Press review


German biotech BioNTech enjoys record financing

BERLIN, 12 July (APM) - BioNTech's $325 million record private fund raising round sparked great excitement for the immunotherapy specialist, said Handelsblatt (p21) and Frankfurter Allgemeine Zeitung (FAZ) (p18, 44) on Wednesday.
Two thirds of the total sum came from new investors from Asia, the U.S. and Europe, while its largest investor, the Strüngmann family office, also contributed. BioNTech's last financing round amounted to $270 million in January 2018, which was at the time the largest financing of any biotech company in Germany.
Such an amount "is normally collected by the entire industry in one year", Siegfried Bialojan, head of the German Life Science Center of consulting firm EY told Handelsblatt.
BioNTech, which has seven candidates in early stage clinical trials, will use the cash to fund studies of the candidates and expand its manufacturing capacity.
In an editorial, Handelsblatt (p28) raised concerns that BioNTech's success would mask the difficulty other German biotechs have in raising money, especially from European investors.

Germany's BfArM to lead HTA for digital health products

German drugs' regulator BfArM will be responsible for the approval and health technology assessment (HTA) of digital health products from January 2020, under the "better care by digitisation and innovation" (DVG) bill presented on Wednesday, FAZ (p16) and Handelsblatt (p6-7) reported on Thursday (APMHE 63657).
Digital products, like smartphone apps, could be covered by statutory health insurance at a launch price chosen by their developer who then would have to collect data to support their claim to improve patient care during a year and submit these data to BfArM for an HTA procedure.
Health minister Jens Spahn wants to accelerate the use of digital health apps which medical benefit is proven, as healthcare start-ups have complained about hurdles in bringing their products to the German market, FAZ said.
In a cross interview with Ada Health founder Daniel Nathrath, who develops diagnostic apps, Spahn said that apps will help physicians and patients to optimise quality of care.

Merck KGaA develops robot to diagnose thyroid disease

Merck KGaA has developed a robot able to check for thyroid disease, says Handelsblatt on Friday (p19).
It is aimed at raising awareness of the disease which often remains undiagnosed. Merck provides the service free of charge and hopes to refinance it if more people are prescribed the company's drugs in the future. The company especially targets the U.S. and Asian markets.
The robot, developed by Merck with Swedish firm Furhat Robotics, includes a software from diagnosis app developer YourMD.

End of homeopathy reimbursement in France finds echos in Germany

The decision by France's health minister to end reimbursement of homeopathic products from 2021 has given new arguments to German globules opponents, weekly Wirtschaftswoche (p60-61) on Friday, FAZ (p15) and Die Welt (p20) on Thursday.
Head of health technology assessment (HTA) body Josef Hecken, told FAZ that Germany should follow France's example as the reimbursement contradicts the general principle of evidence-based medicine.
A fierce debate involving manufacturers, payers and physicians from both sides has been ongoing for months in Germany about homeopathic products which are partially reimbursed on demand - and not automatically as drugs - by German statutory health insurance companies.

German doctors sceptical about female libido drug Vyleesi

German physicians are sceptical about the effect of Palatin Technologies/AMAG Pharmaceuticals' Vyleesi (bremelanotide), approved as a female sexual stimulant for premenopausal women last week by the U.S. Food and Drug Administration, FAZ reported on Sunday (p53) (APMHE 63440).
They doubt whether the drug could increase patients' desire, as libido is considered too complex to be augmented via the hormone system and are concerned about Vyleesi's side effects such as nausea and headaches, FAZ said.

Pharma prices do not have to be revealed in U.S. TV ads - court ruling

The U.S. Ministry of Health cannot force pharma companies to publish their prices in television advertisements as the U.S. Congress has not authorised this action, a federal judge has ruled, FAZ reported on Wednesday (p19) (APMHE 63632).
Amgen, Merck & Co and Eli Lilly had filed a lawsuit challenging the proposed rule for TV ads (APMHE 63350).

Antibiotics weaken flu defences

Antibiotics can leave the lung vulnerable to flu viruses, leading to significantly worse infections and symptoms, according to a study in mice published in Cell reports, Die Welt on Wednesday (p20) reported.
Inappropriate use of antibiotics "not only promotes antibiotic resistance but may also leave us more vulnerable to viruses", said Andreas Wack, who led the research at the Francis Crick Institute.

M&A focus on gene therapies

During the first half of this year, pharma companies and biotechs have been focusing on gene therapies for mergers and acquisitions (M&A), according to a study by consulting firm KPMG, FAZ wrote on Monday (p20).
Takeovers - such as Roche offering $4.3 billion for Spark Therapeutics (APMHE 63624) - become more and more attractive, according to the study, as the global advanced medicines therapy products (ATMP) market could grow 13% a year, reaching a volume of $50 billion by 2025.

Reckitt Benckiser settles U.S. opioid litigation for $1.4 billion

UK healthcare group Reckitt Benckiser will pay up to $1.4 billion to settle all U.S. federal over marketing strategies of opioid addiction treatment Suboxone (buprenorphine+naloxone) film by its former prescription pharmaceuticals business Indivior, FAZ reports on Friday (p20) (APMHE 63658).
At the same time, Indivior announced on Thursday that Suboxone sales declined at a slower pace than expected, prompting Indivior to raise its 2019 guidance to $670 to $720 million, FAZ said (p23).



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