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

Heads roll at Merck & Co. | SAVOR data disappoints? | US Supreme Court says 'sort it out yourselves' on pay-for-delay deals | Xeljanz, Eliquis in need of revival | The blood of the gods

Perlmutter makes his mark at Merck & Co.

In an interview with Forbes last year, Merck & Co.'s head of R&D Roger Perlmutter described himself during his first stint at the company: "I was sort of the angry young man and I believed an enormous number of things needed to be changed." A decade overseeing R&D at Amgen may have calmed Perlmutter down, but just months after returning to Merck he has instigated some, significant changes in terms of management structure.

It's hardly surprising that Perlmutter wants to stamp his own authority on the set-up at Merck, particularly given his damning verdict of the current structure; "virtually everyone has expressed frustration with our system of governance and the complexity of our organisational design."

Perlmutter appears to be in a win-win situation with investor expectations suitably lowered by a series of R&D disappointments under previous R&D head Peter Kim, and has even signed a collaborative deal with the old enemy Pfizer (see ViewPoints: Can a collaboration between old rivals Pfizer, Merck & Co. ignite commercial excitement in SGLT2 space?). Analysts at Leerink Swann suggested this week that Perlmutter's second stint at Merck will likely be characterised by further externalisation initiatives.

See also, ViewPoints: Merck & Co. moves to reinvigorate its slowing R&D momentum and ViewPoints: Spotlight grows on Merck & Co.'s new head of R&D as IMPROVE-IT overhang removed.

SAVOR no saviour

In addition to treating type 2 diabetes, two pertinent questions surround the class of popular therapies known as DPP-4 inhibitors – do these drugs increase the risk of pancreatic cancer and pancreatitis? And do these drugs provide cardiovascular benefit? The answer – based on recent events – is probably not.

Last week the FDA suggested that more data – from large outcomes studies – were necessary to definitively assess any pancreatic risk, and on Wednesday AstraZeneca announced top-line results from its 16,500-patient SAVOR outcomes study, which confirmed that its own DPP-4 inhibitor Onglyza (which is co-marketed with Bristol-Myers Squibb) provides no cardiovascular benefit versus placebo.

Bad news for AstraZeneca and Bristol-Myers Squibb? – it's difficult to decide. The real issue will be if other DPP-4 inhibitors do demonstrate a cardiovascular benefit, which would weaken the position of Onglyza within the class. See ViewPoints: AstraZeneca/Bristol-Myers Squibb SAVOR results – missed opportunity or sigh of relief?

Pay-for-delay deals – still likely to happen, but less frequently

A US Supreme Court ruling on Monday failed to outlaw so called 'pay-for-delay' deals between branded and generic manufacturers, but has given the Federal Trade Commission (FTC) more powers to take legal action on a case-by-case basis. The upshot, suggest analysts and lawyers, is that such settlements will continue to occur but most likely on a reduced basis.

For the FTC, stronger grounds for the pursuit of legal action against these settlements on a case-by-case basis is a key victory, D'vorah Graeser – CEO of Graeser Associates International – told FirstWord. "This will reshape the parameters by which such settlements are entered into," says Graeser, adding "for generics companies in particular, there will be greater consideration regarding the risk that such a deal may fall through or be successfully countered by the FTC, or that such a deal may not be put on the table in the first place if a patent is challenged by the generic company."

Ultimately, this may reduce the number of cases where generic manufacturers are willing to challenge the validity of patents, which would clearly be a positive development for the branded industry. The irony is that such an outcome would delay the availability of generic launches and contradict the FTC's claim that reverse payments are costing US consumers billions of dollars a year. For further analysis read here.

Can Pfizer revive its potential blockbusters?

In its post-Lipitor guise, the re-emergence of a growth narrative has played an important role at Pfizer in recent months – in particular the recent launches of Xeljanz (for rheumatoid arthritis) and Eliquis (co-marketed with Bristol-Myers Squibb; for atrial fibrillation).

Disappointment all-round then when management conceded at the beginning of the week that uptake of both products was slower than anticipated – a cautionary announcement ahead of Q2 results perhaps?

Regular FirstWord readers will not be particularly surprised in either instance; a number of Physician Views polls run in recent weeks has indicated that traction with physicians is slower than most analysts expected.

All is not lost – Pfizer begins direct-to-consumer (DTC) advertising campaigns for both products imminently (which will provide an interesting uptake dynamic to watch), while many advocate that physician experience will boost sales in the long term – only time will tell, but expect the Pfizer break-up narrative to retain centre stage in the meantime.

The future of anticoagulation?

Its (very) early days, but where Eliquis (and other members of the current generation of anticoagulants) has only provided a marginal benefit over warfarin in the anticoagulant space, UK start-up biotech company XO1 hopes to develop a revolutionary therapy.

Winning the imaginary competition for 'best origin for the name of a new drug', ichorcumab (in Greek mythology, ichor was the ethereal fluid in the blood of the gods that conveyed their immortality) is expected to move into clinical trials in the next two years. Most importantly, the agent would appear to demonstrate the potential to dissociate bleeding from anticoagulation – a holy grail in drug development terms.

The origins of ichorcumab stem from the chance hospital administration of a patient with a unique blood clotting profile who was subsequently treated by a clinician with a unique depth of knowledge on the inner workings of coagulation. The drug may be a long way from pivotal-stage trials, let alone the market, but its discovery narrative provides a timely reminder that for all of pharma's sophisticated R&D strategies, sometimes you cannot beat a simple stroke of luck. For further analysis read this blog article written by interim XO1 CEO David Grainger.

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