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AbbVie Announces Extension of Expiration Date for Allergan Notes

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AbbVie Announces Extension of Expiration Date for Allergan Notes
May 05, 2020: AbbVie Announces Extension of Expiration Date for Exchange Offers for Allergan Notes and Expects No Further Extensions of Expiration Date

AbbVie Inc. announced that the extension of the expiration date of the offers to exchange (each, an “Exchange Offer” and, collectively, the “Exchange Offers”) any and all outstanding notes of certain series issued by Allergan Finance, LLC (“Allergan Finance”), Allergan, Inc. (“Allergan Inc”), Allergan Sales, LLC (“Allergan Sales”) and Allergan Funding SCS (“Allergan Funding” and, together with Allergan Finance, Allergan Inc and Allergan Sales, “Allergan”) (the “Allergan Notes”) for new notes to be issued by AbbVie (the “AbbVie Notes”) and the related consent solicitations (each, a “Consent Solicitation” and, collectively, the “Consent Solicitations”) being made by AbbVie on behalf of Allergan to adopt certain amendments to each of the indentures (each, an “Allergan Indenture”) governing the Allergan Notes.

AbbVie hereby extends such expiration date from 5:00 p.m., New York City time, on May 8, 2020, to 5:00 p.m., New York City time, on May 12, 2020 (the “Expiration Date”). AbbVie currently expects that there will be no further extensions of the Expiration Date.

On the early participation date of November 7, 2019, requisite consents were received and supplemental indentures were executed eliminating substantially all of the covenants, restrictive provisions, events of default and any guarantees of the related Allergan Notes in each Allergan Indenture.

Such supplemental indentures will become operative only upon settlement of the Exchange Offers, which is expected to occur on May 14, 2020.

The Exchange Offers and Consent Solicitations were commenced in connection with AbbVie’s previously announced proposed acquisition of Allergan plc (the “Acquisition”) and are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement, dated October 25, 2019, and the related letter of transmittal, each as amended by the press releases dated November 18, 2019, December 20, 2019, January 27, 2020, February 24, 2020, March 9, 2020, March 23, 2020, April 6, 2020, April 20, 2020 and April 27, 2020 and as amended hereby (collectively, the “Offering Documents”), and are conditioned upon the closing of the Acquisition, which condition may not be waived by AbbVie, and certain other conditions that may be waived by AbbVie.

https://news.abbvie.com/news/press-releases/abbvie-announces-extension-expiration-date-for-exchange-offers-for-allergan-notes-and-expects-no-further-extensions-expiration-date.htm

Aberdeen researchers to use artificial intelligence to create test for COVID-19

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Aberdeen researchers to use artificial intelligence to create test for COVID-19
May 05, 2020: “Aberdeen researchers will use artificial intelligence to try to fast-track a test to allow mass screening for COVID-19, after the £140,000 project was green lit by the Scottish Government.

Existing tests can be unreliable and some are not suited to rapid, mass deployment.

The University of Aberdeen team will work with Vertebrate Antibodies Ltd (VAL) and will use VAL’s proprietary artificial intelligence (AI) technology to identify the specific elements of the virus that trigger the body’s defence systems.

It’s hoped this approach could allow the development of a sensitive test that could be used for mass screening of NHS staff/keyworkers, identification of high-risk patients/carriers, provide data on the prevalence of COVID-19, surveillance and in the future allow targeted vaccination programs.

The project was proposed in response to the Scottish Government’s CSO Rapid Research in COVID-19 programme call which was developed to support leading research at Scotland’s universities which could help the national effort.

In addition to the £101,903 from the Scottish Government, the project is being supported by a £38,000 in kind contribution from VAL – a biotech spinout company from the University of Aberdeen specialising in the design and production of sensitive and selective antibodies against multiple targets.  Dr Tiehui Wang, co-investigator from the University of Aberdeen’s School of Biological Sciences, will also play a key role.

The project is due to last six months.

Lead investigator, Professor Mirela Delibegovic from the School of Medicine, Medical Sciences and Nutrition at the University of Aberdeen said: “By working with VAL’s team and using their established expertise in antibody design and production enhanced by harnessing artificial intelligence, we hope to create a diagnostic test that can quickly and effectively identify COVID-19 in individuals.”

“By employing this innovative approach, we hope to achieve high-throughput capacity in a proven format that will enable mass testing which could benefit key workers and the most vulnerable members of society.”

