Press review


R&D 'paradigm shift' needed to prevent pharma slump in Germany

BERLIN, Feb 23 (APM) - Pharma companies are facing limited growth opportunities and will not find their way out of the coming slump without a "paradigm shift" in the way research and development are conducted, Handelsblatt reported on Tuesday (p16-17).
"The pharmaceutical industry is at a crossroads," the paper said, quoting Bayer's head of pharma Dieter Weiland who was speaking at the Handelsblatt Pharma 2018 conference in Berlin (APMHE 56956).
Pharma companies must review their business models and recognise new paradigms such as future medical diagnoses and therapy decisions being made through artificial intelligence (AI) and huge databases, the paper reported.
Outdated R&D models must be replaced with more intensive partnerships in the "scientific world" and, in the future, much less R&D will be done in-house, it said.
Sidonie Golombowski-Daffner, head of pharma for Novartis Germany said: "We need to forge more alliances to improve patient care. Cooperation is necessary not only in research, but also with insurers and technology companies."

Cancer immunotherapies, RNA-based drugs revolutionise medicine

Cancer immunotherapies and RNA-based medicines are leading the revolution in the way diseases are treated, Handelsblatt reported on Tuesday (p17).
This change has had a significant impact on the bottom lines of pharma companies including Bristol-Myers-Squibb and Merck & Co.
The two are a leaders in cancer immunotherapy with the BMS drugs Opdivo (nivolumab) and Yervoy (ipilimumab) and Keytruda (pembrolizumab) from Merck generating sales of around $10 billion in 2017, driving double-digit growth rates in their respective pharma businesses.
Numerous other companies in the industry have meanwhile redirected their research into cancer immunotherapy, the paper said.
Unlike cancer immunotherapy, the RNA-therapy space has not yet been able to come up with any approved drugs. However, after a long period of scepticism, confidence in the technology has grown considerably in recent years. Almost all major pharmaceutical companies have meanwhile invested heavily in alliances with RNA specialists and expectations are high, the paper said.

German biotech Aicuris considers acquisitions and flotation

German biotech Aicuris, boosted by the approval and first launch of a product it partly developed, is considering making acquisitions and a stock market listing, reports FAZ on Friday (p23).
"We are currently scouting for new companies that are synergistic with Aicuris," said Thomas Struengmann, majority owner of Aicuris along with his brother Andreas at a press conference. He added that an initial public offering was an option.
Prevymis (letermovir) against cytomegalovirus (CMV), developed by Aicuris until Phase IIb, was launched in Germany on February 15 by Merck Sharp & Dohme (APMHE 56833).

Merck lowers expectations on price of OTC business

Merck KGaA is ready to lower the selling price for its consumer health business to below 4 billion euros, Frankfurter Allgemeine Zeitung (FAZ) reported on Thursday (p25) (APMHE 56999).
The sale is being hampered by the fact that Pfizer is trying to sell its OTC business at the same time for an estimated price estimated of $20 billion.
Merck's sale has entered a second round of bidding. Interested parties are due to submit binding offers in March, FAZ said.

German generic drugmaker Dermapharm sued over severe side effects from finasteride

German generic drugmaker Dermapharm is being sued over serious side effects such as depression and impotence from its generic version of Merck Sharp & Dohme’s (MSD) baldness treatment Propecia (finasteride), Die Zeit said on Thursday (p13-15).
Propecia has been on the market in Germany since 1999, the paper said. 120,000 prescriptions were sold in German pharmacies in 2017, it added.
An MSD Germany spokesperson told the paper: "In our opinion, there is no reliable scientific evidence for the existence of post-finasteride syndrome." Dermapharm declined to comment on repeated requests from Die Zeit, the paper said.

Medigene's cell therapy given green light for first clinical trial

German biotech Medigene has received approvals for its first clinical trial of TCR therapy MDG1011 in Germany, reported FAZ on Thursday (p25).
German medical regulatory body Paul Ehrlich Institute (PEI) and the clinical trials ethics committee have approved the Phase I/II study design. Around 90 blood cancer patients with acute myeloid leukaemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM) will be recruited.

