Press review

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Police raid German providers of oncology preparations

BERLIN, 20 Dec (APM) - The German police on Tuesday carried out a large-scale raid on pharmacies and pharmacy service provider Cytoservice selling oncology preparations, Frankfurter Allgemeine Zeitung (FAZ) reported on Wednesday (p20).
In addition, 14 pharma company heads, pharmacists and physicians were arrested over allegations of bribery and billing fraud. Pharmacists allegedly have bribed physicians to make them prescribe the pharmacy's oncology preparations by providing them with office furnishing or other gifts, FAZ said.
Pharmacists are also suspected of running medical service centres without a licence. Zytoservice is said to be the centre of a criminal network, which may have caused millions of euros of damage for German payers, according to media reports.

Novartis plans compassionate use programme for 100 Zolgensma doses

Novartis is planning to give away 100 doses of its $2.1 million-per-patient gene therapy Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy (SMA) in 2020 in a compassionate use programme, FAZ reports on Friday (p22) (APMHE 65591).
The programme applies to countries where the gene therapy is not yet approved.
Zolgensma, with sales of $160 million in the third quarter (APMHE 64820), was approved in the U.S. in May (APMHE 63120). Regulatory decisions in Europe and Japan have been delayed until 2020 (APMHE 63984).

Pharma lobbies plan to merge

German pharma lobbies BPI and BAH have announced plans to merge by summer 2020 to "increase strike capacity", FAZ reported on Wednesday (p16) (APMHE 65533).
FAZ said that the merger offers an added value for pharma companies in light of growing economic struggles in the German healthcare system: "Companies did not want to pay membership fees in several lobbies."
The resulting organisation will represent 90% of Germany's pharma companies and will run against research-focused lobby vfa. "The pressure to merge must be high", as pharma lobbies seem to have lost influence on health policy since BPI achieved its biggest success in the 1990s, FAZ said.

Pharma focused on new cancer drugs

The pharmaceutical industry is focusing on the launch of new cancer drugs, as shown by the 2019 statistics of German research-based pharmaceutical companies association vfa, said Handelsblatt (p26) and FAZ (p18, 22) on Tuesday.
Out of 25 new drugs launched in Germany in 2019, 10 were cancer therapies. Seven out of the 10 target specific tumour mutations, such as Bayer's Vitrakvi (larotrectinib), the first drug to be approved for the treatment of cancer regardless of the organ affected, Handelsblatt said.
All the new drugs, except two, were developed by non-German pharmaceutical and biotech companies. Bayer is the only German company to have marketed new drugs in 2019, with haemophilia A drug Jivi apart from Vitrakvi.

Roche raises sales forecast

Roche's success is remarkable as the company has raised its sales forecast three times in 2019, Handelsblatt says in its yearly review on chief executives and companies on Friday (p67, 73).
CEO Severin Schwan creates "the right climate for innovation and is praised by shareholders, analysts and employees alike", the newspaper says, adding that chair Christoph Franz works hand in hand with Schwan with "determination and a steady hand".
Under Schwan's leadership, Roche has so far been able to avoid the dreaded "patent cliff" on several of its cancer drugs thanks to successful new launches - multiple sclerosis drug Ocrevus or Hemlibra for haemophilia.

Gene therapies are financial challenge for healthcare systems

The growing number of gene and cell therapies are a financial challenge for the healthcare systems, Die Welt said on Monday (p20).
The promise of healing uncurable diseases attracts significant interest. The CAR-T cell therapies approved in blood cancers have shown 60% to 80% success rate in clinical trials but it is still unclear how long the effect lasts.
However pharmaceutical companies have set prices at a high level.
Before the EU approval of Novartis' Zolgensma in spinal muscular atrophy (SMA), two young children with SMA have nevertheless been treated in Germany after health insurance companies agreed to pay $2.1 million for an exceptional U.S. import.
Health insurance companies and experts now fear a copycat effect among patients who would increasingly request early access to such therapies before approval.

Innoplexus partners with fintech to predict pharma stocks success

Tech company Innoplexus, working for pharmaceutical companies, has partnered with fintech Catana Capital to use its artificial intelligence-driven tool to make a better selection of pharmaceutical stocks, Handelsblatt said on Monday (p45).
Innoplexus has developed a tool to evaluate the chance of success of research projects. According to founder Gunjan Bhardwaj, Innoplexus forecasting engine has predicted the outcome of clinical studies for more than 400 active ingredients and has been correct in 85% of cases.
The company has already worked with asset manager Acatis Investment to select assets. However, the track record of such AI funds is mixed and some products have already been closed due to lack of success, Handelsblatt said.

Manufacturing concentration main cause of increasing shortages

The concentration in pharma manufacturing is the main cause of increasing drug shortages in Germany, head of German drugs' regulator BfArM Karl Broich told FAZ on Thursday (p4) (APMHE 65572).
However, Broich said that drug prices also are "a crucial factor" in terms of shortages: "Disincentives are created when drugs are too cheap."
BfArM would receive more authority to intervene in drug shortages under the bill on 'fair competition between statutory payers' (GKV-FKG). Moreover, an advisory board on shortages would be created at BfArM whose recommendations would be binding for local drug authorities, Broich said.

Novartis drops asthma drug candidate fevipiprant

Novartis has dropped development of asthma drug candidate fevipiprant after it failed to show efficacy in Phase III, Süddeutsche Zeitung (SZ) reported on Tuesday (p20) (APMHE 65504).
In May, Novartis' chief executive Vas Narasimhan counted fevipiprant among the five blockbuster drugs in its respiratory pipeline, with launches planned for 2021, SZ said. Analysts believe fevipiprant could have been a blockbuster.

Head of Fresenius HR to leave

Jürgen Götz, Fresenius' long-standing head of human ressources department, is to leave the company in June 2020, FAZ reported on Tuesday (p20).
FAZ gave no information on a new post that Götz would take on. Moreover, no successor has been named so far.

UK and U.S. antitrust authorities back Roche's Spark acquisition

UK antitrust agency CMA and U.S. agency FTC have backed Roche's acquisition of gene therapy maker Spark therapeutics, FAZ reported on Tuesday (p20) and SZ on Wednesday (p19) (APMHE 65525).
The $4.3 billion takeover, which Roche initiated in February, will be completed "soon" after both authorities have granted unconditional clearance, SZ said.
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