Press review


FDA warns Bayer on manufacturing practices

Country : Europe, Germany, Greece

Keywords :
BERLIN, Feb 16 (APM) - The U.S. Food and Drug Administration (FDA) issued a stark warning to German pharma giant Bayer on Tuesday over unsanitary conditions at the company’s German main production site and headquarters in Leverkusen, Frankfurter Allgemeine Zeitung (FAZ) (p23), Handelsblatt (p15) and Die Welt (p10) reported on Thursday,
For Bayer, the FDA action is expected to have only a minor impact financially, but it will nonetheless impact the pharmaceuticals division, Handelsblatt said.
After receiving the letter, Bayer began to implement "corrective measures and modernisation work" at its production facilities in Leverkusen, the papers said (APMHE 56887).
But it warned that this could lead to "temporary supply disruptions affecting our mature product portfolio", including antihypertensive Adalat Oros (nifedipine) and erectile dysfunction drug Levitra (vardenafil).

German payers concerned over planned EU joint HTA

German payers are concerned about European Commission (EC) plans to create centralised European health technology assessment (HTA), FAZ reported on Saturday (p20) (APMHE 56688).
"We fear that the high standards we have in Germany for the evaluation of new drugs will be lowered," said vice-chair of umbrella payer group GKV-Spitzenverband (GKV-SV), Johann-Magnus von Stackelberg.
With low-quality ratings, it will become impossible in the long term to compare drugs in an appropriate manner, said chair of major health insurer AOK Martin Litsch.
The chair of higher HTA body G-BA, Josef Hecken, told FAZ he doubts the EC has the right to carry out HTA. The EC has limited competence in the field of healthcare, where HTA ratings influence what benefits national insurers reimburse.

Successful IPO for Dermapharm

German generic drugmaker Dermapharm has successfully sold all shares offered in its initial public offering (IPO) and has received a gross amount of 377 million euros, FAZ reported on Saturday (p27).
Although Dermapharm shares lost around 6% on its first day of trading, closing at 26 euros on Friday, the IPO is still considered a success given the current stock market turmoil.
Dermapharm's owner Wilhelm Beier is a secretive business man, FAZ said on Wednesday (p22). He never talks to the press about his business, not even the IPO. In 2016, he surprised business circles by putting Dermapharm up for sale and then unexpectedly cancelling in the middle of talks with a private equity group (APMHE 47442).

Doubts on Fresenius-Akorn deal

Several analysts continue to doubt whether Fresenius will complete its acquisition of U.S. generic drugmaker Akorn, reported Handelsblatt on Thursday (p34-35).
The deal, announced in April 2017, is still awaiting approval from antitrust authorities.
Although Fresenius CEO Stephan Sturm continues to defend the deal (APMHE 56348), investors view it as overly expensive in light of Akorn's sales performance in the second and third quarters of 2017.

No comment from Nestlé on potential consumer health deal

Nestlé CEO Ulf Mark Schneider refused to comment on its alleged attempt to buy Merck KGaA's consumer health unit in an interview with Handelsblatt on Friday (p16).
Nestlé was said to be the lead bidder (APMHE 56368), but walked away from the process after months of negotiations, according to press reports in early February (APMHE 56734).
"We have a policy not to comment on such rumours," Schneider said, adding that rumours were often "used in all kinds of transactions, often to bid up prices in auctions as well".
Nestlé is acting with caution in its acquisition policy, Schneider said. "We do things step by step, especially when it comes to the health sector."
Schneider said a $2 billion deal to purchase Canadian vitamin maker Atrium Innovations has not yet been concluded.

Gedeon Richter under pressure

Hungarian drug manufacturer Gedeon Richter is under pressure from a European safety warning on its uterine fibroids drug Esmya (ulipristal acetate), FAZ reported on Wednesday (p20).
Its shares fell by more than 10% on Monday after the European Medicines Agency (EMA) recommended suspending prescriptions of the drug while a review of liver damage is carried out (APMHE 56827).
Esmay is one of Gedeon Richter's biggest products. Its sales grew by 35% in 2016, to 93 million euros.

Greek PM calls for investigation into Novartis' alleged bribery

Greece’s prime minister Alexis Tsipras on Monday urged the national parliament to probe politicians in an alleged drug bribery case involving Novartis, reported FAZ (p18), Handelsblatt (p46) and Sueddeutsche Zeitung (SZ) (p20) on Tuesday.
Greek prosecutors referred the case, involving two former Greek prime ministers and eight ministers, to parliament last week. The politicians have been named in connection with allegations that Novartis bribed officials to get its drugs prescribed (APMHE 56779).
Novartis said it would take "fast and decisive action" if an investigation into alleged bribery in Greece were to find that its managers had engaged in unethical or illegal conduct.

Digital agenda for healthcare

For patients' sake, Germany needs to establish a digital agenda for the national healthcare system, with a programme that prioritises digital responsibility, transparency and literacy, SZ reported on Monday (p20).
Many citizens are concerned about the protection of their health data, but this can and must be overcome by education. The new federal government should think less about what is in the best interest of preserving the system and more about the patient, the paper said.
The prohibition of remote diagnosis in the ruling coalition's agreement must be abolished, it said. Also, digital budgets for health insurance companies and outpatient care must be introduced and digital solutions such as online consultations and health apps should be reimbursed.



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