Apotex - Company Report

COMPANY REPORT

Company Report Table of Contents

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View From the Top Américo García | Director General of Mexico and Latin America | Apotex

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Analysis Apotex: Patient-Centric Portfolio for Latin American Patients

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View From the Top Miguel Angelo Ricchiuti | Operations and Supply Chain Director Mexico and LATAM | Apotex Mauricio Rodríguez Leal | Commercial Director | Apotex

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Conference Highlights Telemedicine, Mental Health; How the Pandemic Changed Health

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Analysis Apotex Celebrates 25th Anniversary in Latin America

VIEW TOP Apotex | Company Report | 4

from the

Q: How is Apotex innovating to attend the growing prevalence of chronic diseases in Mexico?

A: At Apotex, we have a portfolio with a wide variety of products for several chronic diseases, including diabetes, arterial hypertension, cholesterol and triglycerides and metabolic syndrome. We are committed to raising patients’ quality of life by offering affordable products that meet the highest quality standards. This is precisely why we are constantly striving for innovation, not only in our product portfolio but also in our communication channels. Entering the digital world to reach more patients means providing better solutions for their health problems, as well as creating a support network that ensures proper treatment completion.

Q: What is the status for production of biosimilars in Mexico? What challenges has the company faced to introduce this division to the country?

A: Undoubtedly, biosimilars are a business opportunity and one of our major priorities. Apotex has created Apobiologix, a specific division to enhance our worldwide presence in this market. As a result, we have launched two biosimilars in Canada: Filgrastrim and Pegfilgrastim, indicated for patients with cancer receiving myelosuppressive chemotherapy. Similarly, we are looking forward to launching important biosimilar products in

Américo García

Latin America.

The regulations to register and receive approval for these kinds of products need to be clearer to accelerate the pace at which

Director General of Mexico and Latin America | Apotex

biosimilars become available in Latin American markets.

Q: What areas of opportunity has Apotex identified with the centralized purchasing scheme?

Apotex’s Protocols Protect Workers From COVID-19

A: We should not lose sight of the main goal, which is universal health coverage through lower costs for medications. However, drug prices are just a small portion of the total budget from the healthcare system. The redesign to an efficient system should cover all aspects and not just the price of medications.

We understand that the purchasing models employed by previous administrations required improvement. Yet, instead of improving the previous scheme and looking for ways to avoid corruption and increase healthcare coverage, the new administration implemented a system that has proven to be less efficient and not necessarily better for patients. There has been a focus on prices, which has left quality aside. If this continues, we could face the collapse of our healthcare system or at the very least a loss of effectiveness. The government should consider price but also quality and effectiveness according to the best possible standards.

Additionally, to reach universal healthcare coverage, the public and private sectors must work together. I do not foresee a future where the public and the private sectors are not aligned and leveraging each other’s strengths. Innovation and quality are key to the public interest. Besides providing patients with affordable treatments, collaboration would create thousands of jobs for qualified Mexicans and push the country forward in technology development to offer quality medicines in Mexico and in other developed countries.

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Apotex: Patient-Centric Portfolio for Latin American Patients Apotex presence in Mexico goes back to 1996, when the pharmaceutical industry was not focused on generics because the country was a brand-focused market. To date, the company’s footprint in the country can be reflected in their pharmaceutical sales and manufacturing as Apotex has a finished product plant, R&D laboratories and pharmaceutical-chemical plants for APIs, making Apotex the only company with API production and complete product manufacturing in both Canada and Mexico.

Apotex allocates 12 percent of its sales in Mexico to R&D and technological innovation as part of its commitment in keeping up-to-date and being on par with the market. Their presence in this market places Apotex among the Top 10 companies in units in Mexico’s generic market, allowing the company to have a double digit grown in the brand market. This market success comes hand in hand with delivering quality, safety and effectiveness in their medicines, which today, responds to 36 therapeutical areas, among these gastroenterology, cardiology, erectile dysfunction and nervous system solutions. More specifically and mainly supporting the needs of the market and of patients, Apotex’s Erectile Dysfunction portfolio has two options for the treatment of this disease: Sildenafil and Tadalafil.

ED is a common global care problem that presents particularly in men over 40. In Mexico, this disease affects approximately 55 percent of men between the ages of 40 and 70, who suffer from diabetes mellitus. It is not only a sexual health problem, it can also be caused by surgery, an injury to the penis, the spine, the prostate, the bladder or the pelvis. There are also several health factors that can led to ED, such as cardiovascular or metabolic disease, diabetes or chronic alcoholism. Likewise, ED can lead develop emotional disorders such as depression.

In 1998, FDA approved the first “on-demand” oral medication for the treatment of ED, called sildenafil. Sildenafil is an oral therapy for erectile dysfunction of a broad range of causes. By selectively inhibiting phosphodiesterase type 5, it allows corpus cavernosum smooth muscle to relax, potentiating erections during sexual stimulation. Sildenafil has demonstrated significant efficacy in ED associated with primarily psychogenic, primarily organic, and mixed etiologies in worldwide clinical trials. It is not effective in the absence of sexual stimulation.

