Friday Five - The Pharma week in review (9 May 2019)

Novartis eyes up US ophthalmology market with Xiidra deal

Novartis agreed to acquire Takeda's dry eye treatment Xiidra at an upfront cost of $3.4 billion. The drug generated global sales just short of $400 million last year.

Based on recent deal making, Novartis is prepared to pay big where it sees fit and will use Xiidra (and the team of around sales 400 personnel who will transfer from Takeda) to help build out its presence in the US ophthalmology market ahead of anticipated approval of its age-related macular degeneration (AMD) treatment RTH258 later this year.

See - Physician Views snap-poll results: Ophthalmologists impressed with brolucizumab, but less frequent dosing for Eylea will act as a deterrent

If Novartis can boost sales of Xiidra to blockbuster levels the price tag for this deal will seem “reasonable,” wrote analysts at Wolfe Research in a note to investors. The anticipated launch of generic versions of Allergan’s rival drug Restasis later this month is one challenge Novartis will need to overcome.

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Data accumulates for AstraZeneca's big bet in breast cancer

AstraZeneca recently confirmed a blockbuster product deal of its own, announcing last month that it would pay $1.35 billion upfront to co-develop Daiichi Sankyo's antibody-drug conjugate (ADC) trastuzumab deruxtecan.

This week, positive top-line data for the ADC in heavily pre-treated patients with HER2-positive breast cancer were released. These will go some way to validating AstraZeneca's enthusiasm for the deal, which drew scrutiny from investors as it was funded with an equity raise; and could potentially be worth up to $6.9 billion.

The task AstraZeneca and Daiichi Sankyo have in front of them is far from straightforward; Roche's Herceptin is the cornerstone therapy for HER2-positive breast cancer and sets a high benchmark. Showing success in patients who failed to respond to Roche's ADC Kadcyla is a good start, however, with AstraZeneca also confident it can open up a market comprising patients who are identified as being HER2 low.

Analysis - ViewPoints: AstraZeneca speculates big to take on Roche and carve out a new breast cancer market

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Novartis, Roche's SMA assets come to the fore

New treatments for spinal muscular atrophy (SMA) attracted much of the focus at last weekend's annual meeting of the American Academy of Neurology (AAN).

Ahead of pending approval with the FDA, which could occur later this month, Novartis presented new data that further rounds out the clinical profile of its gene therapy Zolgensma (ViewPoints: Zolgensma takes its last lap ahead of FDA decision deadline), while Roche presented more promising results for its oral SMA therapy risdiplam (ViewPoints: Roche flexes some neuroscience muscles).

Both products look poised to compete with Biogen's Spinraza, which is expected to generate global sales of approximately $2 billion this year, though cross trial comparisons are beset with caveats and risdiplam remains some years from the market.

Alongside their respective safety profiles, how these products are administered could prove critical. Physicians are familiar with Spinraza, but Biogen's drug requires infusion every four months, while Zolgensma could offer true 'one time' therapy if its effects are sustained over time. Risdiplam could prove disruptive thanks to oral dosing.

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Pfizer's rare disease play

Pfizer continues to build out a rare disease portfolio and pipeline using relatively small deals, announcing this week the acquisition of Therachon for an initial $340 million; the deal provides Pfizer access to an experimental drug for achondroplasia.

In the nearer term, Pfizer's rare disease aspirations will be shaped by the potential readout of data for its experimental DMD therapy and the launch of Vyndaqel and Vyndamax, two different formulations of the same drug, which were approved by the FDA this week for the treatment of cardiomyopathy in patients with wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM).

Analysis - ViewPoints: Pfizer takes a niche approach for Vyndaqel launch

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Drug pricing disclosure

US Health and Human Services Secretary Alex Azar announced this week a final rule from the Centers for Medicare & Medicaid Services (CMS) that will require direct-to-consumer television advertisements for some prescription medicines covered by Medicare or Medicaid to include the list price. Specifically, adverts for drugs must include the wholesale acquisition cost if it is equal to or greater than $35 for a month's supply or the usual course of therapy.

The rule comes after US President Donald Trump, who has previously criticised drugmakers for "getting away with murder," unveiled a blueprint last year targeting drug pricing. The administration later disclosed a plan that would link drug prices paid by Medicare to an international average. 

In March, Johnson & Johnson launched television commercials detailing the monthly list price for Xarelto (rivaroxaban), becoming the first drugmaker to disclose pricing information in television advertisements in the US.  

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