A year after Pfizer tried and failed in its takeover bid for AstraZeneca, the Anglo-Swedish firm says that diabetes will help it maintain its independence.
Chris Boulton, director of marketing at AstraZeneca, told PME at the recent Diabetes UK (DUK) conference that diabetes is key to its future.
“We are very confident [about its growth potential],” he said. “So you just need to look at the patient numbers: the compound annual growth rate with type 2 diabetes patients is about 3% year-on-year, and that growth has been consistent, and we anticipate these numbers going forward.”
But while diabetes has been a sure thing for pharma in terms of growth for the past ten years, it is now becoming less reliable as sales of diabetes drugs from a number of big pharma firms are expected to slow this year.
Sanofi, one of the biggest players in this therapy area, has said that sales of its diabetes therapies “will likely not grow in 2015” as a result of mounting price competition in the US, with the French firm being forced to cut prices for its best-selling product, the Lantus insulin, which makes around $8bn a year. The French firm saw strong sales for its diabetes products in 2014, but this is likely not set to continue into 2015.
Novo Nordisk, the world’s biggest insulin maker and a firm predominantly focused on diabetes, has also been hit, seeing its global market share slip back by 1% last year.
Both companies may in addition soon have to face a threat from biosimilar medicines to its insulin products, although this will likely not begin until 2016.
Bayer is also said to be considering ditching its entire diabetes business, with much of its products being monitoring devices.
Analysts are also noting the shift. Fabian Wenner, an analyst at Kepler Cheuvreux in Zurich, said: “People are getting a bit more wary about the whole diabetes space with regards to price increases of the new products, but also price decreases of the existing ones.”
But AZ’s Boulton said despite analysts’ concerns and other pharma firms’ struggles, the sheer level of the disease and its long-term impact on healthcare means that products for diabetes will only grow in the future. The firm is also not seeking to compete on insulin, but rather oral antidiabetics, which have more space for growth and innovation.
He explained: “Diabetes is a ticking time bomb and we anticipate a doubling of rates of type 2 diabetes over the next 15 years. But then of course, those patients who are being identified and treated are not always having their disease adequately controlled.
“So the only conclusion to make is that people want more treatments. The challenge of course is whether healthcare systems can afford that, but we absolutely believe there is a need for more treatments (see p30 for more on the pricing debate).
“And of course even with the drugs we have, they don’t yet all meet the needs in glucose management, weight, and so on – and there will be more and more innovations needed to try and address that.”
Strong growth
AZ’s diabetes portfolio includes several big drugs for type 2 diabetes, and it recently expanded its efforts in the area with a deal with Bristol-Myers Squibb (BMS), so the firm must continue to keep the faith in the franchise.
Both AZ and BMS had been involved in a diabetes alliance since 2007 and have developed the DPP-4 inhibitor Onglyza (saxagliptin), the saxagliptin/metformin combination product Kombiglyze and the SGLT2 inhibitor Forxiga (dapagliflozin), all of which have received approvals in various parts of the world.
This was then expanded in 2012 when the alliance acquired Amylin, gaining the rights to a portfolio of products for type 2 diabetes, including the long-acting exenatide franchise (Byetta and Bydureon).
However, this alliance drew to a close in February last year after AZ completed its purchase of all BMS assets in the partnership for an initial fee of $2.7bn, potentially increasing by a further $1.4bn if future sales milestones are met.
In fact its diabetes unit jumped 139% for 2014 – thanks to the BMS franchise buyout and a strong showing from its now wholly-owned products, with Onglyza sales growing to $820m. Revenue from this is expected to reach $3bn by the end of the decade.
Boulton added that diabetes was one of the core areas that allowed the firm to repel Pfizer’s failed $118bn takeover bid last May, and it is what will “help allow the company to remain independent” in the future.
Saturated market?
Analysts believe that one of the main reasons why companies are struggling for growth in the diabetes space is simply because there are too many of them, saturating the market and restricting growth across the entire therapy area.
When this is put to Boulton, he says: “I can see where the concern comes from; ten years ago we had metformin, sulphonylureas, insulin and [GSK’s type II medicine] Avandia.
“But here we are now ten years’ later, and we’ve got DDIVs on the market, we’ve got GLP-1s, we’ve got SGLT2 inhibitors; and you’re also now starting to see combination therapies coming – such as insulin-GLP1 combinations, for example.
“So I agree it’s a confusing landscape and there are lots of companies in there. But equally, this is why there has been so much investment in this area, and why you see lots of companies at events like DUK, which is a strong indicator that there is a lot of R&D in the background – so again, along with the unmet need, I think diabetes is a heavy investment area.
We’re always hopeful we can do more to prevent diabetes
“But I think in the short-term, we will see less and less brand new classes of treatments being brought to market. But what you will see – and this mimics areas such as oncology and respiratory – there will be combination therapies. So you’ll also see more of a move toward new combination treatments that will aim to lower weight and have less impact on organ function.”
Boulton says that while pharma will keep striving for new and innovative ways of delivering current medicines, he admits that there is still a lot of work to do on both oral and inhaled insulin.
“I think the jury is out on inhaled insulin,” he says. “Pfizer had one in 2007 [Exubera (insulin human [rDNA origin])], and it failed. But when things look blank on the horizon, that’s where things can start to kick in – that’s when people innovate.”
A good example of this is MannKind and Sanofi’s Afrezza (insulin human), the world’s first inhaled that made it to market. It had a difficult path after several rejections from the FDA, but last year it eventually gained approval, giving patients a new option for delivery.
One of the biggest buzzes from DUK this year was the announcement of a major funding boost to researchers for a type 1 diabetes vaccine.
Research is still in its infancy, but Tesco and DUK, which are co-funding the project, believe such a vaccine could be available within a generation.
Boulton says that the prevention of diabetes rather than treatment is a “massive goal for everyone”.
Despite the funding announcement, however, he says: “We’re a long, long way away from vaccines. But what we have seen from newer treatments is that you can dramatically slow down the progression of diabetes in type 2 patients.
“For example, the use of Forxiga on some patients who are also using insulin can, in some cases, see the need for that insulin stop.
“So you can do a lot to halt the progression of this disease already, but we’re always hopeful that we can do more to prevent diabetes. That is, of course, a multi-factorial challenge and we’ll need support from public health messages and new policies from food industries and so on to make this a reality.
“So the more we can address these issues, around the problems of diet and lifestyle, then of course we can help reduce the numbers of pre-diabetics – which is now double the people with diabetes – and ultimately reduce the level of type 2 diabetes patients.”