It’s no secret that one of the main healthcare issues affecting the entire world is the increasing prevalence of diabetes, with estimates from the International Diabetes Federation (IDF) suggesting that one in ten of the world’s population could have either type 1 or type 2 diabetes by 2035.
Many products are already available to fight the condition, including, of course, the life-saving insulin, originally mass-produced by Lilly and now one of the leading sales drivers at Novo Nordisk and Sanofi.
Non-insulin products for type 2 diabetes are also big business, with Lilly, Novo and Sanofi all making their mark in the field, alongside the likes of Merck & Co with Januvia (sitagliptin) and Bristol-Myers Squibb (BMS), the original marketers of diabetes standard metformin under the brand name Glucophage.
The unmet need in diabetes remains huge, however, and more and more companies are looking to expand their presence in the market.
One of these – AstraZeneca (AZ) – recently made its ambitions clear with its decision to buy former partners BMS out of a multibillion dollar type 2 diabetes partnership at the end of 2013.
The two had been involved in the alliance since 2007 and it proved a fruitful venture. Between them, the companies 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 exenatide franchise (Byetta and Bydureon).
However, the alliance drew to a close at the beginning of February 2014 with AZ completing its purchase of all BMS assets in the partnership for an initial fee of $2.7bn, potentially increasing by a further $1.4bn.
Speaking to PMLiVE, Christopher Boulton, director of marketing and medicines access at AstraZeneca UK, explains that this decision was “a targeted play for leadership in diabetes” as well as recognition of the unmet patient need in the condition.
“We developed some very exciting brands as part of the alliance, but this was a chance to bring them all under one company. This has obvious benefits to simplify and accelerate decision making and drive forward with a focused effort.”
He adds: “The other part is the unmet need and opportunity in diabetes going forward to get more access of great medicines to patients.”
AZ has undergone an extensive shake-up of its approach to research since Pascal Soriot took over as CEO in 2012, including a series of collaborations with biotechs.
According to Boulton, Soriot’s strategy is based on AZ’s three core areas of respiratory disease, oncology and diabetes.
“In the pharma industry if you look at areas like diabetes and oncology there is huge unmet need and huge craving for innovation,” says Boulton.
“It was no surprise when Pascal Soriot joined that his big focus was to bring new medicines and new access to patients in these critical fields. And you can see that most of the top 10 companies are trying to join in these areas.”
The recent development with the BMS alliance confirms AZ’s hopes in diabetes, and the logistics of the deal have moved quickly, says Boulton.
“The deal was announced on December 19 and just five weeks later, in the UK we had 100 employees from BMS join AZ and that is some speed. A lot of work went on to make sure this was a smooth transaction.”
The deal gives AZ full ownership of several products with major potential, with Boulton commenting on the company’s expectations for Forxiga, which was approved as the first SGLT2 inhibitor available in the EU at the end of 2012 and has also recent won approval in the US at the second attempt.
For Boulton, its significant feature is that it can reduce blood sugar levels in the body while also providing a secondary benefit of reducing the weight of a patient due to the way SGLT2 inhibitors work by reducing the amount of glucose absorbed in the kidney and passing it out through urine.
“About 80 per cent of people who have diabetes are overweight and many treatments for type 2 diabetes, such as insulin, actually increase weight,” says Boulton. “The potential for the SGLT2 class of treatments which Forxiga is the first to launch, is tremendous.”
Forxiga is set to face competition from other SGLT2 inhibitors either recently approved or on the horizon, including Janssen/Mitsubishi Tanabe’s Invokana (canagliflozin), Sanofi/Chugai’s tofogliflozin and Boehringer/Lilly’s empagliflozin, but AstraZeneca’s strength is the wide range of oral diabetes products it has to offer, says Boulton.
“We probably have the broadest offering of products in diabetes in that middle space from when people start in metformin to making that insulin decision,” he says.
“We are focused on the non-insulin diabetes market and we have an ambition to be a top three player in that space.”
As AZ can attest, with Forxiga initially being turned down by the FDA and Onglyza under safety review to investigate any link to heart failure, the regulatory environment has been a tough one for oral diabetes drugs in recent years, with the FDA demanding robust cardiovascular safety studies.
This has been a consequence of the safety concerns over GlaxoSmithKline’s Avandia (rosiglitazone) and the subsequent restrictions, which were then lifted in the US after further analysis.
Boulton is confident of the robustness of AZ’s safety measures, however, saying that the 16,492-patient SAVOR study provides the company with a good understanding of Onglyza’s safety profile.
“All drugs have safety expectation,” he says “but it’s a legacy effect of classes of drugs that have been replaced. It’s a high cost but it’s the right thing overall for patients to have large databases of this safety information.”
Putting diabetes at the heart of AZ is also the right thing to do, according to Boulton, for both patients and the company.
“Bringing ex BMS people and products under one roof allows that focus, that decision making, that drive and that ultimate focus on patients.”