Search This Blog

Wednesday, June 10, 2020

Three key studies of COVID-19 vaccines to launch in summer

The WSJ reports that the federal government (National Institutes of Health) plans to fund and conduct pivotal studies of three COVID-19 vaccine candidates starting this summer.
The large-scale trials will test Moderna’s (MRNA +3.8%) mRNA-1273 starting next month, Oxford University and AstraZeneca’s (AZN +2.2%) AZD1222 in August and Johnson & Johnson’s (JNJ +1.4%) Ad26.COV2-S in September. Each is projected to enroll ~30K people.
Pfizer (PFE -0.4%), which is not participating in the NIH testing program, together with collaboration partner BioNTech SE (BNTX -0.8%), plans to launch a Phase 3 study on its candidate, BNT162, as early as next month (four variants of the vaccine are currently being tested).
The feds may include additional large-scale studies of other vaccine candidates, such as those being developed by Sanofi (SNY +0.9%) and Merck (MRK -1.1%) according Dr. Larry Corey, a member of the committee advising NIH on the design of the trials.
https://seekingalpha.com/news/3581971-three-key-studies-of-covidminus-19-vaccines-to-launch-in-summer

Endo International under pressure on NY insurance fraud charges

Endo International (ENDP -12.5%) already under pressure from the large-scale antitrust complaint over alleged price-fixing among generic drugmakers, takes another shot related to its role in the opioid epidemic.
The New York State Department of Financial Services (DFS) has filed charges against the company accusing it of misrepresenting the safety and efficacy of its opioid pain medicines while minimizing the risk of addiction and other deleterious effects.
DFS claims that Endo made 18.4% of the opioids that were distributed in the state from 2006 – 2014.
The company faces penalties of $5,000 plus the amount of the fraudulent claim for each violation under one statute (each prescription considered a violation) and $5,000 per violation under another (also on a per-prescription basis).
A hearing is scheduled for October 26.
https://seekingalpha.com/news/3582055-endo-international-under-pressure-on-ny-insurance-fraud-charges

Lilly’s baricitinib shows sustained benefit in rheumatoid arthritis study

Eli Lilly (LLY +1.3%) announces positive long-term data from a study evaluating Olumiant (baricitinib) in patients with moderate-to-severe rheumatoid arthritis (RA) who were treated for three years. The results were virtually presented at EULAR.
52% of patients who failed to respond adequately to methotrexate who responded to Olumiant therapy by week 24 maintained their responses through week 148.
No new safety signals were reported from 3,770 patients treated with Olumiant for up to 8.4 years.
The FDA approved the JAK inhibitor for RA in June 2018.
https://seekingalpha.com/news/3582063-lillys-baricitinib-shows-sustained-benefit-in-rheumatoid-arthritis-study

Lilly’s COVID-19 treatment maybe available as soon as September

Eli Lilly (NYSE:LLY) Chief Scientific Officer Daniel Skovronsky says the company has human trials underway with two antibody therapies. If things go well in August and September – with folks under treatment not having to move into hospitalization – it could lead to emergency use authorization, he says.
“September, October, November is not unreasonable.”
Lilly also has a third antibody treatment under study that could soon move to human trials.
https://seekingalpha.com/news/3582085-lillys-covidminus-19-treatment-maybe-available-soon-september

AbbVie teams up with Genmab in cancer

AbbVie (NYSE:ABBV) and Genmab A/S (NASDAQ:GMAB) have signed a broad collaboration agreement to jointly develop and commercialize three of Genmab’s bispecific antibodies and enter into a discovery research collaboration for future antibody therapeutics for cancer.
The companies will partner to develop Genmab’s next-generation bispecific antibody programs, epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4.
Under discovery research collaboration, the companies will develop up to four additional differentiated next-generation antibody-based product candidates across solid tumors and hematological malignancies.
Both the companies will share commercial responsibilities in U.S. and Japan, with AbbVie responsible for further global commercialization.
Genmab will book net sales in U.S. and Japan and receive tiered royalties on remaining global sales.
For the discovery research partnership, Genmab will conduct Phase 1 studies for these programs.
Under the terms of the agreement, AbbVie will pay Genmab $750M in upfront payment with total potential milestone payments of up to $3.15B as well as tiered royalties between 22% and 26% on net sales for epcoritamab outside U.S. and Japan.
https://seekingalpha.com/news/3581807-abbvie-teams-up-genmab-in-cancer

‘Price Tag To Test All Americans For Coronavirus: $44 Billion A Year’

