Amgen has forged a solid position as one of the world’s largest independent biotechnology companies. With a market capitalisation of some USD 130 billion and 27 approved medicines, the US-based firm has come a long way from its original biotech upstart status in 1980. Nonetheless, Amgen has faced obstacles in recent times, namely a bid, now dropped, by the Federal Trade Commission to block its USD 28 billion Horizon Therapeutics deal and the impending financial impact of the US Inflation Reduction Act (IRA). Amgen executives from across a number of regions share what is most on their minds.

 

USA: Halving Cardiovascular Events by 2030

Amgen has bold ambitions in the cardiovascular space, having recently convened the American cardiovascular disease community to align around a mission to help patients manage low-density lipoproteins (LDL), or the “bad” variety of cholesterol to halve the number of cardiovascular events in the United States by 2030.

Bob Bradway

 

There’s no disease that is responsible for more death and destruction on our planet than cardiovascular disease

Bob Bradway, Global CEO

 

Amgen’s global CEO Bob Bradway explains the dramatic statistics behind these ambitions: “There’s no disease that is responsible for more death and destruction on our planet than cardiovascular disease.” In addition, he illustrates the impact of LDL. “That [goal] reflects our conviction that we know what the causes of heart disease in our society today are. A very important contributor to heart disease is that people are wandering around with LDL levels that are just simply too high.”

To tackle high LDL levels, Amgen has its Repatha (evolocumab) PCSK9i inhibitor that lowers LDL-C levels by more than 50 percent. But the firm has also embarked on a number of cardiovascular health initiatives, such as its project with the CDC Foundation to expand the evidence base for cardiovascular disease risk factors and a continuing collaboration with the American College of Cardiology.

 

Middle East & Africa: Maturing Technology

While the MEA region may less technologically advanced than other parts of the world, MEA region GM Mohamed Nasser argues that major advances are being made. “With the introduction of mobile networks, which now have a penetration level between 90-200 percent, the ecosystem and use of technology have changed dramatically leading to a booming spread of knowledge.”

Mohamed Nasser

 

Patients are adopting these technologies and are interacting at a higher level and frequency with their providers via telehealth services

Mohamed Nasser, MEA

 

The use of technology as applied to healthcare grew during the COVID-19 pandemic and continues to mature, according to Nasser. “Some of the trends we have seen in the last couple of years continue and are shaping up further, especially in the fields of digitalisation and telehealth,” he says. “Patients are adopting these technologies and are interacting at a higher level and frequency with their providers via telehealth services and digital patient support programs (PSPs).”

Another area where Nasser feels healthcare tech has made headway in the region is in electronic medical records (EMR). “There is improvement in syncing laboratory data and prescriptions. Many private hospitals in the region have started combining patient services (like home care, post-discharge care etc) with more data integration which is better for patients and can be leveraged to enhance the effectiveness of research.”

 

Belux: Biosimilar Advancement

Because of Amgen’s expertise in biologic products and its manufacturing capability, the company decided to move into biosimilars, a field that has picked up significant momentum in recent years, according to its 2022 Biosimilars Trend Report.

For Belux GM Gábor Sztaniszláv, investing in biosimilars was an obvious decision. “We recognized that it would be a mistake not to leverage this knowledge when these products are off-patent. Our manufacturing background and biotechnology expertise allow us to provide reliable and high-quality manufacturing and supply, which is a big advantage for payers and countries.”

Gábor Sztaniszláv

 

We currently have three biosimilars on the market in Belgium, and we plan to launch almost every year another one

Gábor Sztaniszláv, Belux

 

In Sztaniszláv’s opinion, Amgen has an excellent track record in biosimilars. “We focus on the most used biological products, and their patent expiration, and try to be among the first to bring biosimilars to the market. This is critical because it allows us to create an advantage by not just providing these products at an affordable price, but also ensuring supply reliability.”

The Belux affiliate plans to pursue Amgen’s broader biosimilar strategy locally. “We currently have three biosimilars on the market in Belgium, and we plan to launch almost every year another one, in the next three to five years. This is an important part of our strategy.”

Yet introducing biosimilars and finding the right price point is not without its challenges, Sztaniszláv points out. “Finding the right balance between incentivizing the use of lower-priced products and avoiding unreasonable price spirals that could lead to supply issues is a challenge that is not specific to Belgium.”

 

UAE: Rapid Approvals & Advancing Public-Private Partnerships

For Gulf Countries general manager Ahmed Moustafa, the regulatory environment in Gulf countries such as the UAE has become increasingly positive. “The UAE’s drive to bring new innovations to market quickly is backed up by a well-developed regulatory system and a transparent and reasonable pricing system that enables rapid registration.” According to Moustafa, this has led Amgen to put the UAE on its priority list. “This encourages us at Amgen to prioritize the UAE in terms of bringing innovation and incentivizes investment. In fact, Amgen registered a lung cancer medication in the UAE just 12 days after receiving FDA approval, making it the first country in the world, after the US, to make this product available to patients.”

Ahmed Mostafa

 

Amgen registered a lung cancer medication in the UAE just 12 days after receiving FDA approval

Ahmed Moustafa, Gulf Countries

 

In Moustafa’s view, another reason why the UAE market is particularly attractive for the company is the UAE authorities’ willingness to enter into public-private partnerships (PPPs). “Derived from the UAE authorities’ and Amgen’s common understanding that healthcare is an investment and that PPPs are key enablers to building a resilient, strong, and innovative healthcare ecosystem, we continuously partner to find creative solutions to complex challenges.”

He cites the example of a partnership to bring treatment to expats without healthcare coverage. “There is a challenge in the private sector in the UAE since insurance companies do not yet fully cover all expats. We partnered with the healthcare system to create patient assistance programs for critical illnesses including cancer and cardiovascular disease. This collaboration resulted in expanding access to Amgen’s lifesaving medications to more than 100 patients via a third party.”