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Sanofi and GSK today announce that they have signed a letter of intent to enter into a collaboration to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic.

Bouleversee wrote:Do we know that GSK will be paying their quarterly dividend as usual?

Bouleversee wrote:I have had the first one but wondered if they had stated that they would continue as usual now things have hotted up or whether the rest of the year was still under consideration. It would be good to know I could count on one or two.

GSK announces FDA advisory committee votes in favour of positive benefit/risk profile for belantamab mafodotin for patients with relapsed/refractory multiple myeloma

· Recommendation based on review of DREAMM clinical trial programme, including the pivotal DREAMM-2 study

· If approved, belantamab mafodotin will be a first-in-class anti-BCMA therapy for the treatment of relapsed/refractory multiple myeloma

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in favour of the demonstrated benefit of monotherapy treatment with belantamab mafodotin outweighing the risks for patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Two committee members could not participate in the final vote.

· Companies to collaborate on mRNA vaccine and monoclonal antibody research programmes in infectious diseases

· GSK to make equity investment of £130m (€150m) in CureVac, and an upfront payment of £104m (€120m)

GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac today announced the signing of a strategic collaboration agreement for the research, development , manufacturing and commercialisation of up to five mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. The collaboration complements GSK's existing mRNA capabilities with CureVac's integrated mRNA platform.

mRNA (messenger RNA) technology is a rapidl y progressing, cutting-edge platform for the development of new vaccines and medicines, potentially expanding the range of diseases which can be prevented or treated, while also promising to significantly speed up development and manufacturing. mRNA enables protein synthesis in the human body, carrying the genetic code required for cells to manufacture and express proteins. By using mRNA technology in vaccines and medicines, specific proteins, or antigens, can be produced by the body's own cells, enabling the human immune system to prevent or fight disease.

Sanofi and GSK agree with the UK government to supply up to 60 million doses of COVID-19 vaccine


· Agreement relates to vaccine candidate using Sanofi's recombinant protein-based technology combined with GSK's pandemic adjuvant system

· Both companies are committed to making their COVID-19 vaccine candidate affordable and available globally


Sanofi and have reached an agreement, subject to final contract, with the UK government for the supply of up to 60 million doses of a COVID-19 vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK's established pandemic adjuvant technology.

"With our partner GSK, we are pleased to cooperate with the UK government as well as several other countries and global organizations as part of our ongoing efforts to develop a safe and effective vaccine and make it available as quickly as possible. We greatly appreciate the UK government's support of this shared vision," said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur.

Dod101 wrote:Pretty uninspiring I'd say. However there is a lot going on at the moment so it is probably not the right time to judge them.

Dod

· Discussions relate to vaccine candidate using Sanofi's recombinant protein-based technology combined with GSK's pandemic adjuvant system

· Both companies are committed to making their COVID-19 vaccine affordable and available globally

Sanofi and GSK are in advanced discussions with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine. The vaccine candidate developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK's established adjuvant technology. The doses would be manufactured in European countries including France, Belgium, Germany and Italy. This marks a key milestone in protecting and serving the European population against COVID-19.

Sanofi and GSK announce today the start of the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The vaccine candidate, developed in partnership by Sanofi and GSK, uses the same recombinant protein-based technology as one of Sanofi's seasonal influenza vaccines with GSK's established pandemic adjuvant technology.

· ViiV Healthcare's Vocabria (cabotegravir injection) used in combination with Janssen Pharmaceutical Companies of Johnson & Johnson's Rekambys (rilpivirine injection) reduces treatment dosing days from 365 to 12 or 6 per year

· Long-acting regimen is based on co-administration of cabotegravir and rilpivirine injections once-monthly or once every 2-months to treat HIV-1

· Vocabria (cabotegravir) tablets for use as an oral lead-in therapy with Edurant (rilpivirine tablets) prior to starting the long-acting regimen also receives positive CHMP opinion

London, 16 October 2020 - ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) has issued a positive opinion recommending marketing authorisation for Vocabria (cabotegravir injection and tablets) in combination with Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class.[1]

Sanofi and GSK have signed a Statement of Intent with Gavi, the legal administrator of the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines.

Sanofi and GSK intend to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities and subject to contract, to the COVAX Facility. Both Companies intend to contribute to COVAX's ambition to ensure successful COVID-19 vaccines reach those in need, whoever they are and wherever they live, once they obtain appropriate approvals.

Reported Group sales £8.6 billion, -8% AER, -3% CER (Pro-forma -5% CER*, -3% CER excluding divestments/brands under review). Pharmaceuticals £4.2 billion, -7% AER, -3% CER; Vaccines £2.0 billion, -12% AER, -9% CER; Consumer Healthcare £2.4 billion, -4% AER, +2% CER (Pro-forma -6% CER*). Strong performance from key growth drivers in respiratory, HIV, oncology and Consumer Healthcare partly offset by expected disruption from COVID-19

Sales of new and specialty pharmaceuticals (excluding established products) £2.5 billion, +8% AER, +12% CER

Respiratory sales £978 million, +21% AER, +26% CER. Trelegy sales £194 million +40% AER, +45% CER. Nucala sales £251 million, +24% AER, +29% CER

HIV sales £1.2 billion, -4% AER, flat at CER; two-drug regimen sales £222 million, +87% AER, +94% CER

Oncology sales £99 million, +55% AER, +58% CER

Shingrix sales £374 million, -30% AER, -25% CER. US prescriptions rates returned to 2019 levels by quarter-end

Total Group operating margin 21.5%. Adjusted Group operating margin 30.8%. SG&A decline reflecting ongoing and active focus on cost management. R&D costs down in quarter; expect 2020 full year R&D costs to rise mid-to-high single digits as we continue to invest in late-stage pipeline

Total EPS 25.0p, -20% AER, -9% CER reflecting adverse changes on contingent consideration liabilities offset by asset disposals and improved operating performance

Adjusted EPS 35.6p, -8% AER, +1% CER reflecting operating profit growth partly offset by higher effective tax rate and non-controlling interest allocation of Consumer Healthcare profits

Q3 net cash flow from operations £0.9 billion. Free cash flow £(0.2) billion

19p dividend declared for the quarter

Increasing scientific evidence[1] demonstrates that climate change and nature loss are impacting the world and human health in many ways, including: extreme heat contributing to deaths from diseases; increased spread of infectious diseases and air pollution exacerbating respiratory diseases.

Today, GSK has announced ambitious new environmental sustainability goals in both climate and nature, aiming to have a net zero impact on climate and a net positive impact on nature by 2030.

The new goals form part of GSK's Trust priority and ESG approach, which support the company's aim to create long-term value for shareholders and meet the needs of society. Over the next decade, GSK will invest in measures to reduce its environmental impact, in restoration programmes to balance the remaining impact that the company cannot reduce and aim to put back into nature more than the company takes out.