Bayer Seeks to Wipe Out Roundup Verdict as New Trials Multiply

Bayer AG is trying to undo a $289 million verdict over Monsanto’s Roundup weedkiller that it blames on misinformation fed to a jury, while also seeking to avoid having its next test cases go to trial on an accelerated schedule.

If the company can persuade a judge to erase or chip away at the nine-figure verdict — the first case to go to a jury among 8,700 people in the U.S. who blame the popular herbicide for their cancer — legal experts say some plaintiffs may be less eager to pursue their claims. Bayer is also fighting to prevent a “rush to trial after trial” that it says will disrupt the orderly flow of litigation if a judge in California applies a rule that allows sick or old plaintiffs to jump to the head of the line.

Jonas Oxgaard, an analyst at Sanford C. Bernstein & Co., estimates that Bayer’s market value is discounted by as much as $15 billion because the San Francisco verdict in August represents the larger cloud of Roundup liability trailing the company after it acquired Monsanto this year. More trials are scheduled for February.

“Getting the first ruling overturned would be huge for Bayer — likely reversing most of the discount,” Oxgaard said in an email.

At a hearing Wednesday in San Francisco, Bayer will argue before a state court judge that the scientific studies that helped lawyers for an ex-school groundskeeper win his blockbuster award didn’t actually prove Roundup caused his cancer. The judge has the power to void the verdict or reduce the amount.

“The jury’s decision is wholly at odds with over 40 years of real-world use” of glyphostate-based herbicides, along with scientific data proving the chemical is safe that has been thoroughly reviewed by authorities around the world, Bayer said in a statement.

The $289 million award was the second-largest of the year for a product defect case in the U.S. and the ninth-largest verdict overall. The punitive part of the award is so “excessive” that it “shocks the conscience,” Monsanto argued in a court filing. If the verdict isn’t set aside, Monsanto wants the judge to order a new trial.

“The jury’s hard work should be celebrated, not swept aside,” lawyers for plaintiff Lee Johnson fired back in their own filing, casting Monsanto’s arguments as a “rehash.”

Jurors awarded Johnson $39 million to compensate for the cancer he contracted at age 42 and the resulting loss of work and enjoyment of life. His wife, Areceli, works two full-time jobs since Johnson stopped working, his lawyers argue.

The jury also awarded $250 million to punish Monsanto after finding it liable for a design defect and failing to warn of Roundup’s risks. Johnson argued at trial that Monsanto was well aware of the herbicide’s dangers, and hid them from consumers. He also testified that he was getting scared about his exposure and called the company twice over his concerns and never got a call back.

Elderly Couple

At issue in a hearing held Tuesday in Oakland, California, was a request to hold a trial as early as December for an elderly couple who both blame their their non-Hodgkin lymphoma on exposure to Roundup’s key ingredient, glyphosate. Alva and Alberta Pilliod, in their mid-70s, claim they’re entitled to an expedited trial “before they die” under the same law that allowed Johnson to fast-track his case.

Monsanto is asking the judge in that case to block the couple’s request because it would undermine the process already established for 250 plaintiffs whose cases are grouped in that court. Allowing the Pilliods to expedite their case would open the floodgates for others to make the same request, as so many plaintiffs in the Oakland cases are older than 70, the company said in a filing.

“Fortunately, the Pilliods are both in remission, and there is no indication of any imminent cancer recurrence that would justify granting them a trial scheduling preference,” Bayer said in an emailed statement.

Judge Ioana Petrou in Oakland sided with Monsanto in a tentative ruling last week, but indicated at the hearing that she may reverse herself. She said that if she does, a trial isn’t likely until January, at the earliest. The judge told both sides she wants to review Alberta Pilliod’s updated medical records and scheduled another hearing for Nov. 7.

Steven Kazan, a plaintiffs’ lawyer who has litigated asbestos cases, said other states allow old or sick plaintiffs to request expedited trials. But California is the only state in which damages for pain and suffering are irretrievable when a plaintiff dies. That difference can motivate the state’s judges to grant the requests, he said.

“Monsanto would like for these cases to sit somewhere for years,” Kazan said. “Delay is their friend. It is not a friend for those who are aging, especially if they are sick.”

