Press review

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Patient involvement challenges payers on access to Novartis' Zolgensma in Germany

BERLIN, 24 Jan (APM) - Involvement by patients' families is challenging economic decisions on Novartis' gene therapy Zolgensma (onasemnogene abeparvovec), while its decision to draw by lot 100 doses, has raised many questions in Germany, Süddeutsche Zeitung (SZ) (p3), Handelsblatt (p3, 6-7) and Wirtschaftswoche (p54-55) report on Friday.
The "usual routine" of health economic decisions taken among health politicians, payers, physicians and pharma companies is being "criss-crossed" by families with a child with spinal muscle atrophy (SMA) type 1, SZ said.
Several families in Germany have drawn public attention through tabloid and social media to raise funds, up to $2 million, to buy the therapy directly as payers were refusing to cover the costs (APMHE 65019). However, three children in Germany have received Zolgensma treatment to date, with payers finally covering the costs of the drug imported from the U.S., the only country where it is approved.
A fourth child will be treated as the Berlin social court ruled this week that the health insurance must cover the cost, while procedures are ongoing with two other children, Handelsblatt said.
Marina Mantel, mother of one-year old Michael, told SZ how she managed a fund-raising campaign on Instagram, collecting €1.3 million before getting the payer's approval - a sum she now intends to redistribute to other families and research on SMA.
German payers are warning against safety risks as Zolgensma is still under review by the European Medicines Agency.
Novartis has not played any role in these private initiatives or the media coverage, Andrea Hofmaier, Germany head of Novartis' subsidiary AveXis's told Handelsblatt.
Hofmaier also justified the limited access to Zolgensma and the worldwide compassionate programme (APMHE 65591) by the current limited manufacturing capacity.
There will be no quotas per country and a patient who is not selected in a round will automatically move to the next round, Hofmaier told Handelsblatt and Wirtschaftswoche.

Mediator may settle Bayer's glyphosate litigation in a month

Mediator Kenneth Feinberg told Bloomberg he is "cautiously optimistic" of reaching a settlement over U.S. litigation involving Bayer's glyphosate-based Roundup weedkiller within a month, FAZ (p28) and SZ (p28) reported on Saturday.
Bayer refused to comment on Feinberg's view. SZ expects that the group will give an update in its presentation of the full-year results on 27 February.
Bayer said that the number of plaintiffs runs well below 50,000, while Feinberg spoke of 75,000 to 85,000 plaintiffs. However, some documents might not have been transferred yet, SZ said.

Alliance for epidemic innovations to fund three corona virus vaccine projects

The Coalition for Epidemic Preparedness Innovations (CEPI) has announced it will fund three projects to develop vaccines for the new corona virus that has been causing an epidemic in China during the past week, FAZ reports on Friday (p22).
CEPI, founded in 2017 (APMHE 51400), has raised €750 million so far, of which €90 million come from Germany, FAZ said.
German biotech BureVac has been granted funding of €30 million for a mRNA printer technology that could speed up vaccine development, which could be "particularly useful for a quick reaction on viral epedemics, such as the corona virus", CureVac's chief technology officer Ma­rio­la Fo­tin-Mlec­zek told FAZ.

Merck KGaA confident on its pipeline

Merck KGaA has a "very healthy pipeline", which could make up for failures of its more advanced candidates, the company's chief executive Stefan Oschmann told Handelsblatt in an interview published on Monday (p6-7) (APMHE 65908).
A Phase II trial is comparing Merck's bintrafusp alfa (former M7824) against Merck Sharp & Dohme's Keytruda (pembrolizumab).
Oschmann said that Merck has decided to enter into partnerships with other companies in cancer research, as this area requires a certain company size to be competitive.
Oschmann named the examples of its cancer immunotherapies Bavencio (avelumab), developed with Pfizer, and bintrafusp alfa, for which Merck partnered with GlaxoSmithKline.

German pharma lacks transparency on payments to doctors, institutions

Despite promises, payments made by pharma companies to doctors in Germany are lacking transparency, Handelsblatt said on Tuesday (p20-21).
Doctors and medical institutions such as clinics and research institutes are receiving increasing sums of money from the pharmaceutical industry, but a growing number of them are refusing the publication of their names.
The self-monitoring ethics and transparency watchdog, FSA, is supporting the move instead of pushing for more transparency, Handelsblatt said.

Drug traces in waste water heavy burden for environment

Drug traces are a heavy burden for the environment and possibly for people, FAZ reported on Sunday (p53).
The effects of drug traces on people are unknown, but have been shown for water animals. For instance, analgetic and psychotropic drugs and hormone therapies influence health and behaviour of fishes. It is also suspected that traces of antibiotics may cause resistance in bacteria, FAZ said.
Two years ago, a pilot for a fourth layer of waste water treatment was initiated near the Bavarian city of Nürnberg. It showed that, with a combination of ozonisation and filtering, 82 to 92% of trace substances can be removed. Only 20% of trace substances can be eliminated from waste water using current cleaning technology.
To date, financing models and threshold levels for wastewater treatment are missing, as there is no regulation on trace substances at a national level.

Doctors call for European strategy against drug shortages

Europe must take the lead in the search for solutions to solve the increasing number of drugs' shortages, Frank Ulrich Montgomery, chair of the European Medical Association said, Die Welt reports on Friday (p9). (APMHE 65964)
The issue is not only a national or a European, but a worldwide problem, Montgomery said.

Research on superbugs inadequate

Only eight pharma companies are conducting research on drugs able to fight superbugs, although it should be a high priority field, Die Welt said on Wednesday (p12).
Access to Medicines Foundation conducted a review on progress and setbacks in antimicrobial resistance research in a report published this week (APMHE 65945).
The bankruptcies of Achaogen and Melinta - two antibiotic biotech companies which were able to gain approvals for new drugs - showed that a successful clinical development is not enough to become a profitable business.
The World Health Organization (WHO) has also warned that "there has never been a greater threat and need for solutions to deal with the threat of resistant pathogens".
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