José Alberto Peña
Vice President
GlaxoSmithKline (GSK)
/
View from the Top

Adding Value in a Dynamic and Diversified Market

Sat, 09/05/2015 - 12:07

Q: What role does Mexico play in the global strategy of GSK and how important is the local market?

A: Mexico is usually considered an emerging country, but the Mexican pharmaceutical market is in many respects mature and at the same level of development as some European countries. Mexico is among GSK’s top 20 global markets, and is a country where a lot of innovative programs have been undertaken. Although challenging, Mexico is attractive to GSK beyond business and sales terms, due to its dynamics and diversification. R&D has seen exciting growth locally in recent years. Vaccines are at the core of our R&D activities, and Mexico was the top recruitment country for the first global rotavirus vaccine. In addition, we had a successful experience last year in conducting clinical trials for asthma and COPD. Approximately 10% of all patients that participated in these multi-national trials were recruited in Mexico, and as we presented local data for the drug registration process to COFEPRIS, our product was approved within 90 days, representing a significant improvement on the previous three-year timeframe. Nevertheless, there are still some challenges to overcome regarding the approval process for biologics and vaccines in order to ensure better access.

Q: How do you address potential approval delays?

A: Access to innovative medicines is one of the most significant challenges that we currently face in Mexico. The Mexican government faces many constraints in terms of budget and regulatory procedures. What needs to be highlighted is that more effective treatments can enable patients to become economically active again in a shorter time and can therefore have a direct impact on productivity. For this reason, it is important to explore the new paradigm in which innovative products are evaluated on a case-by-case basis.

Q: GSK recently launched an innovative drug for the treatment for Lupus – what is unique about this treatment, and is it available privately and publicly in Mexico?

A: In September 2014 we launched Benlysta, which is the first real innovation for Lupus that has been developed in the last 50 years. The National Formulary has already approved the drug making it available privately and it is currently in the process of being approved by the IMSS Formulary, which will allow widespread access. With increased diagnoses of Lupus in recent years, it represents an excellent opportunity for GSK and for patients who can now receive a treatment that not only focuses on the symptoms but also on controlling the disease.

Q: Some pharmaceutical companies have divested generics and OTC portfolios in order to fully focus on innovation – where is GSK focusing its efforts?

A: We recently closed a three-way deal with Novartis, in which we divested our oncology business. In turn we purchased the vaccine business from Novartis, and a joint venture was created where GSK is the major shareholder of the OTC consumer business. The four long-term corporate level priority areas for GSK are respiratory, HIV, vaccines, and the consumer business. Additionally, GSK has been a pioneer in HIV treatments since the 1980s and we have products without a patent or with expired patents, as well as a new series of innovative products that we will be bringing to Mexico in the near future. Our strategy for Mexico comprises six priorities: respiratory, HIV, vaccines, urology, dermatology, and products that do not have a patent. The consistent revenues from these areas are then further invested in innovation and growth. Dermatology is an interesting segment of the pharmaceutical industry that is growing faster than the industry itself. We began to prioritize dermatology with the acquisition of Stiefel in 2010 and the subsequent purchase of the local leader in 2011. We have previously managed all of our therapeutic areas in a very similar way, and now we customize our strategy based on both our internal needs and the external environment in Mexico.

Q: Vaccines have been the subject of much controversy recently, how is GSK dealing with confused consumers?

A: Unfortunately, there is a global movement in some countries against vaccination, which should be addressed. Vaccines have been responsible for some of the most important developments in healthcare, namely the eradication of polio, smallpox and significant progress in the fight against many other diseases including cervical cancer. The statistics regarding practically eradicated diseases such as measles, that have recently seen significant outbreaks in the US and the UK are compelling. Independent clinical trials and post marketing surveillance have been conducted for vaccines, the results of which show that there is no correlation between vaccines and some of the key issues in question.

Q: How have the different changes in the distribution segment, such as the bankruptcy of Casa Saba and the closing of local pharmacies, affected GSK?

A: There have definitely been significant changes in the distribution segment in the last couple of years. With more than 30% of the market share, Casa Saba had powerful distribution capacities, particularly to independent pharmacies, managing to reach 18,000 out of the total 25,000 to 30,000 pharmacies that operate in the Mexican market. The independent pharmacies are the ones that have suffered the most during this transformation and we have plans this year to diversify our distribution channels, so we are looking for previously unexplored options such as working with regional distributors.

Q: What collaborations do you have with bodies such as CONACYT and academia for advancing research?

A: We recently signed an agreement with CONACYT to sponsor placements for Mexican postgraduates in different GSK centers around the world according to their specialized field. As a unique project in pharmaceuticals, CONACYT and GSK are very proud of the venture, and it has helped to generate further dialogues about a separate initiative that consists of funding research projects in Mexican institutions and research groups. Significantly, GSK will not claim rights on the results from such projects, because our larger aim is the development of scientific research in Mexico. The country has a phenomenal base of researchers and there is a lot of clinical research happening that we want to support. We know from previous experience that these projects really transform the way the government and the pharmaceutical industry collaborate.

Q: What needs to be done to further improve the clinical trials industry?

A: The clinical trials industry has strong potential in Mexico. I visualize that the investment in R&D can be tripled or quadrupled in the next three to five years. Infrastructure, human resources, and the necessary experience exist in the country. We have conducted clinical trials for many products in Mexico including a trial for Benlysta. We must ensure that all of the different actors work together in order to remove the potential barriers so that Mexico can be visibly more attractive and competitive.

Q: What are your top priorities for 2015?

A: We recently re-shaped the way we run the business and our strategies in Mexico. We want to ensure excellent execution at all levels, creating value equally for our shareholders, our people, healthcare professionals, and patients. We are working closely with decision makers in order to hold the right discussions to improve access to innovation and to understand the difficulties we know the government is currently facing. We expect the vaccine business to keep growing, and we applaud the efforts of the government in implementing the official vaccination program, which is arguably one of the best in the world. As global leaders in this field we want to provide further support now that there are several difficulties in the global supply of vaccines. Despite the many challenges that the private market is currently facing, we want to provoke changes in the market in order to maximize our opportunities in this dynamic sector. Finally, we have a global agreement with Save the Children. It is rewarding to belong of a company that takes its social responsibility, previously by working with different stakeholders that are not related directly with our business.