Dr Ayham Alnabulsi, Co- founder & CEO of VAL said: “Vertebrate Antibodies is pleased that it is able to contribute its proprietary AI technology, EpitopePredikt, and the expertise of its technical team to help develop an assay  that could underpin a test that would help with the national effort to manage the COVID-19 pandemic.”

https://www.abdn.ac.uk/news/13990/

Farxiga approved in the US for the treatment of heart failure in patients with heart failure with a reduced ejection fraction

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Farxiga approved in the US for the treatment of heart failure in patients with heart failure with a reduced ejection fraction
May 06, 2020: “Farxiga is the first SGLT2 inhibitor proven to significantly reduce the risk of cardiovascular death and hospitalisation for heart failure

AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D).

The approval by the Food and Drug Administration (FDA) was based on positive results from the landmark Phase III DAPA-HF trial, which showed Farxiga achieving a statistically significant and clinically meaningful reduction of CV death or hospitalisation for heart failure (HF), compared to placebo. 

The decision follows the Priority Review designation granted by the FDA earlier this year and the Fast Track designation granted in September 2019.

Farxiga is the first sodium-glucose co-transporter 2 (SGLT2) inhibitor approved by the US FDA indicated to treat patients with HFrEF (LVEF ≤ 40%).

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “With the approval of Farxiga, we have reached a critical milestone to potentially transform heart failure treatment for the millions of people living with the condition in the US.

We are now one step closer to making a significant impact on their lives by providing a much-needed treatment to help reduce their disease burden and live longer.”

John McMurray, MD, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK, said:

“The ground-breaking results of the DAPA-HF trial have transformed heart failure therapeutics.

Today’s approval provides physicians with a completely novel pharmacological approach that greatly improves outcomes for patients with heart failure with reduced ejection fraction.”

The DAPA-HF trial showed that Farxiga, in addition to standard of care, reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% (absolute risk reduction [ARR] = 5% [event rate/100 patient years: 11.6 vs 15.6, respectively]; p<0.0001) in patients with HFrEF. During the trial duration, one CV death or hospitalisation for HF or an urgent visit associated with HF could be avoided for every 21 patients treated with Farxiga.

The safety profile of Farxiga in the DAPA-HF trial was consistent with the well-established safety profile of the medicine. The data from the DAPA-HF trial were published in The New England Journal of Medicine.

In October 2019 the US FDA approved Farxiga to reduce the risk of hospitalisation for HF in adult patients with T2D and established CV disease or multiple CV risk factors. The approval was based on the DECLARE-TIMI 58 trial.

Farxiga is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D.

HF is a life-threatening disease in which the heart cannot pump enough blood around the body.

It affects approximately 64 million people worldwide (at least half of which have a reduced ejection fraction) and six million in the US.

 It is a chronic disease where half of patients will die within five years of diagnosis.

 There are two main categories of HF related to ejection fraction (EF), a measurement of the percentage of blood leaving the heart each time it contracts: HFrEF and heart failure with preserved ejection fraction (HFpEF).

HFrEF occurs when the left ventricle (LV) muscle is not able to contract adequately and therefore, expels less oxygen-rich blood in to the body.

 HF remains as fatal as some of the most common cancers in both men (prostate and bladder cancers) and women (breast cancer).

 It is the leading cause of hospitalisation for those over the age of 65 and represents a significant clinical and economic burden

DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) is an international, multi-centre, parallel-group, randomised, double-blinded trial in 4,744 patients with heart failure and reduced ejection fraction (LVEF ≤ 40%), with and without T2D, designed to evaluate the effect of Farxiga 10mg, compared with placebo, given once daily in addition to standard of care.

The primary composite endpoint was time to the first occurrence of a worsening heart failure event (hospitalisation or equivalent event; i.e. an urgent heart failure visit), or cardiovascular death. The median duration of follow-up was 18.2 months.

Farxiga (dapagliflozin) is a first-in-class, oral once-daily SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction.

In the DECLARE CV outcomes trial in adults with T2D, Farxiga reduced the risk of the composite endpoint of hospitalisation for HF or CV death versus placebo, when added to standard of care.

Farxiga is currently also being evaluated for patients with chronic kidney disease (CKD) in the Phase III DAPA-CKD trial, which has been stopped early after a Data Monitoring Committee determination of overwhelming efficacy.

