Press review

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Bayer's shares fall to five-year low on fresh legal threat

Country : Germany, Greece, U.S., UK

Keywords :
BERLIN, 17 Aug (APM) - Bayer's share price lost 18% between Monday and Thursday, falling to a five-year low, following multiple legal threats linked to weedkillers produced by newly-acquired Monsanto, Frankfurter Allgemeine Zeitung (FAZ) (p15) and Handelsblatt (p1 and 14-15) report on Friday.
Last Friday's verdict on the carcinogenic nature of Monsanto's Roundup - granting $289 million damages to a victim - dragged the share price down 10% on Monday, reported FAZ (p1 and 22), Handelsblatt (p1 and 14), Die Welt (p9) and Sueddeutsche Zeitung (SZ) (p22) on Tuesday (APMHE 59300).
The shares slid further on Thursday (APMHE 59343) after farmers from Arkansas and South Dakota filed class action lawsuits on weedkiller Dicamba, while a Brasilian federal court has suspended glyphosate use, as reported by weekly Wirtschaftswoche (p8).
In addition, the California Supreme Court turned down Bayer's attempt to keep Roundup's name off a list of known carcinogenic chemicals.
Bayer's CEO Werner Bauman is now under increasing pressure from shareholders who believe Monsanto's legal risk was undermined, analysts told Handelsblatt and reported on Friday. According to Monsanto's most recent publication, 5,200 lawsuits related to glyphosate were pending in the U.S. at the end of February.
However, some analysts pointed out that stock markets over-reacted after Friday's ruling, Handelsblatt said on Tuesday.
The case is a typical example of a jury judgement that may be either dismissed or drastically corrected downwards by professional juges in appeal, Markus Manns, Fund Manager of Union Investment told Handelsblatt.

German regional government under pressure after Lunapharm scandal

Local government of German region Brandenburg is under pressure over allegations that it neglected its duty of drug market surveillance, Die Welt (p5) and FAZ (p4) report on Friday.
Brandenburg's health minister Diana Golze is criticised for delaying action after being informed that Brandenburg-based importer Lunapharma sold cancer drugs that were supposedly stolen in Greece.
Adding to the confusion, Golze, who has set up a task force to investigate, again withdrew Lunapharm's permit as the company's lawyer forced her to take back the first ban.
At least 220 patients have received the drugs, the papers reported. It is still unclear whether the drugs retained efficacy or were damaged because of the unknown terms of transport.
Such a case will be avoided after the EU anti-counterfeit system comes in in 2019, German pharmacist association ABDA told SZ on Monday (p2). A German pharmacist will receive a warning after scanning a pack if the drug has already been registered in another country.

Valsartan recall extends

Multiple recalls of antihypertensive Valsartan in the EU, started in July, have continued after manufacturing issues by a second Chinese manufacturer were identified, reported FAZ (p16) and Die Welt (p12) on Thursday.
One batch of generic drugmaker Aurobindo's valsartan, manufactured by Chinese Zhejiang Tianyu, was recalled from the German market due to a higher level of potentially carcinogenic substance NDMA.
The issue is similar to the one identified with Chinese manufacturer Zhejiang Huahai Pharmaceuticals in July but to a lesser extent. About 900,000 patients are affected by all valsartan products throughout Germany.
On Monday, health minister Jens Spahn told SZ (p1 and 2) that a detailed analysis of the case had started by German and European authorities in order to implement necessary changes "as quickly as possible".

Pfizer and German biotech BioNtech work on flu vaccine

Pfizer and BioNTech, specialised in m-RNA-based drugs, announced on Thursday a joint flu vaccine deal worth potentially $425 million to the German biotech, Die Welt (p9) and FAZ (p19 and 33) report on Friday (APMHE 59338).
BioNTech will receive $120 million in upfront payments and up to an additional $305 million in milestone payments for certain goals.
Under the agreement, Pfizer will assume sole responsibility for further clinical development and marketing of mRNA-based influenza vaccines and acquire a small, but non-quantified stake.

