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GSK unveils plan for UK headquarters of new Consumer Healthcare company

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October 11, 2021: “GSK announced proposals for a major new UK-based headquarters and global campus for the new Consumer Healthcare company following separation in 2022, and its long-term plan for the future headquarters of GSK.

New Consumer Healthcare company headquarters to be based in Weybridge, UK
The proposals announced today form part of GSK’s ongoing work to prepare for the separation of the Group into two leading UK-based companies next year – new GSK, a global pharmaceuticals and vaccines company with an R&D approach focused on the science of the immune system, human genetics and advanced technologies, and a world leading Consumer Healthcare company with annual sales of more than £10 billion, including nine global power brands holding category leadership positions.

Under the proposals announced today the new Consumer Healthcare company will build a new campus in Weybridge, UK. This campus will house the global headquarters for the new Consumer Healthcare business, including an innovation centre (made up of R&D laboratories and the Consumer Healthcare Shopper Science lab) and the company’s global support function teams based in the UK.

It will be home to around 1,400 employees.

The new Consumer Healthcare company will open its new headquarters at the end of 2024, subject to consultation and planning approvals.

Whilst the development of the campus is ongoing, and at the point of separation of the two companies – expected in mid-2022 – Consumer Healthcare teams will leave GSK House in Brentford and will move to a temporary headquarters in Weybridge, at a site close to but separate from the company’s existing facilities in the area.

Brian McNamara, CEO Designate, GSK Consumer Healthcare said: “This investment in a new cutting-edge campus in the UK will bring together our first-in-class teams as we drive towards our ambitions as the world’s leading consumer healthcare company.

Today’s announcement is an important step as we prepare for separation, marking an exciting new beginning for New Consumer Healthcare.”

GSK to move to new UK headquarters after separation
Following separation, GSK will move to a new UK headquarters.

The company will identify an appropriate site that meets the needs of the new organisation, with the search based in the same area as GSK’s current headquarters, maintaining access to the UK’s world-leading science and innovation hubs; GSK will provide a further update on its new headquarters in mid-2022, and expects to remain at the company’s current headquarters, at GSK House in Brentford, until at least the end of 2023.”

https://www.gsk.com/en-gb/media/press-releases/gsk-unveils-plan-for-uk-headquarters-of-new-consumer-healthcare-company/

Amgen Announces New LUMAKRAS™ Combination Data for KRAS G12C-mutated Cancers

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Oct. 7, 2021: “Amgen announced new combination study results from the Phase 1b CodeBreaK 101 study, a comprehensive global master protocol trial evaluating the safety and efficacy of LUMAKRAS™ (sotorasib), the first and only approved KRASG12C inhibitor, in more than 10 different investigational combination regimens for the treatment of patients with KRAS G12C-mutated cancers.

Results from two arms of the study — LUMAKRAS with afatinib, a pan-ErbB tyrosine kinase inhibitor, and LUMAKRAS with trametinib, a mitogen-activated protein kinase inhibitor (MEKi) — will be presented at the plenary session titled ‘Drugging Difficult Targets’ during the AACR-NCI-EORTC 2021 Virtual International Conference on Molecular Targets and Cancer Therapeutics on Saturday, Oct. 9, 2021.

“A critical component of cancer drug development is to interrogate multiple pathways to understand whether different combinations can meaningfully advance cancer care.

For this reason, Amgen has undertaken the broadest and most comprehensive global clinical development program for patients with the KRAS G12C mutation, exploring multiple combinations that will allow us to understand where we can best serve patients,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen.

“Consistent with our master protocol clinical trial design, which allows us to rapidly add, expand or remove cohorts to quickly understand what combinations work best for patients, Amgen will take these afatinib and trametinib results into account as we prioritize which combinations to move forward within our comprehensive LUMAKRAS development program.

We look forward to presenting additional data, including PD-1 and SHP2 combination datasets, in the coming months.”

LUMAKRAS in Combination with Afatinib (Abstract LBA6581) 
The LUMAKRAS and afatinib combination arm enrolled 33 heavily pre-treated patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC), including five patients previously treated with LUMAKRAS monotherapy.

Ten patients received 20 mg of afatinib/960 mg of sotorasib (cohort 1; 4 patients with prior LUMAKRAS experience) and 23 patients received 30 mg of afatinib/960 mg of sotorasib (cohort 2; 1 patient with prior LUMAKRAS experience).