The FDA has granted Fast Track designation for the development of Farxiga in CKD. Additionally, Farxiga is also being tested for patients with HF in the DELIVER (HFpEF) and DETERMINE function and symptom (HFrEF and HFpEF) trials.

 Farxiga has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years’ experience.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/farxiga-approved-in-the-us-for-the-treatment-of-heart-failure-in-patients-with-heart-failure-with-reduced-ejection-fraction.html
 

Coronavirus (COVID-19) Update: Daily Roundup May 5, 2020

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Coronavirus (COVID-19) Update: Daily Roundup May 5, 2020
May 05, 2020: “The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
  • The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers.

    There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
    • The first seller warned, Honey Colony LLC, offers products including “Quicksilver Liposomal Vitamin C w/ Liposomal,” “Jigsaw Magnesium With SRT,” and products labeled to contain silver, including “Silver Excelsior Serum”, for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
    • The second seller warned, Dr. Dhole’s Sushanti Homeopathy Clinic, offers products including “Homeopathic Genus Epidemicus” for sale in the U.S. with misleading claims that the product is safe and/or effective for the prevention of COVID-19.
  • Yesterday, FDA approved two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation:

    succinylcholine chloride injection USP 200 mg/10 mL and cisatracurium besylate injection USP 20 mg/10 mL.

    FDA recognizes the increased demand for certain products during the novel coronavirus pandemic and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 385 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.
    • To date, the FDA has issued 59 individual EUAs for test kit manufacturers and laboratories. In addition, 25 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
    • The FDA has been notified that more than 240 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-5-2020

For More News: https://lifepronow.com/blog/2020/05/06/fda-approves-new-treatment-for-a-type-of-heart-failure/

https://lifepronow.com/blog/2020/05/03/roches-covid-19-antibody-test-receives-fda-emergency-use-authorization-and-is-available-in-markets-accepting-the-ce-mark/

FDA approves new treatment for a type of heart failure

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FDA approves new treatment for a type of heart failure
May 05, 2020: “The U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure.

Heart failure occurs when the heart does not pump enough blood to support the body’s needs, and this type of heart failure happens when the heart’s main pumping chamber, the left ventricle, is weakened.

With the approval, Farxiga is the first in this particular drug class, sodium-glucose co-transporter 2 (SGLT2) inhibitors, to be approved to treat adults with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.

“Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research.

“This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalization.”

Farxiga was shown in a clinical trial to improve survival and reduce the need for hospitalization in adults with heart failure with reduced ejection fraction.

Farxiga’s safety and effectiveness were evaluated in a randomized, double-blind, placebo-controlled study of 4,744 participants.

The average age of participants was 66 years and more participants were male (77%) than female. To determine the drug’s effectiveness, investigators examined the occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits.

Participants were randomly assigned to receive a once-daily dose of either 10 milligrams of Farxiga or a placebo (inactive treatment).

After about 18 months, people who received Farxiga had fewer cardiovascular deaths, hospitalizations for heart failure, and urgent heart failure visits than those receiving the placebo.

Farxiga can cause dehydration, serious urinary tract infections and genital yeast infections. Elderly patients, patients with kidney problems, those with low blood pressure, and patients on diuretics should be assessed for their volume status and kidney function.

Patients with signs and symptoms of metabolic acidosis or ketoacidosis (acid buildup in the blood) should also be assessed.

Farxiga can cause serious cases of necrotizing fasciitis of the perineum (Fournier’s Gangrene) in people with diabetes and low blood sugar when combined with insulin.

This application received Priority Review designation, meaning the agency planned to take action on the application within six months, because the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.

Farxiga is also FDA-approved to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise, and to reduce the risk of hospitalization for heart failure among adults with type 2 diabetes and known cardiovascular disease or other risk factors.

The FDA granted the approval of Farxiga related to heart failure to AstraZeneca Pharmaceuticals LP Wilmington, DE.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-type-heart-failure

for more News: https://lifepronow.com/blog/2020/05/03/roches-covid-19-antibody-test-receives-fda-emergency-use-authorization-and-is-available-in-markets-accepting-the-ce-mark/

https://lifepronow.com/blog/2020/05/01/coronavirus-covid-19-update-fda-includes-ventilator-developed-by-nasa-in-ventilator-emergency-use-authorization/

Study to determine the incidence of novel coronavirus infection in U.S. children begins

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Study to determine the incidence of novel coronavirus infection in U.S. children begins
May 04, 2020: “NIH-funded study also will ascertain percentage of infected children who develop COVID-19.

