Press review

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Recalls of ranitidine-based stomach acid blockers started in Germany

Country : China, Germany, Ireland, Switzerland, U.S., UK

Keywords :
BERLIN, 20 Sep (APM) - Several pharma companies have issued recalls of ranitidine-based stomach acid blockers due to N-nitrosodimethylamine (NDMA) impurities in Germany, Süddeutsche Zeitung (SZ) reported on Thursday (p22).
The recalls of drugs manufactured by Saraca Laboratories come after the European Medicines Agency began investigations earlier this month (APMHE 64362). It remains unclear if other manufacturers or which drugs are involved, SZ said.
Germany's drugs' regulator BfArM said on Tuesday that traces of the potential carcinogen NDMA have been found in some ranitidine-containing drugs that are available over the counter and on prescription in the country.
According to major payer AOK, 748,000 packages of ranitidine-based drugs were prescribed in Germany in 2018.

Fresenius keeps its blood transfusion technology business

Fresenius has decided against plans to sell its U.S. blood transfusion technology business, Frankfurter Allgemeine Zeitung (FAZ) reported on Monday (p19) (APMHE 64370).
Based on a review by investment bank Goldman Sachs, Fresenius confirmed that the transfusion medicine and cell therapies business subdivision of its drug unit Kabi will remain an "important part of the company", which reported sales of €1.1 billion in 2018.
Selling the business to a direct competitor would have raised antitrust measures, which may have reduced the valuation of the deal, FAZ said, referring to industry experts.

Roche confident new drugs will compensate for patent losses

Roche remains confident it will be able to more than compensate for losses in its best-seller cancer drugs with new drugs, according to Pharma head William Anderson, reported FAZ on Tuesday (p18) (APMHE 64388).
The three cancer drugs Avastin (bevacizumab), Herceptin (trastuzumab) and MabThera (rituximab) are expected to lose 9.6 billion Swiss francs in sales due to competition of biosimilars in the five years to 2023, Anderson said on Monday at an investor event in London.
Anderson referred to a consensus estimate by analysts that the recently-launched drugs, which are still in the development stage, should generate total sales revenue of 16.3 billion Swiss francs over the same period.
Roche expects to have 14 blockbusters on the market next year, Anderson said.

German payer incentivises use of Bayer's Gadovist

Regional payer AOK Bayern pays radiologists more if they use Bayer's contrast agent Gadovist (gadobutrol) - they receive a high lump sum of €5,580 per litre as an incentive, instead of a lump sum of €970 for other contrast products, SZ reported on Saturday (p6).
In other regions, lump sums for all contrast agents are also far too high, which creates high expenses for the healthcare system, SZ said. Radiologists buy their supply directly from pharma companies for €800 per litre on average but have received lump sums of up to €4,700, the paper said.
SZ reported in August that lump sums paid by statutory payers to radiologists for contrast agents are too high in five German regions, by €200 millions in total.

Pharma provider Sartorius grows thanks to biotech boom

Pharma provider Sartorius plans steady growth until 2025 thanks the boom in the biological drugs market, Handelsblatt reported on Monday (p18-19).
Its bioprocessing division, which provides materials and equipment for the production of biological drugs such as s bioreactors for cell cultivation, fermenters and purification systems, is expected to achieve double-digit growth in 2019, chief executive Joachim Kreuzburg told Handelsblatt.
Sartorius plans to more than double sales from just under €1.57 billion to around €4 billion by 2025 and increase its operating margin from 25.9 to 28%. "In China, we want to be about three times as big in 2025 as we are today and double our production in the U.S.," Kreuzburg said.

Start-up Qyobo links data on pharmaceutical compounds

German start-up Qyobo is developing an algorithm that links trading data, regulatory information and product lists in order to make information on chemicals and active pharmaceutical ingredients easier to access and compare, Handelsblatt reported on Monday (p27).
Qyobo is one of the 10 start-ups that were distinguished by the Weconomy Wettbewerb award.

Herceptin developers win U.S. clinical research award

The developers of Roche/Genentech's breast cancer drug Herceptin (trastuzumab) Dennis Slamon, Michael Shepard and Axel Ullrich have been awarded U.S. medical prize Lasker-DeBakey Clinical Medical Research Award, FAZ reported on Sunday (p61).
Herceptin has been a "game changer" and has changed the life of millions of breast cancer patients worldwide, leading to a five-year overall survival of 88% for 70,000 patients diagnosed a year globally, the paper said.
Other sections of the award go to immunologists Max Cooper and Jacques Miller for identifying the two classes of B- and T-lymphocytes and vaccines alliance Gavi, FAZ said.

Purdue files for bankruptcy to help finalise opioid settlement

U.S. company Purdue Pharma has filed for bankruptcy to finalise a proposed settlement agreement with more than 2,600 federal and state lawsuits, blaming the company for fuelling the U.S. opioid epidemic, Handelsblatt (p27), FAZ (p1, 18) reported on Tuesday and SZ reports on Friday (APMHE 64368).
Purdue owner, the Sackler family, proposed to transform the company into a public trust dedicated to combat opioid abuse and whose profits are to benefit the plaintiffs.
However, more than two dozen states have rejected the proposed agreement. This is partly because they think it is too easy for the Sackler family to protect their private fortune of several billion dollars, while 130 people die of an opioid overdose each day, SZ says.

Sackler family transfered assets to Switzerland

The Sackler family, owner of the U.S. pharmaceutical company Purdue, which is at the centre of the opioid crisis in the U.S., had transferred at least $1 billion to Switzerland in an attempt to conceal the extent of its assets, Die Welt (p9) and FAZ (p20) said on Monday.
The transfer had been discovered in the course of investigations against Purdue Pharma and members of the family by New York prosecutor Letitia James.

German pharma preparing for Brexit

German pharma companies based in the Hessen region have put in place various measures to prepare for Brexit, FAZ reported on Thursday (p33).
For example, Stada has stockpiled products for the German market, which are manufactured by their UK subsidiary Thronton & Ross. Merck KGaA has stocked up on drugs for export and changed delivery routes to other countries that have passed through the UK.
Fresenius generates only 1.5% of its sales in the UK or Ireland. For drug deliveries from the UK to Fresenius, the company will carry out quality assurance after import, FAZ said.
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