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Tuesday, September 18, 2018

Bayer Steps Up Legal Fight Over Weed Killer Blamed for Cancer


Bayer AG is stepping up the legal defense of its flagship weed killer, after a verdict in a recent case alleging the chemical causes cancer sent shares down sharply and raised the prospect of costly plaintiff payouts.
Bayer on Tuesday said it wants a California state court judge to overturn the jury’s verdict, order a new trial or reduce damages, according to a court filing. The company aims to defeat a $289 million award in August in one of the first of thousands of cases filed by gardeners, farmers and others claiming Bayer’s Roundup herbicide gave them cancer.
The jury in that case ruled unanimously in favor of a former groundskeeper who sought to hold the maker of Roundup liable for his non-Hodgkin lymphoma. The verdict came only two months after the German pharmaceutical and chemical conglomerate sealed its takeover of Monsanto, the U.S. agriculture giant that invented the herbicide.
Bayer shares have dropped about 22% since the verdict to five-year lows. Investors fear a lengthy legal battle and more damage awards could cost the company billions of dollars. Some have questioned whether Bayer Chief Executive Werner Baumann properly evaluated the risks of taking over Monsanto in a 2016 deal valued at more than $60 billion, the biggest ever by a German company.
Bayer now faces 8,700 plaintiffs in the U.S., up from a few hundred in the spring of 2016. Bayer has said it expects that number to grow.
“Werner Baumann must ask himself if Bayer took too lightly the lawsuits against Monsanto,” said Winfried Mathes, a corporate expert from Bayer shareholder Deka Investment. The share-price drop has also rattled employees inside the Leverkusen, Germany-based company, according to people familiar with their thinking.
Mr. Baumann has told investors that Bayer’s arguments about science proving the weed killer’s safety will prevail. “We stand behind the product and the science backing it up,” he said on a conference call in August.
In its filing on Tuesday with the California state court, Bayer argued that the plaintiff’s lawyers relied on flimsy scientific evidence that doesn’t support a link to cancer, and that jurors were swayed by overly emotional and speculative arguments from the plaintiff’s lawyers.
Pedram Esfandiary, an attorney for Baum Hedlund Aristei and Goldman PC, which is representing the plaintiff in the case, said the jury verdict demonstrated that Monsanto’s scientific case wasn’t convincing. “I think the odds are very slim of them prevailing,” he said.
Judge Suzanne Ramos Bolanos is expected to rule on Bayer’s requests by late October or early November.
Bayer entered deal talks with Monsanto in 2016 aware of the problems facing Roundup, people familiar with the negotiations said. Still, there were legal limits to how much information Monsanto could share before antitrust officials approved the merger, Bayer has said.
Representatives for the European Union’s competition authority and the U.S. Department of Justice had no immediate comment.
Bayer first learned of dozens of internal Monsanto emails discussing glyphosate’s safety and strategies to publicly defend it as part of U.S. court proceedings. Those emails include what plaintiffs’ lawyers say is evidence of Monsanto ghostwriting articles for outside scientists to defend the chemical’s safety.
After assuming control of Monsanto this summer, Bayer found no “smoking gun” in Monsanto’s internal communications, Mr. Baumann told investors last month. Lawyers representing cancer victims used those internal communications “out of context on purpose,” he said. Monsanto’s scientists and the article authors denied ghostwriting allegations, Bayer said.
The deal made Bayer the world’s biggest supplier of pesticides and seeds for farmers, which now generate nearly half of group sales. Profit margins are slim for Roundup, its top-selling crop spray, but the bulk of the nearly $11 billion in crop seeds Monsanto sells annually are genetically engineered to withstand glyphosate, the potent weed-killing chemical in Roundup.
The International Agency for Research on Cancer, part of the World Health Organization, in 2015 classified glyphosate as likely having the potential to cause cancer. Monsanto fought back, pointing to studies by academics and agencies like the U.S. National Institutes of Health and Environmental Protection Agency that showed no cancer risk.
Legal academics said successful challenges to jury verdicts aren’t uncommon. Last October, another California state judge overturned a $417 million judgment against Johnson & Johnson after a woman alleged that the company’s baby powder contributed to her developing ovarian cancer.
In January, a judge in Pennsylvania state court overturned a jury’s verdict and $28 million in damages and ruled in Bayer’s favor in a lawsuit alleging the company and Johnson & Johnson didn’t properly warn about internal bleeding risks from the drug Xarelto.
“For Bayer, the most important thing is to have a judge say the science doesn’t hold up,” said Alexandra Lahav, law professor at the University of Connecticut.
Bayer has sometimes settled product lawsuits. In 2005, Bayer paid $1.15 billion to settle some 3,000 death and injury claims over its withdrawn cholesterol-lowering drug Baycol.
The company also spent over $2 billion to settle thousands of cases claiming it didn’t adequately inform women of the risk of thrombosis and other side effects from its hormone-based contraceptive pills Yaz, Yasmin and Yasminelle.

