Alnylam’s European head of market access and GM of mid-size markets, Anant Murthy, shares his perspective on how a US biotech can adapt to the many unique challenges of the EU market.

Though they represent the two biggest markets for pharma companies, the EU and US have some stark differences that can often catch out biotech leaders looking to expand from America into Europe.

Anant Murthy is one leader well-placed to know what it takes to succeed in the region. Originally from the US, he has spent much of his career in Europe, and now heads up market access and several EU countries for mid-sized Alnylam Pharmaceuticals, based in Switzerland, which specialises in RNA interference (RNAi) therapeutics.

He says that the biggest challenge people often face in bringing a US biotech to Europe is in accepting that some European markets will have no problem denying access to specific medicines.

“That’s really uncommon in the US, and for a lot of American biotech leaders who have not worked in Europe it’s a difficult thing to accept,” he says. “It’s a real possibility that an entire country will simply not allow access to a medicine, especially in many rare diseases.”

He adds that many companies have had to learn the unique difficulties in commercialisation in Europe through some challenging experiences.

“Building infrastructure in Europe takes a lot of investment – you need to hire people with skillsets across different countries, you need to build distribution infrastructure and you need to establish legal entities in many countries,” he says.

“You have to do all that several times over just to access the EU. Meanwhile, the time to your first sale could be more than three years after a European regulatory review, and you’re still shouldering that entire infrastructure and all the costs associated with it during that time.

“A lot of emerging biotech companies have learned that the hard way, and many have learned that it’s better to schedule the timing of investments closer to the timing of revenues.”

Murthy stresses, though, that there are just as many opportunities for biotechs in the region as there are challenges – particularly as the sector moves toward highly specialised approaches to disease.

“We’re seeing a lot of interesting technologies focused purely on the biological mechanism of action behind the disease,” he says. “This is certainly true in the RNA field, and this new approach to medicine development has transformed Alnylam’s business.

“It affects how we do clinical trials and it affects the size of the commercial opportunities, because we can target very specific patients. Because of that, payers need to decide within the disease how to segment certain patient populations in order to maximise investments and get the best clinical benefit. That is quite disruptive, and I think that’s only going to continue.”

Murthy says this has also led to some innovative approaches to company formation.

“We’re now seeing a lot of biotechnology companies in Europe that are spinoffs of universities, based on platform technologies. This is great news – more biotechnology company creation leads to additional innovation, additional investments in research, and additional competition for European consumers.”

He also stresses the importance of partnering and collaborating with healthcare systems – which has only become more critical during the COVID-19 pandemic.

“The traditional model has always been somewhat transactional – we develop the medicine, they pay for it. Some of the more innovative biopharma companies are starting to blur those lines.

“Gene therapy is a great example, where you see proposals to engage in innovative, long-term payment models. These initial transactions are now leading to greater partnerships down the road.

“We believe there’s a need for more tailored agreement types like these that address uncertainty whilst limiting complexity and burden for payers. For example, we’ve created a value-based agreement framework for our new medicine for acute hepatic porphyria. This combines payment based on performance with additional financial mechanisms that address the short-term need to ensure payer value for money with the long-term view of budget responsibility, ensuring that what is committed to today is sustainable.”

Murthy adds: “Going forward, companies that want to be successful will need to find ways to be real partners in the development of medicines. That means investing in European research, partnering with European medical centres in developing medicines, and ensuring enrollment of European patients in clinical trials.”

A wide range of diseases

Alnylam’s work focuses on RNA interference therapeutics – which inhibit gene expression or translation by neutralising targeted mRNA molecules. Murthy notes that the field has become incredibly exciting over the last few years, and the company is hoping their new class of medicines will treat a range of diseases in the long-term.

“RNA interference is really a platform technology – it’s a naturally occurring biological process based on Nobel Prize winning research that began over 20 years ago. That basic understanding of biology is now transforming itself into real medicines. We’re only at the beginning.

