GSK GlaxoSmithKline PLC

39.44
+0.35  (+1%)
Previous Close 39.08
Open 39.25
52 Week Low 33.26
52 Week High 42.68
Market Cap $99,213,164,787
Shares 2,515,865,723
Float 2,506,784,340
Enterprise Value $127,077,088,626
Volume 3,539,037
Av. Daily Volume 3,645,883
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Sotrovimab (VIR-7831 / GSK4182136) - (COMET-PEAK)
COVID-19
Phase 2
Phase 2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Sotrovimab (VIR-7831 / GSK4182136) - (COMET-TAIL)
COVID-19
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Adjuvanted COVID-19 vaccine
COVID-19 vaccine
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
COVID-19 (Medicago) vaccine
COVID-19 vaccine
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
BLENREP (belantamab mafodotin) - (DREAMM 5)
Multiple Myeloma
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Sotrovimab (VIR-7831 / GSK4182136) - (ACTIV-3)
Mild to moderate COVID-19
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
ZEJULA (Niraparib) and JEMPERLI (dostarlimab) - MOONSTONE
Ovarian cancer
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
VIR-7832 (AGILE)
COVID-19 vaccine/therapeutic
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Gepotidacin (EAGLE)
Uncomplicated urinary tract infection (uUTI)
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
BLENREP (belantamab mafodotin) and KEYTRUDA (Pembrolizumab) -DREAMM-4
Multiple Myeloma
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
BLENREP (belantamab mafodotin) - (DREAMM-3)
Multiple Myeloma
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
JEMPERLI (Dostarlimab) -(RUBY)
Endometrial Cancer
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Otilimab (MOR103/GSK3196165) - (ContRAst)
Rheumatoid Arthritis
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
BLENREP (belantamab mafodotin) and POMALYST (Pomalidomide) and Dexamethasone - (DREAMM-8)
Multiple Myeloma
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
S-Trimer COVID-19 Vaccine + CpG 1018 adjuvant plus alum (SPECTRA)
COVID-19 vaccine
Phase 2/3
Phase 2/3
Phase 2/3 interim analysis showed primary and secondary endpoints met. 100% efficacy against severe COVID-19 & hospitalization and 84% efficacy against moderate-to-severe COVID-19 , and 79% efficacy against COVID-19 of any severity caused by the Delta variant, noted September 22, 2021.
Bamlanivimab (LY-CoV555) and Sotrovimab (VIR-7831 / GSK4182136) - BLAZE-4
COVID-19 antibody
Phase 2
Phase 2
Phase 2 data released March 29, 2021 - 70 percent (p<0.001) relative reduction in persistently high viral load.
JEMPERLI (Dostarlimab)
Mismatch repair deficient (dMMR) solid tumors
Approved
Approved
FDA Approval announced August 17, 2021.
NUCALA (Mepolizumab)
Chronic rhinosinusitis with nasal polyps
Approved
Approved
FDA approval announced July 29, 2021.
DUVROQ (Daprodustat) - ASCEND
Anaemia in chronic kidney disease
Phase 3
Phase 3
Phase 3 data due 2H 2021.
Sotrovimab (VIR-7831 / GSK4182136) - (COMET-ICE)
COVID-19 antibody
Approved
Approved
FDA Emergency Use Authorization filing approval announced May 26, 2021.
VOCABRIA (cabotegravir) - HPTN 083
HIV
NDA Filing
NDA Filing
NDA rolling submission announced May 4, 2021.
CABENUVA (Cabotegravir + rilpivirine) - ATLAS2M
HIV
sNDA Filing
sNDA Filing
sNDA filing announced February 24, 2021.
BLENREP (belantamab mafodotin)
Multiple myeloma
Approved
Approved
FDA approval granted August 5, 2020.
FLUARIX QUADRIVALENT
Influenza A - children 6-35 months of age.
Approved
Approved
Approval announced January 11, 2018.
DOVATO (Dolutegravir + lamivudine)
HIV
Approved
Approved
FDA approval announced August 6, 2020.
DOVATO (Dolutegravir and lamivudine)
HIV
Approved
Approved
FDA approval announced April 8, 2019.
JULUCA (dolutegravir and rilpivirine)
HIV
Approved
Approved
FDA approval announced January 21, 2021.
JULUCA (dolutegravir and rilpivirine)
HIV
Approved
Approved
Approval announced November 21, 2017.
KRINTAFEL (Tafenoquine)
Malaria
Approved
Approved
FDA Approval announced July 23, 2018.
TRELEGY ELLIPTA
Asthma
Approved
Approved
FDA approval announced September 9, 2020.
TRELEGY ELLIPTA (FF/UMEC/VI)
Chronic obstructive pulmonary disease (COPD)
Approved
Approved
Approval announced September 18, 2017.
RUKOBIA (Fostemsavir)
HIV
Approved
Approved
FDA Approval announced July 2, 2020.
VARUBI (Rolapitant)
Prevention of chemotherapy induced nausea and vomiting, or CINV
Approved
Approved
Approved September 2, 2015.
VARUBI (Rolapitant) - intravenous
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Approved
Approved
CRL January 11 2017. FDA Approval announced October 25, 2017 following resubmission.
VARUBI (Rolapitant)
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Approved
Approved
Approved September 2, 2015.
ZEJULA (Niraparib)
Ovarian cancer
Approved
Approved
FDA Approval announced October 23, 2019.
ZEJULA (Niraparib)
Cancer - ovarian
Approved
Approved
PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
ZEJULA (Niraparib)
Ovarian cancer
Approved
Approved
FDA Approval announced April 29, 2020.
NUCALA (Mepolizumab)
Severe eosinophilic asthma (6-11 yrs)
Approved
Approved
FDA approval announced September 12, 2019.
NUCALA (Mepolizumab)
Severe hypereosinophilic syndrome (HES)
Approved
Approved
FDA approval announced September 25, 2020.
NUCALA (Mepolizumab)
Severe eosinophilic asthma - pediatric
Approved
Approved
FDA Approval announced June 6, 2019.
SHINGRIX
Shingles
Approved
Approved
Approval announced October 20, 2017.
BENLYSTA (belimumab)
Lupus Nephritis
Approved
Approved
FDA approval announced December 17, 2020.
NUCALA (Mepolizumab)
Chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype
CRL
CRL
Advisory Committee July 25, 2018 voted 3-16 against recommending approval. CRL issued September 7, 2018.
NUCALA (Mepolizumab)
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Approved
Approved
Approval announced December 12, 2017.
BENLYSTA (belimumab) - subcutaneous
Systemic lupus erythematosus (SLE)
Approved
Approved
Approval announced July 21, 2017.
JEMPERLI (Dostarlimab)
dMMR endometrial cancer
Approved
Approved
FDA approval announced April 22, 2021.
GSK3359609 and KEYTRUDA (pembrolizumab) - (INDUCE-4)
Head and Neck Squamous Cell Carcinoma
Phase 2
Phase 2
Phase 2 trial to be discontinued - April 14, 2021.
Bintrafusp alfa
Non-small Cell Lung Cancer
Phase 3
Phase 3
Phase 3 trial unlikely to meet primary endpoint - to be discontinued.