A study to help determine the rate of novel coronavirus infection in children and their family members in the United States has begun enrolling participants.

The study, called Human Epidemiology and Response to SARS-CoV-2 (HEROS), also will help determine what percentage of children infected with SARS-CoV-2, the virus that causes COVID-19, develop symptoms of the disease.

In addition, the HEROS study will examine whether rates of SARS-CoV-2 infection differ between children who have asthma or other allergic conditions and children who do not.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring and funding the HEROS study.

“One interesting feature of this novel coronavirus pandemic is that very few children have become sick with COVID-19 compared to adults,” said NIAID Director Anthony S. Fauci, M.D.

“Is this because children are resistant to infection with SARS-CoV-2, or because they are infected but do not develop symptoms? The HEROS study will help us begin to answer these and other key questions.”

The HEROS study team will rapidly enroll 6,000 people from 2,000 U.S. families already participating in NIH-funded pediatric research studies in 11 cities. Study participants will include both healthy children and children with asthma or other allergic conditions.

The study team will prospectively follow these children and their families for six months to determine who gets infected with SARS-CoV-2, whether the virus is transmitted to other family members, and which family members with the virus develop COVID-19.

Leading the HEROS study is Tina V. Hartert, M.D., M.P.H. Dr. Hartert is director of the Center for Asthma and Environmental Sciences Research, vice president for translational research, the Lulu H. Owen Chair in Medicine and a professor of medicine at the Vanderbilt University School of Medicine in Nashville.

“So far, data on the extent of SARS-CoV-2 infection in the U.S. population have been limited to people who physically interact with the healthcare system: those who are tested―especially those who test positive―and those with severe disease,” said Dr. Hartert.

“These data provide real-time guidance in a setting of limited test availability, but they don’t enable us to understand the full extent of SARS-CoV-2 infection in the entire population.

The HEROS study will help fill this knowledge gap and inform public health interventions.”

Preliminary evidence suggests that having an allergic condition paradoxically may reduce a person’s susceptibility to SARS-CoV-2 infection and severe COVID-19 disease.

 A NIAID-funded study(link is external) recently examined upper and lower airway cells for the expression of ACE2, the gene that codes for the receptor that the coronavirus uses to infect cells. ACE2 expression is necessary for a cell to make this receptor, but additional steps also are involved.

In both children and adults, respiratory allergy, asthma and controlled allergen exposure were associated with significantly reduced ACE2 expression.

The expression of ACE2 was lowest in people with high levels of both asthma and sensitivity to allergens.

The HEROS study will further clarify whether reduced ACE2 gene expression in airway cells of children with allergic diseases correlates with a lower rate of SARS-CoV-2 infection and COVID-19. 

The study will be conducted completely remotely. Every two weeks, a caregiver in participating families will collect nasal swabs from the child who is the primary study participant and all other family members who are enrolled in the study, and will mail the samples to a laboratory for analysis. On the same day as the nasal swab, the caregiver will complete online questionnaires about each participant’s current symptoms, social distancing practices, recent activities outside the home, and recent exposure to people who are sick. 

In addition, if any member of the household develops symptoms of a viral illness, the caregiver will fill out another online questionnaire designed to determine the likelihood that the illness is COVID-19.

If COVID-19 is likely, the caregiver will collect nasal swabs from all study participants and a stool sample from the symptomatic participant within 24 hours.

Laboratory analyses of nasal swabs will test for SARS-CoV-2 and assess gene expression in the collected airway-surface cells.

Investigators hope that these gene expression studies will reveal patterns that correlate with higher or lower risk of infection, COVID-19 symptom development and SARS-CoV-2 transmission.

A caregiver also will collect a blood sample from each study participant two weeks, 18 weeks and 24 weeks after enrollment as well as three weeks after the family’s first likely case of COVID-19, if there is one.

The blood will be collected using a new, nearly painless device that extracts a small quantity of blood through the surface of the skin. The blood will be analyzed for antibodies to SARS-CoV-2 once an appropriate antibody test becomes available.

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.