Tadalafil, alongside sildenafil, are the two most common phosphodiesterase 5 inhibitors used to treat ED. A study by the Nanchang University, conducted an analysis to directly compare tadalafil with sildenafil for the treatment of ED. A total of 16 trials that compared tadalafil with sildenafil for the treatment of ED found that tadalafil and sildenafil appeared to have similar efficacies and overall adverse event rates. However, compared with sildenafil, tadalafil significantly improved psychological outcomes. Further- more, the patients and their Read the complete article More about this topic

partners preferred tadalafil over sildenafil, and no significant difference was found in the adherence and persistence rates between tadalafil and sildenafil.

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from the

Q: What are the main benefits for Apotex as an API manufacturer?

MAR: APIs have been key to our development and growth. We have API plants in Mexico and in Canada that supply primarily to our manufacturing sites, which allows us to react faster to market changes. Our vertical integration gives us two main advantages: being the first to develop the APIs and cost benefits from the start. Without vertical integration and close communication, it would be more difficult to ensure availability of affordable products for our patients.

We have seen an increase in demand of over-the-counter

Miguel Angelo Ricchiuti

(OTC) and public sector products. By integrating API manufacturing and refurbishment, we gained an edge to become government suppliers for affordable products as some

Operations and Supply Chain Director Mexico and LATAM | Apotex

current tenders imply a challenge in the fast availability and additional volumes.

Q: Apotex is also betting on biosimilars. How will your supply chain transform to manufacture these products?

MAR: Our Apobiologix division creates biosimilars and we now have three in the market: Grastofil (figlastrim), Lapelga (pegfilgastrim) and Bambevi (bevacizumab). We are a little bit behind in Mexico and Latin America in the development and approval of biosimilars as we are more aligned to the FDA. There is also a wide gap between the US and EU’s biosimilar approval process. While we do not expect to produce biosimilars in our Mexican plant, we will integrate the local supply chain with biosimilars developed and produced in Canada.

Q: How has Apotex used technology to transform its

Mauricio Rodríguez Leal

supply chain and how has this benefited the company?

MAR: Apotex is launching a digital transformation and a “smart factory.” Our SAP system is integrated into the whole chain:

Commercial Director | Apotex

commercial, finance, production, operation and warehousing systems. On the production side, we are investing in new areas to improve employee communication and to make production more automated, all of which we will launch next year. We will

Apotex Mexico Continues Focus on Meeting Demand

be able to control all parameters of manufacturing directly at the machines. Through these investments, we will be at the forefront of technology.

Q: How does digitalization ensure Apotex can bring its products to Mexican patients?

MR: We have to pay attention to trends and the market’s situation. Being close to the market and to clients allows us to capitalize on long-term increases in demand. Our commercial areas are close to the supply chain and operations, which allows us to anticipate trends.

The pandemic paused the in-person visit model so we developed technological tools to establish faster communication, answer questions and provide information.

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In Mexico, we developed an app called Aponet for health professionals. In the past couple of months, about 40 percent of doctors have restarted in-person visits but we will continue using the app. We also built a communication strategy that incorporated social media and blogs.

Conference

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Highlights

Telemedicine, Mental Health; How the Pandemic Changed Health Américo García VP and Director General | Apotex Latam

Rafael Enrique Maciel Martínez President | Asociación Mexicana de Genéricos (AMEGI)

Enrique Culebro Karam Director | Central Media

Edilberto Peña de León

C

OVID-19 exposed healthcare system failures but it also showed a new way of providing services due to the acceleration of the digital revolution. The pandemic is still going strong and continuously changing the health industry,

which will eventually help the population have greater access to healthcare services. However, these new opportunities carry big challenges, agreed industry experts.

“With already 70 percent of the population with access to internet, the Mexico we live in has changed in many aspects, including in its approach to healthcare services. Nowadays, people inform themselves through social media, look for medical solutions on internet and turn to telemedicine.

Some patients even take for granted that doctors should use digital platforms,” said Enrique Culebro Karam, Director at Central Media.

Mexico is a limited country in terms of health access.

Director General | CISNE Mexico

According to OECD, the country is located in 34th place out

Iván Encalada Diaz

of its 37 members in doctors available per 1,000 inhabitants,

Vice President | Consejo Mexicano de Ortopedia y Traumatología AC

Leopoldo Cavazos Castro Health Regulation Consultant | MYC Asociados

places last in hospital beds available per 1,000 inhabitants and 35th in percentage of GDP used for health expenditure.

Mexicans are more adapted to e-commerce, which will affect the business model of health companies, according to Culebro.

Even when the pandemic ends, videoconferences will remain and change the way health services are provided.

COVID-19 also shifted dramatically the mental health industry.

“One of the positive aspects of the pandemic is that there is no return to the stigma people had about mental health.

Psychiatrists became more important than ever after the lockdowns and other measures that COVID-19 brought,” said Edilberto Peña de León, Director General at CISNE México. About 70 percent of the global population changed their sleeping patterns during the pandemic and depressive disorders increased by 20 percent, he added.