The objective response rate (ORR) was 20% in cohort 1 and 35% in cohort 2, and the disease control rate was 70% and 74% in the two cohorts, respectively.

The most common treatment-related adverse events (TRAEs) for this study were diarrhea, nausea, and vomiting. TRAEs of grade 3 occurred in 30% of patients in both dose groups with diarrhea being the most common.

LUMAKRAS in Combination with Trametinib (Abstract LBA6580)
In CodeBreaK 101, the combination of LUMAKRAS and trametinib showed antitumor activity in heavily pre-treated patients with KRAS G12C-mutated solid tumors, including those with prior KRASG12C inhibitor treatment. A total of 41 patients were enrolled in the Phase 1b study with 18 patients with NSCLC, 18 patients with colorectal cancer (CRC) and five patients with other solid tumors.

The maximum tolerated dose tested was 2 mg trametinib/960 mg sotorasib administered daily.

In patients with CRC who were KRASG12C inhibitor naïve, 9% achieved partial response (1 of 11), and 82% achieved disease control (9 of 11). In patients who were previously treated with a KRASG12C inhibitor, 14% achieved partial response (1 of 7), and 86% achieved disease control (6 of 7).

In patients with NSCLC who were KRASG12C inhibitor naïve, 20% achieved partial response (3 of 15) and 87% achieved disease control (13 of 15). In patients who were previously treated with a KRASG12C inhibitor, 67% achieved disease control (2 of 3).

The most common TRAEs for this study were diarrhea, rash, dermatitis acneiform, nausea and vomiting. No new safety concerns were identified.

About LUMAKRASTM (sotorasib)
Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS, a KRASG12C inhibitor.

LUMAKRAS has demonstrated a positive benefit-risk profile with rapid, deep and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation.

In May 2021, LUMAKRAS was the first KRASG12C inhibitor to receive regulatory approval anywhere in the world with its approval in the U.S., under accelerated approval. LUMAKRAS is also approved in the United Arab Emirates, and in Canada and Great Britain under Project Orbis.

Amgen is progressing the largest and broadest global KRASG12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, including triplets, with clinical trial sites spanning five continents.

To date, LUMAKRAS has treated over 3,000 patients around the world through the clinical development program and commercial use.

In the U.S., LUMAKRAS was reviewed by the FDA under its Real-Time Oncology Review (RTOR), a pilot program that aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. 

Amgen is participating in the FDA’s Project Orbis initiative and through the initiative, has Marketing Authorization Applications (MAAs) for sotorasib in review in Australia and Brazil. Additionally, Amgen has submitted an MAA in the European Union, Japan, Switzerland, South Korea, Singapore, Israel, Turkey, Taiwan, Colombia, Thailand, Mexico and Hong Kong.

LUMAKRAS is also being studied in multiple other solid tumors.

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease.

The primary endpoint for the Phase 2 study was centrally assessed objective response rate.

The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and results have been submitted for publication. 

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) has completed enrollment. 

Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment.

A Phase 2 randomized study will evaluate sotorasib in patients with stage IV KRAS G12C-mutated NSCLC in need of first-line treatment (CodeBreaK 201).”

https://www.amgen.com/newsroom/press-releases/2021/10/amgen-announces-new-lumakras-sotorasib-combination-data-from-phase-1b-codebreak-101-study-in-patients-with-kras-g12cmutated-cancers-at-aacrncieortc-2021

Merck Begins Tender Offer to Acquire Acceleron Pharma Inc.

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October 12, 2021: “Merck, known as MSD outside the United States and Canada, is commencing, through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Acceleron Pharma Inc.

On Sept. 30, 2021, Merck announced that it had entered into a definitive agreement to acquire Acceleron.

Upon the successful closing of the tender offer, stockholders of Acceleron will receive $180 in cash for each share of Acceleron common stock validly tendered and not validly withdrawn in the offer, without interest and less any required tax withholding.

Following the purchase of shares in the tender offer, Acceleron will become a subsidiary of Merck.

Merck will file today with the U.S. Securities and Exchange Commission (the “SEC”) a tender offer statement on Schedule TO, which provides the terms of the tender offer.

Additionally, Acceleron will file with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the Acceleron board of directors that their stockholders accept the tender offer and tender their shares.