News releases, fact sheets and other NIAID-related materials are available on the NIAID website.”

https://www.nih.gov/news-events/news-releases/study-determine-incidence-novel-coronavirus-infection-us-children-begins

For More News: U.S. Targets Fraud in Coronavirus Antibody Test Market With Tighter Rules

Coronavirus (COVID-19) Update: Daily Roundup May 4, 2020

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Coronavirus (COVID-19) Update: Daily Roundup May 4, 2020
May 04, 2020: “The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
  • A new FDA Voices, Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy, explains today’s update to a policy from March 16, 2020 on antibody tests for COVID-19.

    The FDA will continue to take steps to appropriately balance assurances that an antibody test is accurate and reliable with timely access to such tests as the continually evolving circumstances and public health needs warrant.
  • FDA issued warning letters to operators of two websites, www.antroids.com and www.foxroids.com, that market unapproved COVID-19 products, as part of the agency’s effort to protect consumers.

    There are currently no FDA-approved drugs to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.

    Consumers can visit BeSafeRx to learn about how to safely buy medicine online.

  • The FDA authorized the first serology, or antibody, test where the results of a new independent validation effort by the U.S. Government provided the scientific evidence used to support the authorization.

    The testing was performed at the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center (FFRDC) sponsored by the National Institutes of Health’s (NIH) National Cancer Institute (NCI).

    The results are among the first to come from a collaborative effort by the FDA, NIH, Centers for Disease Control and Prevention (CDC), and Biomedical Advanced Research and Development Authority (BARDA) to evaluate certain serological tests.

    Essential samples and materials used in the evaluation were provided by the NIH National Institute of Allergy and Infectious Diseases (NIAID), the Mount Sinai Health System, the Icahn School of Medicine at Mount Sinai, including members of the Departments of Microbiology and Pathology, and the Vitalant Research Institute.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.
    • To date, the FDA has issued 58 individual EUAs for test kit manufacturers and laboratories.
      In addition, 25 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
    • The FDA has been notified that more than 235 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-4-2020

JEDI launches billion molecules against COVID19 challenge

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JEDI launches billion molecules against COVID19 challenge
May 05, 2020: “The Joint European Disruptive Initiative is launching on a global basis the JEDI Billion Molecules against Covid19 Grand Challenge.

Stage 1 of this unique, concrete, impact-driven competition will run for 33 days until June 6.

● Open to the best scientific & technology teams in the world, it has one objective: screen billions of molecules with blocking interactions on SARS-CoV-2, and ultra-fast-track the route to a therapeutic treatment, which is, with the development of a vaccine, the only exit from the current global crisis.

● Stage 1 is a real moonshot: instead of testing individual molecules – what is happening all over the world – the participant teams will, at a scale never seen before, screen enormous molecular libraries against protein targets of the virus, using supercomputing and AI.

Results will be cross-correlated to determine a “high potential” list of unprecedented quality, allowing a fast track to clinical testing. Overall time to find active compounds reliably will be massively shorter as compared to current methods.

● Already before the start of the JEDI GrandChallenge, more than 45 teams from the best research institutions, biotechs and corporates have pre-registered to participate, a particularly strong mobilization to solve a very hard problem.

● As several countries come together for the Global Response pledging event of the EU, we call upon them, as well as all private & public donors, to join JEDI and its partners, the AXA Research Fund, Merck and the BMW Foundation, in this highly ambitious and impact-driven initiative, with results shared with the world, in Open Science. “

https://jedi.group/wp-content/uploads/2020/05/JEDICovid19GrandChallengeENGRelease-04052020.pdf

Sanofi/Regeneron’s Libtayo® (cemiplimab) shows benefit in BCC

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Sanofi/Regeneron’s Libtayo® (cemiplimab) shows benefit in BCC
May 5, 2020: “Topline data for a pivotal, single-arm, open-label trial for Sanofi and Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) in patients with advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to prior hedgehog pathway inhibitor (HHI) therapy were announced today.

Libtayo demonstrated clinically meaningful and durable responses in this group of patients for whom there are no approved treatments. Sanofi and Regeneron plan regulatory submissions in 2020.

BCC is a skin cancer and is the most common cancer worldwide, with approximately two million new cases diagnosed every year in the U.S. alone.

While the vast majority of BCCs are caught early and cured with surgery or radiation, a small proportion of tumors can become advanced and penetrate deeper into surrounding tissues (locally advanced), which is more difficult to treat.

