Bayer CEO’s term extended, makes progress on Roundup settlement

Bayer boss Werner Baumann’s contract has been extended until 2024, in a show of support from the drugmaker’s new chairman just months after the company agreed an $11 billion outline settlement of U.S. lawsuits over its Roundup weedkiller.

In a statement late Thursday, Bayer also said it was making progress in finalising the settlement of claims that Roundup and other glyphosate-based herbicides cause cancer, which Bayer inherited as part of a $63 billion takeover of Monsanto.

A judge in July raised concern about an agreement with plaintiffs’ lawyers on how to handle a class of claims that may be brought in the future, throwing the overall settlement deal into doubt.

“The details of the revised class plan will be finalised over the coming weeks and a motion for preliminary approval will be filed (with the court) upon completion of the formal agreement,” Bayer said.

Just weeks after becoming chief executive in 2016, Baumann unveiled plans to purchase Monsanto.

He had the full backing of then-Chairman Werner Wenning, who retired in April this year and was succeeded by Norbert Winkeljohann, a former head of six European countries at auditing and consulting firm PwC.

Shareholders denied Bayer’s top management a largely symbolic vote of confidence at the 2019 general meeting after the legal problems, but Baumann and his team won the investor vote at this year’s iteration.

Ingo Speich, head of sustainability and corporate governance at mutual funds firm Deka Investment, remains critical.

“The timing of the contract extension is surprising because no significant legal dispute has actually been resolved,” he told newspaper Rheinische Post.

Baumann’s new three-year contract will start from April 2021. The 57-year-old said he could have been given up to four more years, but opted for a shorter contract to “accommodate my personal plans”.

Winkeljohann said he expected “the glyphosate litigation will be handled in a way that is satisfactory for the company, makes economic sense and is structured in a way that enables potential future cases to be efficiently resolved.”

Bayer’s shares were up 1.3% at 1250 GMT on hopes for a final resolution to the legal dispute.

The arrangement on future cases is unprecedented because glyphosate will remain on the market without a cancer warning, with the backing of the U.S. pesticides regulator.

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/Bayer-CEO-s-term-extended-makes-progress-on-Roundup-settlement-31269471/?countview=0

Galapagos’ Ziritaxestat successful in systemic sclerosis study

Galapagos (NASDAQ:GLPG) perks up 8% premarket on the heels of positive top line results in the Phase 2a NOVESA trial with investigational ziritaxestat (GLPG1690) in patients with diffuse cutaneous systemic sclerosis (dcSSc), a severe autoimmune disease. The trial enrolled 33 patients.

Ziritaxestat reached the primary endpoint of the study with a statistically significant change from baseline in the modified Rodnan Skin Score (mRSS) at Week 24, of -8.3 (1.2), p=0.0411 vs -5.7 (1.7) for placebo.

GLPG1690 was generally well-tolerated. No deaths were reported.

94% of patients (31 of the 33) who completed the trial continued in the long-term open-label extension trial.

Ziritaxestat is a small molecule, selective autotaxin inhibitor co-developed with Gilead Sciences.

https://seekingalpha.com/news/3613202-galapagos-ziritaxestat-successful-in-systemic-sclerosis-study

Genentech’s Ocrevus shows positive action in multiple sclerosis study

Roche (OTCQX:RHHBY) unit Genentech announces new data from Phase IIIb CASTING study that shows Ocrevus (ocrelizumab) is a highly effective treatment option for people with relapsing-remitting multiple sclerosis (RRMS) who experienced a suboptimal response to their prior disease modifying therapy (DMT). Findings will be presented at the MSVirtual2020 meeting.

Approx. 75% of RRMS patients (492/658) had no evidence of disease activity (NEDA; brain lesions, relapses and worsening of disability) two years after switching to twice-yearly Ocrevus treatment in the primary analysis of the CASTING study.

Further, 78% of patients treated with only one prior DMT compared with 70% treated with two prior DMTs achieved NEDA.

A 97% treatment persistence for Ocrevus patients at 18 months, and strong adherence to infusions every six months, was seen in an interim analysis of more than 1,600 patients in the ongoing German CONFIDENCE study.

