Press review


Germany touts 'moving skills' in EMA charm offensive

BERLIN, Sep 15 (APM) - Germany's health minister Hermann Groehe was in Brussels this week to promote the application of Bonn to host the European Medicines Agency when it leaves London, Die Welt reports on Friday (p15).
"Nobody can manage such moves" better than Germany, Groehe and Bonn's Mayor Ashok-Alexander Sridharan said, Welt reported. Bonn is also offering two years of free rent for the agency and German regulator BfArM - the largest in the EU with almost 1,100 employees - is already located in the city, he said.
There is considerable competition to Bonn, with Vienna offering free rent including ancillary costs for 25 years, Denmark offering the Copenhagen Towers free for 20 years, plus electricity, heating and water and Warsaw offering 50% leasing discount for 10 years and "no indigenous terrorism and no known terrorist organisation," Welt said.

CAR-T therapy spotlight may help Germany's Medigene

The current focus on CAR-T therapies after U.S. approval of Novartis' Kymriah and the acquisition of Kite Pharma by Gilead, may help Germany's biotech Medigene to attract some attention to its business, reported Frankfurter Allgemeine Zeitung (FAZ) on Saturday (p30).
Medigene's TCR gene therapy which is ready to start a Phase I study, may surpass the potential of CAR-T therapies, because it is more sensitive and can recognise and address considerably smaller tumours, Thomas Taapken, CFO since November, told FAZ.
The biotech, listed on the TecDAX for 17 years, has had difficulty convincing the stock market of its value. It has avoided being dropped from the index thanks to a recent 50% jump that boosted its value from 200 to 300 million euros, making it no longer the smallest, but the second-smallest TecDAX company.

Immuno-oncology potential strong

Recent setbacks for some immuno-oncology drugs must not put a shadow on their overall potential, Handelsblatt said on Monday (p20-21).
Negative clinical trial results for Bristol-Myers Squibb's Opdivo (nivolumab) (APMHE 54582), AstraZeneca's Imfinzi (durvalumab) (APMHE 54083) and Roche's Tecentriq (APMHE 53004) do not significantly diminish progress in the area, said Christof von Kalle, head of Germany's National Center for Tumor Diseases (NCT) in Heidelberg.
About 2,000 trials are ongoing for the seven approved immuno-oncology drugs, of which 200 started in May.
There will be other setbacks but also other successes, von Kalle said. Immunotherapies have opened many "new possibilities" in cancer treatment but cannot solve every issue.

'U.S.-compatible CFO for Bayer'

The new chief financial officer recruited by Bayer, Wolfgang Nickl, is a top German manager who is compatible with the potential challenges the company faces in the U.S. after its proposed acquisition of Monsanto, Handelsblatt (p21), FAZ (p22) and Sueddeutsche Zeitung (SZ) (p20) said on Wednesday.
The Monsanto deal will make Bayer more "American" and Nickl's U.S. profile is seen as a plus, said FAZ.
Nickl is currently CFO at Dutch chip supplier ASML but spent almost 20 years in the U.S. working with various IT providers.
Nickl, who will join Bayer at the end of April 2018, was recruited outside of the group, which is a first for the CFO position, to replace Johannes Dietsch, who had been working for more than 30 years at Bayer and was CFO since 2014.
Dietsch will leave at the end of May 2018, in order to accomodate the $66 billion planned takeover of Monsanto.

Bayer sells more Covestro shares

Bayer continues to withdraw from its plastics company Covestro, selling another 19 million of its shares which generated in 1.2 billion euros for the company, FAZ reported on Thursday (p21).
Bayer still owns 31.5% of Covestro which was spun off two years ago, the paper said. Bayer intends to continue easing its position in the "medium term." The move will help Bayer strengthen its balance sheet as it nears the proposed acquisition on Monsanto.

Hexal's generic Truvada accessible at lower cost in HIV prevention

A pilot project has begun making generic of Gilead's Truvada (emtricitabin+tenofovirdisoproxil) available for 50 euros a month only in seven German cities to protect people with a high risk of HIV infection, FAZ reported on Thursday (p9) (APMHE 54660).
According an agreement with a pharmacist, Hexal, part of Novartis's generics arm Sandoz, will provide its generic for pre-exposure prophylaxis (PrEP) for HIV prevention through a special programme. The drug is not covered by insurance in this indication in Germany.