“In the earlier stages of RNAi therapeutics, there were delivery challenges – how do you get these unstable RNAi molecules into the body without them degrading? Tremendous advances in biology, chemistry, and delivery of medicines have allowed us to go from applications that would require frequent infusions of high volumes of medicine to monthly or even quarterly subcutaneous injections.

“Now that we’ve cracked that delivery problem, the road is endless in terms of the number of diseases that we could address. We have announced research programmes in the CNS space, and have programmes in diseases ranging from hypercholesterolemia to pediatric diseases affecting the kidney. There are very few companies that could say that.”

And for a company that often deals with rare genetic diseases, the digitisation of healthcare services, delivery, and research has been a powerful boon.

“The biggest challenge with these conditions is often finding patients who are out there in the community. It’s unfortunate because they’re suffering when a treatment is already available, but you don’t find them until physicians can put the clues together.

“The digitisation of medical records and the ability, for example, to retrospectively screen records using risk factors or algorithms with propensity scores to find these people, has the potential to transform how physicians diagnose their diseases.”

However, Murthy says that while in other areas of digital health there are a lot of exciting concepts, he does not see much translation of those concepts into real practice.

“Fundamentally, the way most biopharma companies develop medicines hasn’t changed that much. In order for them to truly change, you need to look at the regulatory frameworks around research and development.

“I personally have not seen the type of change that I would have thought we would be facing in 2020 when I was imagining the future a few years ago.”

COVID and beyond

Alnylam has even been able to leverage its RNAi technology for a candidate to treat COVID-19, in partnership with Vir Biotechnology. The companies are aiming to move the asset into clinical trials at the end of the year.

“That has been a very rapid development process. In general, it has been tremendously exciting to see so many companies looking into developing or repurposing drugs to fight the pandemic.

“We’ve also noticed much more cooperation in the sector. Our president of research mentioned that it’s not uncommon for him to get a call from his counterpart in another company asking to compare notes in areas where we have expertise. That level of collaboration is really unprecedented.”

Conventional wisdom might say that the sector’s work during the pandemic will change how people view the industry for the better – but Murthy says there is some way to go in changing the appreciation of pharma’s value in Europe, and he hasn’t seen a noticeable shift yet.

“I hope that changes, but at the moment most of the recognition is framed around what the industry could bring to the economy for member states.

“When we meet with payers or government authorities, I’m frequently asked how many people we employ in their country, what our contribution to their GDP is, etc. If you are a small research-based biotechnology company, completely dependent on investment capital because you’re trying to bring forward cutting edge science, by definition you’re not going to be a major employer.

“If that is the standard by which European Union member states value our sector, that’s really going to devalue basic scientific innovation.”

Nevertheless, Anant says it’s important for people working in this industry to push themselves outside of their comfort zone if they want to make a difference in Europe.

“That’s how you really make an impact. Of course, that means there’s a chance you may fail because you’re going to be doing something that you’ve never done before – but that’s where the real opportunities lie.”

About the interviewee

Dr Anant Murthy is currently a vice president at Alnylam Pharmaceuticals where he is the head of the MidSize Market Region, comprising Canada, the Nordics, Netherlands, Belgium, Luxembourg, and Portugal. In addition, he is the managing director of Alnylam Netherlands. Murthy is also the head of market access, pricing, and public policy, overseeing the company’s interactions with payers and governments across the European Union and Canada. He has led Alnylam’s successful launch of the world’s first RNA-interference medicine in several countries.

About the author

Dr Paul Tunnah founded pharmaphorum in 2009, which combines industry leading publications (www.pharmaphorum.com) with a specialist strategy and content marketing/communications consultancy (www.pharmaphorumconnect.com). He is a recognised author, speaker and industry advisor on content marketing, communications and digital innovation, having worked with many of the world’s leading pharmaceutical companies and the broader ecosystem of healthcare organisations.

In June 2020, he became chief content officer for Healthware Group, a next-generation integrated consulting group that operates at the intersection of the transformation of commercial operations and digital health, offering a unique range of services combining design, strategy, communication and innovation with technology and corporate venturing.

Connect with Dr Tunnah at https://www.linkedin.com/in/paultunnah/ or https://twitter.com/ptunnah

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