Investment Opportunities in Biotech

Q: Amgen has one of the most remarkable portfolios in the pharmaceutical industry. What new products do you have in the pipeline?

A: We have been present in Mexico since 2006 with our R&D operations and we started commercializing our products in 2009. We have launched 10 products to the market and eight are already included in the National Basic Formulary. The main focus of our company is innovation and we keep investing in R&D. Last year we devoted 19 percent of global revenue to this area, accounting for US$3.9 billion worldwide, and focusing mainly on oncology, hematology, bone health and nephrology. At this point we have 20 new molecules in the pipeline, some of which are already in phase III trials.

Q: What role are emerging markets such as Mexico playing in the company’s growth?

A: Amgen is present in more than 100 countries and we expect Mexico to continue growing as it is the second largest market in Latin America after Brazil. We are focused on innovation and increasing access.

Q: How much local and multinational competition do you see in the Mexican biopharmaceutical market?

A: Biotechnology is continuously growing in the pharmaceutical industry at a faster pace than chemical entities. Data from FUNSALUD show that the ratio of biotechnology products to chemical entities is 3:1, hence we expect this segment to continue growing. According to COFEPRIS, 35 percent of the drugs that are approved in Mexico are biologics and we assume this to be a sustainable trend. Moreover, biologics account for around 30 percent of the products undergoing clinical development.

Q: What market needs are you aiming to satisfy in the Mexican market with your upcoming products?

A: We will launch an important cardiovascular disease drug – the first biologic to be approved worldwide for the treatment of hypercholesterolemia. This is a monoclonal antibody that aims to cover a significant portion of the Mexican population. As we know, obesity and hypercholesterolemia are prevalent diseases in the country and this medicine will target LDL cholesterol levels in patients who are uncontrolled. We are certain that our new medicine will set up a revolutionary trend in the treatment of high cholesterol.

Q: What barriers do you think your product Evolocumab will have to overcome to gain access to the public sector?

A: Mexico is a very important market but still has much room to improve access to innovation in the public sector. Equivalence agreements between COFEPRIS, the FDA and EMA have made drug approvals more expedite. But the public sector can further improve patients’ access to high-specialty drugs since a new drug can still take up to four years to be included on institutional basic formularies. All players in the healthcare sector have to workincollaborationtoimprovethissituation.Weare committed to continue working with local authorities to improve the timelines for both approval and access to innovative drugs.

Q: To what extent are Mexican product registrations already recognized in other countries?

A: COFEPRIS has signed equivalence agreements not only with the FDA and EMA but also with other Latin American countries. This does not mean all products registered in Mexico can immediately enter other markets in the region but the process is actually faster. Regulatory recognition among countries is evolving and will certainly play a much more relevant role in upcoming years.

Q: What sort of patients should be prescribed with Evolocumab?

A: High cholesterol has been traditionally treated with statins. There is still a need in the market because there are many high-risk patients with uncontrolled levels of cholesterol despite being on a statin regime. Genetic diseases such as familial hypercholesterolemia are also a good target for this new treatment, as well as patients with statin intolerance. This medicine represents a unique opportunity for both patients and healthcare professionals.

Q: Innovative biotech drugs are perceived as expensive treatments in the public sector, which is always pushing for lower costs, how are you going to valuate this new drug in the market?

A: Innovation requires significant investment. The development of a new medicine can take more than 10 years of work and between US$1 billion to US$2 billion, so these efforts must be compensated to continue existing. Healthcare institutions also have to realize that in most cases, innovation represents savings in the long term as new treatments solve medical problems faster and more effectively. Ensuring ROI is crucial in the biotech industry given that patent expirations are likely to be followed by the launch of biosimilars. When this happens, the system can increase savings because costs go down, whereas innovative companies have to ensure a continuous return. Amgen is committed to developing and launching biosimilars since they can cover a wider population, helping the healthcare system. These medicines require a significant effort to be developed because their comparability and effect has to be demonstrated through clinical studies, not only through physicochemical characterization methods. We expect to launch our first biosimilar in a couple of years in Mexico.

Q: What are your biggest priorities for 2016?

A: We will continue promoting our products and expanding access in the public market in Mexico. Also, we will keep focusing on our R&D operations. Amgen has invested more than MX$300 million and we have 18 ongoing clinical trials in important centers such as INCMNSZ and La Raza. Our new treatment for high cholesterol is also going to be on top of our agenda thanks to the opportunity it offers to control cholesterol levels. Mexico’s potential to grow in clinical research is very promising compared to other countries. We have to make sure this medicine gets to Mexico and physicians use it as soon as possible. Mexico is a very important market for the global pharmaceutical industry because of its huge population, and we see a significant opportunity to increase our investment in clinical trials. Mexico’s potentialtogrowinclinicalresearchisverypromising compared to other countries. The industry is investing US$160 million in clinical research in the country today, and there is potential to increase that investment up to US$5 billion in 10 years.