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Monday, September 30, 2019

Bristol-Myers higher after Opdivo update

Bristol-Myers Squibb (BMY +1.8%) is out with results from a Phase 3 Attraction trial of Opdivo for patients with esophageal cancer.
The company says Opdivo demonstrated a 23% reduction in the risk of death and 2.5-month improvement in median overall survival compared to chemotherapy
BMY management is updating on the results at a Presidential Symposium during the European Society for Medical Oncology 2019 Annual Congress.
Source: Press Release
https://seekingalpha.com/news/3502671-bristol-myers-higher-opdivo-update

Pfizer eyes commercial scale-up as Array colorectal cancer combo hits its marks

Positive new colorectal cancer data has Pfizer envisioning a launch for its newly acquired Array BioPharma meds. And the company is getting prepared.
Monday at the European Society for Medical Oncology annual meeting, the New York drugmaker presented data showing that its Braftovi and Mektovi, when combined with anti-EGFR drug Erbitux, could extend previously treated patients’ lives for a median nine months, compared with just 5.4 months for standard-of-care therapy. In other words, it decreased the risk of death by 48%.
The numbers have Pfizer “very excited” and planning an FDA submission for the fourth quarter of this year, Andy Schmeltz, global president and general manager of Pfizer’s oncology unit, said.
The prognosis for this patient pool is “very poor, and to have a new option that can really extend life … is very significant,” he said.

But the company is also “mindful of the resources that will be required for a successful launch” in that arena—resources that hadn’t yet been allocated when Pfizer swallowed Braftovi and Mektovi’s maker, Array, for $11.4 billion in July.
“There had not been the scaling up to prepare to launch in colorectal cancer, and that’s what we’re partnering right now to prepare for,” Schmeltz said, adding that “we’re going to size and scale as appropriate.”
Thanks to the acquisition, the pharma giant now also has the chance to throw its weight behind the duo in melanoma, where Array got off to a flying start. After just a year on the market, the combo is already grabbing 1 in 3 new patient starts, despite competition from two other in-class combos.
Still, “the focus for Array had really been in the cancer centers,” Schmeltz said. Given that the company had only been marketing the drugs for a year when it agreed to tie the knot with Pfizer, its reps “hadn’t really had the opportunity yet to engage more broadly with community-based oncologists.”
“This gives us the opportunity to do that,” he noted.

While Pfizer will add staffers and funding to the effort, though, it’ll still be leaning on Array for its experience in the melanoma field. “Pfizer Oncology did not have a presence in melanoma, so we need the expertise that the Array colleagues bring to the table,” Schmeltz said. He pointed out that “it’s not an integration about synergy,” which is a pharma favorite term for cost-cutting.
“We’re working together to bring” the Array employees on board, and everything’s going very smoothly, he said.
https://www.fiercepharma.com/pharma/esmo-pfizer-eyes-commercial-scale-up-as-array-colorectal-cancer-combo-hits-its-marks

What Do the J&J and Purdue Pharma Outcomes Mean to the Pharma Industry?

