Friday Five – This week’s key news stories

Takeda's persistence pays off

It took five separate proposals - the fifth reportedly put forward even before the fourth had been rejected - but Shire appears ready to accept Takeda's takeover vision.

In its provisionally final form, the acquisition looks more like a merger such is the contribution of Takeda stock. Inability to offer a cash-richer proposal looked set to scupper Takeda's intentions at one point, but Shire has relented.

CEO Flemming Ornskov, pressured by Shire's declining valuation in recent months, has earnt back some goodwill. Talk of rival bidders never materialised, but Shire has made the most of the hand it was dealt, helped by the peculiarities of UK legislation.

The biggest threat now is that Takeda shareholders mobilise to thwart the deal under the shadow of a mounting debt pile, said analysts at Bernstein.

Biogen sees the sense in Spinraza successors

Biogen is banking on antisense drug technology to drive evolution of its R&D pipeline over the next decade, thanks largely to the recent success of its newest growth driver; the spinal muscular atrophy (SMA) treatment Spinraza. This week Biogen committed $375 million in upfront cash and $625 million in share investment to gain exclusive access to compounds from Ionis' antisense platform for 10 years.

One small problem; first-quarter Spinraza revenues in the US market fell short of expectations, results also released this week reveal. 

Biogen insists there is no reason for investors to panic. Spinraza has achieved faster than expected penetration among an initial bolus of infant and paediatric SMA patients; onus now will be on driving utilisation in older patients, the majority of whom are yet to receive therapy. Furthermore, ex-US sales are growing faster than expected, said management.

JAK-backed (kind of)

The commercial prospects for Eli Lilly's JAK inhibitor baricitinib in the US market look increasingly marginalised following a mixed review by an FDA advisory committee. Panellists voted to support a lower 2mg dose from an overall risk/benefit perspective, but not the 4mg dose.

Experts in the rheumatoid arthritis field note that early sentiment towards baricitinib in Europe - where it is marketed as Olumiant - has been positive; though dosing flexibility (both the 2mg and 4mg are approved) has played a key role in favoured use over Pfizer's Xeljanz. 

Likely non-approval of the 4mg dose in the US market is also a blow to Incyte, which is still reeling from a major setback for its oncology pipeline. Having out-licenced baricitinib to Eli Lilly, Incyte CEO Herve Hoppenot previously explained to FirstWord how the resulting royalty stream will play an important role in funding the company's expansion.

Importantly, AdCom panellists suggested thrombosis-related safety concerns appear to be specific to baricitinib; a number of other companies have high commercial hopes for the JAK class. 

More work needed on TMB

Does recently presented data from Bristol-Myers Squibb's CheckMate-227 trial validate tumour mutation burden (TMB) as a prospective biomarker for cancer immunotherapy - specifically use of PD-1/CTLA-4 combination therapy in first-line lung cancer patients?

Oncologists are unsure, according to our latest Physician Views snap-poll, though the data are promising, suggest even the naysayers - Physician Views Poll Results: Oncologists see early promise in Bristol-Myers Squibb's latest lung cancer data.

Can Amgen, Novartis avoid another drug pricing headache?

A new chapter in the US drug pricing debate is poised to open if and when the FDA approves Amgen and Novartis' Aimovig, the likely first in a new class of migraine therapies. The regulator is expected to act by next month at the latest.

Novartis has previously talked up the potential of launching Aimovig with outcomes or value-based pricing schemes, a discussion echoed by Amgen executives during the company's first-quarter earnings call this week.

In addition to an outcomes-based pricing approach, pharmacy benefits manager (PBM) Express Scripts cited emergence of this new drug class as an opportunity for pharma to tackle the disparity between publicly available list prices and the rebated price subsequently negotiated with PBMs and other healthcare providers. This would appear to be an about turn by Express Scripts, which has previously touted the discounts it has negotiated with increasingly aggressive exclusionary tactics, and may be designed to deflect the growing attention that PBMs often receive as little understood middlemen in the US healthcare supply chain.

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