Friday Five - The pharma week in review (11 Apr 2019)

Amgen puts a price on friendship

At first glance, Amgen’s bid to dissolve a high profile marketing partnership with Novartis may be construed simply as a bid to wrestle back full commercial ownership of the migraine therapy Aimovig; a potential blockbuster in the making.

A number of analysts have since speculated, however, that these actions may be part of a broader legal strategy Amgen is implementing; one designed to put pressure on Novartis to reach a settlement for its proposed biosimilar version of Enbrel (a key profit driver for Amgen) and which allows Amgen to extract itself from a partnership which also stipulates the sharing of development costs for Novartis’ BACE inhibitor CNP520 in Alzheimer’s disease

Amgen’s termination notice came to light two weeks after Biogen and Eisai announced the recent failure of aducanumab, wrote Evercore ISI analyst Umer Raffat in a note to investors.

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PBMs take their turn in the pricing spotlight

As sure as spring following winter, pharmacy benefit manager (PBM) executives brought before a US Senate Finance Committee this week blamed pharmaceutical manufacturers as being primarily responsible for the country’s high drug prices; essentially a reverse of the key narrative from an earlier hearing, during which pharma CEO’s blamed PBMs and the complexities of the US healthcare system.

Bipartisan legislation in response to these hearings looks likely to focus on ensuring greater transparency around drug price rebating and could extend to a ban on so-called ‘spread pricing’ where Medicare and Medicaid plans are charged a higher amount than other customers for the same drug. 

Given that the committee’s republican Chairman Chuck Grassley and his democratic counterpart Ron Wyden have been particularly critical of the role played by PBMs, however, their questioning of executives was not as aggressive as many were anticipating.

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EASL in focus

The annual meeting of the European Association for the Study of the Liver (EASL) kicked off in Vienna on Wednesday (April 10) with new data in non-alcoholic steatohepatitis (NASH) expected to take centre stage.

Read our conference primer here.

See also - ViewPoints: EASL19 - Intercept’s NASH dash hits a few bumps in the road

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New approvals of note

New FDA approvals this week include ViiV’s HIV therapy Dovato and Amgen and UCB’s osteoporosis treatment Evenity.

Dovato extends ViiV’s strategy of prioritising two drug regimens as a potential new standard of care for HIV, in this case for treatment naïve patients. Later this year it expects to present data which could support use of Dovato in patients switching from other therapies; a significantly larger share of the market.

Having overcome a complete response letter from the FDA which was issued two years ago, Amgen and UCB have circumvented safety concerns to bring Evenity to market; a process largely confirmed by smooth passage through an advisory committee meeting in January.

Feedback from experts suggests there is a definite - albeit defined - market for the postmenopausal osteoporosis (PMO) drug.

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Regeneron bets big on Alnylam

Regeneron is to partner up with RNAi specialist Alnylam and has committed $800 million upfront to secure the deal.

This may seem like a lot of money but the two companies have a lot in common, writes Michael Flanagan…

Regeneron and Alnylam have a lot in common. The companies are recognised as industry leaders in discovering and developing drugs in specific modalities – mAbs and RNA interference, respectively. They have each used big-money partnerships with Sanofi to help build out R&D platforms that have produced marketed products but are now winding down. They both realised the value of PCSK9 as a druggable target and pursued it with vigour, though neither has really cashed in from a commercial perspective – yet.

In fact, Regeneron and Alnylam are not strangers. The two partnered up just over a year ago to apply the latter company’s RNAi therapeutics to a liver disease target that the former had recently discovered but sooner realised was not amenable to mAbs. 

More here on why the Regeneron/Alnylam partnership is one to watch…

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