Press review

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Bavencio is Merck KGaA's first European cancer drug approval in 13 years

BERLIN, Sep 22 (APM) - The approval of Merck KGaA's cancer drug Bavencio (avelumab) in Europe is its first in 13 years, reports Frankfurter Allgemeine Zeituig (FAZ) on Friday (p41).
Merck, which developed Bavencio with Pfizer, announced the approval in a rare type of skin cancer on Thursday (APMHE 54798).
Bavencio is considered Merck's next potential blockbuster, FAZ says.

Decision on Monsanto takeover delayed slightly

The final decision on Monsanto takeover by Bayer may be made at the beginning of 2018 instead of the end of 2017 as initially planned by Bayer, Sueddeutsche Zeitung (SZ) reported on Wednesday (p15).
Bayer's head of crop science, Liam Condon, said that Bayer has asked the European Commission to extend the audit period to January 22.
"In view of what we want to achieve, a few weeks more or less make no difference," said Condon.
Bayer apparently needs more time to explain to the EU antitrust authorities its view of the future business.

Germany too far behind in healthcare data collection - Roche

Roche's chief executive officer Severin Schwan said data are collected digitally in more than a dozen EU countries whereas "Germany does not even have an electronic health card", in an interview with FAZ (p25) on Sunday.
Schwan advocated a less strict regulation in health data protection in Germany and the use of anonymised data so that the country does not fall by the way side (APMHE 54749).
Digital data collection is necessary to reimburse new immuno-oncology drugs according to the real benefits they provide individual patients, he said.

Boehringer's CFO has clear stance on pharma profitability

Boehringer Ingelheim's chief financial officer Simone Menne says pharma has a social responsibility and offers her stance on the issue of generating a profit from disease in a Monday interview with SZ (p18).
Pharma rightly derives a profit because it relieves and cures people, she said. "The alternative would be to no longer generate medical progress or finance research and medicines through taxes," she said.
"Good margins are only earned when you're first on the market," and are used to finance products in development and to cover costs of failed drugs, Menne added.
Menne expressed hope for the potential of big data to speed up new drug discovery and development and to save on costs. She acknowledged Germans are more cautious than other nations when it comes to sharing data but "caution can slow progress".

CFO's do more than count figures

Evelyne Freitag, Sanofi Germany's chief finance officer, sees her role as more than just counting figures, she said in an interview with FAZ on Wednesday (p38).
Freitag, in position since April, wants to "shape new business models" using figures and data, she said.
Those were her words in the 90s with Daimler's subsidiary Smart by working on the then new car-sharing and "pay-per-use" concepts. Prior to Daimler, Freitag helped reshape finances and supply chain management at Pfizer Germany, managed the German, Austrial and Swiss business of tire manufacturer Goodyear Dunlop and consumer goods group Kraft.
Freitag is not concerned by the low number of women in senior pharma positions. "This is typical German issue," she said.

Internal investigation at Stada continues

The investigation into possible breaches of duty by former Stada managers continues, reported Handelsblatt on Monday (p23).
Among other media, FAZ reported on Saturday (p27) that the inquiry into former chief executives officers Hartmut Retzlaff and Matthias Wiedenfels and former chief financial officers Helmut Kraft was over without having found any evidence of misconduct.
But a Stada's spokesperson confirmed to Handelsblatt that the inquiry is going.

MorphoSys in talks with FDA for fast approval of lymphoma drug

MorphoSys is in talks with the U.S. Food and Drug Administration to get a "fast" approval for MOR208, a drug developed in lymphoma, without specifying which kind, FAZ reported on Saturday (p28).
MorphoSys expects an answer from the FDA by the end of 2017, CEO Simon Moroney told FAZ.
Phase II data on a combination of MOR208 and Celgene's cancer drug Revlimid (lenalidomide) for relapsed or refractory diffuse large B cell lymphoma (DLBCL) are "very promising". Results will be presented at the American Society for Haematology (ASH) congress in mid December.