The tender offer will expire at 5:00 p.m., Eastern Time, on Nov. 10, 2021, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC.

The closing of the tender offer is subject to certain conditions, including the tender of shares representing at least a majority of the total number of Acceleron’s outstanding shares, receipt of applicable regulatory approvals, and other customary conditions.

The transaction is expected to close in the fourth quarter of 2021.

About Merck

For over 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives.

We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships.

Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world.

Important Information About the Tender Offer

This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Acceleron Pharma Inc. (“Acceleron”) or any other securities, nor is it a substitute for the tender offer materials described herein. A tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed today by Merck Sharp & Dohme Corp. (“Merck”) and Astros Merger Sub, Inc., a wholly owned subsidiary of Merck, with the Securities and Exchange Commission (the “SEC”), and a solicitation/recommendation statement on Schedule 14D-9 will be filed by Acceleron with the SEC.

INVESTORS AND SECURITY HOLDERS ARE URGED TO READ CAREFULLY BOTH THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES.

https://www.merck.com/news/merck-begins-tender-offer-to-acquire-acceleron-pharma-inc/

FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers

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October 12, 2021:”The following quote is attributed to Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research:“The FDA is committed to providing timely guidance to support continuity and response efforts during the COVID-19 pandemic.

Throughout the pandemic, the agency has continuously assessed the needs and circumstances related to hand sanitizers and issued temporary guidances to provide regulatory flexibility to certain firms to help meet the increased demand.

As relevant needs and circumstances evolve, the FDA updates, modifies or withdraws policies as appropriate.

In recent months, the supply of alcohol-based hand sanitizer from traditional suppliers has increased, and now, most consumers and healthcare personnel are no longer having difficulty obtaining these products.

Therefore, we have determined it’s appropriate to withdraw the temporary guidances and are providing manufacturers time to adjust their business plans related to production of these products under these temporary policies.

The FDA commends all manufacturers, big and small, who stepped in to provide American consumers and health care professionals with hand sanitizer products while they were in high demand during the pandemic.

We stand ready to help those who no longer plan to produce hand sanitizers, as well as help those who wish to continue doing so, to ensure they are complying with the appropriate requirements.”

Additional Information

  • The U.S. Food and Drug Administration announced that it intends to withdraw, effective Dec. 31, 2021, guidances originally issued in March 2020 outlining temporary policies for manufacturers that were not drug manufacturers at the time to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers during the public health emergency.
  • Effective Dec. 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products.

    After that date, manufacturers wishing to continue producing hand sanitizer can do so provided they comply with the tentative final monograph for over-the-counter topical antiseptics and other applicable requirements, including the FDA’s Current Good Manufacturing Practice requirements.
  • Manufacturers who no longer plan to produce these products are able to deregister by following the instructions on the Electronic Drug Registration and Listing Instructions page.
  • Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidances must no longer be sold to wholesalers or retailers by March 31, 2022.”

    https://www.fda.gov/news-events/press-announcements/fda-brief-fda-withdrawing-temporary-guidances-alcohol-based-hand-sanitizers

Novartis announces FDA and EMA filing acceptances of Beovu® for diabetic macular edema

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October 13, 2021: “Novartis announced that the US FDA has accepted the company’s supplemental Biologics License Application (sBLA) and that the European Medicines Agency (EMA) has validated the type-II variation application for Beovu® (brolucizumab) 6 mg for the treatment of diabetic macular edema (DME).

Additionally, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) accepted an application for Beovu in the treatment of DME.

Regulatory decisions for Beovu in DME are expected in mid-2022 for the US and Europe.

If approved, DME would be the second indication for Beovu following its approval for wet age-related macular degeneration in October 2019 (FDA) and February 2020 (European Commission).

DME is the leading cause of blindness in adults in developed countries, affecting 12% of people with type 1 diabetes and 28% of those with type 2 diabetes.

Consistently high blood sugar levels associated with diabetes can damage small blood vessels in the eye, causing them to leak fluid.

Unmet needs in DME include improving fluid resolution and addressing the burden of frequent treatment schedules.

“People living with diabetes often need to manage multiple comorbidities related to diabetes and there is a significant need to provide better disease management. 

If approved, Beovu has the potential to provide better fluid resolution and fewer injections during the loading phase and throughout maintenance treatment,” said Jill Hopkins, SVP and Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals.

