Press review

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Bayer investigated over Iberogast liver failures and death

BERLIN, 26 July (APM) - The Cologne public prosecution department is investigating whether Bayer might have committed murder by negligence by not flagging potential health risks of its over-the-counter stomach drug Iberogast, Handelsblatt reported on Monday (p20-21), Süddeutsche Zeitung (SZ) (p14) and Die Welt (p11) on Tuesday.
After a reported liver transplant and subsequent death in June 2018, Bayer was forced to add a warning in the leaflet of Iberogast about potential liver damage and a contraindication for use during pregnancy and breastfeeding.
Bayer refused to change the leaflet for 10 years, although over 50 cases of liver damage were known to German regulator BfArM, Handelsblatt said.
Iberogast is one of Bayer's top-selling products, with €120 million in sales.

Bayer damages reduced in three glyphosate lawsuits

U.S. courts have decided to reduce damages awards in all three glyphosate lawsuits that have been ruled, SZ reported on Saturday (p26).
The latest decision came last week when a California judge said a $2 billion award to couple Alva and Alberta Pilliod, granted in May, are not constitutional (APMHE 63769).
Also last week, a U.S. district judge in San Francisco slashed the damages award to Edwin Hardeman to $25.27 million from $80.27 million (APMHE 63721).
In August 2018, a U.S. jury first awarded $289 million to plaintiff Dewayne Johnson, reduced to $78 million in October 2018 (APMHE 60267).
However, the judges in all three cases decided to maintain the juries' decisions instead of dismissing the damages claims, which gives an indication for the 13,400 lawsuits pending over glyphosate-based weedkillers causing cancer, SZ said.

Bayer sells consumer health brand Dr Scholl's

Bayer has signed a deal to sell its foot care brand Dr Scholl's to investment firm Yellow Wood Partners for $585 million, SZ (p17), FAZ (p20) reported on Tuesday (APMHE 63789).
The 110 years-old brand Dr Scholl's generated sales of $234 million in 2018. Yellow Wood Partners will make Dr Scholl's a stand-alone company and will keep on 30 employees in the U.S. and Canada.

Payers and doctors cannot agree on e-prescriptions

Umbrella payer group GKV-Spitzenverband (GKV-SV) and doctors' association KBV cannot agree on a framework for electronic prescriptions, Handelsblatt reported on Thursday (p9).
Under the bill on "better safety in drug supply" (GSAV), expected to come into force at the end of July or in August, umbrella payer group GKV-SV, pharmacists' and doctors' associations have to agree on a regulatory framework for e-prescriptions (APMHE 60672).
The Health Ministry told KBV in a letter that e-prescriptions would not become mandatory for doctors but the choice should be made by patients, but GKV-SV does not agree, Handelsblatt said.

Breath Therapeutics acquired by Zambon in deal worth up to €500 million

Munich-based start-up Breath Therapeutics has been acquired by Italian pharma group Zambon in a deal worth up to €500 million, Handelsblatt reports on Friday (p16) (APMHE 63818).
Zambon said it will pay €140 million now, but that the total deal is worth up to €500 million subject to regulatory and sales milestones.
Breath is working on a inhalation formulation of immunosupressant cyclosporine A in two indications, one of which is preventing graft rejection after lung transplants.

Bayer and Boehringer invest in drug partners for immunotherapies

Last week, major German pharma companies Boehringer Ingelheim and Bayer made investments in biotechs who are working on drug partners for immunotherapies to foster the immune response against solid tumours, Handelsblatt reported on Monday (p19).
Boehringer signed a deal to buy Swiss AMAL Therapeutics in a deal worth up to €325 million, planning to partner AMAL's lead vaccine ATP128 with Boehringer's anti-PD1 compound BI754091 in patients with stage IV colorectal cancer (APMHE 63710).
In a €22 million series A-financing, Bayer has become the main investor in newly-founded U.S. biotech Pyxis oncology.
Pyxis is developing new compounds to turn 'cold' tumours - which do not respond to immunology treatments - 'hot' by stimulating tumour-killing T-cells in the tumour micro-environment, Handelsblatt said.

Executives' association critical of Bayer's M&A strategies

A poll among members of the executives' association of the chemical industry has shown that Bayer's executives are critical of their employer's strategies in relation to the Monsanto buyout, FAZ reported on Saturday (p23).
Of 23 companies, Bayer is 18th in the 2019 edition, whereas it was ranked 9th in 2018. Boehringer Ingelheim is ranked 5th, FAZ said.

Gene therapies

The three gene therapies approved in the U.S. - bluebird bio's gene therapy Zynteglo (lentiglobin) in beta thalassemia, Novartis' Zolgensma (onasemnogene abeparvovec) in spinal muscular atrophy and Sparks's Luxturna (voretigene neparvovec) hereditary blindness - could be cost-effective for healthcare systems even at their high prices, Handelsblatt reported on Tuesday (p20-21).
If Zolgensma one-off treatment is durable, it could save the systems half the expenses for these patients, even considered its $2.1 million price, according to Novartis, Handelsblatt said.
However, new payment models are needed to help payers finance gene therapies. Moreover, new drugs like bispecific antibodies in immuno-oncology therapy could be tough competition to gene and CAR-T therapies, as they are much less expensive, Handelsblatt said.
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