Latest News

    • First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps to target eosinophilic inflammation
    • Fourth indication for mepolizumab in the US for eosinophil-driven diseases

    GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

    CRSwNP accounts for 2-4% of the US population, affecting more than 5 million…

    • First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps to target eosinophilic inflammation
    • Fourth indication for mepolizumab in the US for eosinophil-driven diseases

    GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

    CRSwNP accounts for 2-4% of the US population, affecting more than 5 million people. CRSwNP is one of a variety of diseases arising from inflammation in different tissues associated with elevated levels of a type of white blood cell called eosinophils. It is often characterised by raised eosinophil levels, in which soft tissue growth, known as nasal polyps, develop in the sinuses and nasal cavity. CRSwNP can cause chronic symptoms such as nasal obstruction, loss of smell, facial pressure and nasal discharge.

    Mepolizumab is the first anti-IL-5 biologic to be approved for adult patients with CRSwNP in the US.

    Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK said: "More than 5 million people in the US suffer with chronic rhinosinusitis with nasal polyps and today's approval provides these patients with the first anti-IL-5 treatment option and an alternative to surgery to help reduce symptoms of this disease. GSK is committed to exploring the role of IL-5 inhibition in eosinophil-driven diseases to help address unmet needs of patients."

    Tonya Winders, CEO & President, Allergy and Asthma Network (AAN) and President of Global Allergy and Airways Patient Platform (GAAPP) commented: "Patients with chronic rhinosinusitis with nasal polyps experience unpleasant symptoms across a range of severities. As there have been limited treatment options, particularly for those patients with severe disease, they may rely on oral steroids and recurrent surgery to manage their condition. We welcome the news that mepolizumab will now offer appropriate patients and healthcare providers a novel treatment option and alternative to surgery."

    The approval of mepolizumab as a treatment for CRSwNP is based on data from the pivotal SYNAPSE study which explored the effect of mepolizumab vs. placebo in over 400 patients with CRSwNP. Mepolizumab achieved significant improvement in reducing the size of nasal polyps and nasal obstruction. All patients in the study received standard care, had a history of previous surgery (approximately one in three had ≥3 surgeries) and were in need of further surgery due to severe symptoms and increased size of their polyps. SYNAPSE showed that there was a 57% reduction in the proportion of patients who had surgery in the group treated with mepolizumab vs. placebo, HR=0.43 (95% CI 0.25, 0.76). In addition, the proportion of patients requiring systemic corticosteroid use during the 52-week treatment period was lower in patients who received mepolizumab.

    Mepolizumab is also approved for use in three other eosinophilic driven diseases, the first indication being for patients with severe eosinophilic asthma aged six years and older. Additionally, mepolizumab was the first biologic therapy indicated for adults with eosinophilic granulomatosis with polyangiitis (EGPA) and also the first biologic to be approved for patients aged 12 years and older with hypereosinophilic syndrome (HES).

    With 41 clinical trials, mepolizumab has been studied in over 4,000 patients. GSK is committed to improving the lives of those living with disease associated with uncontrolled eosinophilic inflammation, continuously innovating in order to address the unmet needs in this broad patient group.

    Nucala is indicated in the US:

    • As an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. Nucala is not indicated for the relief of acute bronchospasm or status asthmaticus.
    • For the treatment of adult patients with EGPA.
    • For the treatment of adult and paediatric patients aged 12 years and older with HES for ≥6 months without an identifiable non-hematologic secondary cause.
    • As an add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

    About chronic rhinosinusitis with nasal polyps (CRSwNP)

    CRSwNP is a chronic inflammatory disease of the nasal passage linings or sinuses which can lead to soft tissue growths known as nasal polyps and is often characterised by elevated levels of eosinophils. The resultant swellings can grow in both nostrils (bilateral) greatly impacting a patient due to various symptoms including nasal obstruction, loss of smell, facial pressure and nasal discharge. Surgery may be indicated for severe cases. However, polyps have a strong tendency to reoccur often leading to repeat surgery.

    About mepolizumab

    First approved in 2015 for severe eosinophilic asthma (SEA), mepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels. A normal level of blood eosinophils being less than 500 eosinophils/microliter. The mechanism of action for mepolizumab has not been definitively established.

    Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils. It has been studied in over 4,000 patients in 41 clinical trials across a number of eosinophilic indications and has been approved under the brand name Nucala in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with SEA. It is approved for paediatric use in SEA from ages six to 17 in Europe, the US and several other markets. In the US, Japan, Canada and a number of other markets, it is approved for use in adult patients with EGPA. Mepolizumab was approved for use in HES in the US in September 2020, followed by Brazil in February 2021 and Argentina in May 2021. Mepolizumab is currently being investigated in COPD. It is not currently approved for use in COPD anywhere in the world.

    Important safety information

    The following information is based on the US Prescribing Information for Nucala in licensed indications only. Please consult the full Prescribing Information for all the labelled safety information for Nucala.

    CONTRAINDICATIONS

    Nucala should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

    WARNINGS AND PRECAUTIONS

    • Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of Nucala. Discontinue Nucala in the event of a hypersensitivity reaction.
    • Do not use to treat acute bronchospasm or status asthmaticus.
    • Herpes zoster infections have occurred in patients receiving Nucala. Consider vaccination if medically appropriate.
    • Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with Nucala. Decrease corticosteroids gradually, if appropriate.
    • Treat patients with pre-existing helminth infections before therapy with Nucala. If patients become infected while receiving treatment with Nucala and do not respond to anti-helminth treatment, discontinue Nucala until parasitic infection resolves.

    ADVERSE REACTIONS

    Most common adverse reactions (incidence ≥5%) in severe asthma clinical trials included headache, injection site reaction, back pain, and fatigue. Injection site reactions (e.g. pain, erythema, swelling, itching, burning sensation) occurred in 8% of subjects treated with 100 mg of Nucala versus 3% treated with placebo.

    In a clinical trial in patients with EGPA receiving 300 mg of Nucala, no additional adverse reactions were identified to those reported in severe asthma clinical trials. Injection site reactions (e.g. pain, erythema, swelling) occurred in 15% of subjects treated with 300 mg of Nucala versus 13% treated with placebo.

    In a clinical trial in patients with hypereosinophilic syndrome, no additional adverse reactions were identified to those reported in the severe asthma trials. Injection site reactions (e.g. burning, itching) occurred in 7% of subjects treated with 300 mg of Nucala versus 4% treated with placebo.

    In a clinical trial with CRSwNP, the most common adverse reactions (incidence >/= 5%) in patients receiving NUCALA 100 mg was oropharyngeal pain and arthralgia. Injection site reactions (e.g., erythema, pruritus) occurred in 2% of patients receiving Nucala versus <1% treated with placebo.

    GSK's commitment to respiratory disease

    For over 50 years, GSK has led the way in developing medicines that advance the management of asthma and COPD. From introducing the world's first selective short-acting beta agonist in 1969, to launching six treatments in five years to create today's industry-leading respiratory portfolio, we continue to innovate so we can reach the right patients, with the right treatment. Working together with the healthcare community, we apply world-class science to discover and understand the molecules that become the medicines of tomorrow. We won't stand still until the simple act of breathing is made easier for everyone.

    About GSK

    GSK is a science-led global healthcare company. For further information please visit www.gsk.com/about-us.

    Cautionary statement regarding forward-looking statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

    Registered in England & Wales: 

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS

    View Full Article Hide Full Article
  1. LONDON and SAN FRANCISCO, July 28, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced they have signed a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of sotrovimab, an investigational single dose SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The Joint Procurement Agreement enables participating European Union (EU) Member States to quickly purchase sotrovimab, following local emergency authorization or authorization at the EU level, to treat high-risk…

    LONDON and SAN FRANCISCO, July 28, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced they have signed a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of sotrovimab, an investigational single dose SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The Joint Procurement Agreement enables participating European Union (EU) Member States to quickly purchase sotrovimab, following local emergency authorization or authorization at the EU level, to treat high-risk patients with COVID-19 who may benefit from early treatment with sotrovimab.

    This action follows the positive scientific opinion issued by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), under Article 5(3) of Regulation 726/2004, which can be considered by the national authorities in EU Member States when taking evidence-based decisions on the early use of the medicine prior to marketing authorization. Sotrovimab is included in the European Commission's portfolio of promising candidate therapies as part of its COVID-19 Therapeutics Strategy. In addition, the documentation to support the forthcoming marketing authorization application for sotrovimab is under rolling regulatory review with the EMA. In June, the companies announced confirmatory full results for the Phase 3 COMET-ICE trial, which resulted in a 79% reduction (adjusted relative risk reduction) (p<0.001) in hospitalizations for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial.

    George Katzourakis, senior vice president, Europe, GSK said: "This agreement with the European Commission represents a crucial step forward for treating cases of COVID-19 in participating EU Member States, as it enables access to sotrovimab for high-risk patients who have contracted the virus. As the COVID-19 landscape continues to evolve and we meet new challenges – such as the Delta variant spreading across the globe – there remains an urgent need for treatment options to help those who do get sick to potentially avoid hospitalization or death."

    George Scangos, Ph.D., chief executive officer of Vir, said: "It remains abundantly clear that additional treatment options are needed to fully address the toll of this pandemic. This agreement recognizes that monoclonal antibody treatments for those who become infected are essential, and we are pleased that European healthcare providers and their patients now have access to sotrovimab. Notably, the fact that sotrovimab was designed from the beginning to maintain activity against the evolution of this virus and has demonstrated, in vitro, its ability to maintain activity against the tested circulating variants of concern and interest, including Delta and Lambda, underscore its critical role in the fight against COVID-19."

