Search This Blog

Wednesday, June 24, 2020

Biogen comes up empty in effort to block Tecfidera generic competitor

The U.S. Court of Appeals for the Federal Circuit has turned down requests from Biogen (BIIB -1.4%) seeking reconsideration of an April ruling preventing it from blocking Banner Life Sciences from selling a generic version of top seller Tecfidera (dimethyl fumarate) or a hearing before all active judges (instead of the 3-judge panel that decided on the matter).
The court found that the extension given to Biogen related to the disputed patent, which expired last week, only covers the active ingredient, not a related molecule given at a different dosage.
Despite the setback, the company still has its ‘514 patent expiring in 2028 to stiff-arm generic competitors until then, although a court in West Virginia agreed that Mylan showed it to be “invalid for lack of written description” in a ruling announced on June 18.
The multiple sclerosis med accounted for 39% of Biogen’s 2019 product sales.

NY, NJ, CT impose inbound Covid quarantine; CA, TX cases surge

As Covid-19 cases rise in some of the heaviest populated states in the U.S., renewed attention is coming to California, Texas and Arizona as their case curve inflects higher.
NY, Connecticut and New Jersey jointly impose a travel advisory on any inbound travelers from high case count states to help prevent cases from flaring back up. States are asking those traveling to self-quarantine for 14 days.
Non-residents violating the quarantine order could face mandatory quarantine, $2K fine ($5K fine for 2nd violation, $10K if you are found to have caused harm), effective at midnight, NY Governor Cuomo said in his daily briefing.
Latest figures from California put new cases near 7,000 for the first time since the pandemic began, with only NY ever having a larger daily total.
Latest figures from Texas, on the hospitalization front, indicate that more than 5,000 have been hospitalized, a new record-high. Monday the state reported the 11th consecutive record-high hospitalizations with more than 3,700 cases. The case count has prompted the Governor to issue a few proclamations in recent days, including allowing local authorities to place restrictions on gatherings over 100 people.
Arizona, a state with significantly fewer people than TX and FL, recorded a new record on Tuesday, with nearly 3,600 new cases. More than 80% of ICU and inpatient beds were filled in the state as of Monday.
Florida cases also are on the rise, with new records there of more than 5,500 new cases.
Note: The White House in June picked 5 Covid vaccine candidates in early June, for “Warp Speed” initiative. AstraZeneca (NYSE:AZN), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) were among those companies developing products.

718 Pipeline Drugs Now Associated with COVID-19

New information released Tuesday by GlobalData showed that there are now more than 718 pipeline drugs associated with COVID-19. In addition, 70% of these products are in the discovery or preclinical stages.
“These drugs include combinations of novel agents and repurposed drugs, and new ones are added daily as new studies are announced or completed at a rapid rate,” said Johanna Swanson, product manager at GlobalData.

According to the most recent statistics, there are more than 2,000 clinical trials being conducted around the world, with 398 of them focused on chloroquine or hydroxychloroquine. A total of 22 of them are trials looking into remdesivir, an investigational drug that is still being examined by the U.S. Food and Drug Administration (FDA) for use in patients.
Gilead Sciences released new data on June 1 from its Phase III SIMPLE trial, examining remdesivir and how it can potentially help hospitalized COVID-19 patients with moderate pneumonia. The open-label study evaluated five-day and 10-day courses of remdesivir when used with standard care, versus standard care alone.
Statistics from the Phase III SIMPLE trial showed that patients in the five-day remdesivir treatment group were 65% more likely to show clinical improvement at Day 11, compared to their counterparts. The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard care alone were also favorable. However, they did not show statistical significance.
“Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve,” said Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School. “These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients.”
On June 15, the FDA issued a new warning to healthcare providers pertaining to a new drug interaction related to remdesivir, which had received emergency use authorization for the treatment of hospitalized COVID-19 patients. The FDA revised its fact sheet for healthcare providers to reflect the potential interactions between remdesivir and chloroquine phosphate or hydroxychloroquine sulfate – the co-administration of remdesivir with these products may reduce the antiviral activity of the drug, according to the FDA.
The FDA is not aware of any instances of this reduced activity occurring in a clinical setting, but is continuing to evaluate the use of remdesivir and all data surrounding the drug.
“Over the course of this unprecedented pandemic, the FDA has issued emergency use authorizations for a variety of medical products after evaluating the available scientific evidence and carefully balancing any known or potential risks against the benefits of making these products available during the current public health emergency,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “We understand that, as we learn more about these products, changes may be necessary based on new data – such as today’s updates for health care providers about a potential drug interaction and other important information about using remdesivir to treat COVID-19 patients. As we have done throughout the pandemic, the FDA continues to evaluate all of the emergency use authorizations issued and their related materials and will continue to make changes as appropriate based on emerging science and data.”

