Interview: building on Spiriva – Boehringer Ingelheim's Allan Hillgrove

I meet Allan Hillgrove, the amiable Australian head of pharma marketing and sales at the family-owned German pharma group Boehringer Ingelheim, during the company's annual results conference. He talks enthusiastically about the company's pioneering innovations in digital health and other "beyond the pill" initiatives aimed at enhancing its offering through technology and services. These have ranged from an award-winning app for inhaler training to the Facebook social game Syrum, in which players run a virtual pharma company.

Allan Hillgrove, Boehringer Ingelheim head of pharma marketing and sales

However, Mr Hillgrove believes that "value will continue to come primarily from the IP in the molecule" even if "added services will aid in the differentiation" of a company's products. It's just that it is becoming increasingly incumbent on pharma companies to prove the value of their molecules, he points out.

Mr Hillgrove is equally enthusiastic about the company's debut in the cancer space with recently-launched Gilotrif/Giotrif for non-small cell lung cancer: "Oncology is an exciting place to be," he says, noting that Boehringer hopes to have won five new approvals for oncology products by 2017. Clearly, meeting unmet medical needs in oncology offers a pharma company a good opportunity to demonstrate the value in its molecules.

Meanwhile, Boehringer Ingelheim's financials have been boosted by the blood thinner Pradaxa, which was approved in the US in 2010 and became a blockbuster in 2012. It continues to win label expansions, but on the flip side, it has to struggle with competition from Bayer's newer Xarelto, and a shadow has also been cast by recent lawsuits from patients claiming it caused internal bleeding.

Separately, hope is fading for Boehringer Ingelheim's prospects in hepatitis C, a new market for the company that it now looks unlikely to crack after dropping its combination therapy studies and after several rival developers announced stellar clinical trial results that it can't hope to beat.

Put simply, it cannot be overlooked that Boehringer Ingelheim's portfolio of currently marketed drugs is dominated by the respiratory franchise, of which the market-leading long-acting muscarinic antagonist (LAMA) drug for chronic obstructive pulmonary disease, Spiriva (tiotropium), is the undisputed king. In 2013, Spiriva contributed a quarter of the company's net sales, and a third of its prescription medicine sales. But Spiriva revenues were flat at €3.55bn.

If Boehringer wants to sustain its business and grow further, then life cycle management in the respiratory space has to be a part of its strategy, particularly as Spiriva's dominance comes under threat from newer combination therapies like GlaxoSmithKline's Anoro (a LAMA/LABA product) and Breo (which combines a corticosteroid and a LABA), before eventually risking greater exposure through patent loss.

This imperative is all the greater given that Boehringer's fourth-best selling product, Combivent (ipratropium/salbutamol), to treat bronchospasms in patients with reversible obstructive airway diseases, is already in decline: sales fell 13% in 2013 to €711m.

"Look, going forward we have Spiriva Respimat for asthma," declares Mr Hillgrove, referring to the company's plans to file Spiriva in the company's newer soft-mist inhaler also for the indication asthma. This will be an add-on treatment to inhaled corticosteroid therapy for patients not adequately controlled on their ICS alone, which will limit it sales potential, though. Mr Hillgrove also admits that "it's not too far from patent expiry," but argues that it still represents "a good opportunity that is good for patients too."

Then there's olodaterol (Striverdi Respimat), the long-acting beta 2 adrenoceptor (LABA) agonist that has already been approved in Europe as monotherapy for COPD. The trouble is, that product is held up at the FDA, where it had a positive advisory committee vote in January 2013 but where regulatory approval will not move forward until resolution of manufacturing issues identified by the US agency at the company's plant in Ingelheim (a re-inspection occurred recently and the company is hopeful of resolving matters as soon as possible). Again, Mr Hillgrove acknowledges that this represents "a smaller opportunity" because LABA monotherapy is no longer the preferred therapy option.

The best bet for Boehringer is a third product, though.

"The once-a-day tiotropium/olodaterol combination [ie a rival LAMA/LABA to GSK's Anoro - ed.] is a strong product for us," Mr Hillgrove says, claiming that Boehringer enjoys an advantage because the "big differentiation between the two" is in Spiriva's well-established track record and data, for example on exacerbations (although there have been no head to head trials of the two products).

This does look to be the mainstay of Boehringer's strategy to defend its respiratory franchise, particularly since the company is not developing a triple therapy, unlike some of its rivals.

But there is uncertainty over how long the manufacturing compliance saga will continue to hold up US registrations. The company has held off filing Spiriva Respimat in asthma despite unveiling positive data, and is still discussing its plans internally. It remains to be seen if the combination product, which has also completed Phase III, will be held back when the time comes for filing.

Assuming the products do get through the FDA in a reasonable timeframe, has Boehringer Ingelheim got enough product firepower to maintain the respiratory sales?

"In the short term, yes, we will sustain the sales. Growth will slow, but low growth will continue, and with the launch of Spiriva Respimat for asthma growth will pick up again," declared Mr Hillgrove. "We can maintain a strong respiratory franchise."