    Recognizing the acute urgency of patient need across the world, the companies are engaging with governments and procurement bodies to make sotrovimab available to support the pandemic response. GSK and Vir have secured supply agreements with multiple governments around the world and will continue those efforts as the pandemic continues to evolve. In May 2021, sotrovimab was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19 in high-risk patients. GSK and Vir have announced plans to submit a Biologics License Application (BLA) to the U.S. FDA in the second half of 2021. Sotrovimab has also been authorized for emergency use in Bahrain, Kuwait, Qatar, Singapore and United Arab Emirates.

    GSK and Vir are committed to ongoing evaluation of sotrovimab as the COVID-19 landscape continues to evolve at different rates across the globe and new variants of concern and interest emerge. Updated in vitro data, published in bioRxiv, demonstrate that sotrovimab retains activity against currently circulating variants of concern and interest of the SARS-CoV-2 virus including Alpha (B.1.1.7), Beta (B.1.351), Delta (B.1.617.2), Epsilon (B.1.427/B.1.429), Gamma (P.1), Iota (B.1.526), Kappa (B.1.617.1) and Lambda (C.37), as well as new variants from Bristol (B.1.1.7+E484K) and Cameroon (B.1.619), which encodes both N440K and E484K mutations that may lead to reduced activity for other neutralizing monoclonal antibodies against the SARS-CoV-2 virus. GSK and Vir are continuing to evaluate the ability of sotrovimab to maintain activity against new and emerging variants through in vitro studies. The clinical impact of these in vitro variant data is not yet known.

    About the COMET-ICE Study

    The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated intravenous (IV) infusion of sotrovimab in adults with mild-to-moderate COVID-19 at high risk of progression to severe disease. In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrollment due to evidence of profound efficacy and is continuing to follow trial participants for 24 weeks. Interim data results have been shared with regulatory authorities and formed the basis of the positive scientific opinion reached by the EMA's CHMP, under Article 5(3) of Regulation 726/2004.

    This ongoing trial evaluated the safety and efficacy of a single IV infusion of sotrovimab (500 mg) or placebo in non-hospitalized participants globally. The primary efficacy endpoint was the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for greater than 24 hours for acute management of any illness or death from any cause.

    The final COMET-ICE trial results in the full study population of 1,057 participants demonstrated a 79% reduction (adjusted relative risk reduction) (p<0.001) in hospitalization for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial. The number of patients who were hospitalized for >24 hours for acute management of any illness or death from any cause at Day 29 was six patients in the sotrovimab arm (1%), versus 30 patients in the placebo arm (6%). In the sotrovimab arm, it is possible that half of those patients who were hospitalized were for reasons other than progression of COVID-19 (e.g., small bowel obstruction, lung cancer and diabetic foot ulcer); this was not the case for patients in the placebo arm.

    In the safety analysis, 1,037 participants were followed through at least 29 days. The most common adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo.

    About the Sotrovimab Clinical Development Program

    In addition to the COMET-ICE trial, the full COMET clinical development program for sotrovimab includes:

    • COMET-PEAK, a pharmacokinetic trial in outpatients with mild-to-moderate COVID-19 investigating intramuscular (IM) administration of sotrovimab, is near completion and initial data are expected in the second half of 2021.
    • COMET-TAIL has been initiated. This is a Phase 3 trial evaluating the role of IM-administered sotrovimab for the early treatment of mild-to-moderate COVID-19 in high-risk non-hospitalized adult and pediatric patients (12 years of age and older). Data are anticipated in the first half of 2022.

    The companies also plan to investigate the use of sotrovimab in uninfected immunocompromised adults to determine whether sotrovimab can prevent symptomatic COVID-19 infection.

    About Sotrovimab

    Sotrovimab is an investigational SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor's Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

    Important Information about Sotrovimab in Europe

    For more information on the EMA positive scientific opinion, please review the EU Conditions of Use.

    All side effects have been mild or moderate. Healthcare professionals should look out for side effects and take appropriate action.

    Reporting of suspected adverse reactions

    Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

    Sotrovimab in the United States

    Healthcare providers in the U.S. should review the Fact Sheets for information on the authorized use of sotrovimab and mandatory requirements of the EUA.

    Sotrovimab has been authorized by the U.S. FDA for the emergency use described below. Sotrovimab is not FDA-approved for this use. 

    Sotrovimab is authorized only for the duration of the declaration that circumstances exist justifying the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 

    Authorized Use 

    The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

    Limitations of Authorized Use 

    Sotrovimab is not authorized for use in patients: 

    • who are hospitalized due to COVID-19, OR 
    • who require oxygen therapy due to COVID-19, OR 
    • who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity).

    Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

    Please see the FDA Letter of Authorization, full Fact Sheet for Healthcare Providers and full Fact Sheet for Patients, Parents, and Caregivers.

    About the Vir and GSK Collaboration

    In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

    GSK Commitment to Tackling COVID-19

    GSK's response to COVID-19 has been one of the broadest in the industry, with three potential treatments in addition to our vaccine candidates in development with partner organizations.

    GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, we recently announced positive Phase 2 data from our collaboration with Sanofi to develop an adjuvanted, protein-based vaccine candidate and started a Phase 3 trial in Q2. An earlier stage collaboration with SK Bioscience is also ongoing. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people.

    GSK is also working with mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac's first generation COVID-19 vaccine. GSK is also providing manufacturing support for up to 60m doses of Novavax' COVID-19 vaccine in the UK.

    GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

    Vir's Commitment to COVID-19

    Vir was founded with the mission of addressing the world's most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir advanced into the clinic. It was carefully selected for its demonstrated promise in preclinical research, including an anticipated high barrier to resistance and potential ability to both block the virus from entering healthy cells and clear infected cells. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with its partners.

    About GSK

    GSK is a science-led global healthcare company. For further information please visit www.gsk.com/about-us.

