Daily Brief: Amgen offers Repatha deals in Europe, will Persephone slash Herceptin use?

Hello and welcome to another round up of news from pharma, biotech and healthcare.

Today’s collection of stories all seem to point in one direction – pharma having to respond to a very different pricing environment, be it at launch or a little further down the line when revenues don’t live up to expectations.

The Persephone trial is striking example in a trend for governments and clinicians to step in to generate data when pharma can’t or won’t.

First up is the US approval of Novartis and Amgen’s first in class migraine drug Aimovig, where the pharma partners have gone in with a much lower launch price than expected. Read more:

As Repatha gets expanded European label, Amgen offers price cuts for access

Earlier this month Sanofi and Regeneron announced a massive price cut to their cholesterol treatment Praluent in the US in order to perk up disappointing sales – and now rivals Amgen has signalled the price war is on in Europe as well.

Amgen’s Repatha has just been granted EU approval to treat adults with established atherosclerotic cardiovascular disease, an important step towards broadening its uptake.

This puts it ahead of its fellow PCSK9 product and rival, however Sanofi and Regeneron unveiled strong strong cardiovascular outcomes data from their ODYSSEY trial in combination with the huge cut to Praluent's US price, down from $14,600 to between $4,500 and $8,000 a year.

Now that it has EU marketing approval, Amgen is saying loud and clear that it wants to do deals with European healthcare systems,and is willing to offer significant price cuts in exchange for access for more patients.

Amgen is in a hurry as analysts says that Praluent’s cardiovascular data could have the edge on its rival: the ODYSSEY trial showed a benefit in mortality in patients, whereas Amgen’s FOURIER reduced heart attack risks by 27%, stroke risks by 21% and coronary revascularisations by 22%, but didn't provide a mortality benefit.

“With its proven ability to prevent heart attacks and strokes, Repatha offers hope for one of the greatest health challenges we face today. However, the majority of patients in Europe who could benefit from treatment with a PCSK9 inhibitor remain unserved and at risk of a cardiovascular event,” said Anthony Hooper, executive vice president of Global Commercial Operations at Amgen.

He added that Amgen was willing to work with payers to “help manage affordability concerns from increased patient access” and collaborate with healthcare systems to deliver “comprehensive solutions for patients”.

EUROPE

European approval for Cabometyx in RCC

The European Commission has approved Ipsen and Exelixis’ Cabometyx for the first-line treatment of adults with advanced renal cell carcinoma (RCC).

The approval is based on data from the CABOSUN trial, which showed that Cabometyx extends progression-free survival (PFS) in treatment-naive advanced RCC patients with intermediate- or poor-risk disease.

The drug will have to contend with strong competition from a wave of new immunotherapy regimens. This includes BMS’ Opdivo plus Yervoy, which gained US approval last month and showed strong superiority in reducing the risk of death compared to current RCC standard, Pfizer’s Sutent.

ONCOLOGY

Persephone: the Herceptin trial Roche isn’t so keen on

Among the thousands of abstracts released ahead of ASCO, a small but significant minority were from non-industry sponsors, often investigating questions which pharma can’t or won’t.

One stand out in this category is Persephone – a long awaited trial funded by the UK’s Department of Health and NIHR Health Technology Assessment Programme, and looking to see if treatment with Roche's top-selling Herceptin can be cut from 12 months to just six months without compromising the disease free survival in HER2+ early stage breast cancer patients.

The results showed there was no virtually no difference in outcomes: 89.4% of patients taking Herceptin for six months were alive and disease free four years on, compared to 89.8% on a 12 month course.

The study also found that halving the duration of treatment halved the number of women who stopped taking Herceptin prematurely due to heart-related problems, a well known problem with the treatment.

The trial is sponsored by Cambridge University Hospitals NHS Foundation Trust and University of Cambridge, and could have a major impact on how patients are treated in this setting.

Baroness Delyth Morgan, Chief Executive at UK charity Breast Cancer Now (pictured) said:  “This marks a really promising step towards being able to safely offer patients a much shorter course of Herceptin, which could reduce their risk of heart damage while making significant cost-savings for the NHS.

“We now look forward to further results to understand the impact of halving the duration of Herceptin on patients’ quality of life, and to help identify whether there are sub-groups of patients who may still benefit from the 12-month course.

“Herceptin remains one of the most important advances in breast cancer treatment in decades. This crucial study shows the importance of using research to optimise our use of existing drugs and to address the critical issue of overtreatment, making sure patients only receive therapies for the duration that will benefit them.”

The trial comes as numerous biosimilar versions of Herceptin are hitting the market in Europe, though Roche’s subcutaneous formulation will still be widely used in many settings.