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Friday, January 24, 2020

Bayer faces fourth U.S. Roundup cancer trial in Monsanto’s hometown

Bayer AG is set to face a fourth U.S. jury trial over allegations that its Roundup weed killer causes cancer, with four cancer patients in the hometown of its agricultural subsidiary Monsanto scheduled to begin making their case on Friday.

The lawsuit marks the first multi-plaintiff trial in the litigation over whether glyphosate, Roundup’s active ingredient, is carcinogenic, and is the first trial outside of California. It is being held in St. Louis, where Monsanto was headquartered before Bayer bought the company in a $63 billion deal in 2018.
Three consecutive juries found the company liable for causing cancer with damages of tens of millions of dollars awarded to each plaintiff. Bayer is appealing those verdicts.
Court-appointed mediator Ken Feinberg has put the number of Roundup cancer claimants at more than 75,000 while Bayer said the claims it has been served with in court were below 50,000.
Bayer’s share price has tumbled since the first verdict in August 2018 but the stock rose 3% on Friday after Bloomberg reported a possible out-of-court settlement with some plaintiffs that could lead to a total payout of about $10 billion.
While traders said the market likes the idea of Bayer settling the litigation, some cautioned that the prospect of a comprehensive deal remained uncertain.
Analysts have estimated the size of any such settlement at $8-$12 billion.
SEE YOU IN COURT
While most plaintiffs’ lawyers have agreed to postpone trials pending negotiations, some have decided to pursue their clients’ day in court.
The case in Missouri’s Circuit Court for the 22nd Judicial Circuit of the City of St. Louis is scheduled to last several weeks, with both sides presenting extensive scientific evidence through expert witnesses.
Bayer denies all allegations that Roundup or glyphosate causes cancer, saying decades of independent studies have shown the world’s most widely used weed killer to be safe for human use and noting that regulators around the world have approved the product.
“At the end of the day, this trial should come down to the weight of the science, and we remain confident in the extensive scientific record and regulatory assessments that support the safety of our glyphosate-based herbicides and that they do not cause cancer,” the company said in a statement.
Several court cases have been postponed by both parties in the past to expedite settlement talks. By pursuing the St. Louis trail The Miller Firm LLC, a key player in the litigation, is seeking to increase pressure on Bayer.
The case involves the claims of Bryce Batiste from Louisiana, Ann Meeks from Florida, Glen Ashelman from Pennsylvania and Christopher Wade, a St. Louis resident. All four have been diagnosed with non-Hodgkin’s lymphoma, a blood cell cancer that plaintiffs in the litigation allege is caused by Roundup.
Some legal experts said Bayer could benefit from a home advantage in the St. Louis trial, where Monsanto has century-old roots. But juries in the city are also known to dole out massive damages awards against large corporations.

https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-faces-fourth-U-S-Roundup-cancer-trial-in-Monsanto-s-hometown-29884415/?countview=0

Genentech Tecentriq Phase III Misses Goal in Muscle-invasive Urothelial Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMvigor010 study evaluating Tecentriq® (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC). Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.
“Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers.”
The goal in treating MIUC early is to reduce the risk of the disease recurring or spreading to other parts of the body. More treatment options following surgery are needed as approximately half of people with MIUC will develop a recurrence of their disease within two years of surgery.
In addition to ongoing Phase III studies in early and advanced bladder cancer, Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
https://www.biospace.com/article/releases/genentech-provides-an-update-on-phase-iii-study-of-tecentriq-in-people-with-muscle-invasive-urothelial-cancer/

FDA approves Epizyme’s treatment for epithelioid sarcoma

Epizyme (NASDAQ:EPZM) says the Food and Drug Administration granted accelerated approval of its Tazverik (tazemetostat) treatment for the patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma, a rare, slow-growing type of cancer.
The company says continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.
Tazverik, Epizyme’s lead drug candidate, also is in multiple clinical trials for other types of cancer including follicular lymphoma, which is under review by the FDA.
https://seekingalpha.com/news/3534219-fda-approves-epizymes-treatment-for-epithelioid-sarcoma

Coronavirus scare shutters Shanghai Disney

Shanghai Disneyland (NYSE:DIS) will be closed from Saturday to help prevent the spread of a deadly coronavirus that broke out in the Chinese city Wuhan.
It’s a crucial time for the theme park, with China on a seven-day Lunar New Year holiday starting Friday.
Last year, Shanghai Disney had to stop selling tickets to visitors as the park was overcrowded.
https://seekingalpha.com/news/3534237-coronavirus-scare-shutters-shanghai-disney

Community Health prices debt offering

Community Health Systems (NYSE:CYH) has priced its $1.462B aggregate principal amount of 6.625% Senior Secured Notes due 2025 at par.
The size of the offering was increased by ~$442M.
Net proceeds will be used to purchase 5.125% Senior Secured Notes due 2021, redeem the remaining 2021 Notes, purchase in one or more privately negotiated transactions or redeem ~$425.5M 6.250% Senior Secured Notes due 2023 and pay related fees and expenses.
The sale of the Notes is expected on February 6.
https://seekingalpha.com/news/3534266-community-health-prices-debt-offering

Ipsen hits potential roadblock with palovarotene

Ipsen (OTCPK:IPSEY) has suspended dosing in its Phase 3 clinical trial, PVO-1A-301, evaluating palovarotene in patients with fibrodysplasia ossificans progressiva (FOP) as well as its Phase 2 extension studies, PVO-1A-202 and PVO-1A-204, after a futility analysis by the Independent Data Monitoring Committee (IDMC) showed that the late-stage study was unlikely to meet the primary endpoint.
Citing “signs of encouraging therapeutic activity” in preliminary post-hoc analyses of the 301 trial, the company will conduct further assessments of the dataset. The IDMC did not recommend terminating the study. It noted that the highly contrasting data precluded a confident conclusion about futility.
The FDA’s partial clinical hold for the pediatric population under the age of 14 for FOP and multiple osteochondromas instituted on December 4, 2019, remains in effect (suspended further enrollment).
Management will provide updated guidance next month with its earnings announcement.
Ipsen acquired the rights to palovarotene via its acquisition of Clementia Pharmaceuticals in April 2019.
https://seekingalpha.com/news/3534282-ipsen-hits-potential-roadblock-palovarotene

Tonix Pharma up 42% premarket on advancement of TNX-102 SL

Tonix Pharmaceuticals (NASDAQ:TNXP) has completed fed-fasting and dose proportionality tests of TNX-102 SL in healthy volunteers, data that, it says, should satisfy the pharmacokinetic requirements for its U.S. marketing applications for posttraumatic stress disorder (PTSD) and fibromyalgia.
Preliminary data showed no significant effect from a fatty meal on the rate or extent of absorption of TNX-102 SL 5.6 mg administered as 2 x 2.8 mg sublingual tablets.
Observed dose proportionality confirmed the prototype 2.4 mg formulation.
Shares up 42% premarket.
https://seekingalpha.com/news/3534291-tonix-pharma-up-42-premarket-on-advancement-of-tnxminus-102-sl