    About Vir Biotechnology

    Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

    GSK Cautionary Statement Regarding Forward-Looking Statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

    Vir Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the ability of sotrovimab to treat and/or prevent COVID-19, our collaboration with GSK, an agreement with the European Commission to supply sotrovimab and other potential supply agreements, the clinical development program for sotrovimab and the ability of sotrovimab to maintain activity against circulating variants of concern. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Vir's competitors, changes in expected or existing competition, delays in or disruptions to Vir's business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS



    Vir Biotechnology Contacts:
    
    Heather Rowe Armstrong
    VP, Investor Relations
    harmstrong@vir.bio
    +1 415 915 4228
    
    Cara Miller
    VP, Corporate Communications
    cmiller@vir.bio
    +1 415 941 6746
    
    GSK Contacts:
     
    Media:
    
    Tim Foley
    +44 (0) 20 8047 5502
    (London)
    
    Kristen Neese
    +1 804 217 8147
    (Philadelphia)
    
    Kathleen Quinn
    +1 202 603 5003
    (Washington DC)
    
    Lyndsay Meyer
    +1 202 302 4595
    (Washington DC)
    
    Analysts/Investors:
    
    James Dodwell
    +44 (0) 20 8047 2406
    (London)
    
    Sonya Ghobrial
    +44 (0) 7392 784784
    (Consumer)
    
    Mick Readey
    +44 (0) 7990 339653
    (London)
    
    Jeff McLaughlin
    +1 215 751 7002
    (Philadelphia)
    
    Frannie DeFranco
    +1 215 751 4855
    (Philadelphia)

    Primary Logo

    View Full Article Hide Full Article
  2. LONDON and PHILADELPHIA, July 26, 2021 /PRNewswire/ -- GlaxoSmithKline plc today announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals.

    Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA in 2017 for the prevention of shingles in adults 50 years of age or older. Shingrix is not indicated for prevention of primary varicella infection (chickenpox). The approval for this new population expands the number of people who can be protected against shingles by Shingrix.

    "We're proud to offer Shingrix in the US for the prevention of shingles in those who are immunocompromised, with FDA granting a broad indication for use in adults at increased risk of this disease," said Thomas Breuer, Chief Medical Officer, GSK Vaccines. "Older age and being immunocompromised are the most common risk factors for shingles disease. GSK is committed to this important patient population at increased risk for shingles disease and its complications by bringing them a vaccine option that can help prevent this painful condition."

    The GSK Clinical Development Program evaluated the benefit-risk profile of Shingrix in heterogeneous immunocompromised patient populations.

    This approval for a new population was based on clinical studies examining the safety and efficacy of Shingrix in adults (≥18 years of age) who had undergone an autologous hematopoietic stem cell transplant (auHSCT) and those undergoing treatment for hematological malignancies (post-hoc analysis). Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.1,2,3,4,5,6 

    "In addition to this new patient population, there are more than 100 million adults 50 years and older in the US already recommended to receive Shingrix," said Breuer. "We know many of these individuals missed recommended vaccines during the pandemic and we hope this can be a reminder to them to catch up on all their immunizations, including Shingrix."

    According to recently published report from Avalere Health and supported by GSK, more than 17 million doses of recommended vaccines, including Shingrix, were missed by adults during the pandemic.

    Shingrix is the first shingles vaccine indicated for use in those who are at increased risk of the disease due to being immunodeficient or immunosuppressed due to disease or therapy. It combines a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant system to generate a Varicella Zoster Virus (VZV)-specific immune response. For immunocompetent adults, Shingrix is intended to be administered in two doses, 2 to 6 months apart.

    However, for adults who are or will be immunodeficient or immunosuppressed due to known disease or therapy and who would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first dose.

    The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has begun discussions to consider recommendations for use of Shingrix in immunocompromised adults.

    Shingrix was previously approved by the European Commission (EC) for prevention of shingles and post-herpetic neuralgia (PHN) in adults 18 years of age or older at increased risk of shingles and granted marketing authorization on August 25, 2020.

    About Shingles

    Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox.7 Nearly all older adults have the VZV dormant in their nervous system, waiting to reactivate with advancing age.8 As people age, the cells in the immune system lose the ability to maintain a strong and effective response to VZV reactivation.7,9 

    Shingles typically presents as a painful, itchy rash that develops on one side of the body and can last for two to four weeks.9,10 The pain associated with shingles is often described as burning, shooting or stabbing. Even once the rash is gone, a person can experience postherpetic neuralgia (PHN), pain lasting from at least three months up to several years.7 PHN is the most common complication of shingles, occurring in 10 to 18 percent of all shingles cases.7,11

    There are an estimated 1 million cases of shingles in the US each year.7  More than 99 percent of those over 50 years old are infected with VZV, and one in three Americans will develop shingles in their lifetime. The risk increases to one in two for adults aged 85 years and older. 

    About Shingrix

    Shingrix is a non-live, recombinant subunit vaccine approved in the US, Canada, EU, UK, China, Japan, Hong Kong, Australia, New Zealand, and Singapore to help prevent shingles (herpes zoster) in people aged 50 years or older. It combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a Varicella Zoster Virus (VZV)-specific immune response immune response that can help overcome the decline in immunity as people age.

    Shingrix was previously approved by the European Commission (EC) and in the UK for prevention of shingles and post-herpetic neuralgia (PHN) in adults 18 years of age or older at increased risk of shingles and granted marketing authorization on August 25, 2020.

    The updated US Prescribing Information will be available soon at www.gskpro.com.

    Important Safety Information for Shingrix

    The following is based on the US Prescribing Information for Shingrix. Please consult the full Prescribing information for all the labeled safety information.