“We look forward to bringing this potential new treatment option that may help to address unmet needs in the DME patient population.”

The regulatory applications are based on year one data from the Phase III, randomized, double-masked KESTREL and KITE* studies, which met their primary endpoint of non-inferiority in change in best corrected visual acuity (BCVA) from baseline versus aflibercept at year one.

In KESTREL and KITE, following the loading phase, over half of patients in the Beovu 6 mg arm remained on a 12-week dosing interval through year one.

Fewer eyes treated with Beovu had intraretinal and/or subretinal fluid (IRF/SRF) at week 32 and week 52 versus eyes treated with aflibercept.

The KESTREL and KITE trials are the first pivotal trials to assess an anti-VEGF treatment on six-week dosing intervals in the loading phase, suggesting Beovu may offer fewer injections from the start of treatment.

Overall, Beovu demonstrated a favorable benefit-risk profile in KESTREL and KITE. The most common ocular and non-ocular adverse events (≥5%) in KESTREL and KITE were conjunctival hemorrhage, nasopharyngitis and hypertension.

IOI rates in KESTREL were 4.7% for brolucizumab 3 mg (including 1.6% retinal vasculitis), 3.7% for Beovu 6 mg (including 0.5% retinal vasculitis), and 0.5% for aflibercept 2 mg.

IOI rates in KITE were equivalent (1.7%) between the Beovu 6 mg and aflibercept 2 mg arms with no retinal vasculitis reported.

Retinal vascular occlusion was reported in KESTREL for brolucizumab 3 mg (1.1%) and 6 mg (0.5%), and in KITE for brolucizumab and aflibercept (0.6% each).

The majority of these events were manageable and resolved with or without treatment.

Novartis remains committed to bringing Beovu to the patients who may benefit most from this important medicine.

About the KESTREL and KITE clinical trials
KESTREL and KITE are global, randomized, double-masked, Phase III, two-year studies comparing the safety and efficacy of Beovu and aflibercept in the treatment of DME.

KESTREL and KITE involved 926 patients in 36 countries. In the loading phase of both trials, patients in the Beovu arms were treated every six weeks for a total of five doses; patients in the aflibercept arms were treated every four weeks for a total of five doses, in line with its label at the start of the studies.

Following the loading phase, patients in the Beovu arms were subsequently treated every 12 weeks, with those demonstrating disease activity moved to dosing every eight weeks for the remainder of the study.

At week 72 of KITE, Beovu patients dosed every 12 weeks could be extended to dosing every 16 weeks, and patients dosed every eight weeks could be extended to every 12 weeks.

As in year one, those demonstrating disease activity were moved to dosing every eight weeks for the remainder of the study.

Through the entirety of both two-year trials, patients in the aflibercept arms were treated every eight weeks.

About diabetic macular edema (DME)
DME is a common microvascular complication in patients with diabetes that may have a debilitating impact on visual acuity, eventually leading to blindness.

DME is the leading cause of blindness in adults in developed countries, affecting 12% of patients with type 1 diabetes and 28% of those with type 2 diabetes.

Consistently high blood sugar levels associated with diabetes can damage small blood vessels in the eye, causing them to leak fluid.

This damage leads to an excess of vascular endothelial growth factor (VEGF). VEGF is a protein that stimulates the growth of blood vessels.

At elevated levels in DME, VEGF stimulates the growth of abnormal, leaky blood vessels.

The resulting accumulation of fluid (known as edema) in the macula can lead to vision loss.

The macula is the area of the retina responsible for sharp, central vision.

Early symptoms of DME include blurry or wavy central vision and distorted color perception, although the disease can also progress without symptoms at early stages.

About Beovu (brolucizumab) 6 mg
Beovu (brolucizumab, also known as RTH258) 6 mg is approved for the treatment of wet age-related macular degeneration (AMD) in more than 70 countries, including in the US, EU, UK, Japan, Canada and Australia.

Additional trials, which study the effects of brolucizumab in patients with wet AMD, diabetic macular edema (DME), and proliferative diabetic retinopathy (PDR), are currently ongoing.”

https://www.novartis.com/news/media-releases/novartis-announces-fda-and-ema-filing-acceptances-beovu-patients-diabetic-macular-edema

Sanofi presented brain-penetrant tolebrutinib at ECTRIMS 2021

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October 13, 2021: “Sanofi’s investigational oral Bruton’s tyrosine kinase (BTK) inhibitor, tolebrutinib, demonstrated favorable one-year tolerability in a Phase 2b long-term extension study (LTS) in patients with relapsing forms of multiple sclerosis (RMS).

