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Tuesday, June 16, 2020

Amarin settles with Apotex, delays generic Vascepa until 2029

Amarin (NASDAQ:AMRN) has settled its patent infringement dispute with Apotex over the latter’s marketing application seeking approval to sell a generic version of Vascepa (icosapent ethyl) in the U.S.
Amarin’s appeal of an adverse patent ruling allowing generic competition to Vascepa remains pending.
Under the terms the the settlement agreement, Apotex may not sell its generic product until August 9, 2029 (the same date under a 2018 settlement agreement with Teva Pharmaceutical Industries) or earlier under certain circumstances (including if Amarin loses its appeal).
https://seekingalpha.com/news/3583607-amarin-settles-apotex-delays-generic-vascepa-until-2029

Texas Insurance Dept Data: PBM Industry Maximized Profit At Patient Expense

The Alliance for Transparent and Affordable Prescriptions (ATAP) reacted today to a report issued by the Texas Department of Insurance (TDI) showing the financial activity of the pharmacy benefit manager (PBM) industry in the Lone Star State. Texas law requires that PBMs annually report to the Insurance Commissioner aggregate data on rebates.
“The Texas rebate report is unambiguous. The PBM industry has been generating significant profits while patients struggle to afford the cost of prescription drugs,” stated ATAP’s President Dr. Robert Levin. “Since 2016, through a complex rebate and price concession, the PBM industry in Texas pocketed more than $350 million in revenue, while passing a mere $16 million in savings to enrollees.”
The data as reported by the PBM industry and compiled by the TDI may be found here:  https://www.tdi.texas.gov/reports/documents/drug-price-transparency-PBMs.pdf
“PBMs owe it to patients to pass along savings to them,” Dr. Levin continued. “Now that Texas is making rebate information publicly available, it will be easier for other states’ officials and regulators to see the need for reforms.”
ATAP will continue to advocate for more states to collect aggregated rebate data from PBMs and have the information be released to the public. Additionally, ATAP supports transparency and reporting requirements for all entities involved in the prescription drug supply chain – PBMs, insurers, and manufacturers. In fact, the Texas law that put in place the requirement for aggregate rebate reporting also included certain reporting requirements for insurers and manufacturers, reflecting the usability of ATAP’s model language.
“Patients today are suffering under a system that prevents them from getting medicine they need. The PBM industry profits significantly off rebates while interrupting the provider-patient relationship, solely to increase its own profits,” Dr. Levin said. “Now that light is shining on the previously hidden profit motives of the PBM industry, patients, physicians and legislators have the power to effect meaningful change. I am proud of the role ATAP holds in reforming the rebate system and look forward moving future legislation forward to-that-end.”
https://www.prnewswire.com/news-releases/data-proves-pbm-industry-maximized-profit-at-patient-expense-301077011.html

FDA OKs Novartis’ canakinumab for rare type of arthritis

The FDA approves Novartis’ (NVS +1.6%) Ilaris (canakinumab) for the treatment of adult-onset Still’s disease, a rare type of inflammatory arthritis characterized by fever, rash and joint pain.
The FDA originally approved the interleukin-1-beta blocker in June 2009 for a rare inflammatory disorder called cryopyrin-associated periodic syndrome (CAPS). Indications for juvenile idiopathic arthritis and three rare periodic fever syndrome were added in May 2013 and September 2016, respectively.
https://seekingalpha.com/news/3583557-fda-oks-novartis-canakinumab-for-rare-type-of-arthritis