    • Shingrix is contraindicated in anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of Shingrix.
    • Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of Shingrix.
    • In a postmarketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with Shingrix.
    • Syncope (fainting) can be associated with the administration of vaccines, including Shingrix. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
    • In individuals aged 50 years and older: Solicited local adverse reactions were pain, redness, and swelling. Solicited general adverse reactions were myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms.
    • In autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and >50 years of age): Solicited local adverse reactions were pain, redness, and swelling. Solicited general adverse reactions were fatigue, myalgia, headache, gastrointestinal symptoms, shivering, and fever.
    • The data are insufficient to establish if there is vaccine-associated risk with Shingrix in pregnant women.
    • It is not known whether Shingrix is excreted in human milk. Data are not available to assess the effects of Shingrix on the breastfed infant or on milk production/excretion.
    • Vaccination with Shingrix may not result in protection of all vaccine recipients.

    About GSK

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    GSK Enquiries:















    US Media enquiries:

    Evan Berland

    +1 215 432 0234

    (Philadelphia)



    Sean Clements

    +1 215 740 3088

    (Philadelphia)









    Analyst/Investor enquiries:

    James Dodwell

    +44 (0) 20 8047 2406

    (London)



    Sonya Ghobrial

    +44 (0) 7392 784784

    (Consumer)



    Mick Readey

    +44 (0) 7990 339653

    (London)



    Jeff McLaughlin

    +1 215 751 7002

    (Philadelphia)



    Frannie DeFranco

    +1 215 751 4855

    (Philadelphia)

    Cautionary statement regarding forward-looking statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS

    1 Bastidas A, et al. JAMA 2019;132:123–133.

    2 Berkowitz EM, et al. J Infect Dis 2015;211:1279–1287.

    3 Vink P, et al. Cancer 2019;125:1301–1312.

    4 Dagnew AF, et al. Lancet Infect Dis 2019;19:988–1000.

    5 Vink P, et al. Clin Infect Dis 2019. doi: 10.1093/cid/ciz177.

    6 Stadtmauer E, et al. Blood. 2014;124(19):2921-2929.

    7 Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008 Jun;57(RR-5):1-30.

    8 Gnann et al. Clinical practice. Herpes zoster. N Eng J Med. 2002;347(5):340-6.

    9 Johnson RW et al. Herpes zoster epidemiology, management, and disease and economic burden in Europe: a multidisciplinary perspective. Therapeutic Advances in Vaccines. 2015;3(4):109-120.

    10 Lal H et al. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. N Engl J Med. 2015;372:2087-96.

    11 Yawn et al. Health care utilization and cost burden of herpes zoster in a community population. Mayo Clin Proc. 2009;84(9):787-94.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/shingrix-approved-in-the-us-for-prevention-of-shingles-in-immunocompromised-adults-301341032.html

    SOURCE GlaxoSmithKline plc

    View Full Article Hide Full Article
  3. Midatech Pharma PLC ('Midatech' or the 'Company') Midatech Strengthens Management Team with Appointment of Dr. Dmitry Zamoryakhin as Chief Scientific Officer

    ABINGDON, OXFORDSHIRE / ACCESSWIRE / July 12, 2021 / Midatech Pharma PLC ((AIM:MTPH, NASDAQ:MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, announces the appointment of Dr. Dmitry Zamoryakhin as Chief Scientific Officer, a non-board role, with immediate effect.

    Dr. Zamoryakhin has broad experience across all phases of development of drugs and medical devices, working with regulatory authorities including the EMA, FDA, PMDA, and NMPA. Most recently, he was Chief Medical Officer of Oxford Biomedica plc (LON: OXB), having previously…

    Midatech Pharma PLC ('Midatech' or the 'Company') Midatech Strengthens Management Team with Appointment of Dr. Dmitry Zamoryakhin as Chief Scientific Officer

    ABINGDON, OXFORDSHIRE / ACCESSWIRE / July 12, 2021 / Midatech Pharma PLC ((AIM:MTPH, NASDAQ:MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, announces the appointment of Dr. Dmitry Zamoryakhin as Chief Scientific Officer, a non-board role, with immediate effect.

    Dr. Zamoryakhin has broad experience across all phases of development of drugs and medical devices, working with regulatory authorities including the EMA, FDA, PMDA, and NMPA. Most recently, he was Chief Medical Officer of Oxford Biomedica plc (LON: OXB), having previously held positions of increasing responsibility at Grunenthal GmbH, Daiichi Sankyo Company Limited (TYO:4568), Ono Pharmaceutical Co., Limited (TYO:4528), and GlaxoSmithKline plc ((LON:GSK, NYSE:GSK). He qualified as a doctor of medicine at Perm State Medical Academy, Russia, before earning a diploma in Pharmaceutical Medicine at PHARMED, Universite Libre de Bruxelles, and an MBA at Warwick Business School.

    Dr. Zamoryakhin will take over from Steve Damment, EVP R&D who, after six years with the Company, has decided to retire from full-time employment at the end of September 2021.

    Commenting, Stephen Stamp, CEO, and CFO of Midatech said: 'I am delighted to welcome Dmitry to the Midatech team. He is a medic, was big pharma trained, and has been biotech battle hardened. His breadth of experience will be invaluable as we move our Q-Sphera programmes and MTX110 through proof of concept to partnering.

    'On behalf of everybody at Midatech, I should also like to express our thanks to Steve Damment for his service to the Company and, in particular, the key role he has played in championing MTX110.'

