BERLIN, 1 Nov (APM) - German payers are concerned about the overall costs of the newest therapies for spinal muscular atrophy (SMA), Biogen's Spinraza (nusinersen) and Novartis/AveXis' Zolgensma (onasemnogene abeparvovec), weekly Wirtschatfswoche said on Thursday (p48-51).
Costs for Spinraza, which has been marketed since 2017, is estimated at €460,000 in the first year and €230,000 from the second year, while those for Zolgensma, a one-off gene therapy which is awaiting marketing authorisation in Europe, are expected to be around €1.8 million.
Even if the number of patients is limited, smaller statutory payers could possibly "be driven to ruin". Payer Gemeinsame Betriebskrankenkasse Köln (GBK) was in great difficulty in 2010 because of two haemophiliac patients.
Bayer sees U.S. litigation cases soar
Bayer's glyphosate lawsuits are soaring in the U.S., with the number of plaintiffs having doubled to 42,700 since July, reported Handelsblatt (p1,4-5, 23), Frankfurter Allgemeine Zeitung (FAZ) (p18), Süddeutsche Zeitung (SZ) (p26) Die Welt (p10) on Thursday.
These are considerably greater than Bayer's two other major class action cases - the 11,000 lawsuits filed on blood lipid-lowering drug Lipobay in 2001 or 25,000 on the anticoagulant Xarelto (rivaroxaban), which was settled in 2018, Handelsblatt said.
It now nears the 50,000 plaintiffs in diet pill "fen-phen" case in which Wyeth withdrew the products because of side effects and paid $20 million in a settlement.
Bayer's mediator Kenneth Feinberg told Handelsblatt that the high number of additional lawsuits would not make a settlement "more difficult and significantly more expensive".
The pressure to reach a settlement is growing on Bayer. Estimates of the potential sum vary from $5 billion to $20 billion. From an operational point of view, Bayer posted good third-quarter results (APMHE 64928
), the papers said.
AiCuris looks for Chinese partner for hepatitis B candidate
Germany's AiCuris is looking for a partner in China to finance a Phase II study for its hepatitis B drug candidate acquired with Bayer's anti-infectives pipeline, FAZ reports on Friday (p20).
The study is planned for 2021. AiCuris is offering the marketing rights for China and would market the drug in the remaining world, chief executive Holger Zimmermann told FAZ in an interview without naming the product.
According to Zimmermann, AiCuris is well funded, among others by investors Thomas and Andreas Strüngmann. As the biotech has earned €260 million from licensing cytomegalovirus drug Prevymis (letermovir) to Merck & Co. A stock market flotation is not planned in the near future, Zimmermann said.
Prevymis uptake is "even better than MSD expected", with 15,000 patients treated in the U.S., EU and Japan. Data from an ongoing study in kidney transplant patients are expected for 2021. Newborns, cancer patients and patients in intensive care could extend Prevymis' indications, he added.
Fresenius results better than expected
Fresenius on Tuesday reported better-than-expected financial results, with sales from its drug division Kabi increasing 5% to €1.76 in currency-adjusted terms, FAZ wrote on Wednesday.
In the U.S., Kabi sales decreased organically since the German group stopped profiting from shortages of competitor products for several quarters. Global group sales rose 6% in adjusted terms to €8.9 billion.
On Tuesday, Fresenius' share price rose by up to 6%, which made it the top of German index Dax that day, FAZ said.
Prognosis for paediatric cancer patients improved
The 10-year prognosis for paediatric cancer patients younger than 15 who developed cancer between 2006 and 2015 has improved to 83%, compared to 66% in the 1980s, according to data from the national registry of cancer in children, Der Spiegel reported on Saturday (p60).
New diagnostics such as genetic testing and imaging have refined therapies and lead the way to truly personalised medicine, Der Spiegel said.
Clinical trial evaluates methadone in colon cancer
A clinical trial sponsored by non-profit organisation Deutsche Krebshilfe evaluates methadone in metastasised colon carcinoma, FAZ reported on Tuesday.
The leading hypothesis is that methadone enhances the sensitivity of the tumour to chemotherapy, according to principal investigator Thomas Seufferlein of Ulm University.
Physicians prescribe 10% fewer antibiotics
Physicians in the Hessen region have prescribed 10% fewer antibiotics over the past decade, compared to 11% in the whole of Germany, a report by payer KKH has found, FAZ reported on Tuesday (p24 & 48).
Antibiotics' prescriptions for children up to the age of five have been reduced by 29%.
As 4% of patients catch a bacterial infection while in hospital, 400,000 of which are caused by resistant bacteria EU-wide, 700,000 patients die each year of these infections. By 2050, this number could increase to 10 million, FAZ said.