Customers asked to waive right to sue in case of coronavirus infections

As businesses reopen across the US after coronavirus shutdowns, many are requiring customers and workers to sign forms saying they won’t sue if they catch COVID-19.
Businesses fear they could be the target of litigation even if they adhere to safety precautions from the Centers for Disease Control and Prevention and state health officials. But workers’ rights groups say the forms force employees to sign away their rights should they get sick.
The liability waivers, similar to what President Trump’s campaign is requiring for people to attend a Saturday rally in Tulsa, Oklahoma, would protect businesses in states that don’t have liability limits or immunity from coronavirus-related lawsuits.
So far, at least five states — Utah, North Carolina, Oklahoma, Arkansas and Alabama — have such limits through legislation or executive orders, and others are considering them. Business groups such as the US Chamber of Commerce are lobbying for national liability protections.
The novel coronavirus has sickened more than 2 million people in the US and killed more than 115,000, according to Johns Hopkins University.
At Salon Medusa in West Hartford, Connecticut, hairstylist Lena Whelan says they’re using only two of six styling stations since reopening June 1. Customers have to wait outside and wear masks, and all stations and tools are disinfected between clients.
Despite all those safety measures, customers must sign a form saying they won’t sue if they become infected with the novel coronavirus. The form, which also asks patrons if they or any family members have virus symptoms, gives the salon extra legal protection, Whelan said.
Critics argue that liability waivers open the door for corporations to skirt protocols like erecting Plexiglas barriers, providing face masks and other protective equipment, and keeping people the proper distance apart without suffering any repercussions.
The waivers are particularly onerous for workers who may feel compelled to sign them in order to keep their jobs, unlike customers who at least have a choice to walk away.
“It’s a terrible choice for an employee,” said Hugh Baran, an attorney with the National Employment Law Project, a worker advocacy group. “Do you sign this and potentially give up your legal recourse or do you refuse and feel like you are going to lose your job?”
Worse yet, in many states, if workers refuse to sign the waivers and return to work, they risk losing unemployment benefits, Baran said. Also, immunity legislation and liability waivers disproportionately affect black and Latino workers, many of whom have jobs that can’t be done remotely, he said.
Lawyers say many business clients are asking about the waivers.
Whether they can be enforced varies by state and is open to debate. Owners are wise to take a “better safe than sorry” approach, said John Wolohan, a sports law professor at Syracuse University.
“It’s hard for me to believe people don’t understand the danger of going out in public and interacting. But when somebody gets sick, I’m sure they’re going to claim the business didn’t protect them the way they should have. By having a waiver, the business will better withstand the lawsuit,” Wolohan said.
In 45 states and the District of Columbia, courts will generally enforce voluntary waivers, according to “Law for Recreation and Sport Managers,” a book Wolohan co-wrote with Doyice Cotten.
Connecticut, Hawaii, Louisiana, Virginia and Wisconsin offer consumers the best chance to challenge liability waivers.
But Baran says a lot depends on how state contract laws have been interpreted by the courts. Many states, he said, have laws on the books saying that businesses have a general duty to maintain healthy and safe working conditions. In some instances, however, courts have determined that employees can sign away those rights, he said.
“This is a new situation,” Baran said of the liability forms related to the coronavirus. “It’s hard to know how state courts would view such waivers.”
Data on just how many businesses require liability waivers of employees or customers is difficult to find.
Lawyers say the forms are showing up at small businesses such as hair salons and gyms where it’s hard to maintain social distancing.
But it’s also showing up at the New York Stock Exchange, where Jonathan Corpina, senior managing partner with Meridian Equity Partners, said Monday he was required to sign a waiver in order to enter the trading floor.
Cheryl Falvey, a partner at the Crowell and Moring law firm in Washington, DC, and a former top lawyer at the federal Consumer Product Safety Commission, said she does not think most employers would try to get their workforce to sign them.
Falvey also noted there are circumstances that waivers would not cover, including if someone who signs a waiver gets infected and then spreads the disease to family members or neighbors.
“I don’t think these waivers would cover that,” Falvey said. The wife of someone infected might argue, “I didn’t sign that waiver. You let him in and you didn’t protect him,” she said.
Harold Kim, president of the US Chamber of Commerce Institute for Legal Reform, said federal legislation would be better for businesses rather than a patchwork of conflicting state laws.
The legislation sought by the chamber would be temporary and grant protections only if businesses followed CDC and state guidelines on the virus, he said. It would not give businesses immunity if they were grossly negligent.
“You don’t get those protections if you don’t follow that guidance,” Kim said.
Employees who get sick on the job might not be able to sue their employers, but would have access to workers’ compensation to cover lost wages and medical care, legal experts said. Proposed federal legislation wouldn’t affect workers’ compensation programs, which most states have, Kim said.
Through Monday, there were 2,741 lawsuits filed in the US over COVID-19 infections, according to a complaint tracker maintained by the Hunton Andrews Kurth law firm.
Many of the cases were over government shutdown orders and which businesses were deemed essential. Only seven came from consumers and 49 were filed by employees over exposure to the virus or other related injuries. Kim said federal legislation would prevent a big surge in litigation.
https://nypost.com/2020/06/16/customers-asked-to-waive-right-to-sue-in-case-of-coronavirus-infections/