Approximately 20,000 U.S. patients have advanced BCC and it is estimated that about 3,000 die each year. BCC marks the second non-melanoma skin cancer for which Libtayo has demonstrated first-in-class data and follows its initial U.S. approval in advanced cutaneous squamous cell carcinoma (CSCC) in 2018.

In the trial, the objective response rate (ORR) for patients (n=84) with locally advanced disease was 29% (95% CI: 19%-40%), with an estimated duration of response (DOR) exceeding one year in 85% of responders.

The durable disease control rate (DCR —response or stable disease lasting at least 6 months) was 60% (95% CI: 48%-70%).  In a preliminary analysis of patients (n=28) with metastatic disease, the ORR was 21% (95% CI: 8%-41%), with an estimated DOR exceeding one year in 83% of responders.

The durable DCR was 46% (95% CI: 28%-66%). All data were assessed by an independent central review. Data are expected to continue to evolve with further follow-up across both patient groups.

“While PD-1 inhibitors have transformed the outlook for many patients with melanoma, progress for patients with non-melanoma skin cancers has not been as rapid,” said Peter C. Adamson, M.D, Global Head of Oncology Development at Sanofi.

 “We are continuing to address this unmet need by first bringing Libtayo to patients with advanced cutaneous squamous cell carcinoma, and now, with this second trial, as a potential therapy for patients with advanced basal cell carcinoma.

These important new results further demonstrate Libtayo’s potential in patients with difficult-to-treat, non-melanoma skin cancers.”


There were no new safety signals in this trial. Among the 132 patients assessed for safety (84 locally advanced and 48 metastatic), 95% of patients experienced an adverse event (AE), 32% had a serious AE and 13% discontinued due to an AE.

There were 10 deaths in the locally advanced group and nine deaths in the metastatic group; none of the deaths were considered treatment-related. Sanofi and Regeneron will present additional trial findings at an upcoming medical meeting.

“Libtayo is being investigated as a monotherapy treatment and as a foundation therapy for combinations with novel therapeutic approaches being developed by Regeneron and our collaborators,” Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron.

 “These data in advanced BCC provide the third instance where Libtayo monotherapy has demonstrated robust and clinically meaningful outcomes in advanced cancer, and follows last week’s announcement in advanced non-small cell lung cancer where the pivotal trial was stopped early for positive overall survival.”

In this ongoing global Phase 2 trial, patients received Libtayo 350 mg intravenously every three weeks for up to 93 weeks or until disease progression, unacceptable toxicity, withdrawal of consent or confirmed complete response.

ORR is the primary endpoint and key secondary endpoints include overall survival, progression-free survival, duration of response, safety and quality of life.

Libtayo is being jointly developed and commercialized by Sanofi and Regeneron under a global collaboration agreement.

The use of Libtayo to treat advanced BCC is investigational and the safety and efficacy have not been evaluated by any regulatory authority.

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

Libtayo is the first and only immunotherapy approved in the U.S., EU, and other countries for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

In the U.S., the generic name for Libtayo in its approved indication is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. In skin cancer, this includes trials in adjuvant and neoadjuvant CSCC.

Libtayo is also being investigated in potentially registrational Phase 3 trials in non-small lung cancer and cervical cancer, as well as in trials combining Libtayo with novel therapeutic approaches for both solid tumors and blood cancers.

These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.”

https://www.sanofi.com/en/media-room/press-releases/2020/2020-05-05-07-00-00

Newron Reports Top-Line Results from its STARS Study Evaluating Sarizotan in Patients with Rett Syndrome

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Newron Reports Top-Line Results from its STARS Study Evaluating Sarizotan in Patients with Rett Syndrome
May 05, 2020: “Shares in Newron Pharmaceuticals have taken a massive hit from the failure of sarizotan to show a clear benefit in patients with Rett syndrome, a severe neurodevelopmental disorder primarily affecting females.

The company revealed top-line data from the pivotal Phase II/III STARS trial of the drug, an experimental 5-HT1A receptor agonist and D2 receptor antagonist, showing that it was not effective on primary or secondary endpoints.

The primary endpoint was a percentage reduction in episodes of apnoea during waking time versus placebo, while secondary goals related to respiratory symptoms and motor behaviour.

Newron confirmed that on the back of the data it will discontinue sarizotan’s development programme.