New Teva CEO

Teva has hired experienced pharmaceutical manager Kare Schultz to be its new CEO, although his start date has not been decided yet, Die Welt (p10) and SZ (p18) on Tuesday (APMHE 54631).
Schultz has been at the top of Danish pharma Lundbeck since 2015. Before that he was, with Novo Nordisk, the papers said.

U.S. Native American tribe shields Amgen patents

The Saint Regis Mohawks, a 13,000 member Native American tribe in upstate New York has signed a multi-million dollar deal with Allergan to take the patents of its top-selling dry eye drug Restasis (cyclosporine), in order to protect them, FAZ reports on Friday (p22) (APMHE 54678).
Allergan is transferring the patents because the tribe is recognised as a sovereign government with a special legal status making it immune to certain patent disputes, the paper says. The six patents transferred can be protected by the tribe until 2024.
The $13.75 million upfront payment and potential further $15 million in annual royalties (APMHE 54637) pales in comparison to the $1.4 billion in revenue Restasis brought to Allergan in 2016, the paper said.

Celesio changes its name to McKesson Europe

German drugs wholesaler Celesio has changed its name to McKesson Europe, reported SZ on Wednesday (p22) and FAZ von Friday (p22).
U.S. wholesale 'giant' McKesson took the company over in 2014 (APMHE 37104) but previously had not insisted on a name change, the paper said.
McKesson Europe operates in 13 European countries and generates about 20 billion in annual sales, the paper said.

Payers rely on biosimilars to control costs but uptake slow

With costs of new "tailor-made" drugs climbing to several tens of thousands of euros a year per patient, many health insurance companies are looking to biosimilars as a way to cope, Die Welt (p22) reported on Tuesday.
In 2016, statutory health insurance funds saved around 77 million euros by switching from biologics to biosimilars, according to German payer AOK. This is only a quarter of the total potential, it added. With a more systematic conversion to biosimilars, a further 214 million euros could have been saved.
But doctors are still reluctant to prescribe biosimilars. According to a survey of more than 300 inflammatory diseases specialists from the European Crohn's and Colitis Organization (ECCO), two-thirds said they would not want to convert eligible patients to the cheaper biosimilars because there is no adequate disease-specific knowledge about the effects of such a change, the paper said.

Cancer research not as expensive as claimed

Research by U.S. cancer specialists published in JAMA Internal Medicine shows that research and development investment in new drugs is not as high as manufacturers claim but profit margins are immense, SZ reported on Tuesday (p16).
With $22 billion in sales since it was first marketed in 2014 and R&D of about $300 million, profit from Johnson & Johnson/AbbVie's Imbruvica (ibrutinib), is almost 80-times higher than its development costs, the paper said. The yearly treatment costs of Imbruvica in Germany is 96,000 euros, it added.
This shows that the pharma companies' pricing policies have long been independent of the actual costs of research and development, it said.
According to Germany's higher health technology assessment (HTA) body G-BA, half of new cancer drugs in Germany cost more than 100,000 euros per annual treatment but patients usually only benefit from less than six months of extended survival time, with significant side effects, the paper said.

Severe complications from methadone in cancer

A German oncologist from the Jena University Hospital outside of Leipzig, is warning against using methadone to treat cancer based on her experience treating patients who have experienced severe complications from the drug, SZ reported on Thursday (p14).
In an interview with Jutta Huebner, the paper said methadone is highly addictive and has not been clinically tested yet in combination with cancer drugs so its efficacy in this context is unknown (APMHE 54377).

By 2025 AI systems will dominate healthcare

Economic experts predict that by 2025, artificial intelligence (AI) systems will be used in every part of the healthcare sector, SZ reported on Thursday (p18).
With a total of $667 million spent on AI in the healthcare in 2016, it is the fastest growing market for the new technology. Investment is expected to grow to nearly $8 billion by 2022, the paper said.
IBM medical supercomputer Watson and Google's various AI projects, are currently the most promising candidates for the position of assistant physician, the paper said. However, much more data and systems training are needed before progress will be seen.

Antibiotic use in agriculture decreasing

From 2015 to 2016, the voume of antibiotics used in animals decreased 8% to 742 tonnes, according to the Federal Office for Consumer Protection and Food Safety, Die Welt reported on Thursday (p20).
However, the quantity of broad-spectrum antibiotics used is still high and above the value of 2011. This antibiotic class is of particular importance in resistance formation, the paper said.



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