The results showed that after 48 weeks of treatment, tolebrutinib reduced multiple sclerosis (MS) disease activity as measured by magnetic resonance imaging (MRI).

These data are being presented as ePosters at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on October 13 – 15, 2021.

“Understanding the ability of a brain-penetrant therapy to slow disability accumulation has the potential to bring new hope to people suffering from difficult-to-treat MS. 

For nearly two decades, Sanofi has been unwavering in its efforts to accelerate research and treatment options for these patients,” says Erik Wallström, M.D., Ph.D., Therapeutic Area Head, Neurology Development at Sanofi.

Ninety-eight percent (122/125) of LTS-treated patients remained in the Phase 2b extension study through Week 48. The extension study was designed to evaluate the safety of tolebrutinib and provided the opportunity to evaluate efficacy parameters and report MRI outcomes.

The LTS consisted of Part A, a double-blind treatment period where patients continued the same tolebrutinib dose as administered in the dose-finding study (5, 15, 30 or 60mg/day) and Part B, where all participants switched to the 60mg tablet (5/60mg, 15/60mg, 30/60mg, 60/60mg), which is the dose being tested in the Phase 3 trials.

“Results showed favorable safety and efficacy for tolebrutinib, and nearly all patients remained enrolled at the one-year mark of the long-term extension study,” says Anthony Traboulsee, M.D., Professor and Research Chair, MS Society of Canada at University of British Columbia and Phase 2b Extension Study Investigator. 

“Evaluating the impact BTK inhibitors can have on preventing disability accumulation is critical to addressing the needs of people living with MS. These long-term outcomes of tolebrutinib reinforce its potential as a new treatment option for MS patients.”

Safety and Efficacy Outcomes:

  • Safety data showed continued favorable tolerability of tolebrutinib and no new safety signals.
    The most frequent AEs were headache (10%), COVID-19 (9%), upper respiratory tract infection (8%) and nasopharyngitis (7%).
  • At baseline, mean Expanded Disability Status Scale (EDSS) scores across treatment groups ranged from 2.18 to 2.65. Over 48 weeks of treatment, mean EDSS scores remained relatively stable in all treatment groups.

    For the 60/60mg treatment group, mean (SD) score was 2.65 (1.22) at baseline and 2.45 (1.31) at Week 48.
  • Patients treated with tolebrutinib 60mg experienced low annualized relapse rate (ARR) of 0.17 (95% CI: 0.10, 0.29) over the 48-week treatment period.
    The majority of patients (89.5%) were free of relapses during this period. The relapse rate for these patients was 1.23 in the year prior to the Phase 2b study.

MRI Outcomes:

  • At Week 48 of the extension study, the mean number of new Gd-enhancing lesions/scan remained low (<0.4) in the 60/60mg arm.

    Patients who switched to 60mg in Part B (Weeks 15-47) of the LTS experienced a reduction in Gd-enhancing lesions, approaching values observed in the 60/60mg treatment arm.

The company also presented data on the effect of tolebrutinib on human microglia that support its capacity to modulate neuroinflammatory processes directly within the central nervous system (CNS).

Results from this study extended upon previous findings in mouse microglial cells to show that BTK-dependent inflammatory signalling in human microglia and tri-cultures can be modulated using tolebrutinib in vitro.

This research contributes to an improved understanding of BTK signalling in neuroinflammation and how BTK inhibitors target the neuroinflammation believed to contribute to disability progression in people with MS.

Tolebrutinib is the only BTK inhibitor in development for MS which has been shown to directly modulate microglia, based on publicly available information.

About tolebrutinib:

Tolebrutinib is an investigational brain-penetrant Bruton’s tyrosine kinase inhibitor that achieves CSF concentrations needed for targeting B lymphocytes and microglial cells, modulating neuroinflammation.

Tolebrutinib is being evaluated in Phase 3 clinical trials for the treatment of relapsing forms of MS (RMS), non-relapsing secondary progressive MS (nrSPMS), and primary progressive MS (PPMS), and its safety and efficacy have not been confirmed by any regulatory authority worldwide.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-10-13-09-00-00-2313117

Sandoz completes acquisition of GSK’s cephalosporin antibiotics business

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October 11, 2021: “Sandoz, a Novartis division, has successfully completed the acquisition of GSK’s cephalosporin antibiotics business.

