Setting the Pace for Specialized InnovationSat, 09/05/2015 - 12:04
Q: Which particular AstraZeneca accomplishments do you think have been pivotal to advancements in the local market?
A: Today, AstraZeneca is a company worth US$26.1 billion. We are expecting strong and consistent revenue growth to meet our targets for 2017, leading to annual revenues of more than $45 billion by 2023, when we hope to be serving close to 200 million patients globally. Since the merger between Astra and Zeneca in 1999, AstraZeneca has been defined as one of the most innovative companies in Mexico, setting the pace for developing and launching new medicines onto the market. We have an innovative portfolio, with several market- leading products, across cardiovascular disease, diabetes, oncology, and respiratory diseases all of which shows how AstraZeneca has been exceptional in matching strategy with execution. In 2001, AstraZeneca was ranked the 18th largest pharmaceutical company in Mexico. Today, we are in fifth place, having climbed 14 positions due to the strategic management of important medicines such as Crestor and Nexium. We are leading with these products even in the face of competition from generics. Today, AstraZeneca is shifting towards the development of highly specialized medicines, with biologics now accounting for almost 50% of our pipeline. Naturally, we are aware of the importance of primary care so we will maintain our diabetes and respiratory portfolio. However, our plans for innovation focus on further specialization within our main therapy areas with targeted medicines, including immunotherapies, with a view to building a more sustainable, durable, and profitable company.
Q: Why was a transition from primary care to highly specialized areas implemented as a strategy in Mexico?
A: Three strategic priorities support the implementation of this transition on a global level: achieving scientific leadership, a return to growth, and becoming a great place to work, specific goals that were set so that AstraZeneca could become a leading company in the specialty care area. Return to growth represents reallocating resources to our main therapy areas and key growth platforms. In Mexico, we employ four growth platforms that focus on acute coronary syndrome, and diabetes, respiratory, and oncology portfolios. Our goal is to become one of the three leading companies in this sector, and to do so, we will be launching six new products over six years. This includes our broad pipeline of next-generation medicines, focused on four main disease areas: breast, ovarian, lung, and hematological cancers. Moreover, the company’s portfolio for respiratory diseases includes drugs for chronic obstructive pulmonary disease (COPD) and asthma, among others, and we are developing several promising assets to treat inflammation and autoimmune diseases. Consecutively, we are investing in human capital to attract new talent, hence science and innovation is at the center of this transition, and our staff and organizational culture must support this.
Q: To what degree do you need to work with the Mexican public sector to reach these goals?
A: We stand out in the way we manage our medical affairs capabilities, which is a specialty many companies lack. We are now closer to key opinion leaders and stakeholders, running continuous education programs, and developing relationships with the public sector. It is clear that Mexico is moving in the direction of providing universal healthcare coverage, so we must build strategic alliances with public entities so that patients can access our innovative products. In the past, AstraZeneca’s stability relied on its primary care portfolio. Today, with increasingly innovative medical advances, complicated healthcare delivery and budgetary issues, we have to develop new alliances and partnerships with public institutions to generate advances in science and care to the Mexican population. This is the only way we can truly impact society and help patients.
Q: How would you rate Mexico’s medical innovation capabilities in comparison with countries such as Colombia and Argentina?
A: Mexico, along with Brazil, is one of the few countries in Latin America that continues to invest in pharmaceutical innovation. Public hospitals were not available for clinical research in the past but this has changed and IMSS can now conduct a considerable proportion of the clinical trials operating in Mexico, which will strengthen innovation. Moreover, some years ago, COFEPRIS saw significant delays in the approval of clinical trials. This used to take more than 24 months, discouraging companies from carrying out clinical trials in Mexico. Today, this process has been accelerated with the aim of Mexico becoming one of the most efficient countries in launching new products. Drugs tested on Mexican patients can now be registered much faster, which means Mexico is closer to becoming a reference country for clinical trials in the region. COFEPRIS has recently been recognized by PAHO as a regulatory reference agency, making the approval process for new drugs easier in both Mexico and Latin America.
Q: Does Mexico represent a significant R&D base for AstraZeneca?
A: Mexico has become an important country for our R&D operations in the area of clinical trials. Currently, Mexican patients are participating in a total of 27 clinical trials. We will soon be conducting several new oncological clinical trials, and the fact that IMSS has reopened the door to these trials represents a big opportunity for advancing research. Furthermore, AstraZeneca funds local innovation carried out by CINVESTAV and UNAM under the investigator-sponsored research scheme. Two key aspects for advancing innovation in Mexico are improving access to innovations and ensuring that we have strong intellectual property law for pharmaceutical and biotechnological developments. If both aspects are addressed, companies will be able to operate efficiently in Mexico and more patients will benefit from the medicines.
Q: Do you foresee a clash between the innovative and the generic sector as they grow?
A: We welcome a robust and competitive generic sector. However, we need to ensure that regulatory and legal frameworks value innovation and the underlying intellectual property necessary to develop new and improved medicines for patients. It provides the incentives required to conduct the research and development that produces new medicines for patients globally. It takes approximately 10-15 years and over US$1 billion to develop a medicine. For every medicine that makes it to patients, there are thousands of other drug candidates that have failed.
Q: With healthcare expenditure in Mexico still at only 6.2% of GDP, do you see real innovation being supported in the medium term in Mexico?
A: Mexico’s expenditure on healthcare is certainly below the Latin American average, but it seems that more opportunities for innovation may occur. Public budget savings from using generics could potentially be directed into innovation. Seguro Popular is willing to provide access to innovative medicines too. Greater collaboration between the private and public sector is necessary to include more innovative products in the National Formulary. On the other hand, the private sector has to develop new collaboration proposals for the government. It is impossible to compete with generics on price, but we know that our medical and scientific expertise and global experiences, including integral services and disease management programs are second to none. In addition to this, companies should develop more programs addressing affordability issues. In Mexico, we have incorporated innovations in different public institutions across the country by demonstrating the cost-effectiveness of doing so.
Q: What should be done to improve oncology care in Mexico?
A: I do not think Mexico lacks oncology care, as there are several oncology clinics throughout the country. However, there seems to be a lack of coordination of efforts in this area. Few resources are allocated in specialized clinics and more awareness is needed regarding the importance of treating such diseases in specialized units. Oncology institutions can integrate their services in order to work alongside other organizations, such as local and global diagnostic laboratories, companies that transport biological samples, and clinical research centers. Moreover, infrastructure requires further improvement. To achieve this, the government needs to improve communications among different institutions as there exists a breadth of knowledge base in IMSS and in the National Institutes of Health.
Q: What motivated AstraZeneca’s sale of its Over the Counter (OTC) portfolio to Genomma Lab?
A: AstraZeneca defines its core business as a being biopharmaceutical innovations. We focus on the discovery, development, and commercialization of prescription medicines, which is why the Mexican OTC portfolio was sold. We do not foresee future efforts to penetrate the OTC market, as it is not part of our corporate strategy. Innovation is our main focus, so this was a mutually beneficial arrangement. Other pharmaceutical companies have more diverse portfolios, while AstraZeneca is working on creating innovation organically. We have 13 New Molecular Entities in the pipeline, either at the pivotal phase 2-3 stages or under regulatory review. We are focusing on the highly specialized and personalized medicines of the future, which is pure science.
Q: How does access to information influence the development of the Mexican Health sector?
A: Mexico has sufficient data and information about health, although it is not updated as frequently as that of Europe and the US. Mexico is pretty similar to other parts of the world: half of the patients do not know they have a given disease, and only half of those who are aware of their disease receive treatment.