    For more information, please contact:

    Midatech Pharma PLC

    Stephen Stamp, CEO, CFO

    Tel: +44 (0)29 2048 0180

    www.midatechpharma.com

    Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker)

    Freddy Crossley, Emma Earl (Corporate Finance)

    Rupert Dearden (Corporate Broking)

    Tel: +44 (0)20 7886 2500

    Turner Pope Investments (TPI) Limited (Joint Broker)

    Andrew Thacker / James Pope (Corporate Broking)

    Tel: +44(0)20 3657 0050

    IFC Advisory Limited (Financial PR and UK Investor Relations)

    Tim Metcalfe / Graham Herring

    Tel: +44 (0)20 3934 6630

    Email: midatech@investor-focus.co.uk

    Edison Group (US Investor Relations)

    Maxwell Colbert

    Tel: +1 (646) 653 7028

    Email: mcolbert@edisongroup.com

    About Midatech Pharma PLC

    Midatech Pharma PLC ((dual listed on LSE AIM: MTPH, NASDAQ:MTP) is a drug delivery technology company focused on improving the bio-delivery and bio-distribution of medicines. The Company combines approved and development medications with its proprietary and innovative drug delivery technologies to provide compelling products that have the potential to powerfully impact the lives of patients.

    The Company has developed three in-house technology platforms, each with its own unique mechanism to improve delivery of medications to sites of disease. All of the Company's technologies have successfully entered human use in the clinic, providing important validation of the potential for each platform:

    · Q-Sphera™ platform: a disruptive micro-technology used for sustained release to prolong and control the release of therapeutics over an extended period of time (from weeks to months).

    · MidaSolve™ platform: an innovative nanotechnology used to dissolve insoluble drugs so that they can be administered in liquid form directly and locally into tumours.

    · MidaCore™ platform: a leading-edge nanotechnology used for targeting medications to sites of disease.

    The platform nature of the technologies offers the potential to develop multiple drug assets rather than being reliant on a limited number of programmes. Midatech's technologies are supported by 36 patent families including 120 granted patents and an additional 70 patent applications. Midatech's headquarters and R&D facility is in Cardiff, UK. For more information please visit www.midatechpharma.com

    Forward-Looking Statements

    Certain statements in this press release may constitute 'forward-looking statements' within the meaning of legislation in the United Kingdom and/or United States Private Securities Litigation Reform Act. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.

    Reference should be made to those documents that Midatech shall file from time to time or announcements that may be made by Midatech in accordance with the London Stock Exchange AIM Rules for Companies ('AIM Rules'), the Disclosure and Transparency Rules ('DTRs') and the rules and regulations promulgated by the US Securities and Exchange Commission, which contains and identifies other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Midatech are expressly qualified in their entirety by the cautionary statements above. Except as may be required under the AIM Rules or the DTRs or by relevant law in the United Kingdom or the United States, Midatech does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or otherwise arising.

    This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

    SOURCE: Midatech Pharma PLC



    View source version on accesswire.com:
    https://www.accesswire.com/655103/Midatech-Pharma-PLC-Announces-Appointment-of-Chief-Scientific-Officer

    View Full Article Hide Full Article
    • Alector and GSK to co-develop progranulin-elevating monoclonal antibodies, AL001 and AL101, for a range of neurodegenerative diseases, including frontotemporal dementia, amyotrophic lateral sclerosis, Parkinson's disease and Alzheimer's disease
    • Companies will co-commercialize and share profits in the US; GSK will retain exclusive commercialization rights outside the US
    • Alector will receive $700 million in upfront payments, up to $1.5 billion in potential milestone payments, profit sharing and royalties
    • Alector management to host conference call today at 8:30 a.m. ET

    SOUTH SAN FRANCISCO, Calif. and LONDON, July 02, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC) and GlaxoSmithKline plc (NYSE:GSK), today announced a strategic global collaboration…

    • Alector and GSK to co-develop progranulin-elevating monoclonal antibodies, AL001 and AL101, for a range of neurodegenerative diseases, including frontotemporal dementia, amyotrophic lateral sclerosis, Parkinson's disease and Alzheimer's disease
    • Companies will co-commercialize and share profits in the US; GSK will retain exclusive commercialization rights outside the US
    • Alector will receive $700 million in upfront payments, up to $1.5 billion in potential milestone payments, profit sharing and royalties
    • Alector management to host conference call today at 8:30 a.m. ET

    SOUTH SAN FRANCISCO, Calif. and LONDON, July 02, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (NASDAQ:ALEC) and GlaxoSmithKline plc (NYSE:GSK), today announced a strategic global collaboration for the development and commercialization of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels. PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments.

    The collaboration brings together Alector's leading immuno-neurology expertise with GSK's R&D focus on the science of the immune system and human genetics, proven late-stage drug development capabilities and global footprint. Enrollment is currently underway for a pivotal Phase 3 trial for AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). FTD-GRN is a rapidly progressing and severe form of dementia found most frequently in people less than 65 years old at the time of diagnosis and has no approved treatments. AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a mutation in the C9orf72 gene and is planned to enter Phase 2 development for amyotrophic lateral sclerosis (ALS) in the second half of 2021. AL101 is in a Phase 1a clinical trial and is designed to treat patients suffering from more prevalent neurodegenerative diseases, including Parkinson's disease and Alzheimer's disease.

    Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Our focus on human genetics and the science of the immune system gives us unique insights into the potential of targets such as progranulin to help patients with a number of neurodegenerative diseases. Working with Alector's world class scientists will allow us to investigate the potential of these immuno-neurology therapies to help patients with frontotemporal dementia, a devastating disease without any currently approved treatments, as well as explore the ability to help patients with other neurodegenerative diseases, such as ALS, Parkinson's and Alzheimer's."

    Arnon Rosenthal, Ph.D., Chief Executive Officer, Alector, said: "This transformative collaboration brings together Alector's leading immuno-neurology expertise with GSK's commitment to immunology and human genetics, proven drug development capabilities and global footprint, to help expand and accelerate the development of our progranulin franchise into large indications, while bolstering the build out of our own late-stage development and commercial capabilities. Importantly, this collaboration is designed to fully support AL001 and AL101's development and to enable Alector to continue building a fully integrated company as we strive to address the high unmet medical need in patients suffering from neurodegenerative diseases. We are confident that GSK's extensive experience launching ground-breaking medicines at the intersection of immunology and human genetics, will ensure that AL001 and AL101 are developed to their full potential."