Through this transaction, Sandoz has acquired rights to three established brands (Zinnat, Zinacef and Fortum)) in more than 100 markets, further reinforcing its leading global position in antibiotics.

In 2020, the three brands had combined sales of approximately USD 140 million in the relevant markets.

“Antibiotics are the backbone of modern healthcare systems and a central pillar of our worldwide Sandoz patient offering”, said Sandoz CEO Richard Saynor.

“The successful and timely closing of this important transaction is further proof of our commitment at Sandoz to be a leading global supplier of these essential medicines.

“Cephalosporins are the largest antibiotic segment by global sales and this acquisition complements our #1 position in generic penicillins, the other key segment. It also sets us up for additional synergies driven by an increased promotional footprint across markets.”

The transaction excludes rights to certain brands previously divested by GSK in the US, Australia and Germany. GSK will also retain full brand rights in China (excluding Taiwan, Hong Kong and Macau), India, Pakistan, and Egypt and to certain brands in Japan.

In line with its integrated manufacturing strategy, Sandoz intends in the longer term to manufacture Zinnat at sites in its own network, which has global antibiotics production centered on its lead production site in Kundl, Austria.

In May, Sandoz announced plans to invest more than EUR 150 million in its uniquely vertically-integrated, European-based antibiotics network.”

https://www.novartis.com/news/media-releases/sandoz-completes-acquisition-gsks-cephalosporin-business-reinforcing-leading-global-position-antibiotics

AZD7442 reduced risk of developing COVID-19 in TACKLE Phase III trial

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October 11, 2021: “Positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AstraZeneca’s AZD7442, a long acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19.

A total of 90% of participants enrolled were from populations at high risk of progression to severe COVID-19, including those with co-morbidities.

The trial met the primary endpoint, with a dose of 600mg of AZD7442 given by intramuscular (IM) injection reducing the risk of developing severe COVID-19 or death (from any cause) by 50% compared to placebo in outpatients who had been symptomatic for seven days or less.

The trial recorded 18 events in the AZD7442 arm (18/407) and 37 in the placebo arm (37/415). The LAAB was generally well tolerated in the trial.

In a prespecified analysis of participants who received treatment within five days of symptom onset, AZD7442 reduced the risk of developing severe COVID-19 or death (from any cause) by 67% compared to placebo, with nine events in the AZD7442 arm (9/253) and 27 in the placebo arm (27/251).

AZD7442 is the first LAAB with Phase III data to demonstrate benefit in both prophylaxis and treatment of COVID-19 and is easily administered by IM injection.

Hugh Montgomery, Professor of Intensive Care Medicine at University College London, and TACKLE principal investigator, said: “With continued cases of serious COVID-19 infections across the globe, there is a significant need for new therapies like AZD7442 that can be used to protect vulnerable populations from getting COVID-19 and can also help prevent progression to severe disease.

These positive results show that a convenient intramuscular dose of AZD7442 could play an important role in helping combat this devastating pandemic.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “These important results for AZD7442, our long-acting antibody combination, add to the growing body of evidence for use of this therapy in both prevention and treatment of COVID-19.

An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months.”

TACKLE included 903 participants in a 1:1 randomisation AZD7442 to placebo. The primary analysis was based on 822 participants.

AstraZeneca will be discussing the data with health authorities. On 5 October 2021, the Company announced that it had submitted a request to the US Food and Drug Administration for Emergency Use Authorisation for AZD7442 for prophylaxis of COVID-19.

Full results from TACKLE will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/azd7442-phiii-trial-positive-in-covid-outpatients.html

FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia

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October 08, 2021: “The U.S. Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder.

Rethymic is the first thymus tissue product approved in the U.S.“Today’s action marks the first FDA approval of a therapy to treat this very rare and devastating disease in children,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

“We remain committed to helping advance the development of safe and effective medical products for patients affected by rare diseases – an area of such critical need.”

Congenital athymia is a rare immune disorder in which a child is born without a thymus – an organ that plays a critical role in helping the body learn to fight infections.