Safety use of hydroxychloroquine, azithromycin combination in Sars-CoV-2

LuciePothen
https://doi.org/10.1016/j.tmaid.2020.101788
Based on studies showing in vitro antiviral activity of chloroquine (CQ) and hydroxychloroquine (HCQ) on SARS-CoV-2 [1], Belgian COVID interim guidelines rapidly (March 13th, 2020) recommended treating hospitalized patients suffering from severe COVID-19 with HCQ, 400 mg bid the first day followed by 200 mg bid for 4 additional days (for GFR > 30 ml/min).
Despite some encouraging preliminary clinical data [2,3], major concerns have been raised about the use of HCQ to treat COVID-19 [5], particularly regarding potential cardiac toxicity (i.e. QTc increase and risk of torsade de pointe). Because HCQ has been safely used for many years for various indications (e.a. connective tissue diseases) [6], we decided to follow interim Belgian guidance for all eligible patients hospitalized in our COVID-19 wards. Moreover, we decided to add azithromycin (AZM), 500 mg Id for 3 days, for selected patients, based on our knowledge of its antibiotic, immunomodulatory and possible antiviral actions [3].
Between March 8 and April 15, 2020, a total of 114 patients with confirmed COVID-19 pneumonia were hospitalized in our dedicated units. Patient characteristics are summarized in Table 1. The mean age was 63 years and men represented 55.3%. A vast majority (n = 104) presented with severe disease and half (n = 59) had cardiovascular disease history. Other comorbidities are listed in Table 1. HCQ was administered to 107 patients after QTc evaluation by electrocardiogram (ECG). HCQ was avoided in patients under palliative care (n = 4), if QTc was over 500 msec (n = 1), and if patients had received prior treatment with CQ (n = 2). Mean initial QTc was 429 msec (Bazett formula used for correction). Biochemistry was followed on a regular basis, and ionic disturbances (hypokalemia, hypomagnesemia) were treated by supplementation if present. Repeat ECG was not systematically performed during HCQ treatment, except in case of drug-drug interaction which could potentially increase QTc (see foot note of Table 1). The main drug-drug interaction was driven by addition of AZM (n = 28). In this group, QTc was controlled at day 2 of combination therapy (n = 24). We observed a significant increase in mean QTc, from 418 to 433 msec (p < 0,01 with paired t-test), but none of the patients showed a QTc over 500 msec.
Table 1. Characteristics of patients.
No. Patients 114
Age, mean [range], years 63 [19–95]
Sex
Male (%)
Female (%)
63 (55.3)
51 (44.7)
Patients with comorbidities (%)
None
Cardiovascular disease
Hypertension
COPD
Diabetes
Immunosuppression
29 (25,4%)
59 (51,8%)
56 (49,1%)
17 (14,9%)
25 (21,9%)
17 (14,9%)
O2 sat. on admission. while breathing ambient air, mean [range], % 90,1 [55–99]
Clinical presentationa (%)
Mild disease
Moderate disease
Severe disease
0 (0%)
10 (8,8%)
104 (91,2%)
HCQ (%) 107 (93.8)
ECG pretreatment (% of HCQ) 100 (93.4)
QTc initial, mean [range] msec 429 [342–493]
Drug-drug interaction (% of HCQ)
Azithromycin
Otherb
34 (31.8)
28 (26.2)
6 (5.6)
ECG CTRL at day 2 (% of patient w. drug-drug interaction)
Azithromycin
Other
27 (79.4)
24 (70.5)
3 (8.8)
a
“Mild disease” was define as symptoms of upper respiratory infection (fever, fatigue, myalgia, cough, sore throat, runny nose, sneezing) or digestive symptoms (nausea, vomiting, abdominal pain, diarrhea); “moderate” as clinical (fever and cough) and radiological pneumonia (infiltrates) without hypoxemia; “severe” as clinical and radiological pneumonia with hypoxemia (O2 saturation < 93%).
b
Other consisted in escitalopram, citalopram, fluconazole, valproate, mirtazapine and olanzapine.
Furthermore, in our entire cohort there were no sudden deaths nor syncope requiring resuscitation or ICU admission. All ICU admissions (n = 13) were linked to respiratory failure resulting from COVID-19 pneumonia. One patient on HCQ presented AV nodal reentry tachycardia in parallel with respiratory failure, and was successfully treated with adenosine. All deaths in our cohort (n = 12) were attributed to COVID-19 infection.
In conclusion, based on our clinical experience, no safety issues were encountered with the use of HCQ for the treatment of COVID-19. In coherence with recent data published here (7), its association with AZM also seems to be safe, despite a significant increase of QTc that should be carefully monitored. The efficacy of HCQ and its combination with azithromycin on COVID-19 infection needs, of course, to be strengthened with further evidence from large randomized clinical trials. However, at this point of the COVID-19 pandemic, we find it relevant to share our clinical experience with this well-known, readily available compound (HCQ) which has limited contraindications and may help in the fight against this outbreak.
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https://www.sciencedirect.com/science/article/pii/S1477893920302787