Viking has more catalysts in store this fall


Positive results from a mid-stage clinical trial sent Viking Therapeutics Inc. shares soaring 87% on Tuesday.
But don’t tell Viking Therapeutics Chief Executive Brian Lian VKTX, +87.30%  . As of midday, when he spoke to MarketWatch, he hadn’t even checked the stock price.
“It gets distracting if you start checking it all the time,” Lian said, comparing it to when someone has recorded a show and doesn’t yet want to find out what happened.
In the company’s phase 2 trial for non-alcoholic fatty liver disease (NAFLD), Viking Therapeutics’ VK2809 showed reductions in LDL-C and liver fat content, which were the trial’s primary and secondary endpoints, respectively. Though Tuesday’s results pertained to a relatively small number of patients, or 47 across subgroups, NAFLD is a large disease area seen as a big opportunity for drugmakers.
The primary and secondary endpoints required baseline and postbaseline measures, and patients who didn’t get both weren’t included in the analysis. To that end, only 45 patients were included in the primary endpoint; the company didn’t disclose the patient population for the secondary endpoint but said around 37 was a fair estimate.

The drug, which is taken orally, had a good safety profile, according to the company, and no serious side effects were reported from trial participants. VK2809 could also have potential benefits for heart health, Lian said, which is significant because non-alcoholic fatty liver disease has been linked to cardiovascular disease.
NAFLD is caused by fat buildup in liver cells at higher-than-normal levels and is not linked to alcohol use, according to the American Liver Foundation. It affects an estimated 100 million people in the U.S., and a subgroup of those individuals have a more serious form of the disease called non-alcoholic steatohepatitis (NASH).
More news should be coming from the company, in what Maxim Group analyst Jason McCarthy has described as a “busy autumn.”
The biotech hopes to present more information about reductions seen in LDL-C at an upcoming conference in November, which is why the company hasn’t yet released a more detailed breakdown, Lian told MarketWatch.
More data may also be released at a European conference in April, and the company plans to meet with the FDA to discuss its next clinical study in the first half of 2019.
In future studies, Lian would like to see VK2809 show improvements in other features of the disease, like inflammation and damage to liver cells, something that takes more time to demonstrate.
Viking Therapeutics additionally plans to present results from a phase 2 trial of VK5211 in patients with hip fractures at the end of this month, and the company is also testing VK2809 in a condition called glycogen storage disease.
There has also been plenty of speculation about big drugmakers acquiring or partnering in this area. Viking rival Madrigal Pharmaceuticals Inc. MDGL, -9.25%whose shares dropped 11% in Tuesday trade, has been discussed as a potential target because small biotech companies don’t really have resources to make a big drug commercially successful
Lian told MarketWatch that bringing a product like VK2809 to market is a big endeavor. At the same time, any opportunities should be considered on a case-by-case basis, he said.
“I think any small company has to be prepared to move realistically into a large phase 3 study, but I also think you have to be open-minded and opportunistic when a partner approaches and proposes something that makes sense for shareholders,” he said. “A company always has to be prepared to move alone if the partnerships never materialize.”
Viking shares have surged 60.8% over the last three months, compared with a 4.8% rise in the S&P 500 SPX, +0.54%  and a 5.2% rise in the Dow Jones Industrial Average DJIA, +0.71%  .

Colon cancer is caused by bacteria and cell stress


“With our study we originally wanted to study the role of bacteria in the intestines in the development of intestinal inflammation,” explains Professor Dirk Haller from the Department of Nutrition and Immunology at the Weihenstephan Science Centre of the TUM. “However, the surprising result for us was the discovery that bacteria together with stress in cells caused tumours (exclusively in the colon) and without the involvement of inflammation.”
The investigations were initially carried out using the mouse model. In germ-free (i.e. sterile) animals, in which the activated transcription factor ATF6 regulated stress in the intestinal mucosa (intestinal epithelium), no change could be observed. But as soon as the microbiota, i.e. all the microorganisms in the intestine, were transplanted back into germ-free animals, tumours developed in the colon of the mice. Using Koch’s postulates, Haller and his team were able to show that microorganisms are involved in the development of cancer in the colon.
The transcription factor ATF6 regulates stress in cells, and the intensity and duration of activation is increased with diseases. “However, it is not cell stress alone that leads to tumour growth, but the combination of stress and microbiota that favours cancer growth,” says Haller, head of ZIEL — the Institute for Food & Health at TUM.
ATF6 incidence found to be increased in colon cancer patients
Subsequently, in cooperation with the clinic on the right side of the Isar (Prof. Janssen), the data of 541 patients with colon cancer were examined. In those cases where the level of transcription factor ATF6, which triggers cell stress, was significantly increased, the recurrence rate after surgery increased: About ten percent of patients were at risk of getting colon cancer a second time.
“In certain patients, the protein ATF6 could serve as a diagnostic marker for an increased risk of colon cancer and could indicate the start of therapy at an early stage,” said Prof. Haller — “a microbial therapy is conceivable, when we know more about the composition of the bacterial flora. What now became clear, however: Chronic inflammation has no effect on cancer development in the colon.”
Story Source:
Materials provided by Technical University of Munich (TUM)Note: Content may be edited for style and length.