The San Francisco case is Dewayne Johnson v. Monsanto Co., CGC-16-550128, California Superior Court, County of San Francisco (San Francisco). The Oakland case is Pilliod v. Monsanto Company, RG17862702, California Superior Court, County of Alameda (Oakland).

https://www.bloomberg.com/news/articles/2018-10-09/bayer-seeks-to-wipe-out-roundup-verdict-as-new-trials-multiply

Cigarette giant Altria said to be in talks for stake in cannabis producer Aphria

Canadian cannabis grower Aphria (APHQF) is on the rise after a news report said Altria Group (MO) is in talks to acquire a minority equity stake in the company. Sources told the Global and Mail that the U.S. tobacco giant may eventually hold a majority of the company’s shares. MINORITY STAKE IN APHRIA: Altria Group is said to be in talks to acquire an equity stake in Aphria, according to the Global and Mail, citing people familiar with the matter. Details of the proposed investment are still being finalized, sources noted, adding that Altria has expressed an interest in acquiring a minority stake in the cannabis grower with the intention of eventually holding a majority of the company’s shares. Further, the report said Altria executives have met with Aphria’s management on several occasions, but it could take time for the two companies to strike a deal. Aphria is a low-cost cultivator of marijuana. WHAT’S NOTABLE: Back in August, Constellation Brands (STZ) announced it was increasing its ownership interest in Canada’s Canopy Growth (CGC) to 38% by acquiring 104.5M shares, with the option of raising its stake further to 50%. As a result, Canopy Growth will “immediately upon closing have proceeds of approximately C$5B to bolster its leadership position in the global cannabis industry,” the companies stated. Other publicly traded companies in the cannabis space include Aurora Cannabis (ACBFF), CV Sciences (CVSI), Cronos Group (CRON) and Tilray (TLRY). PRICE ACTION: In afternoon trading, shares of Altria are fractionally up to $63.15, while Aphria’s stock trading in New York has jumped almost 17% to $15.65.

https://thefly.com/landingPageNews.php?id=2802469

Mazen Animal Health Sees Breakthrough in Valley Fever Vaccine Development

Mazen Animal Health, a biotechnology company focused on developing and commercializing novel maize-based vaccines and therapeutics that address unsolved challenges in animal health, announces a breakthrough in the development of a first-ever Valley fever sub-unit vaccine for companion animals. In mice, the vaccine was found to reduce the burden of Coccidioides, the fungus that can cause Valley fever.

Today, there is no vaccine for Valley fever, in part because the antigen is poorly expressed in microbial systems leading to a high cost of production. With funding from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, (Contract No. HHSN272201600035C), Mazen's technology partner, Applied Biotechnology Institute (ABI) has produced a sub-unit vaccine candidate in maize grain at levels that are a hundred-fold higher than what is possible with traditional fermentation. Maize-produced antigen allows for both injectable and chewable formats for vaccination and sub-unit vaccines are considered one of the safest approaches to vaccines.
Valley fever is a fungal infection that leads to disease not only in humans but also dogs, and other species, including llamas and alpacas. With 12 million dogs in the southwestern United States and an increasing population of camelids at risk, cases of Valley fever are increasing and can be very costly. The disease can last years and is currently treated with expensive anti-fungal medications. In Arizona alone, it's estimated that Valley fever costs dog owners at least $60 million per year. It can cause severe lung, spleen and bone infection, often leading to death.
"We are thrilled with the early animal-model results showing that the vaccine reduced fungal burden in mice followed by our successful challenge study in mice with this patent-pending product," said Dr. Jenny Filbey, CEO, of Mazen Animal Health.  "A Valley fever vaccine is a great fit with Mazen's focus on addressing unmet needs in animal health."
Mazen Animal Health, Inc. is a biotechnology company developing and commercializing novel biological vaccines and therapeutics that disrupt the status quo. We believe all animals should be protected from preventable disease, but today that isn't the case. We intend to change that. Building on over 20 years of R&D, our vaccine production platform enables edible vaccines that can be delivered with feed.  We will disrupt the animal vaccine market in four distinct ways, by providing: (1) cost effective vaccines - removing the economic thresholds that control the vaccination decision today; (2) a safer method of vaccine administration; (3) improved vaccine efficacy; and (4) vaccines with a global reach because of ambient temperature stability and ease of delivery.
Visit www.mazenanimalhealth.com for more information.
https://www.biospace.com/article/releases/mazen-animal-health-reports-breakthrough-in-valley-fever-vaccine-development/

White House to Remove “Gag” on Pharmacists; Can Discuss Drug Pricing

Pharmacists dispensing medicines to patients will now have some new authorities to help save money.

Today President Donald Trump is expected to sign two bills that will release pharmacists from a so-called “gag order” that prevented them from telling customers when there is a price difference on medicines between paying cash or going through the insurance copay. Prior to the signing of this bill, pharmacists were not allowed to inform customers of the price difference, Kaiser Health News reported.

The president is expected to sign two bills today, one for Medicare beneficiaries and another that concerns employment-based policies and individual policies. Both bills were overwhelmingly passed by Congress in September, KHN said.

