Friday Five - 5 questions raised this week in pharma

Can diabetes catalysts deliver?

The diabetes market remains an important one for many pharma players and the GLP-1 agonist class is expected to evolve notably over the next few years.

Important developments over the past week or so include top-line data from Eli Lilly's AWARD-6 study – which demonstrated non-inferiority of dulaglutide versus Novo Nordisk's market-leading treatment Victoza – and confirmation earlier this week that AstraZeneca has received FDA approval for a more convenient pen to be used with its once-weekly GLP-1 agonist Bydureon.

We ran two Physician Views polls this week to ascertain the potential impact of these developments on the GLP-1 agonist market. Analysis and results from the poll on the commercial implications of the dulaglutide launch (approval expected in Q3) can be read in Physician Views Poll Results: Weight-loss profile will be key to driving uptake of Eli Lilly's dulaglutide, say endocrinologists, while results and analysis from the second poll assessing the role of delivery devices on product usage will be available on Monday (see Physician Views: What role will device development play in the future GLP-1 agonist market?).

See also Spotlight On: Too little too late? – Intensifying competition and pricing pressure likely to limit AstraZeneca's progress via new Bydureon device.

Who can catch Johnson & Johnson?

Our list of the 50 biggest growing pharmaceutical products in 2013 illustrated a clear winner at the company level. Johnson & Johnson was responsible for marketing or co-marketing seven drugs on the list, five of which were among the 15 products that delivered the largest year-on-year revenue increases.

Johnson & Johnson's impressive performance was noted back in January when the company kicked off the Q4 earnings season (see In Focus: How Johnson & Johnson's pharma growth is laying the foundations for long-term success). Furthermore, Johnson & Johnson was recently ranked at the top of IDEA Pharma's Productive Innovation Index.

IDEA Pharma CEO Mike Rea told FirstWord "there is an interesting corporate humility in place at [Johnson & Johnson], which has led to products being launched appropriately. They have a view that products should launch well but become great over time." Interestingly, Rea suggests that this humility extends to the senior management; "while some companies ignored the index and some wanted to boast, [Johnson & Johnson's] was the only senior leadership to ask what they could be doing better."

Can Roche bounce back quickly?

One company typically associated with innovation and R&D success – particularly in oncology – is Roche. Thus analysts and investors were caught off-guard this week when the company confirmed that it has stopped Phase III development for its experimental non-small-cell lung cancer (NSCLC) therapy MetMab (see ViewPoints: Roche suffers rare setback in cancer development space as analysts predict end of the road for MetMAb); a somewhat surprising development given positive mid-stage data that had recently formed the basis for analysts at Goldman Sachs to suggest that the antibody could be one of '10 products to transform the market'. See also In Focus: Can Roche's conveyor belt of oncology blockbusters continue...meet MetMAb – the non-small-cell lung cancer therapy profiled>.

Significantly – for Roche and the industry as a whole – chairman Franz Humer also stood down this week, to be replaced with ex-Lufthansa CEO Christoph Franz. One of Franz's first moves was to tell shareholders that continuity will be the name of the game at Roche given that "the company is on track."

See also ViewPoints: Roche – The making of a modern pharmaceutical giant: a Franz Humer timeline and ViewPoints: Relationships rather than R&D to shape tenure of new Roche chairman.

Does NICE have a defined ultra-orphan pricing policy?

Ultra-orphan drug manufacturers will be watching with interest to see how Alexion Pharmaceuticals responds to a request from the UK's National Institute for Health and Care Excellence for additional information relating to the development costs for its product Soliris – as a means to justify its price.

While a number of European bodies ask for this information, it is new ground for NICE, Pharma Price International's Adam Barak told FirstWord, confirming the view of a handful of other market-access experts interviewed by FirstWord – see Spotlight On: NICE's Soliris request – a watershed for ultra-orphan drugs or more of the same?

Barak continues "one has to question NICE's terms of reference for this to suddenly appear with no prior announcement that such information was going to be formally considered as a part of its assessment criteria."

"NICE is appearing to make up policy on the hoof here as there are no formalised benchmarks for what level of R&D cost is considered acceptable to support a given cost and hence it is unclear what Alexion (in this case) would need to demonstrate in order to support its price. Clearly, expensive medicines with a budget impact of >£100k / year require some degree of formal review and assessment, but the age-old problem with R&D for drugs for orphan diseases with so few patients (

What is the rationale for declining industry payments to doctors?

New analysis this week by ProPublica suggests that a number of the industry's largest players have been reducing their payments to doctors – to fund promotional talks – possibly as the Physician Payments Sunshine Act nears.

Comments from the companies themselves do not suggest a watershed moment is on the horizon, however, but rather cutting promotional talk spend is yet another way for Big Pharma to trim unnecessary fat as business models evolve.

See also Spotlight On: What is the driving force behind pharma's drive for transparency?

Experts told FirstWord last year that such expenditure levels will be scrutinised more closely moving forward, primarily as individual companies will not want to stand out from the norm. However, a shift from a point of sale to business-to-business commercialisation model is the driving force here. That said, despite a downward trend in spending levels, don't expect Big Pharma en masse to adopt the more stringent approach of GlaxoSmithKline, which has scrapped spending on promotional talks altogether, as well as removing sales targets based on drug volumes.

Although forms of incentive payments are likely to be greatly reduced moving forward, say key opinion leaders (thereby helping to redefine the traditional sales rep model), it will not be cost effective for rival players to create and administer the qualitative data programmes implemented (not necessarily out of choice) at GlaxoSmithKline.

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