The Friday Five – Five of the past week's pharma stories you can't afford to ignore...

Amgen – Biotech or Big Pharma?

The suggestion (accusation?) that US biotech giant Amgen is steadily becoming a Big Pharma player is not a new one. The company has, for some time, faced a number of challenges familiar to the likes of Pfizer and Merck & Co.; a high rate of dependency on a select number of key blockbuster brands and exposure to generic (biosimilar) competition spring to mind. The trappings of success have also created a company of considerable scale – where it is increasingly difficult for new launches to 'move the needle.'

Mooted expansion into emerging markets and notable investment in the biosimilars space represent recent growth strategies of a biotech company that has outgrown many of its peers; where cutting edge innovation has to some extent been swapped for margin protection.

A small but significant deal struck by Amgen with Servier on Tuesday (to gain US rights for Procoralan – an oral drug for chronic heart failure and stable angina) is the latest evidence of Amgen's steady transformation. Although analysts at Goldman Sachs view the deal as an incremental positive for the company – the characteristics of Procoralan are typical of a Big Pharma product.

This is not to suggest that Amgen is actively distancing itself from its biotech heritage; the company's pipeline comprises a number of promising assets and recent efforts to acquire Onyx demonstrate Amgen's retained affinity with the biotech peer set and the oncology market. It is with some irony, therefore, that although Amgen has kick-started an auction process for Onyx, many analysts believe that the company will end up in the hands of an established Big Pharma rival with deeper pockets and a better credit rating. See ViewPoints: A summer of M&A speculation?

Can the FDA meet heightened expectations for faster drug approvals?

The merits of the FDA's breakthrough therapy designation continue to be hotly debated. The administration continues to provide further insight into how the status will benefit those companies to whom it is granted, most recently via a new guidance document.

Some uncertainty is likely to prevail, however, until industry commentators, analysts and investors are provided a better idea of how the designation will work in practice. Faster than expected submission of Johnson & Johnson and Pharmacyclics' ibrutinib – which has received three indication-specific breakthrough therapy designations – could provide an important benchmark - see ViewPoints: Will the FDA send out message on breakthrough therapy status with speedy approval for Johnson & Johnson, Pharmacyclics' multi-billion dollar candidate ibrutinib?.

Similarly, to gauge how rapidly a company can gain breakthrough therapy status for a product that has demonstrated potentially paradigm shifting in a very small patient population, Clovis Oncology – a star of ASCO 2013 – is a company to watch. FirstWord Pharma PLUS subscribers can read our analysis of Clovis here.

Lipitor's longevity

According to a new report by the AARP Public Policy Institute, Pfizer's Lipitor – once the world's best selling pharmaceutical product – will continue to generate sales of $3 billion in 2015, some four years after the loss of US patent exclusivity (which occurred in November 2011).

The report – which can be accessed here – provides an analysis of the aggressive retention strategies that Pfizer has implemented, as does this analysis from FirstWord published in February 2012 (when Lipitor's post-expiry performance was a headline-making event).

Further insight into Lipitor's status among the industry's most extraordinary commercial examples can be found here.

Success beyond oncology continues to evade Roche

Despite being recognised as the industry leader in oncology drug development, Roche has flattered to deceive in launching new drugs from other therapy areas over the past decade. There have been some successes – Lucentis (age-related macular degeneration) and Actemra (rheumatoid arthritis) being the key examples – but these launches highlight an associated trend; that Roche's internal drug develop efforts (i.e. not Genentech or Chugai) continue to struggle.

Any criticism must be set in context against the remarkable track record that Roche – via Genentech – has delivered in oncology and the strategy it has implemented to retain the innovation culture that has been nurtured at the US biotech. The decision to terminate development of aleglitazar for the treatment of diabetes, which was announced on Wednesday, will be a particularly hard pill to swallow for investors seeking reassurances of diversification beyond oncology. Given the poor track record within the PPAR drug class – approximately 50 clinical failures due to safety concerns, according to a 2009 paper written by Bernard Charbonnel, of the University of Nantes in France – was Roche the best positioned company to buck the trend? For further analysis click here.

Biosimilar bonanza?

The biosimilar bandwagon continues to gather momentum – most recently due to European recommendation for Celltrion and Hospira's Remicade biosimilar (expected to be the first biosimilar antibody to gain approval) – although questions remain over its commercial outlook.

Although the profitability of biosimilar development remains in some doubt, FirstWord's analysis of the most targeted branded biologics demonstrates that enthusiasm remains high (see FirstWord Lists: Which biologics face the most competition from biosimilars?). And perhaps with some justification; this week's FirstWord Physician Views poll confirmed that rheumatologists and gastroenterologists based in the 5EU markets are expectant for biosimilar anti-TNF products such as Remicade. FirstWord Pharma PLUS subscribers can view the results here.

What to watch out for in the coming week on FirstWord...

What are the biggest selling products of all time in terms of lifetime revenue contribution

Our Q2 earnings season preview

The low-down on pharma’s newest M&A target – Onyx Pharmaceuticals

...and more analysis, insight and opinion.

To read more Friday Five articles, click here.