Opioid abuse and addiction continue to ravage communities across the United States. Nora Freeman Engstrom of Stanford Law School reported in Suing the Opioid Companies, on August 30, 2018, that 2.4 million Americans had an opioid-use disorder with 300,000 lives lost, including 42,000 in 2016 alone. The financial burden on state governments in the form of increases in the cost for public health services, law enforcement, medical treatment, rehabilitation programs, housing, and related services has left state governments seeking the funds required to adequately deal with this crisis. Oklahoma was the first state to file suit against opioid manufacturers. The success of their legal strategy will have a significant impact on the opioid–and pharmaceutical–industry going forward.
What Oklahoma claimed
In the Judgement After Non-Jury Trial for the State of Oklahoma vs. Multiple Pharmaceutical Defendants in the District Court of Cleveland County during the spring/summer of 2019, the document shows that the state of Oklahoma claimed the defendants caused a public nuisance, for which the state was seeking relief in the form of “abatement of the nuisance.” None of the parties disputed the fact that Oklahoma was suffering a crisis related to the use of opioid drugs. They also agreed on several other indicators of the extent of this crisis, including the fact that in 2015, enough opioid pills were dispensed in Oklahoma “for every adult to have 110 pills.”
In his ruling, Judge Thad Balkman wrote that the challenged conduct was the “Defendants’ “misleading marketing and promotion of opioids. … Defendants engaged in a false, misleading, and deceptive marketing campaign designed to convince Oklahoma doctors, patients, and the public at large that opioids were safe and effective for the long-term treatment of chronic, non-malignant pain. The greater weight of the evidence shows that Defendants did, in fact, engage in such false and misleading marketing and the law is clear that such conduct qualifies as the kind of act or omission capable of sustaining liability under Oklahoma’s nuisance law.”
The action by the state of Oklahoma was successful where the suits of individuals and class action had not been because the individual and class action suits dealt with the specifics of an individual or group. Since the medications in question were FDA-approved and the individuals had chosen to take the medication, it was difficult to prevail. With class action suits, it was extremely difficult to assemble a group that had enough of the essential traits in common for the suit to succeed. By using the fact that the opioid addiction situation in Oklahoma was a crisis that had created a public nuisance, delving into the private lives of specific individuals was not required.
Ultimately, the court agreed that the defendants had caused a nuisance as defined to consist “in unlawfully doing an act, omitting to perform a duty, which act or omission annoys, injures or endangers the comfort, repose, health or safety of others; or, in any way renders other persons insecure in life, or in the use of property…” Judge Balkman ordered Johnson & Johnson to pay $572 million – an amount significantly less than sought, but one The New York Times reported would pay for a year’s worth of the services needed to combat the epidemic in Oklahoma. Purdue Pharma settled for $270 million in this same suit, one of the many in which it was named as a defendant.
Purdue Pharma, together with members of the Sackler family that own the company, is the name in a large opioid settlement relating to a lawsuit. Filed in December 2018 by Connecticut and a number of other states, it alleges that the company continued to push patients toward OxyContin® even after the addiction rate became evident. Connecticut Attorney General William Tong told ABC News in April 2019, “Our investigation left no room for doubt—Purdue and the Sacklers ignored all human cost while pushing deadly opioids in blind pursuit of profit.”
In a September 9th interview on NPR with North Carolina Attorney General Josh Stein, host Brian Mann – who covers opioid litigation for NPR – explained that “there’s a legal argument being made by some of these states [still seeking abatement] that the Sacklers effectively stripped billions of dollars out of Purdue Pharma over the years. In part, it’s alleged, because the family suspected their company would eventually face lawsuits like this. So, 17 states are already suing the Sacklers Directly to try to claw back some of these profits.” Stein agreed, stating “many states, like mine, will be filing lawsuits against the Sacklers in their individual capacity in creating this epidemic. I think almost more than any other family and company, they have to wear that burden.” On September 15, Purdue Pharma filed for bankruptcy in Chapter 11 as part of their $3 billion settlement of the 2018 suit. Whether or not future litigation directly against family members will succeed remains to be seen.
What it Means for Pharma
In the opinion of Stanford legal experts Michelle Mello and Nora Freeman Engstrom in an August paper, the outcome of the case was not a foregone conclusion. Nuisance claims are very hard to prove and by the time the suit went to court, “Oklahoma’s various causes of action got winnowed down to the singular claim that J&H had created a public nuisance by aggressively and deceptively marketing opioid products to Oklahoma’s doctors and patients.” As the first case of its kind, the Oklahoma case is a bellwether case – it leads the way to future litigation.
“The verdict,” say the authors, “suggests that this litigation has legs, and that judges and juries may be willing to pin blame not just on Purdue, the maker of OxyContin®, but on others who played an arguably less central role in fueling this public health crisis.” This has to be a concern to pharma companies and others in the industry alike. The fact that FDA-approved opioid drugs, marketed and sold through widely accepted means, have been the target of successful litigation as a public nuisance is certainly a game changer. The potential culpability of companies in the pharma space has undergone a paradigm shift.
Mello and Engstrom summed it up well. “What is striking is how damming Judge Balkman’s factual conclusions about J&J’s conduct are, and how similar they are to the allegations made against other opioid manufacturers in other cases. All the things he objected to regarding J&J’s marketing practices are things that others, too, allegedly have done. Some of them are things that multiple companies banded together to do. Plaintiff’s attorneys should be feeling pretty confident about their chances of persuading other courts that those practices are problematic.”
https://www.biospace.com/article/what-do-the-j-and-j-and-purdue-pharma-outcomes-mean-to-pharma-/