While the White House declined to comment on the KHN report, Trump has used his Twitter account to express support for the legislation. Ahead of the Senate vote last month, the president tweeted that he supports “legislation that will remove gag clauses.” The legislative change was something that was part of the president’s blueprint to curb prescription drug prices unveiled in the spring.

Under the current rules, pharmacists can be fined for informing customers of the price difference, KHN said, citing Ronna Hauser, vice president of payment policy and regulatory affairs at the National Community Pharmacists Association. Hauser told KHN that members of the organization have said pharmacy benefit managers will call the pharmacists and warn them not to inform customers of the price difference. If a pharmacist did tell a customer of the cost-savings between paying cash price versus insurance-sponsored copay, Hauser said that in addition to a potential fine, pharmacists could be dropped from insurance networks.

In its report, KHN noted that for Medicare Part D patients, there has been a significant amount of overpayment. Citing a report in the Journal of American Medical Association, KHN said in 2013 Medicare Part D-covered individuals overpaid for prescriptions by $135 million. The JAMA report showed that copayments were higher than the cash price for 25 percent of medications bought under Medicare Part D in 2013. The report said that patients overpaid by 33 percent for 12 of the 20 most commonly prescribed drugs.

While the legislation will release pharmacists from the gag order, it will not require them to inform customers of the potential savings by paying the cash price. Consumers will need to take the initiative and ask for the difference, KHN said.

In addition to eliminating the gag order, the White House’s healthcare proposal has included plans to require pharmaceutical companies to disclose the prices of prescription drugs in television advertisements, as well as the possibility of importing foreign drugs in case of shortages or price gouging. Earlier this year, Trump was successful in getting Pfizer to roll-back a second round of price hikes on some drugs. The administration has also suggested it might take a hard look at the use of drug rebates in prescription pricing. The rebates are part of the cost negotiated between drugmakers and pharmacy benefits managers (PBMs). The rebates are part of the current pricing system that are supposed to reduce the cost of prescription medications.

Despite the moves made by the White House though, the Associated Press reported this week that drug price increases “slowed somewhat and were not quite as steep as in past years.” Overall though, there has been no “massive” drug price cuts, BioSpace reported.

https://www.biospace.com/article/white-house-to-remove-gag-on-pharmacists-can-discuss-drug-pricing-with-customers/

Silent Heart Attack Deadly Long Term?

Small, silent infarcts found only on cardiac MRI were associated with a mortality risk that crept up over 10 years to match that of patients with a clinically detected MI, according to longer follow-up of the ICELAND MI cohort study.

Those unaware of MI until baseline cardiac MRI had the same 3% risk of all-cause mortality at 3 years as peers without any MI, while both groups were at lower risk than patients with a known history of MI (9% at 3 years).

Yet the picture was different at 10 years, Andrew Arai, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Maryland, and colleagues reported in JAMA Cardiology.

At that point, 30% of patients who had no MI at baseline had died, compared with 49% of those who had unrecognized MI and 51% of those with a recognized MI.

“Being more prevalent than recognized MI, unrecognized MI constitutes an underappreciated public health problem,” the researchers wrote. “Whether early detection of unrecognized MI by cardiac MRI could allow for the institution of risk factor management and thus reduce the associated long-term risks merits further investigation.”

“Although [the study] is important, until such time as we have studies that show that treating patients with unrecognized MI changes outcome, it is not clear that routine screening CMR [cardiac MRI] would be indicated,” cautioned Christopher Kramer, MD, of the University of Virginia in Charlottesville, who was not involved in the study.

Elsayed Soliman, MD, MSc, of Wake Forest School of Medicine in Winston-Salem, North Carolina, agreed, saying it “should be considered very carefully in the context of cost-benefit and the possibility of false positive results.”

Nevertheless, the study contributes to mounting evidence that unrecognized MI is not benign and “should be taken as seriously as any MI,” Soliman told MedPage Today. He also was not involved in the study.

The study comprised 935 community-dwelling older people in Iceland (48.3% men; mean age 76 years). There was no loss to follow-up, as outcomes were gathered from a national database of death and healthcare records.

Unrecognized MI was associated with worse outcomes at 10 years compared with MI on multivariate analysis for the following:

• Death: HR 1.61, 95% CI 1.27-2.04
• Combined death, non-fatal MI, heart failure: HR 1.56, 95% CI 1.26-1.93
• MI: HR 2.09, 95% CI 1.45-3.03
• Heart failure: HR 1.52, 95% CI 1.09-2.14

Unrecognized MI carried as high a 10-year risk of death (HR 0.99, 95% CI 0.71-1.38) and major adverse cardiac events (HR 1.23, 95% CI 0.91-1.66) as recognized MI.

There are two potential reasons for the eventual convergence between the mortality curves of unknown and known MI, the investigators suggested.