Green party MP warns of side effects from Bayer's Iberogast

Green party member of parliament Cordula Schulz-Asche has warned the government about the hepatic side effects of Bayer's herbal medicine Iberogast, used for gastrointestinal disorders, reported FAZ on Thursday (p23).
Schulz-Asche criticised the government for not being tough enough on the issue. She said requests from regulatory body BfArM to include safety warning for pregnant and breastfeeding women made in 2008 have been ignored by Bayer.
Bayer told FAZ that no change in the information to patients and physicians is planned.

Healthcare consulting firm buys Mundipharma's German plant

A group of investors led by German healthcare consulting firm Fidelio Healthcare has acquired Mundipharma's German plant, reported FAZ on Wednesday (p20) (APMHE 56979).
The plant was scheduled to close at the end of 2018, after Mundipharma decided to restructure its business in Germany (APMHE 52341).
Investors have signed a three-year supply contract with Mundipharma but the plant will also supply other pharma companies, Fidelio said. Around 100 jobs will be secured.

BfArM prepares itself for Brexit

German regulatory body BfArM is preparing itself to face an increased workload as a consequence of Brexit, reported FAZ on Tuesday (p19).
BfArM has already increased staff numbers by 10% and will continue to hire, BfArM chair Karl Broich said (APMHE 56645). Broich expects a sharp increase in demands on the agency, which is one of the largest in Europe.
Broich warned pharma companies that they must refile drugs which were approved through a decentralised procedure in the UK in a timely manner. This is the case for many generic drugmakers. Otherwise the regulatory agencies will be overwhelmed and some generic drugs may be withdrawn.
BfArM is also prepared to give support to the European Medicines Agency if its business is slowed down in the first months after its move from London to Amsterdam in 2019.

Individual drug imports under threat in Germany

Imports of individual drugs to Germany are threatened by a lawsuit, Handelsblatt said on Monday (p22-23).
Importers of unmarketed drugs are waiting for the ruling of the federal social court to see whether overall costs of an import must be entirely covered by health insurers.
Overall costs include the drug price and transportation costs, which can double the bill. Costs are usually covered by health insurers provided that the patient has proven the necessity of the prescription.
Germany's niche market for individual drug imports consists of a handful of companies, FAZ said. Around one million packages are sold each year, representing less than 1% of total drug sales volume in Germany.

National plan to increase people's health competence

German federal ministry of health has launched "National Action Plan on Health Competence" to increase knowledge on healthcare and the national health system among Germans, reported FAZ on Tuesday (p18).
According to researchers at the University of Bielefeld, one in two people in Germany has limited health competence. They estimate that this lack of knowledge costs up to 15 billion euros a year.
A survey commissioned by health insurer AOK, shows only one in three Germans sees himself in a position to differentiate between serious and dubious health information on the web.

Swiss companies fight for foreign employees

Swiss companies, trade unions and employee associations have formed an alliance to fight back against a popular initiative restricting the rights of EU citizens to work in Switzerland, reported FAZ on Saturday (p26).
Roche is part of the alliance fighting the national conservative Swiss People's Party (SVP) initiative. The SVP wants to cancel the Agreement on the Free Movement of Persons, which allows EU citizens to work in Switzerland.
Roche's CEO Severin Schwan warned that cancelling the agreement would seriously harm Switzerland as a business location. "We would not be able to continue our activities," he said.

Analysts see positive outlook for Gedeon Richter

Pharma analysts are still positive about Gedeon Richter's business despite the European safety warning on their main product Esmya (APMHE 56827), said FAZ on Saturday (p28).
Gedeon's management expects sales of Esmya to shrink by half in 2018 in view of the review by the European Medicines Agency which is expected to be completed in the spring.
According to Raiffeisen Centrobank, the uncertainties with Esmya are already "completely factored in" and Gedeon Richter remains an "attractive" stock.
According to Erste Group, Gedeon Richter shows "solid prospects".



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