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Morning brief: Sanofi's shaky start, pharma begins talks with UK government and more

SanofiSanofi falling behind in Amgen cholesterol battle

First quarter results from Sanofi show the company has got off to shaky start in 2018, including signs that it its PCKS9 inhibitor cholesterol treatment Praluent is falling behind Amgen’s rival Repatha. Amgen recorded $123m for Repatha in Q1, with Sanofi and Regeneron’s Praluent achieving around half of that, $59m down on the previous quarter’s revenues. Read more here.

NHS England’s Simon Stevens - no Trump drug price rhetoric here

The UK pharmaceutical industry is beginning crucial talks with the government on the future of drug pricing for the next four years, and this time around NHS England is set to make it very much a three-way conversation.

NHS England has taken on responsibility for many aspects of price setting and market access for England’s NHS in the last few years especially for the specialised and high cost medicines, which are now most frequently emerging from the industry’s pipelines.

Quizzed by conference chair veteran journalist Jonathan Dimbleby about disagreements over drug prices, Stevens played down the suggestion of an adversarial approach - but did comment on an ongoing row with Vertex over its cystic fibrosis drug Orkambi. Read more here.

Omeros gains second Breakthrough nod

Omeros has gained an FDA Breakthrough Therapy Designation for its OMS721 drug, a novel treatment for patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), specifically those patients who have persistent TMA despite modification of immunosuppressive therapy.

This is the second breakthrough therapy drug designation for OMS721, which gained the status last year for treatment of Immunoglobulin A (IgA) nephropathy, in which pivotal phase III trials recently begun.

AlexionAlexion buoyed

Rare disease biotech company Alexion saw its shares rise 15% yesterday thanks to a better than expected Q1 performance.

It saw revenues increase by 7% to $931m, underpinned by a 2% rise in sales of flagship brand Soliris, including its launch in new indication AchR Antibody-Positive Generalized Myasthenia Gravis (gMG).

It also unveiled positive top-line data from its Phase III trial of ALXN1210, a long-acting form of its flagship treatment Soliris.

ALXN1210 in patients with paroxysmal nocturnal hemoglobinuria (PNH) need only be administered once every eight weeks compared with every two weeks as required with Soliris.

Foundation’s diagnostic revolution gathering pace, with China deal and breakthrough liquid biopsy

Foundation Medicine is a major player in the emerging field of next generation cancer diagnostics and genomic profiling, and two developments yesterday confirmed it as a leader in what will undoubtedly be a revolution in medicine.

Roche holds a 58% share in the Boston, Massachusetts company and the two companies unveiled yesterday a new partnership with DIAN Diagnostics to tap into China’s huge cancer treatment market.

The three-way partnership will look to integrate Foundation’s comprehensive genomic profiling (CGP) assays into clinical care in mainland China and will exploit DIAN’s presence and knowledge of its home market.

While this vision to integrate the tests won’t happen overnight, DIAN already has a network of 30 laboratories in the country of 1.4 billion cases and 4.3 million new cases of cancer each year. It was one of the first to receive a licence to pilot next generation sequencing (NGS) in the country. It has also set up “precision treatment centres” with medical institutions and hospitals in the country.

Foundation earned just $153m last year, but this looks set to accelerate rapidly with the launch of new products, including those that can be used in tandem with targeted therapies and immunotherapies. In December it gained FDA approval for its FoundationOne CDx assay, which profiles solid tumours.

Meanwhile, yesterday also saw the FDA grant Breakthrough Device Designation to Foundation’s new liquid biopsy assay, an expanded version of its FoundationACT assay. The new assay will include more than 70 genes and genomic biomarkers for microsatellite instability (MSI) and blood tumour mutational burden (bTMB). If approved, this test could be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to help tailor treatment of targeted cancer drugs and immunotherapies.

Article by
Andrew McConaghie

27th April 2018

From: Research, Sales, Regulatory, Healthcare



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