It may be that unrecognized MI represents a different coronary disease phenotype with more small-vessel involvement and atrial fibrillation, thus charting a different natural course. The other possibility is that patients with recognized MI lowered their risk through preventive therapy and changed risky behaviors, such as smoking.

Patients with MI, recognized or not, tended to have more cardiovascular risk factors.

The group with unrecognized MI had coronary artery calcium scores and left ventricular ejection fractions that fell between those of the recognized- and no-MI cohorts. Previously-undetected infarcts were also significantly smaller than those in recognized MI.

In subgroup analysis, men, people with diabetes, and those under age 70 actually had a higher risk of death from unrecognized MI but comparatively lower mortality risk with recognized MI, the researchers reported.

“These directionally opposite stratified outcomes of unrecognized MI and recognized MI may be due to distinct pathophysiological mechanisms or may represent a treatment effect,” Arai and colleagues noted, though they cautioned that these are hypothesis-generating findings.

Arai disclosed nonfinancial support from Siemens and other support from Bayer. He also has two patents issued.

LAST UPDATED 10.10.2018

• Primary Source

  JAMA Cardiology

  Source Reference: Acharya T, et al “Association of unrecognized myocardial infarction with long-term outcomes in community-dwelling older adults: The ICELAND MI study” JAMA Cardiol 2018; DOI: 10.1001/jamacardio.2018.3285.

https://www.medpagetoday.com/cardiology/myocardialinfarction/75623

Teva, Celltrion announce FDA committee unanimously recommends CT-P10

Celltrion and Teva Pharmaceutical Industries (TEVA) announced the FDA Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody biosimilar to Rituxan for the treatment of adult patients in three proposed indications. The proposed indications are: relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma as a single agent; previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and non-progressing, low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy. The FDA will take the committee’s recommendation into consideration before taking action on the Biologics License Application for the proposed Rituxan biosimilar.
https://thefly.com/landingPageNews.php?id=2802397

Gene-editing biotech LogicBio eyes $75M IPO

LogicBio Therapeutics’ Nasdaq IPO is slated for next week and the gene-editing player has set its terms—it plans to raise $75 million to advance its lead asset, a treatment for the genetic liver disease methylmalonic acidemia (MMA), into the clinic.

The Cambridge, Massachusetts-based biotech could raise up to $81 million if it hits the high end of its price range, according to a Renaissance Capital report. The IPO haul would fund a phase 1/2 trial for the LB-001, LogicBio’s gene-editing treatment for MMA, “through the initial data read-out, clinical development outsourcing, drug manufacturing and internal personnel costs,” the company said in its S-1, filed in September.

MMA is a disorder in which the body cannot process certain proteins and fats properly. It can be caused by mutations in several genes, though the NIH estimates that mutations in the MUT gene account for 60% of cases. Children develop the condition in early infancy and can experience symptoms such as weak muscle tone, developmental delay, enlarged liver and lethargy. MMA can lead to long-term complications, including chronic kidney disease, pancreatitis and intellectual disability.

Treatment focuses on carefully controlling the child’s diet—timing protein intake and using supplements. Liver and/or kidney transplants have been shown to help some patients break down methylmalonic acid. There is no cure.

LogicBio’s LB-001 aims to incorporate a functional copy of the MUT gene into the genome of MMA patients. The goal is to make the edit early in a patient’s life to head off severe disabilities. The treatment is based on the company’s GeneRide platform, a technology that uses homologous recombination that is designed to allow site-specific transfer of therapeutic genetic material without the use of promoters or nucleases. LogicBio says it also has access to a library of synthetic, non-pathogenic, recombinant adeno-associated viral (rAAV) vectors developed at Stanford that allows for better predictability of vector performance in clinical trials.

The IPO will also bankroll the discovery and preclinical development of a handful of candidates developed for liver indications. These include hemophilia B, Alpha-1 antitrypsin deficiency (A1ATD), which can cause lung and liver disease, and Crigler-Najjar syndrome, in which patients cannot clear bilirubin from the body.

The deal comes a year after LogicBio picked up a $45 million B round from the likes of Arix Bioscience, OrbiMed and Rothschild.

“Early intervention for rare genetic disorders in children is important and LogicBio is uniquely positioned at the forefront of this research area with its proprietary genetic therapy technology to deliver a durable cure for young patients with life-threatening genetic diseases and otherwise limited options. LogicBio has huge potential and, alongside its excellent team and investors, we look forward to supporting the company to achieve continued success in this area,” said Joe Anderson, Arix Bioscience CEO, at the time.

https://www.fiercebiotech.com/biotech/gene-editing-biotech-logicbio-eyes-75m-ipo