largest market worldwide. But you need certainty, and this is missing. Overall, the dynamic is changing. Before, IMSS and the Ministry of Health worked together. Now, it is IMSS as a single bloc. There is no certainty as to whether the government will approve new products soon, because COFEPRIS is delaying approvals for new entrants at the moment.