New drugs approved with less evidence

New drugs introduced in Germany are increasingly expensive but are approved with less evidence, according to the analysis of health insurer TK, reported Handelsblatt on Wednesday (p11) (APMHE 54796).
A growing number of drugs are approved in an accelerated procedure in the EU with lower requirements for efficacy and safety evidence, health economist Gerd Glaeske, co-author the "Innovation report 2017" commissioned by TK said.
Companies should be forced to provide additional data on efficacy and side effects that are missing at the time of approval. An additional assessment should be made compulsory after three years on the market, he said.

EMA homosexual workers concerned about possible move to Eastern Europe

A group of lesbian, gay, bisexual and transgender people (LGBT) who are employed by the European Medicines Agency, sent a letter in August to EU authorities expressing concern about the next location of the agency, reported SZ on Wednesday (p6).
There is a risk that same-sex partners who are not EU citizens will not be granted a residence permit at the new EMA headquarters, they said.
The group did not name any country but clearly Warsaw, Bratislava, Bucharest and Sofia are located in countries which do not recognise same-sex marriages or partnerships, the paper reported.
EMA head Guido Rasi replied to the letter saying that their concerns will be taken seriously.
The issue is delicate for the European Commission. On the one hand, it wants to avoid the impression that the rights of homosexuals are not taken seriously enough but it also does not want to strengthen the current tensions between Eastern and Western EU countries.

Teva sells women’s health business

Teva has made a further step to reduce its debt by selling its women’s health business to the financial investor CVC Capital and U.S. drug producer Foundation Consumer Healthcare for a total of $1.38 billion, reported FAZ on Tuesday (p20) (APMHE 54758).
After selling its contraceptive business Paraguard to Cooper Surgical last week, Teva surpassed its goal of reaching inflows of at least $2 billion through sales, said interims CEO Yitzhak Peterburg.

Antibiotics 'too cheap'

The price of antibiotics must rise in order to reverse gratuitous prescriptions and incentivise research and development into new medicines for multi-resistant bacteria, Die Welt said (p24) on Monday in an interview with head of the German national academy Leopoldina, Joerg Hacker (APMHE 54751).
In addition to price increases, Hacker said greater cooperation between companies and the public sector is necessary to fight growing antimicrobial resistance.
Public funding for the development of reserve antibiotics that will not be marketed but held in case of emergency is essential and must be economically viable, he said.

Dementia awareness

This week is third annual, government sponsored dementia awareness week in Germany, Die Welt reported on Monday (p 24).
With a 99.6% clinical trial failure rate reported in 2014, research in the field has been disappointing, the paper said. Approximately 1.6 million people in Germany have the disease. The German Alzheimer Society estimates that the number could grow to around three million by 2050.

U.S. public insurer restricts access to expensive, but less addictive opioid

U.S. public health insurer Medicare has restricted access to an expensive but less additive painkiller despite the current opioid epidemic, reported SZ on Thursday (p23).
Research by ProPublica, a non-profit investigative journalism organisation, and the New York Times, showed that only a third of the people covered by Medicare have access to Butrans (buprenorphine), a painkilling skin patch which is less addictive than other opioids.
Patients need prior approval if they are prescribed lidocaine patches, which are not addictive. But almost all patients have access to common opioids without barrier.
According to Leo Beletsky, professor of law and health sciences at the Northeastern University, reimbursement schemes have a huge responsibility in the current opioid epidemic.
Several states, including New York and California, have started investigations to gather evidence on addictive potential of painkillers, reported SZ.

U.S. senator criticises Allergan patent protection manoeuvre

Ohio democratic senator Sherrod Brown has criticised the agreement between Allergan and a Native American tribe from New York to sell the patent rights of eye drug Restasis (cyclosporine) in a bid to block generic challenges, SZ reported on Monday (p19) (APMHE 54637).
Brown said the deal "ripped-off" consumers and should not become an acceptable norm. He pledged to work with congress to "close loopholes that drug companies exploit to avoid competition”.
If Allergan's strategy is used by other pharmaceutical companies, it could make things more difficult for generics manufacturers and make it easier for pharma to defend their "monopoly" on medicines, the paper said.
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