Press review


Germans hope cheaper Truvada can curb new HIV infections

BERLIN, Dec 8 (APM) - The 87% price cut in Germany of Gilead's HIV drug Truvada (emtricitabine+tenofovir) for pre-exposure prophylaxis (PrEP) for HIV prevention has raised hopes of lowering the country's intractable rate of new HIV infections, Die Welt reports on Friday (p5).
Before the price drop (APMHE 55871), Truvada for PrEP was prohibitively expensive in Germany because it is not covered by health insurers in this indication. Procuring the drug at a reasonable cost was only possible thanks to the EU's open trading borders and some determination.
The new price is expected to significantly increase access to the drug in Germany and has led to hope among healthcare professionals of stemming the roughly 3,000 annual new cases of HIV infection - a number which has remained stagnant for years, the paper said.

Bayer loses first trial on Xarelto safety risks in U.S.

Bayer and Janssen have lost their first case in a series of U.S. trials over their failure to warn of internal bleeding risks with anticoagulant Xarelto (rivaroxaban) (APMHE 55936), Handelsblatt (p19) and the Frankfurter Allgemeine Zeitung (FAZ) reported on Thursday (p25).
The companies have been ordered to pay $27.8 million in damages to a woman from Indiana, U.S. and her husband after she was prescribed Xarelto to prevent stroke and was subsequently hospitalised with severe gastrointestinal bleeding, the papers said.

Sanofi's dengue vaccine under investigation in the Philippines

The Philippines has ordered Sanofi to stop the sale of its Dengvaxia dengue vaccine and has launched an investigation, reported Handelsblatt (p22) on Tuesday and Sueddeutsche Zeitung (SZ) (p16) and Die Welt (p10) on Wednesday. (APMHE 55897)
The investigation should clarify if and when Sanofi has warned of the possible dangers of Dengvaxia and how the officials in the health ministry have responded.
Sanofi previously announced that it found evidence that Dengvaxia worses dengue in people who have not previously been exposed to the infection. The Philippines has already immunised nearly 734,000 children aged nine and over.

Bayer/Monsanto takeover makes progress in U.S.

Bayer's $66 billion takeover of U.S. seeds giant Monsanto has been cleared by the committee on foreign investment in the U.S. (CFIUS) (APMHE 55859), FAZ reported on Saturday (p26).
Bayer still has antitrust hurdles to overcome in both the U.S. and Europe, but the CFIUS clearance is significant because a number of deals have been derailed this year by committee objections, the paper said.

Deadline approaches for offers for Merck KGaA's OTC division

Purchase offers for Merck KGaA's non-prescription drugs division should be submitted by December 15, writes Wirtschafts Woche on Friday (p46-48).
Head of Merck's healthcare operations Belen Garijo is spending much of her time before Christmas looking for a potential buyer, writes the weekly in a portrait.
The transaction is expected to be completed in 2018.

Bayer eyes non-organic growth opportunities in cancer

Bayer intendeds to supplement its proprietary cancer research with purchases of active ingredients from outside businesses, FAZ reported on Saturday (p26).
The announcement comes after Bayer's cancer research unit had to unblind a late-stage patient trial for its prostate cancer drug Xofigo for safety reasons because of an unusually large number of deaths in one arm of the study. (APMHE 55852)
However, the company has not revised its sales expectations for the drug. Bayer still expects peak sales of at least one billion euros for Xofigo, the paper said.

Monoclonal antibodies may be useful against migraine

Monoclonal antibodies such as Sanofi/Amgen's erenumab and Teva's fremanezumab showed positive Phase III results in the prevention of migraine, reported FAZ on Wednesday (p37).
Trials for both drugs demonstrated a significant reduction in the number of migraines and headaches, the paper said.
Both drugs are taken intravenously once a month or every three months, whereas current migraine drugs are tablets taken daily.

Regulatory know-how gives big pharma edge over tech - Merck KGaA

Deep knowledge of drug regulation and experience with payers give pharma the edge over tech companies in the race to be the next-generation suppliers of medicine, Merck KGaA CEO Stefan Oschmann said in an interview with FAZ published on Sunday (p27).
"If you look at the recent successes of technology companies in the field, it's not overwhelming," Oschmann said. Data experts are "agnostic" and do not care whether an application is about "oil drilling or the cancer drug supply chain in Guatemala". This approach collides with the concerns of regulators, he said.
Data analysis has great potential to "radically" improve the use of biomarkers to predict drug effectiveness, he added. Merck is changing its internal culture in order to communicate with "techies" better and to "travel in both worlds," he said.

German pharmacists fear planned CVS/Aetna merger

The $69 billion planned merger between U.S. pharmacy CVS and health insurer Aetna is fuelling fears in Germany that a new wave of mergers will bring Amazon into the pharmaceutical market, Die Welt reported on Wednesday (p12).
Amazon has already shown some interest in entering the German market, Friedemann Schmidt, head of pharmacists' lobby ABDA, told the paper. The CVS/Aetna merger could catalyse a market shake-up extending across the Atlantic, he said.
German pharmacists feel insecure in their market position, particularly in light of the European Court of Justice (ECJ) decision in October 2016 that foreign-based mail order pharmacies have no obligation to respect the German fixed sales prices for prescription drugs (APMHE 50062).

Statutory payers under investigation for fraud

The Hamburg public prosecutor's office has been investigating fraud allegedly committed by several statutory healthcare payers including AOK Rhineland/Hamburg for over a year, Die Welt reported on Monday (p10).
The insurers have been accused of colluding with doctors to document as many severe illnesses as possible for their members, so that they get more compensation from government health funds, the paper said.
In addition to the AOK, the head of TK Jens Baas is also under investigation, the paper said.

Citizens' insurance programme not worth the effort

One potential consequence of another grand coalition in Germany between the conservative (CDU) party and the social democrats (SPD) is the formation of a "citizens insurance" in Germany to replace the current statutory and private insurance schemes, SZ (p17) and Die Welt (p2) reported on Tuesday.
While in theory the "two-class" system is not entirely fair, every citizen gets what they need when medically necessary and an overhaul would be expensive and labour-intensive and not worth the effort, SZ said.

'Wise decision-making' needed in antibiotic prescribing

"Wise decision making" as espoused by the German Society for Internal Medicine and "thinking twice" as encouraged by the WHO in recent PR campaigns are what is necessary to curb unnecessary antibiotic use, SZ reported on Tuesday (p2).
Well-trained doctors, laboratory specialists and proper hygiene are needed to effectively counter the threat of resistance, the paper said. Healthcare payers should understand that investment in these areas is imperative and ultimately cost-effective.
Patients should understand that antibiotics are not a panacea and that not every trivial infection needs to be treated with them, the paper said.



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