Ravi Anand chief medical officer of Newron, said the company is “very disappointed” with the outcome of the trial.

“The results of this well designed and executed study, based on highly promising data from a genetic model of Rett syndrome in mice, indicate the difficulties inherent in translating effects in animal models to human clinical studies,” he noted.

“We are currently awaiting results of additional explanatory analyses and will continue to analyse the full data set from the study to understand more about the results”.

The news will come as a particular blow to the Rett community, as there are currently no approved treatments for the condition, which is characterised by a loss of acquired fine and gross motor skills and the development of neurological, cognitive and autonomic dysfunction, which leads to loss of ability to conduct daily life activities, walk or communicate.

https://www.newron.com/ENG/Default.aspx?PAG=19&MOD=NWRPRS

Menarini Group to Acquire Stemline Therapeutics in Transaction Valued at Up to $677 Million

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Menarini Group to Acquire Stemline Therapeutics in Transaction Valued at Up to $677 Million
May 4, 2020: “Menarini Group announced a definitive agreement under which Menarini Group will acquire Stemline in a transaction valued up to $677 million.

Under the terms of the agreement, a wholly owned subsidiary of the Menarini Group will commence a tender offer for all outstanding shares of Stemline, whereby Stemline shareholders will be offered a total potential consideration of $12.50 per share, consisting of an upfront payment of $11.50 in cash and one non-tradeable Contingent Value Right (CVR) that will entitle each holder to an additional $1.00 in cash per share upon completion of the first sale of ELZONRIS in any EU5 country after European Commission approval.

Stemline launched ELZONRIS for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients, two years or older, following the approval by the United States Food and Drug Administration in December 2018.

ELZONRIS is a novel targeted therapy directed to the interleukin-3 (IL-3) receptor-α (CD123).

With the support of Menarini’s infrastructure, Stemline will continue its efforts to develop additional applications of ELZONRIS to serve the unmet needs of patients suffering from difficult to treat diseases and cancers.

Following its strong U.S. launch of ELZONRIS, Stemline will benefit from Menarini’s experience in bringing products to markets in Europe and emerging markets as it prepares for a successful international launch upon receipt of regulatory approval in ex-U.S. territories.

Elcin Barker Ergun, CEO of Menarini Group, commented, “Stemline is an excellent fit for Menarini, enabling us to expand our presence in the U.S. with an established biopharmaceutical company focused on developing oncology therapeutics.

Through this acquisition, we will continue to strengthen our portfolio and pipeline of oncology assets and deliver novel therapies around the world. We look forward to uniting together with the Stemline team to advance our shared mission of serving patients.”

Ivan Bergstein, M.D., Chairman, CEO and Founder of Stemline, said, “Joining Menarini represents a unique opportunity for Stemline to advance the commercialization of ELZONRIS across the globe and to accelerate the development of our pipeline of oncology assets.

We have transitioned Stemline over the last several years into an established commercial-stage operation with a novel treatment, a growing pipeline and a strong foundation.

We are excited to be combining with a like-minded organization in Menarini, in a transaction that will deliver immediate and significant cash value to our shareholders, while also allowing our shareholders to participate in the future upside of ELZONRIS’s European launch.

We look forward to working closely together on our unified goal of helping and delivering hope to patients worldwide.”

Transaction Terms

Under the terms of the agreement, a wholly-owned subsidiary of the Menarini Group will commence a tender offer for all outstanding shares of Stemline, whereby Stemline shareholders will be offered a total potential consideration of $12.50 per share, consisting of an upfront payment of $11.50 per share in cash, along with one non-tradeable Contingent Value Right (CVR).

Under the terms of the non-tradeable CVR, Stemline shareholders will be paid an additional $1.00 per share upon completion of the first sale for use or consumption by the general public of ELZONRIS in BPDCN in any one of the following countries: 

United Kingdom, France, Spain, Germany, or Italy after receiving approval by the European Commission of a Marketing Authorization Application (MAA), through the centralized procedure, on or before December 31, 2021.

There can be no assurance such approval or commercialization will occur or that any contingent payment will be made.

Menarini will acquire any shares of Stemline not tendered into the tender offer through a second-step merger for the same per share consideration as will be payable in the tender offer. The merger will be effected as soon as practicable after the closing of the tender offer.

The transaction has been unanimously approved by the Boards of Directors of both companies.