Dana-Farber Study Confirms Accuracy of GRAIL’s Blood Test for Cancer

A new blood test in development from GRAIL, Inc. and studied by investigators at the Dana-Farber Cancer Institute has the ability to accurately screen for numerous types of cancer.
Data from the study was presented at the European Society for Medical Oncology (ESMO) 2019 Congress. The study showed that the next-generation sequencing technology can probe DNA for chemical tags known as methylation that influence whether genes are active or inactive, Dana-Farber said this morning. According to the study, the technology probed 3,600 blood samples, some from patients with cancer and some from those who had not been diagnosed, and the test was able to pick up on cancer signals. Additionally. The test correctly identified the tissue from where the cancer began. Dana-Farber said the test’s specificity was high, as was its ability to pinpoint the organ or tissue of origin, researchers found.
GRAIL’s test looks for DNA, which cancer cells shed into the bloodstream when they die. In contrast to “liquid biopsies,” which detect genetic mutations or other cancer-related alterations in DNA, the technology focuses on modifications to DNA known as methyl groups, Dana-Farber said. Methyl groups are chemical units that can be attached to DNA, in a process called methylation, to control which genes are “on” and which are “off.” Abnormal patterns of methylation turn out to be, in many cases, more indicative of cancer — and cancer type — than mutations are. The test zeroes in on portions of the genome where abnormal methylation patterns are found in cancer cells, Dana-Farber noted in its announcement.
Dana-Farber’s study showed that the GRAIL test had a specificity of 99.4%, meaning only 0.6% of the results incorrectly indicated that cancer was present. The sensitivity of the assay for detecting a pre-specified high mortality cancers was 76%. Within this group, the sensitivity was 32% for patients with stage I cancer; 76% for those with stage II; 85% for stage III; and 93% for stage IV. Sensitivity across all cancer types was 55%, with similar increases in detection by stage. For the 97% of samples that returned a tissue of origin result, the test correctly identified the organ or tissue of origin in 89% of cases, Dana-Farber said in its announcement.
Dana-Farber’s Geoffrey Oxnard and lead author of the study said previous work indicated that methylation-based assays outperform traditional DNA-sequencing approaches to detecting multiple forms of cancer in blood samples.
“The results of the new study demonstrate that such assays are a feasible way of screening people for cancer,” Oxnard said in a statement. He added that the results of this study indicate that if the test were in wide use, it could help patients receive more effective treatments.
Data presented by GRAIL in the spring at the 2019 American Society of Clinical Oncology showed GRAIL’s investigational multi-cancer blood test detected a strong signal for 12 deadly cancer types at early stages with a very high specificity of at least 99%. The test was aimed at 12 pre-specified cancer types, including anorectal, colorectal, esophageal, gastric, head and neck, hormone receptor-negative breast, liver, lung, ovarian, and pancreatic cancers, as well as multiple myeloma and lymphoid neoplasms. These types of cancer make up about 63% of cancer deaths in the United States, the company said. The combined analysis of this group of cancers showed robust detection at early stages, 34%, 77%, and 84% at stages I, II, and III, respectively, GRAIL noted at the time it presented its own data.
https://www.biospace.com/article/blood-test-can-accurately-screen-for-cancers-dana-farber-study-shows/

Zymeworks upped to Strong Buy by Raymond Jame

Target to $40 from $36
https://www.benzinga.com/stock/ZYME/ratings

Unitedhealth cut to Market Perform by BMO

https://www.benzinga.com/stock/UNH/ratings

Humana cut to Market Perform by BMO

Target to $290 from $345
https://www.benzinga.com/stock/HUM/ratings