Interview: Allan Hillgrove, Boehringer

This year has been a crucial one for Boehringer Ingelheim, the family-owned German firm that has grown from humble beginnings as a tartaric acid salt factory in the late 19th century to become one of the world's biggest pharma companies.

So far in 2013 the company has seen continued growth of its next-generation anticoagulant Pradaxa against fierce competition from rival drugs from Bristol-Myers Squibb/Pfizer and Bayer; pledged to publish all scientific data from all clinical studies for which the company is responsible; and challenged the drug reimbursement system of its home nation Germany after several high profile products failed to win recommendations.

Perhaps Boehringer's most significant advance was its entrance into the world of oncology thanks to approvals in both the EU and US for its first cancer drug Giotrif/ Gilotrif (afatinib), which received the green light as a treatment for patients with non-small cell lung cancer (NSCLC) who have the epidermal growth factor receptor (EGFR) gene mutation.

As acknowledged by Allan Hillgrove, the member of the company's board of managing directors with responsibility for pharmaceutical marketing and sales, it is an “exciting” time for the company.

“We are moving more into oncology and we have oncology launches that will start over the next year around the world,” he said, with the US the first country to see Gilotrif.

What's driving the company to move into new therapy areas, such as oncology, is the potential to introduce a medicine that can have a real impact on patients with few options, according to Hillgrove.

“What we do on an ongoing basis is look at the therapeutic areas that we're conducting research in, and one of the key points that we look at when we conduct our therapy area reviews is the topic of unmet medical need,” he says.

It's a method that is also seeing Boehringer enter the increasingly attractive rare diseases market through its investigational drug nintedanib, which is in studies assessing its effectiveness as a treatment for idiopathic pulmonary fibrosis (IPF) – a rare lung disease, characterised by by the formation of scar tissue within the lungs, that has nearly as bad a prognosis as lung cancer and for which very few treatments are available. 

This is in addition to nintedanib's potential as an oncology product, with the drug also in phase III trials as a treatment in lung cancer.

“By working in the way we do,” says Hillgrove, “diseases such as IPF come up as areas where there is a major opportunity to provide increased benefit for patients and to find better means of treating those conditions.”

It isn't just new disease areas that hold major opportunities for Boehringer though, and Hillgrove's greater ambitions for the company lie very much in emerging markets.

The German HTA system will have to change ... over time patients will become too frustrated with it

At the forefront for Boehringer is China, primarily due to its remarkable potential for companies working in diabetes, with more than 114 million people – or 11.6 per cent of the nation's adult population – thought to have the condition based on results from a study published in the Journal of the American Medical Association.

Boehringer's interest in the area is a relatively recent one and is focused on its major partnership with Lilly, which so far has produced Trajenta – a DPP-4 inhibitor for the treatment of type 2 diabetes.

“We have Trajenta registered in China earlier this year and we will introduce it into China together with Lilly as part of our worldwide collaboration,” explains Hillgrove

“Clearly China is a major market for everything. But the number of diabetes patients is growing strongly there. We see an opportunity for the portfolio we have with Lilly to build a strong diabetes business there and add value to diabetes patients in China.”

This interest in China expands beyond Lilly and diabetes, however, and Boehringer's additional efforts include educational partnerships, such as a joint effort with the Chinese Society of Cardiology and the American College of Cardiology (ACC) to educate cardiologists in China about stroke prevention in atrial fibrillation (AF) – a condition for which Boehringer markets Pradaxa (dabigatran).

“That is an area in which we will continue to invest and continue to partner with local medical associations,” says Hillgrove.

“What these partnerships show is our commitment to China and our increased investment and our optimism around the business and patient opportunities in the country,” says Hillgrove. “But of course, we are not alone in this field.”

One emerging market that doesn't quite have the immediate prospects for Boehringer that China holds is India, with company chairman Andreas Barner describing the patent situation for medicines as “strange” during Boehringer's annual conference in April.

Clearly China is a major market for everything, but we see an opportunity there for our diabetes portfolio

For Hillgrove, India is a “challenging” market, although one that has potential for the future.

“I strongly believe that over time India will be an attractive and large market,” he says, “but for Boehringer, it is very small at the moment.”

“The short term focus in emerging markets is on China and expanding our number of employees there significantly,” he adds. “We are positive on India, but I think it's going to take a little bit longer to develop.”

As for other future prospects, although Boehringer has no current plans to enter a similar large commercial partnership as its Lilly alliance, it would not dismiss the notion completely, with Hillgrove speaking very positively of the companies' collaboration on diabetes. “Lilly has a lot of experience in diabetes and we had the short term portfolio and medium portfolio and it was a good fit,” he says of the decision to partner.

“The launch of Trajenta has been positive in many markets around the world. We are pleased with how Trajenta is tracking. It's always great when the first product in a new alliance is going well. 

“We wouldn't rule out any future partnerships. But there needs to be a driving reason for it.”

Of more pressing concern for the company is the changing healthcare environment in Europe, which has seen many countries cut expenditure on medicines and implement stricter measures to recommend new drugs for reimbursement.

The latter of these issues has perhaps been most seriously felt in Germany, which in 2011 introduced a new AMNOG system to assess the cost-effectiveness of medicines, leading to the reimbursement body IQWIG refusing to recommend several new drugs, including Boehringer's diabetes treatment Trajenta.

It was a topic that caused great consternation for the Germany-based company at its annual meeting when head of finance Hubertus von Baumbach commented that the country's health technology assessment (HTA) policy made it “increasingly difficult to continue to invest in the research and development of innovative medicines”.
Hillgrove backs these statements, asserting that “the system will have to change”.

“I think that over time, patients in Germany will become frustrated at the fact that they can't get the same innovation as other countries. And I think there will be some change in the system in Germany.”

Boehringer isn't alone in its view either, and Bayer, Cell Therapeutics, Almirall, GlaxoSmithKline and Eisai have all seen drugs fail to impress the country's authorities.

“It's not a Boehringer topic,” says Hillgrove, noting that the trade body for pharma in Germany, the VFA, is leading discussions with politicians. “That tends to be the route through which the companies go to present a united front.”

And Hillgrove is confident that changes will be made. “Inherently I am positive,” he says. “But let's wait and see what comes.”