Friday Five – This week’s key news stories

Will President Trump's drug pricing proposals hit pharma hard?

The initial take was they wouldn't.

But thanks to a number of speeches made by Health and Human Services (HHS) secretary Alex Azar this week, that view has shifted slightly; changes could have a profound impact if they are implemented (but it's a big 'if').

Azar's tone became more aggressive as the week wore on, culminating in Wednesday's suggestion that proposals to introduce price negotiations for drugs covered under Medicare Part B is one of pharma's worst nightmares.

ViewPoints: Regeneron, Roche, Amgen exposed to any Medicare Part B price proposals that become reality

Celgene can’t catch a break

Azar also said Monday the administration will be happy to call out individual companies as part of its push to lower prices.

Indirectly, Celgene became the first company to attract ‘special attention’, with Azar noting, during a discussion about the potential reform of six protected drug classes under Medicare Part D, that “the company that makes one of the 10 most common drugs in these categories raised that drug’s price 20 percent in the last 12 months.”

That drug is Celgene’s cancer therapy Revlimid and new expenditure data from the Centres for Medicare and Medicaid Services show that Part D plans spent $2.7 billion on Revlimid in 2016.

Celgene relies heavily on Revlimid revenues and has been seeking to diversify its portfolio; but in recent months has suffered a number of setbacks that have put management under scrutiny. Continuing this trend, abstracts released ahead of ASCO (see below) showcase disappointing data for Jounce Therapeutics JTX-2011; a drug Celgene partnered on in 2016.

As ISI Evercore analyst Umer Raffat noted, Revlimid’s cornerstone status in multiple myeloma is unlikely to see the drug excluded from Medicare formularies, but price increases as a means to drive growth will come under scrutiny.

Furthermore, the week ended on another sour note for Celgene with the FDA delivering its promise to identify the companies it says are ‘gaming’ Risk Evaluation and Mitigation Strategies (REMS); Celgene and Revlimid feature prominently.

And what role for biosimilars in this brave new world?

The FDA approved its tenth biosimilar this week (Pfizer's biosimilar version of Epogen/Procrit), but just three have launched in the US market to date.

US payers are still hopeful that a greater number of biosimilars will result in cost savings and/or improved patient access to biologic therapies, but have lost confidence that growth in the biosimilar market alone will have a significant impact on overall expenditure trends.

Will FDA commissioner Scott Gottlieb, a leading proponent of the biosimilar model, follow through with his recent tough talk?

See ViewPoints: Do biosimilars fit into Trump's drug pricing vision?

The issue is likely to come to a head later this year when biosimilar versions of Humira - the world's biggest selling pharmaceutical - are launched in Europe. By comparison, Humira biosimilars look unlikely to reach the US market until 2023.

ASCO abstracts go live

The global oncology community will descend on Chicago in early June for this year's annual ASCO meeting with abstracts released on Wednesday - read our round-up of key trends to watch 

Loxo Oncology - leading a march towards the potential treatment of RET fusion positive tumours - was the early winner in terms of share price movement; response rates with its experimental therapy LOXO-292 were higher than expected; Jounce Therapeutics was the early loser (ViewPoints: With so-so combo data, Jounce becomes the first ASCO fatality).

Competitive positioning for immunotherapies in the first-line non-small-cell lung cancer setting will remain a key theme at ASCO. Beyond the players that have dominated this area to date (predominantly Merck & Co. and Bristol-Myers Squibb), Merck KGaA looks to have the most intriguing lung cancer data at ASCO; which could validate broader revitalisation of the German company's R&D pipeline.

CAR-T in focus

CAR-T therapies are enjoying steady uptake in specialist US centres, according to experts interviewed by FirstWord for a new report.

European approvals for Gilead Sciences' Yescarta and Novartis' Kymriah are expected later in 2018 and commercialisation challenges will be different from those in the US market, suggest KOLs.

On a related note, Gilead announced this week acquisition of a large manufacturing facility in the Netherlands designed to support the supply chain of Yescarta and other future gene therapies in Europe - ViewPoints: Gilead looks to head off any European CAR-T supply concerns with facility acquisition

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