Stemline’s Board of Directors recommends to shareholders of Stemline that they tender their shares into the tender offer.

The transaction is expected to close in the second quarter of 2020, subject to customary closing conditions, including the tender of more than 50% of all shares of Stemline outstanding at the expiration of the offer and receipt of Hart-Scott-Rodino clearance.

The terms and conditions of the tender offer will be described in the tender offer documents, which will be filed with the U.S. Securities and Exchange Commission.

Menarini expects to fund the acquisition through existing cash resources.

Advisors

Goldman Sachs International is acting as exclusive financial advisor and Fried, Frank, Harris, Shriver & Jacobson LLP is acting as legal advisor to Menarini. PJT Partners and BofA Securities are acting as financial advisors and Skadden, Arps, Slate, Meagher & Flom LLP and Alston & Bird LLP are acting as legal advisors to Stemline.

ELZONRIS® (tagraxofusp), a targeted therapy directed to CD123, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with BPDCN.

For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA).

BPDCN, formerly blastic NK-cell lymphoma, is an aggressive hematologic malignancy, often with cutaneous manifestations, with historically poor outcomes.

BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera.

The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers.

The World Health Organization (WHO) termed this disease “BPDCN” in 2008; previous names included blastic NK cell lymphoma and agranular CD4+/CD56+ hematodermic neoplasm. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.“

https://ir.stemline.com/news-releases/news-release-details/menarini-group-acquire-stemline-therapeutics-transaction-valued

U.S. Targets Fraud in Coronavirus Antibody Test Market With Tighter Rules

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U.S. Targets Fraud in Coronavirus Antibody Test Market With Tighter Rules
May 4, 2020: “The United States on Monday began requiring antibody tests for the new coronavirus to undergo a regulatory agency review, acknowledging that its earlier policy had opened the door to fraud.

The U.S. Food and Drug Administration had previously required only that companies attest their product was valid and labeled as unapproved, attracting 170 companies to the antibody test market including unscrupulous vendors making false claims, Reuters reported last week..

When the FDA put the policy in place on March 16th, it had been under pressure to move fast following a slow ramp up of COVID-19 diagnostic tests that hindered public health efforts.

“Flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” the FDA said in a statement.

Blood tests for antibodies are used to determine who has been previously been infected with the virus. As the new coronavirus can be easily spread by people with no symptoms, widespread antibody testing is seen as a critical piece in the effort to get Americans back to work safely, as the presence of antibodies to the virus many indicate possible immunity to future infection.

The FDA said that it had taken action against firms for unlawfully marketing tests by detaining and refusing illegitimate test kits at the border. It declined to provide specific examples.

Reuters reported that an electronics salesman was hawking an unauthorized home test kit and a former physician convicted in a fraudulent gold-peddling scheme had also begun selling test kits.

Under the new policy, test makers must submit requests for emergency use authorization of their tests within 10 days from when the test is validated. Companies with tests currently on the market under the previous policy must submit an application for emergency use authorization (EUA).

There are about a dozen tests on the market that have already received EUAs.

The FDA said it would share information on its website and with potential buyers of these tests, such as states and hospitals, if they were no longer in compliance with its notification requirements and de-listed from its website.

The agency also set specific performance threshold recommendations for specificity and sensitivity for all serology test developers to ensure a high level of accuracy.

As part of a new emergency use authorization process announced late last week, the FDA set a minimum level of correct positive results at 90% of the samples tested – known as sensitivity, and a minimum for tests showing negative results correctly at 95% – called specificity.

Former FDA head Scott Gottlieb, who has criticized antibody testing before, said Monday on CNBC that these tests are not accurate enough to be relied upon by individuals to make decisions that affect their health. Critics also question if having the antibodies translates into immunity, and how long the immunity from the new coronavirus could last.

In the past two weeks, pressure over the lax policy intensified among lawmakers who called for its reversal. Democratic Congressmen Raja Krishnamoorthi headed a subcommittee investigation that looked into the release of tests that failed to provide the promised results.

Democratic Congressman Lloyd Doggett of Texas said in a statement on Monday that the FDA’s policy change had not gone far enough to assure consumer protection and that fraudulent tests must be removed from the market.”

https://www.usnews.com/news/us/articles/2020-05-04/us-fda-tightens-regulations-for-covid-19-antibody-tests

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