Mylan prides itself on being a company that never sleeps and, when your public goal is to create access to medicines for seven billion people, there is little room for a relaxed approach to drug development.
The generic giant is in the thick of it, doubling its pipeline through R&D and acquisitions, fixing a deal with Roche in the race to launch a biosimilar (trastuzamab) to Herceptin while taking a buffeting over trading in the US, despite European growth contributing strongly to $2.96bn second quarter revenues.
The action rages around Mylan but this is part of the company’s DNA, as celebrated in its self-portrait publication ‘50 Years of Unconventional Success’ marking its 50th birthday in 2011, which features a dedication from then company president Heather Bresch, stating: “Mylan is drawn to the unfamiliar, the bold and the seemingly impossible.”
She adds tellingly: “When conditions change, and they always do, we adapt.”
Bresch has been elevated to CEO and the publication may be gathering dust on office book-shelves but the mantra lives on and is warmly taken up by Jacek Glinka, the company’s European president: “The last three years have been very exciting as we have developed from being a purely generic player to working in many different segments with different customers,” he says.
“We can now work across channels, with physicians, pharmacists, payers, distributors and hospitals, with an infrastructure that can reach all potential customers.
“Our mission was always to provide access to quality medicines for seven billion people and that wasn’t possible before but now we can reach them. We have grown the business from $1bn to $4bn and grown the capabilities from generics to all kinds of models, so we can work to satisfy the current market but also be flexible enough to transform into whatever is needed for future markets.”
One of its core abilities, he says, is to balance the disciplines of being a heavy-hitting global player with a light touch to accommodate local sensitivities and nuances at territory level.
High value
“It has been very smart to combine global and local aspirations,” adds Glinka, who joined the company in 2013 after serving as CEO of Poland’s Polpharma, a small biopharma whose revenues he doubled to $1bn. “Mylan is a big US company but at the same time it is able to look into local opportunities and respond to local needs. What we have seen over recent years in the pharmaceutical industry is more specialisation, with companies combining original and generic products but exploring this under separate organisations rather than under one roof. We knew we wanted to have an integrated approach to our customers and we have built this vision to create these capabilities across all channels and geographies to realise the mission.”
It has manoeuvered into pole position to grab a significant slice of Roche’s $2bn-a-year European Herceptin market and, despite the recent setback when the EMA asked for a resubmission because of manufacturing issues at Indian biotech partner Biocan, Glinka predicts a bright future built on Mylan’s new, strengthened structure and the ambition to make the most of the patent cliff of high-value biologics across Europe.
“We are ready to accelerate the expansion,” he says. “We have built a platform to operate across all segments so now we can reflect on what to implement, such as moving products around the globe or leveraging the best practice, or bringing new innovative products which we were limited in the past because of our infrastructure. There is now no limit on the product commercialisation strategy that we can execute and that gives us more opportunities to commercialise almost every pharmaceutical product. Looking at the future, I think it is going to be bright.”
He quickly revises his estimate: “This is a diamond opportunity. It’s that good, the most precious,” he smiles. “We are in the front of a big patent cliff which creates a tremendous opportunity.”
Mylan, and many others, are relishing the challenge of launching biosimilar rivals to the blockbusters but despite their confident rallying call, they are all wrestling with the handbrake of financial and regulatory constraints imposed by national healthcare systems.
Savings and increased access have been the billboard claims since the first biosimilar was launched in Europe in 2006. This is underscored by research from analysts QuintilesIMS stating, notably, that biosimilars have increased patient access by 44% overall in the EU5 nations.
Promised land
‘The increased competition results from biosimilars entering the market affects not just the price of the respective biosimilars reference product, but also the price of the whole product class,’ its report for the European Commission in May this year comments. ‘It can have almost as large an impact on the total market price as it has on biosimilar/reference product price.’
But reports and forecasts do not shift governments and Glinka recognises that promise is not the same as delivery. Mylan’s biosimilar of the multiple sclerosis injection therapy copaxane is not gliding to the promised land, and delays have given rivals Momenta and Novartis’ Sandoz a tilt at the multibillion-dollar field.
“We are launching one of these products but we struggle with this opportunity because we see that the governments, the payers – the illness funds in Germany – the patients and the physicians are not set up to capture this opportunity,” says Glinka.
Dialogue to unravel restrictive approaches is slow-paced, he admits. “We are surprised stakeholders are still prepared to pay a high price for a product when they could make significant savings,” he says. “We are trying to engage in dialogue with the illness funds to improve this but it is very slow at the moment.
“There are lots of patients with no access to biologics so we expect more proactive behaviour from physicians and the illness funds in Germany to figure out how we can increase the uptake – in other areas we have seen that you can generate a 60-80% uptake with the right incentive – and share the gain of saving around €25m.
“We have many examples where small molecule and biosimilars have improved uptake such as the case of infliximab in Norway, which was supported by the government that sponsored clinical trials showing efficacy and safety and introduced quotas for physicians, thereby achieving a switch of the majority of the patients very quickly. But we have seen the same product in a different area only achieving 1-2% of the market because there was no support from the government and other institutions.”
Inflection point
He identifies the UK as having an open approach to generics – the health policy think tank, the King’s Fund and citing the NHS as using generics for 84% of its prescriptions – while other countries struggle to reach 20% penetration.
“It is disappointing but you have to keep talking and it should not be just down to one pharma player, as it may not have the strength to leverage the argument on its own. There should be a multi-stakeholder debate to figure out how the systems can evolve to increase levels of generics being dispensed to patients.
“There is a long way to go but we will only get there by talking. It will take longer in some areas but we should not let that stop us having those talks or setting ourselves aggressive targets. The European Commission and European Medicines Agency should have a role in encouraging faster work from governments.”
He adds: “The most important thing is that we are creating access to quality treatments and that patients can be treated; there cannot be a better motivation. If you relate this to your families, what better value can you deliver than better healthcare and a healthier life? That is our motivation and I really believe Mylan is strong enough to deliver on a promise to reach 500 million people in Europe with quality, affordable medicines.”
Bresch underscored the hope and the challenge of current markets last month, stating: “Our industry, along with the entire healthcare sector, is at an inflection point. This is providing investors with an opportunity to differentiate between pharmaceutical companies focused solely on generics and/or specialty medicines and those capable of delivering a broad and diverse portfolio across multiple channels in various geographies, which remains Mylan’s strategy.”