The CD20-directed cytolytic antibody, dosed every six months, is the only therapy approved for both relapsing (including relapsing-remitting MS) and active, or relapsing, secondary progressive MS (and clinically isolated syndrome in the U.S.) and primary progressive MS.

https://seekingalpha.com/news/3613228-genentech-s-ocrevus-shows-positive-action-in-multiple-sclerosis-study

MediciNova rallies on preclinical data for rationale of COVID-19 vaccine

MediciNova (NASDAQ:MNOV) is up 13% premarket on light volume in reaction to the announcement of encouraging preclinical results on an intranasal RSV vaccine by SARS-CoV-2 vaccine development partner BioComo.

The RSV vaccine, based on BP-PIV and VLP-BC-PIV platform technology developed by BioComo and Mie University, induced high neutralizing antibody titers in mice.

BC-PIV, a non-transmissible viral vector derived from the recombinant human parainfluenza virus type 2 (hPIV2), is the same vector used in their intranasal COVID-19 vaccine candidate.

The RSV vaccine mouse study was conducted at Fraunhofer Institute (IZI) for Cell Therapy and Immunology in Leipzig, Germany. MNOV plans to work with IZI on animal studies for the COVID-19 vaccine.

https://seekingalpha.com/news/3613232-medicinova-rallies-on-preclinical-data-supporting-rationale-of-covidminus-19-vaccine

Lilly’s migraine med lasmiditan successful in another late-stage study

Eli Lilly (NYSE:LLY) announces positive results from a 1,471-subject Phase 3 clinical trial, CENTURION, evaluating 100 mg and 200 mg doses of Reyvow (lasmiditan) for the acute treatment of migraine in adults, with or without aura, across four attacks. The data are being presented virtually at PAINWeek.

Reyvow showed its superiority over placebo on all gated endpoints, including proportions of study participants who after treating their first migraine attack reported pain freedom at 1 hour (200 mg dose), pain relief at 1 hour and 2 hours (both doses), sustained pain freedom at 24 hours (both doses) and 48 hours (200 mg dose), and no disability at 2 hours (both doses).

The proportion of patients achieving pain freedom at hour 2 in the 200 mg arm was 29.3% versus 8.4% in the control arm (p<0.001). The proportion achieving the same endpoint in the 100 mg arm was 25.8% (p<0.001).

The proportions of patients in the 200 mg and 100 mg arms achieving sustained pain freedom at hour 24 were 17.3% and 13.6%, respectively, compared to 4.3% in the placebo arm (both p values were less than 0.001).

Two earlier Phase 3s, SAMURAI and SPARTAN, were also successful. The FDA approved the 5-HT1F receptor agonist in October 2019.

https://seekingalpha.com/news/3613241-lillys-migraine-med-lasmiditan-successful-in-another-late-stage-study

Genetic Technologies up on availability of breast cancer risk assessment test in U.S.

Genetic Technologies (NASDAQ:GENE) announces that initial sales of its GeneType for Breast Cancer Risk Assessment have now commenced in the U.S. via an online health platform, elicity by InTeleLabs, an independent telehealth medicine company.

The secure online health platform enables women meeting the required criteria to purchase the test and receive results via telehealth clinicians.

GeneType for Breast Cancer is a disease risk prediction test that provides results that inform individuals if they are at low, average or high-risk of developing breast cancer.

The test will sell for $249 and include the telemedicine consultations.

https://seekingalpha.com/news/3613259-genetic-technologiesplus-23-on-availability-of-breast-cancer-risk-assessment-test-in-u-s

Atara Bio lead candidate shows sustained benefit in MS

Atara Biotherapeutics (NASDAQ:ATRA) announces updated results from an ongoing Phase 1 clinical trial evaluating lead candidate ATA188 in patients with progressive forms of multiple sclerosis (MS). The data are being presented virtually at the joint ACTRIMS-ECTRIMS Meeting.

Participants in the four cohorts showing sustained disability improvement (SDI) at month 6 maintained improvement through month 12. In addition, a dose-related increase in the number of patients with SDI at month 12 was observed (42% in cohorts 3&4 versus 17% in cohorts 1&2).

Data from the open-label extension with redosing at month 12 showed that all three patients who achieved SDI at that time point maintained SDI at month 15 while one maintained SDI at month 18 and another at month 24.

ATA188 is an allogeneic Epstein-Barr virus (EBV) cytotoxic T lymphocyte immunotherapy that targets EBV antigens that the company believes play a key role in the treatment of MS.

https://seekingalpha.com/news/3613294-atara-bio-lead-candidate-shows-sustained-benefit-in-ms-patients