Journal Reference:
  1. O.I. Coleman, E.M. Lobner, S. Bierwirth, A. Sorbie, N. Waldschmitt, E. Rath, E. Berger, I. Lagkouvardos, T. Clavel, K.D. McCoy, A. Weber, M. Heikenwalder, K.P. Janssen, D. Haller. Activated ATF6 Induces Intestinal Dysbiosis and Innate Immune Response to Promote Colorectal TumorigenesisGastroenterology, 2018; DOI: 10.1053/j.gastro.2018.07.028

Zapping Airway Nerves May Help COPD Patients Breathe


 Thousands of Americans struggling with chronic obstructive pulmonary disease (COPD) may have a new treatment option to help them breathe easier.
COPD, which is often linked to smoking, is a progressive deterioration of lung function that involves a combination of bronchitis and emphysema symptoms. It’s the third leading cause of death in the United States, and while treatments can ease symptoms, there is no cure for COPD.
However, researchers on Tuesday presented promising new findings from a phase 2 clinical trial. The trial focused on a new COPD treatment called targeted lung denervation (TLD).
In this therapy, doctors disrupt nerves lying on the outside of the patients’ airways.
The new trial involved 82 COPD patients treated at medical centers in six European countries. According to the researchers, the treatment reduced problematic symptoms by more than 50 percent compared to patients who got a sham treatment.
“We have been able to significantly reduce chronic respiratory symptoms such as shortness of breath, exacerbations of the disease, infections and hospitalizations in a group of COPD patients who are already on aggressive medical therapy,” said lead researcher Dr. Dirk-Jan Slebos, of the University Medical Centre Groningen, in the Netherlands.
In addition, patients saw a better quality of life and improved lung function, he said.
One expert in respiratory care said new treatment options are needed for COPD patients.
Dr. Len Horovitz is a pulmonary specialist at Lenox Hill Hospital in New York City. He explained that TLD works by inactivating nerves lying outside the airways. This results “in dilatation of previously constricted airways, and less production of mucous,” he explained.
“While there is medication that COPD patients use to accomplish the same effect, the addition of TLD appears to confer additional therapeutic benefit,” said Horovitz, who wasn’t involved in the new trial.
The study was funded by Nuvaira, the Minneapolis-based maker of TLD technology. The findings were scheduled for presentation Tuesday at the European Respiratory Society International Congress, in Paris.
In the treatment, a catheter is passed through a tube called a bronchoscope into the lungs. The catheter delivers an electric charge to the nerves on the outside of the airways, altering their normal function.
This allows the airways to relax and widen, make less mucus and also eases inflammation to the airway wall. The catheter and bronchoscope are then removed.
When combined with drugs designed to relax the airway, TLD appears to have an even greater effect, the researchers said.
Among the 82 patients in the trial, the investigators found that in the six months after the procedure, 71 percent of those who received the sham treatment experienced a serious flare-up of their COPD, compared with only 32 percent of those who were treated with TLD.
“Furthermore, the positive benefit has continued in those receiving TLD treatment, with the number of patients hospitalized for respiratory complications in the first year reduced by more than half in the treatment arm versus the sham arm,” Slebos said in a meeting news release.
The study team reported that no patients died. Among those receiving TLD, five patients experienced side effects that included nausea, abdominal bloating and digestion discomfort. These problems were short-lived and gone within six months.
According to Horovitz, the invasive nature of the procedure may not make TLD appropriate for all COPD patients. “This procedure would be contemplated in patients who are very symptomatic with shortness of breath and frequent exacerbations,” he said.
A much larger, phase 3 trial is being planned for 2019, the researchers said.
Experts note that research presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.
More information
For more about COPD, visit the American Lung Association.
SOURCES: Len Horovitz, M.D., pulmonary specialist, Lenox Hill Hospital, New York City; European Respiratory Society, news release, Sept. 18, 2018