    As part of the recent Investor Update day on 23 June 2021, GSK committed to an R&D approach focused on maximizing opportunities by leveraging an increased understanding of the science of the immune system and human genetics. The collaboration with Alector on AL001 and AL101, two antibodies designed to elevate PGRN levels and potentially slow the progression of FTD and other neurological disorders, provides GSK access to a promising clinical program in immuno-neurology.

    Terms of the Collaboration

    Under the terms of the collaboration agreement, Alector will receive $700 million in upfront payments. In addition, Alector will be eligible to receive up to an additional $1.5 billion in clinical development, regulatory and commercial launch-related milestone payments.

    Alector will lead the global clinical development of AL001 and AL101 through Phase 2 proof-of-concept. Thereafter, Alector and GSK will share development responsibilities for all late-stage clinical studies for AL001 and AL101 and all costs for global development will be divided between the two companies.

    The companies will be jointly responsible for commercialization in the U.S. and will share profits and losses. Alector will lead commercial efforts associated with AL001 in orphan indications and GSK will lead the commercialization of AL101 in Alzheimer's and Parkinson's disease. Outside the U.S., GSK will be responsible for commercialization of AL001 and AL101 and Alector will be eligible for tiered royalties.

    The collaboration agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

    About the Progranulin-Elevating Monoclonal Antibodies - AL001 and AL101

    Decreased levels of PGRN, a key regulator of immune response, lysosomal function, and neuronal survival in the brain, are genetically linked to many neurodegenerative disorders. AL001 and AL101 are novel human monoclonal antibodies that elevate levels of progranulin by blocking the sortilin receptor responsible for progranulin degradation. AL001 is currently in a pivotal Phase 3 clinical study in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a C9orf72 mutation, with another Phase 2 study in patients with ALS planned to begin in the second half of 2021. AL101, is designed to treat people suffering from more prevalent neurodegenerative diseases and is currently in a Phase 1a study in healthy volunteers. AL101 is intended to be developed for treatment of Parkinson's disease and Alzheimer's disease.

    About Frontotemporal Dementia (FTD)

    Frontotemporal dementia is a rapidly progressing and severe form of dementia. It affects 50,000 to 60,000 people in the United States and roughly 110,000 in the European Union, with potentially higher prevalence in Asia and Latin America. There are currently no FDA-approved treatment options for FTD.

    There are multiple heritable forms of FTD. In one form, FTD-GRN, people have a mutation in the progranulin gene. This population represents 5% to 10% of all people with FTD. Mutations in a single copy of a progranulin gene leads to a 50% or greater decrease in the level of progranulin protein and invariably leads to development of FTD. In another form, people with mutations in the chromosome 9 open reading frame 72 (C9orf72) gene can develop FTD. FTD-C9orf72 is associated with abnormal accumulation of the protein TDP-43, which is also a hallmark in FTD-GRN. To date researchers have identified more than 120 inherited loss of function mutations in the progranulin gene that lead to FTD.

    Alector Conference Call Information

    Alector management will host a conference call to discuss the collaboration today at 8:30 a.m. ET. Analysts and investors are invited to participate in the conference call by dialling (888) 705-0365 from the U.S. and Canada or (415) 817-9241 internationally and using the conference ID 9476664. The live webcast can be accessed on the investor page of Alector's website at investors.alector.com. A replay of the webcast will be available on Alector's website approximately two hours after the completion of the event and will be archived for up to 30 days.

    About GSK

    GSK is a science-led global healthcare company. For further information please visit www.gsk.com/about-us.

    About Alector

    Alector is a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. The Company is developing a broad portfolio of innate immune system programs, designed to functionally repair genetic mutations that cause dysfunction of the brain's immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. The Company's immuno-neurology product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer's disease. This scientific approach is also the basis for the Company's immuno-oncology programs. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.

    GSK Cautionary Statement Regarding Forward-Looking Statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

    Alector Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the current expectations and beliefs of Alector. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to the outcome, benefits and synergies of the proposed collaboration with GSK, the anticipated completion of the proposed transaction and risks and uncertainties related to market conditions, Alector and its business as set forth in Alector's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 25, 2021, as well as the other documents Alector files from time to time with the SEC. These documents contain and identify important factors that could cause the actual results for Alector to differ materially from those contained in Alector's forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alector specifically disclaims any obligation to update any forward-looking statement, except as required by law.

    Alector Contacts:

    Michelle Corral

    VP, Communications and Investor Relations

    650-808-7016

    michelle.corral@alector.com

    1AB (media)

    Dan Budwick

    973-271-6085

    dan@1abmedia.com

    Argot Partners (investors)

    Joseph Rayne

    Argot Partners

    212.600.1902

    joseph@argotpartners.com

    GSK enquiries:   
    Media enquiries:Simon Steel+44 (0) 20 8047 5502(London)
     Tim Foley+44 (0) 20 8047 5502(London)
     Kristen Neese+1 804 217 8147(Philadelphia)
     Kathleen Quinn+1 202 603 5003(Washington DC)
        
    Analyst/Investor enquiries:James Dodwell+44 (0) 20 8047 2406(London)
     Sonya Ghobrial+44 (0) 7392 784784(Consumer)
     Mick Readey+44 (0) 7990 339653(London)
     Jeff McLaughlin+1 215 751 7002(Philadelphia)
     Frannie DeFranco+1 215 751 4855(Philadelphia)

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS



    Primary Logo

    View Full Article Hide Full Article
View All GlaxoSmithKline PLC News