The digital transformation triggered by the pandemic also impacted the mental health industry, which became more open to telemedicine, according to Peña de León. Remote healthcare opened new possibilities for psychiatrists and doctors in general, who are now able to attend patients from different places. “Ten percent of my medical office’s patients are from different states and even countries,” said Peña de León.

Conference

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Highlights

“In 2018, Mexicans’ peak connection times were early in the morning and late at night, which means they used these media for entertainment. During the past two years, usage peaks shifted to the afternoon, which tells us that people are using internet for more productive tasks including the search for health information,” said Culebro.

Videoconference usage rate grew 25 times during 2020, according to Culebro, opening big opportunities not only for telemedicine but for doctors’ constant medical learning and communication. “Nowadays, there is no need to be flying around the world to keep preparing ourselves or listening to conferences. Even communication with colleagues and the pharmaceutical industry has become more direct and effective,” said Peña de León.

The technological acceleration has been useful in many medical areas but it has not replaced in-person visits. While surgical operations still need to be done on-site, telemedicine could help in post-operatory monitoring and communication with patients, according to Iván Encalada Diaz, Vice President at Consejo Mexicano de Ortopedia y Traumatología AC. Telemedicine opens the field to more possibilities to serve patients.

Benefits almost invariably carry responsibilities and challenges.

The health sector’s digital transformation is not the exception.

The main challenges involve regulations and the creation of a clear legal framework that protects patient data and helps public institutions, according to Leopoldo Cavazos Castro, Consultant at MYC Asociados en Regulación Sanitaria en México.

“It is imperative to create a government body that standardizes and applies the same regulations at every institution. COFEPRIS and the Ministry of Health have already made some advances in this regard. The ideal scenario is that every actor from the industry, doctors, pharmaceutical companies, public institutions and patients operate under the same, clear legal framework.

Also, accelerating COFEPRIS’s approval mechanisms would help both the industry and people to have earlier access to effective treatments,” said Cavazos.

Standardization is not only important in regulation but also in the medical procedures themselves. “One of the biggest issues with our health system is standardization. We have more than 10 systems, such as IMSS, ISSSTE, Pemex and private sector, and surgical matters are treated differently in each of them. Itis difficult to have a correct, complete medical file, either physical or electronic in this way,” said Encalada.

Prevention campaigns and several adjustments are needed for the Mexican healthcare system to improve, according to Rafael Enrique Maciel Martínez, President at Asociación Mexicana de Genéricos. He argued that the pandemic showed that Mexico has to be “more proactive than reactive,” invest more money in its healthcare system, strengthen COFEPRIS and boost biocompatible medicines. “A strong COFEPRIS creates a strong industry and guarantees people’s access to quality and affordable medicines. Generic drugs are used when economic situations demand it. That is exactly what we need in Mexico: Read the complete article More about this topic

to produce quality generic medicines to fight against the most common illnesses, such as chronic-degenerative diseases,” said Maciel.

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Apotex Celebrates 25th Anniversary in Latin America Canada’s Largest Pharmaceutical Company, Apotex, is celebrating its 25-year anniversary in Latin America, where it has pioneered on generics’ introduction.

Apotex manufactures and commercializes generic and innovative medicines in over 115 countries and has invested over US$1 billion during the past 10 years to develop innovative product solutions. In Mexico Apotex has a finished product plant, R&D laboratories and pharmaceutical-chemical plants for the manufacture of pharmaceutical grade active ingredients (API), which makes Apotex the only company with API production and complete product manufacturing in both Canada and Mexico.

Apotex allocates 12 percent of its sales in Mexico to R&D and technological innovation as part of its commitment in keeping upto-date and being on par with the market.

When Apotex entered the Mexican market in 1996, the pharmaceutical industry was not focused on generics because the country was a brandfocused market, making it difficult for the company “to establish a foothold when we began,” said Americo García, Director General of Mexico and Latin America at Apotex during an interview with MBN. García explained that a few key distributors already had contracts with innovative companies, and were not interested in generics. However, the company began to develop new channels, including directly supplying pharmacy chains. “Apotex was able to harness the true potential of the market. Once it was established that generics are high-quality drugs, many companies entered the market,” he said. Today, its market in Mexico is made up of pure generics and branded generics, which contrasts with the market commonly seen in developed countries.

The quality, safety and effectiveness of its medicines, place Apotex among the top 10 companies in units in Mexico’s generic market, allowing the company to have a double digit growth in the brand market.

For Mexico, the company has a specialized portfolio for the prevalent chronic disease, including diabetes, arterial hypertension, high cholesterol and triglycerides and metabolic syndrome. “We are committed to raising patients’ quality of life by offering affordable products that meet the highest quality standards,” said García, “this is precisely why we are constantly striving for innovation, not only in our product portfolio but also in our communication channels.” García shared that Apotex is Read the complete article More about this topic

entering the digital world to reach more patients means providing better solutions for their health problems, as well as creating a support network that ensures proper treatment completion.