LHC Group and Orlando Health in JV

For better home health and home and community based services, LHC Group (LHCG +0.2%) and not-for-profit healthcare network, Orlando Health have entered in a joint venture which will include six total locations from both the companies divided equally.
JV would be finalized on August 1 wherein LHC will purchase majority ownership and takeover management responsibility.
LHC Group estimates incremental annualized revenue of ~$3.5M from the JV, no impact on the adjusted EPS OF FY20.

Alpine Immune Sciences doses first patient in Phase 1 study of ALPN-202 June 24, 2020

Alpine Immune Sciences (ALPN -3.0%) announces that the first patient has been successfully dosed in its NEON-1 Phase 1 study of ALPN‑202, a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in patients with advanced malignancies.
As the study continues, ALPN-202 is likely to support in establishing the clinical relevance of localized CD28 costimulation to checkpoint inhibition in cancer.

CVS to offer employers COVID-19 testing program

As U.S. employers grapple with trying to keep workers healthy and on the job amid fresh spikes in COVID-19 cases, CVS Health Corp has begun selling companies a diagnostic testing program.
In addition to onsite and pharmacy testing, CVS also will create plans for temperature and symptom checks, seasonal flu vaccines and other immunizations and offer add-on services like contact tracing technology for employees and other services.
The unexpected surge in COVID-19 cases in states in the South and West has increased demand in recent weeks for testing workers on a regular basis, such as every two weeks or every month, said Troy Brennan, chief medical officer of the company, which operates pharmacies, a pharmacy benefit management (PBM) service and the Aetna insurance plan.
“The general perception is that there is not going to be a sustained lull over the course of the summer, and in fact it looks like it is building somewhat, and that is changing people’s views,” Brennan said.
States including Florida, Arizona, and Texas, as well as Georgia, Oklahoma, South Carolina and Utah have all reported an increase in COVID-19 cases and hospitalizations in recent weeks.
The United States has had more than 2.3 million cases and over 120,000 COVID-19 deaths, about a quarter of the world’s total.
States hard hit early in the pandemic, such as New York and New Jersey, have experienced dramatic declines in cases. But many states that reopened before achieving safety metrics or are not requiring mask wearing are seeing record increases. Overall U.S. cases rose 25% last week with 10 states reporting a greater than 50% rise in new infections, according to a Reuters analysis.
Other companies such as Labcorp Holdings and Quest Diagnostics Inc have also created testing services for corporations. Quest is working with Delta Air Lines.
CVS, however, is one of the nation’s largest healthcare companies. Between its PBM services and insurance business, CVS serves some of the largest U.S. companies with hundreds of thousands of employees.
The new service, dubbed Return Ready, is open to all companies, not just current customers.
CVS declined to provide details about companies that have already signed up, but said they are in discussions with media companies, financials services, sports leagues and the public sector.
ANTIBODY TESTING NOT INCLUDED
Return Ready is aimed at large employers or smaller ones who self-insure, meaning they pay for employee healthcare costs rather than insurers – and instead pay CVS to manage the tests and other services.
CVS declined to provide pricing for the program. Diagnostic tests can cost more than $100 each.
While the U.S. government has required health insurers to cover COVID-19 diagnostic testing, that coverage is largely restricted to “medically necessary” testing for those with symptoms and does not cover these back-to-work programs.
CVS is not offering tests that detect coronavirus antibodies to show prior infection.
Earlier this year, antibody tests were seen as key to getting the United States back to work, while in Europe some countries have considered related “immunity passports.” But it is not yet known whether the presence of those antibodies confers some level of immunity against future infection or how long any immunity might last.
Healthcare consulting firm Willis Towers Watson does not advise employers to use antibody tests because of the uncertainty about what they indicate, health management practice leader Jeff Levin-Scherz said in a recent interview.
Even regular diagnostic testing offers no guarantees. If everyone is tested and the tests are completely accurate, workers can still become infected a day after they test negative, he said.
“You still couldn’t assume that your workplace is a bubble and no COVID would come in,” Levin-Scherz said.


FDA lifts partial hold on Innate Pharma’s lacutamab study

The FDA has lifted partial clinical hold placed on Innate Pharma SA’s (NASDAQ:IPHA) TELLOMAK Phase II clinical trial, evaluating the efficacy and safety of lacutamab in patients with advanced T-cell lymphomas. The company is taking operational measures to re-activate trial in U.S.
The agency’s decision is based on a quality assessment of a new Good Manufacturing Practice (GMP)-certified batch that has been successfully manufactured for the lacutamab program.
The Company can now resume recruitment of new patients with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two prior systemic therapies.
The TELLOMAK trial was put on partial hold due to GMP deficiencies at a subcontractor site responsible for fill and finish operations.
Data from the trial for MF are expected in 2021 and for Sézary syndrome in 2022.