First verdict on Fresenius-Akorn dispute in three months

The first verdict on the legal battle on the aborted acquisition of U.S. generic drugmaker Akorn by German group Fresenius is due in the next three months, reports Wirtschaftswoche on Friday (p54-56).
The last hearing by Delaware Judge Travis Laster takes place on Thursday.
A member of Fresenius supervisory board told the magazine that CEO Stephan Sturm would be in great trouble if the judge rules that he has behaved in an unprofessional way during the acquisition process.

Fresenius fails to stop use of its drugs in death sentence in U.S.

Fresenius has failed in its lawsuit in the state of Nebraska to halt a planned execution using two of its drugs, reported FAZ on Thursday (p7 and 19).
Fresenius claimed Nebraska obtained illegally cisatracurium and potassium chloride drugs included in the lethal cocktail.
A 60-year-old prisoner Carey Dean Moore, convicted of murdering two taxi drivers, was executed by lethal injection on Tuesday.

Biotest reduces first-half loss

Biotest increased its sales by 18% to €200.7 million in the first half of 2018, reported FAZ on Wednesday (p32).
The loss after tax in continuing operations decreased to €8 million from €30.2 million in the prior-year period. In 2017, the recall of the protein preparation human albumin impacted business.

Big data can potentially speed up drug development

Pharma companies see a great potential in the use of big data and digital technologies to speed up drug development and make it cheaper, reported FAZ on Monday (p19)
Novartis is already using Big Data to set up simulation models to rule out mistakes that led to flops in other studies, Novartis' global head of drug development, Badhri Srinivasan, told FAZ.
It may also be easier to recruit patients in clinical trials by identifying which clinics have already conducted studies on similar diseases.
According to data analysis specialist Medidata, control arms in clinical studies may disappear at one point because the appropriate comparative data collected for previous studies can be identified and used.
Roche has already successfully used a "virtual control arm" in a Phase II study on its lung cancer drug Alecensa (alectinib), FAZ said.

EMA head warns on Brexit consequence

Director general of the European Medicines Agency Guido Rasi is warning in an interview with Handelsblatt on Tuesday, about potential drug shortages when the UK leaves the European Union at the end of March.
According to an EMA survey, there are "serious doubts" that 108 medications - 88 human drugs, 20 veterinary drugs - with a UK-based approval can be further marketed after March because manufacturers have run out of time to switch authorisations to another EU country.
Rasi is surprised at how many pharmaceutical companies are unprepared despite multiple warnings in the last two years, he told the Handelsblatt.
Up to 44% of EMA's 900 employees could leave the agency before the move to Amsterdam, above the first estimate of 20%, Rasi said.
However, he remains optimistic about the continuation of activity as the EMA has received more than 3,000 applications on the newly-advertised jobs in Amsterdam.

Novartis snaps up Siemens' compliance head

Novartis has appointed the experienced Klaus Moosmayer from German Siemens as its new head of ethics risk and compliance, reported Handelsblatt on Wednesday (p46) (APMHE 59310).
As Novartis faces accusations of misconduct in several countries, including Greece (APMHE 56854) and the U.S. (APMHE 58940), Moosmayer's expertise is welcome, Handelsblatt said.
Moosmayer was in charge of negotiating the settlement of a bribery case in public works contracts that ended with $1.6 billion with American and European authorities in 2008.

Pharma-sponsored seminar not certified

Tuesday's SZ reported (p 15) that Baden-Württemberg regional doctors' association has denied certification to doctors who had attended a pharma-sponsored continuing medical education event organised by OmniaMed in Stuttgart.
Anti-corruption doctors' association Mezis welcomed the decision as it believes that OmniaMed has breached the German law on a regular basis.
According to Mezis's analysis, 90% of referents hired by OmniaMed for its medical events were paid by sponsors and up to €200,000 in sponsoring went into one-day-events, although medical training events in Germany must be free of economic interests.
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