Press review


German MP calls for increased controls on drug quality

BERLIN, 10 Aug (APM) - Following recent scandals over stolen and contaminated medicines in Germany, a drug expert and ruling CDU party MP is calling for stricter monitoring of drug production and finished products in a Friday interview with FAZ (p1 and 15).
Michael Hennrich recommends on-the-spot checks at generic drug plants and left open the possibility of regulatory bodies or generics manufacturers themselves taking direct control of oversight of suppliers in China and India.
According to the federal government, up to 900,000 patients in Germany may have taken contaminated valsartan-containing drugs manufactured by China's Zhejiang Huahai Pharmaceuticals (APMHE 58888).
The MP also said he is considering introducing legislation with stricter quality requirements for tenders made by health insurance companies.
Hennrich also pointed out that local drug control authorities are understaffed, as in the case of German drug wholesaler and importer Lunapharm which - it was revealed in July - had engaged in the illegal sale of stolen cancer products.
In a parallel move, a broad front of German pharmacists, pharma companies and associations are organising a battle against pricing pressure on generics which they blame for the current problems in the generics supply, Die Welt reported on Sunday (p1, 33) and Tuesday (p23) and Sueddeutsche Zeitung (SZ) on Tuesday (p18).
Pharmacists association ABDA is demanding that health insurance companies agree to pay more for generics, allowing for more production in Europe. The pharma industry is seeking political support on the issue.
Die Welt quoted Roche Germany head Hagen Pfundner calling the debate about poor quality and counterfeit drugs as "hypocritical".
"On the one hand, we want innovative industries, high wage levels and top quality products in Germany. But we Germans want to pay as little as possible for it," he said.

Merck KGaA CEO calls for development of outcome-based pricing

Outcome-based pricing must be developed in Germany, said Merck KGaA CEO Stefan Oschmann in an interview with Handelsblatt on Wednesday (p1 and 4-5) (APMHE 59244).
New pricing models based on 'pay for performance' would reflect the real added value of a drug.
"The price must be based on how much better the drug is compared to existing treatment options" and the amount of savings made, for example on hospital stays, Oschmann said.
"We are ready for such a change of system; it is politicians' turn to act," Oschmann added.

Merck KGaA's Q2 results dragged down by strong euro

Negative currency effects have almost wiped out the organic sales increase at Merck KGaA in Q2 2018, reports FAZ on Friday (p18) (APMHE 59262).
Group sales grew only by 0.5% to €3.7 billion, whereas organic revenues jumped by 5.2%.
"We have announced that 2018 will be a year of transition. This impression was confirmed after the first half of the year," said CEO Stefan Oschmann in a telephone conference.

Evotec boosted by partnerships

Sales at biotech Evotec were boosted in the second quarter of 2018 by successful partnerships, reports FAZ on Friday (p18).
Evotec's turnover was up 67% to €174 million in Q2 2018, and it expects more than a 30% increase in total sales in 2018. In early trading on Thursday, its share price rose by more than 3.5% to €8.95 a share, reports FAZ.
However, Evotec needs to increase research and development expenses after the deal made with Sanofi in infectious disease in July (APMHE 58772).

Apogenix to launch asunercept by end of 2020

German biotech Apogenix plans to launch its leading drug candidate asunercept, developed in glioblastoma, by the end of 2020, reported FAZ on Tuesday (p18).
It is currently discussing the final details of a Phase III trial, which is planned to begin in the first half of 2019, with the European Medicines Agency (EMA), Apogenix CEO Thomas Hoeger told FAZ.
Asunercept was granted PRIME status by the European Medicines Agency (EMA) in May 2017 (APMHE 53269).

Stada Q2 growth driven by generics

Growth at German generics drugmaker Stada in the second quarter of 2018 was driven by its generics business, FAZ reports on Friday (p18) (APMHE 59263).
Adjusted generics sales increased 3% to around €352 million in the second quarter and adjusted operating income (Ebitda) was up 25% to €101 million. Chief financial officer Mark Keatly said efficiency programmes were making the biggest difference, the paper said.
The results prove that Stada's new owners, Bain Capital and Cinven, are doing everything they can to strengthen and further develop the company, Handelsblatt writes on Friday (p22).
Despite the momentum from new ownership, employees continue to feel insecure about when the financial investors will sell off their billion-dollar commitment and resell the company, it said.

Roche challenged by biosimilars

Profitability at Swiss group Roche is being challenged by biosimilars that will compete with its three top-selling cancer drugs in 2020, Handelsblatt wrote on Monday (p18-19).
No other pharma company has ever approached such a patent cliff, the paper said. The combined sales of Avastin (bevacizumab), Herceptin (trastuzumab) and MabThera/Rituxan (rituximab) amount to €19 billion, half of Roche's turnover.
Many analysts see Roche facing a hard time and believe that the group will stagnate in the next few years at best.
However, Roche may well prevail thanks to a well-stocked research pipeline, financial strength and the peculiarities of its cancer drugs that may not be reproduced as easily by biosimilars as other biological drugs, Handelsblatt said.

BASF forced to reduce production due to heatwave

Chemicals company BASF has had to cut back its chemicals production, including drug compounds, at its main German plant due to the persistent high temperatures and low water levels in the Rhine, reported FAZ on Saturday (p22).
The low water level in the Rhine has several consequences on BASF's main plant in Ludwigshafen, which uses the water for cooling purposes and receives most of its raw material and goods by ship.
The amount of water withdrawn from the Rhine and the re-entry temperature of the cooling water have been limited by the authorities, and because of the low water levels ships can only transport about one third of the maximum load.



Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to our last stories

Request a trial to assess coverage that includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.


an initial 10 day temporary access of APM Health Europe.