U.S. judge dismisses concussions lawsuits against World Wrestling


A federal judge has dismissed lawsuits by dozens of former professional wrestlers who accused World Wrestling Entertainment Inc of failing to protect them from concussions and other head trauma, including chronic traumatic encephalopathy (CTE).
Many claims filed on behalf of 53 wrestlers like Joseph “Road Warrior Animal” Laurinaitis and Jimmy “Superfly” Snuka were brought too late and some were frivolous, U.S. District Judge Vanessa Bryant in Hartford, Connecticut, ruled on Monday.
Bryant also found no basis to suggest the defendants, including WWE Chief Executive Officer Vince McMahon, knew of any link between wrestling and CTE before 2007, which was after most of the plaintiffs had retired.

“The court is also unwilling to find that the diagnosis of one wrestler with CTE is sufficient to imbue WWE with actual awareness of a probable link between wrestling and CTE,” Bryant added.
WWE shares rose 2.3 percent to $89.74 on Tuesday.
CTE is a neurodegenerative disease often caused by repeated trauma to the head, and cannot be diagnosed before death.
A large part of Bryant’s 40-page decision focused on the plaintiffs’ lawyer Konstantine Kyros, who the judge said “persistently” ignored her orders and caused a “considerable waste” of time and resources over 3-1/2 years of litigation.
“The opinions expressed about my strong advocacy are inaccurate, bizarre and unworthy of the court,” Kyros said in an email on Tuesday, adding that Bryant should have let the case go to a jury. “We trust the wrestlers’ claims will be better received in the appeals courts,” he added.
Jerry McDevitt, a partner at K&L Gates representing Stamford, Connecticut-based WWE, welcomed the ruling.
“It was a thoughtful decision,” he said in an interview. “The WWE did not engage in misconduct, and had educated wrestlers about the risks.”
Laurinaitis has experienced memory loss, dizzy spells and sleep apnea, according to an amended complaint filed last November, while Snuka had CTE, dementia and Alzheimer’s disease when he died in January 2017 at age 73.
The cases are McCullough et al v World Wrestling Entertainment Inc, U.S. District Court, District of Connecticut, No. 15-01074; and Laurinaitis et al v World Wrestling Entertainment Inc et al in the same court, No. 16-01209.

Zealand Pharma A/S (ZEAL) PT Raised to $29 at Needham


Needham & Company analyst Alan Carr raised the price target on Zealand Pharma A/S (NASDAQ: ZEAL) to $29.00 (from $26.00) .

AI test detects early signs of dementia


A pioneering artificial intelligence (AI) computer test can help detect whether individuals are in the early stages of dementia.
Through a series of questions with an interactive on-screen avatar, a computer programme designed by researchers from Osaka University and Nara Institute of Science and Technology, can discern whether responses given by individuals indicate cognitive problems.
The team behind the research was seeking simple alternatives to the medical imaging used by hospitals to pick up the disease, particularly as rates of the illness soar.
They also wanted to lower the chance of people becoming used to being asked the same set of questions by doctors determining whether someone is showing signs of dementia.
Through algorithms, the programme assesses gaze, delay in responses, intonation, the percentage of verbs and nouns used, voice articulation and recall. It also asks fixed and random questions.
These algorithms were based on features of speech, language, and faces from recorded dialogues with elderly participants, some of whom had been diagnosed with dementia plus other, healthy individuals.
Thanks to artificial intelligence that allows machines to learn without being programmed, computers were able to distinguish individuals with dementia from healthy controls at a rate of 90% via six questions. Each question took two to three minutes.
Senior author Takashi Kudo said: “If this technology is further developed, it will become possible to know whether or not an elderly individual is in the early stages of dementia through conversations with computer avatars at home on a daily basis.
“It will encourage them to seek medical help, leading to early diagnosis.”
The need for early intervention is pressing, as someone worldwide develops dementia every three seconds. Alzheimer’s Disease International, which looks at the global incidence of dementia – which is an umbrella term for a group of symptoms – estimates that around 50 million people had the condition in 2017.
This number is expected to escalate dramatically, reaching 75 million in 2030 and 131.5 million in 2050. Research has shown that most people living with dementia have not been formally diagnosed, underlining the need for simpler, more accessible ways to ascertain whether someone is affected.
It is also important to note that dementia is not a natural aspect of ageing. The Alzheimer’s Society states that 40,000 people under 65 in the UK have dementia. While there is no cure, treatments can help patients to lead active lives and manage their symptoms.