Henry Ford Health System still moving forward with hydroxychloroquine study

President Donald Trump had been hyping the antimalarial drug hydroxychloroquine as a potential coronavirus treatment, which led to Detroit heading up the first large-scale study of the drug as a potential preventive measure against COVID-19 at Henry Ford Health System. However, in recent weeks the drug has seen a string of bad publicity: Trump revealed he had secretly been taking it, shocking medical professionals due to the drug’s potential adverse effects for people with heart conditions, and then a within a week announced he was no longer taking it. Then, on Monday, the U.S. Food and Drug Administration withdrew its emergency use authorization for hydroxychloroquine for COVID-19 patients.
Henry Ford Health System, however, says the FDA’s new reversal does not impact its study, which is is expected to wrap up in July.
The FDA’s decision bars the use of hydroxychloroquine sulfate and a similar drug called chloroquine phosphate from the Strategic National Stockpile for hospitalized COVID-19 patients. But the use of the drug as a prophylaxis, or preventive measure, is not impacted by the FDA decision.
“The ongoing WHIP COVID-19 study is an FDA-approved study looking at hydroxychloroquine as a potential preventative medication for healthy, pre-screened individuals,” Dr. Steven Kalkanis, chief executive officer of the Henry Ford Medical Group, told Metro Times in a statement on Monday. “It is not affected by the FDA’s decision today, and there is no evidence that the use of hydroxychloroquine as a potential prophylaxis presents a health risk in that setting.”
Kalkanis says hydroxychloroquine has been used as a treatment in hospitalized patients, which falls under the FDA’s Monday directive. The early results of a retrospective study looking at the drug as a treatment look promising, but the results are not final and still pending peer review.
“We have analyzed our data and have seen a significantly improved outcome in a group of COVID-19 patients who received hydroxychloroquine,” he said.
In response to the FDA decision, Henry Ford Health System suspended the use of hydroxychloroquine as a COVID-19 treatment outside of clinical trials.
“The safety and wellbeing of our patients remains our top priority and we will continue to monitor all available data regarding safety and outcomes and adjust accordingly,” Kalkanis said.
Another study at University of Michigan is also still moving forward.
On Tuesday, officials announced potential in another drug. Scientists at the University of Oxford said a steroid called dexamethasone was found to reduce the number of deaths in hospitalized COVID-19 patients.
https://www.metrotimes.com/news-hits/archives/2020/06/16/henry-ford-health-system-still-moving-forward-with-hydroxychloroquine-study

Admin: Future Covid-19 vaccines will be free for ‘vulnerable’ Americans

The Trump administration on Tuesday pledged to provide a future Covid-19 vaccine for free to “vulnerable” Americans unable to afford it.
The remarks constitute the federal government’s most concrete pledge to date about vaccine affordability, which has emerged as a sticking point in recent congressional hearings and in legislation to address the pandemic.
“For any American who is vulnerable, who cannot afford the vaccines, and desires the vaccine, we will provide it for free,” said a Trump administration official, speaking on the condition of anonymity, on a conference call with reporters.
Officials also indicated that commercial insurers have expressed interest in covering vaccines at no cost to their beneficiaries.
Officials also said the federal government would employ a “tiered approach” for distributing a future vaccine to high-risk individuals like elderly Americans, those with pre-existing health conditions, and frontline health care workers. People in those categories would be prioritized such that they received a vaccine before the general public, officials said.
The federal government’s sweeping vaccine-development initiative, known as Operation Warp Speed, aims to distribute 300 million doses of Covid-19 vaccine to Americans by January 2021, the officials said — a nakedly ambitious goal that would shatter records for vaccine development, and that has drawn heavy skepticism from scientists.
While some health policy experts aligned with the Democratic party have expressed concerns that the November election could lead to a politicized vaccine-approval process, Trump administration officials maintained that any Covid-19 vaccine still would require approval by normal standards of safety and efficacy.
Officials also stressed that they could not guarantee the year-end deadline with 100% certainty.
Both government and private-sector figures have remained optimistic, however. On Monday, the CEO of the Massachusetts drugmaker Moderna said the company hoped to reveal efficacy data for its Covid-19 vaccine candidate by Thanksgiving. And in briefing materials, the Trump administration has repeatedly expressed hope that a competing vaccine candidate from the British drugmaker AstraZeneca could deliver its first doses to high-risk U.S. patients by October.
The U.S. government has already awarded nearly $500 million to Moderna’s vaccine-development effort, and over $400 million to AstraZeneca’s — though government support for AstraZeneca’s vaccine could reach $1.2 billion.
Trump administration pledges future Covid-19 vaccines will be free for ‘vulnerable’ Americans