The cost of swabbing and testing all Americans for the coronavirus strain Covid-19 plus the price tag for testing them for virus antibodies could be as much as $44 billion a year, a new analysis funded by health insurers says.
“Diagnostic testing would cost between $6 billion and $25 billion a year, and antibody testing would cost between $5 billion and $19 billion a year,” the report from the Wakely Consulting Group, funded by the health insurance lobby America’s Health Insurance Plans (AHIP), says. “These estimates include both the cost of the tests, as well as affiliated health care services (e.g., provider visit, urgent care visit) for administering the tests.”
The U.S. fight against Covid-19 has put diagnostic testing in the spotlight to get patients treatment while helping society re-open to get Americans back to work and children back to school this fall. But it’s unclear who will pay for the tests with some members of Congress and state lawmakers looking at the health insurance industry as a potential target to pick up the tab.
But health insurers say it’s not that simple, indicating costs should be spread around.
“Testing strategies need to be part of a holistic public and occupational health strategy,” said AHIP, which includes Anthem, Cigna, Centene and CVS Health, parent of Aetna, as members. “Federal guidance should consider funding for testing in that context, and should clearly articulate the roles of insurance providers, employers, and public health officials.”
The first wave of testing is already well underway with clinicians including doctors, retail clinics and hospitals testing Americans for the virus with molecular assays to diagnosis COVID-19 virus so they can begin treatment. These medically necessary tests made by companies like Abbott Laboratories, Roche and others are designed to diagnose or treat the disease.
Lately, companies including Abbott and Roche are beginning to roll out antibody tests for the mass population to know who has the virus so others don’t catch it and spread it in the future. Some states, including New York, have already begun antibody testing with medical care providers in their regions in an effort to know who has had the disease and whether they have built up immunity.
Costs of testing in the report varied widely in part because it would depend on who administered the tests and whether there was adequate supply and materials to carry out either diagnostic testing or antibody testing.
As one example of the wide range of test costs, the Wakely Consulting Group report said the estimated cost of the testing would vary depending on which line of health insurance picked up the tab.
“It was assumed to be between $40 and $70 for diagnostic testing for Medicare and Medicaid and between $30 and $50 per test for antibody testing for Medicare and Medicaid,” the report said. “Commercial testing was assumed to be approximately 25% higher than the average cost for Medicare and Medicaid.”
https://www.forbes.com/sites/brucejapsen/2020/06/10/price-tag-to-test-all-americans-for-coronavirus-44-billion-a-year/amp/

Japan’s AnGes speeds towards 2021 rollout in coronavirus ‘vaccine war’

Japanese biotech AnGes Inc expects its coronavirus vaccine to be ready as early as the first half of 2021, if it can overcome supply chain and production hurdles, the company’s founder said.
The Osaka-based firm had a headstart in the potential COVID-19 vaccine development by repurposing its hypertension vaccine that had already passed through high safety and regulatory standards and other hurdles.
Ryuichi Morishita told Reuters that Japan’s health ministry and Pharmaceuticals and Medical Devices Agency “already had strong confidence in our product” because of that experience.
The comments come as Japan’s government has earmarked $1.3 billion in its latest budget for vaccine production as it seeks to put the coronavirus vaccine into use and hopes to host a delayed Tokyo Olympics next year.
Drugmakers around the world are scrambling to develop treatments and vaccines for COVID-19, the respiratory disease caused by the highly infectious new coronavirus which has so far killed more than 400,000 people worldwide.

There are 10 vaccines in clinical trials and dozens more in pre-clinical evaluation, according to the World Health Organization, but mass production and allocation remain significant challenges.
Morishita also warned that shortages in everything from drug compounds to glass vials, as hundreds of institutes and companies carry out research simultaneously, have emerged in what he calls a “vaccine war” and could complicate production.
AnGes’s candidate is one of Japan’s best hopes at a coronavirus vaccine, as development is further along than some being produced by other firms such as Shionogi & Co and Daiichi Sankyo Co.
The AnGes candidate is a plasmid DNA vaccine that disables the connection between the protein spikes of the coronavirus and receptors in human cells.
Early results from tests in mice show increased antibody production, and tests in 30 human volunteers are due to begin in July, with first results expected in September.
By contrast, other candidates such as U.S. firm Moderna Inc’s vaccine are based on messenger RNA (mRNA) that instructs human cells to make specific coronavirus proteins that produce an immune response. Other varieties are based on inactivated forms of the virus.
Morishita, who launched AnGes 20 years ago out of Osaka University, has seen the company’s market valuation surge more than five fold to $2.4 billion since it announced its coronavirus campaign in March.
“The future of COVID-19 is very mysterious,” said Morishita, adding that any vaccine would likely need constant tweaking as the virus mutates and returns.
https://www.reuters.com/article/us-health-coronavirus-japan-anges/japans-anges-speeds-towards-2021-rollout-in-coronavirus-vaccine-war-idUSKBN23H115