Children impacted by this disease typically die within the first two years of life and may have repeated, often life-threatening infections because they lack adequate working T cells (a kind of infection-fighting white blood cell).

Rethymic is composed of human allogeneic (donor-derived) thymus tissue that is processed and cultured, and then implanted into patients to help reconstitute immunity (improve immune function) in patients who are athymic.

Dosing is patient customized, determined by the surface area of the Rethymic slices and the body surface area of the patient. Rethymic is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).

The safety and efficacy of Rethymic were established in clinical studies that included 105 patients, with ages from one month to 16 years, who each received a single administration of Rethymic, from 1993 – 2020.

Rethymic improved survival of children with congenital athymia, and most children treated with this product survived at least two years.

Children treated with Rethymic who survive past the first year generally survive long-term. Rethymic also reduced the frequency and severity of infections over time.

The most common adverse reactions in patients that received Rethymic include high blood pressure, cytokine release syndrome, low blood magnesium levels, rash, low platelets and graft versus host disease.

Because Rethymic is derived from human tissue, it carries a risk of transmitting infectious disease.

Based on effective donor screening procedures and product manufacturing processes, the risk of infectious disease transmission is remote – but not completely eliminated.

It takes six months or longer to reconstitute the immune function in treated patients; therefore, it is important that until immune reconstitution occurs patients continue to take strict precautions to prevent infections and healthcare providers should treat accordingly.

This application was granted a rare pediatric disease voucher by the FDA. A description of rare pediatric disease designation and voucher programs can be found in the Guidance for Industry: Rare Pediatric Disease Priority Review Vouchers.

The FDA granted approval of Rethymic to Enzyvant Therapeutics, Inc.”

https://www.fda.gov/news-events/press-announcements/fda-approves-innovative-treatment-pediatric-patients-congenital-athymia

FDA Issues Final Order and Guidance on Surgical Staplers and Staples for Internal Use

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October 07, 2021: “The U.S. Food and Drug Administration announced several actions related to surgical stapler and staple regulation and safety.

“At the heart of our public health mission is protecting the public by regulating medical devices to ensure they are safe to use,” said William Maisel, M.D., M.P.H., chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health.

“The increasing reliance on surgical staplers by surgeons to perform more procedures that are minimally invasive, together with the agency’s analysis of adverse events associated with surgical staplers and implantable staples, prompted the FDA to increase regulatory oversight of these devices while continuing to educate health care providers and patients about their benefits and risks.

Following our rigorous internal review and input from the public, today’s actions will increase the safe use of surgical staplers and staples as an important alternative to manual suturing.”

The agency issued a final order reclassifying surgical staplers for internal use from Class I (general controls) to Class II (special controls) and requiring them to undergo premarket review.

As a result, surgical staplers for internal use will be subject to more stringent regulatory requirements, including requiring premarket notification and special controls to help mitigate known risks of the device.

The FDA also issued final guidance that describes labeling recommendations for manufacturers of surgical staplers and staples for internal use to help promote the safe and effective use of these devices by providing recommendations for developing labeling to convey information about specific risks, limitations and directions for use of the device.

An updated Letter to Health Care Providers was issued along with the final order and guidance to alert health care professionals to information about the safe and effective use of surgical staplers.

Through its monitoring of the use of surgical staplers and implantable staples for internal use, the FDA became aware of malfunctions and misuse associated with these devices that have resulted in serious adverse events.

Today’s actions will help increase the safe and effective use of surgical staplers and staples for internal use.

Surgical staplers for internal use are specialized prescription devices used during surgery to deliver compatible staples to divide, seal and connect internal tissues together and allow for healing.

They are safe and effective surgical tools when used by surgeons following clear labeling with information about specific risks, limitations and directions for use of the device.

Surgical staplers and staples may be indicated for use in a wide range of surgical applications, including gastrointestinal, gynecologic and thoracic surgeries. These devices may shorten surgical procedure time compared to manual suturing.

The large number of medical device reports received in recent years about serious injuries, patient deaths and device malfunctions associated with surgical staplers and staples for internal use signaled the FDA to take actions to ensure the safe and effective use of these devices.

Surgical staplers and staples for internal use are used as a system; therefore, the FDA analyzed the medical device reports submitted for both surgical staplers and implantable staples to obtain a comprehensive picture of the safety profile for these devices, which found that the primary cause of adverse effects attributed to surgical staplers and staples for internal use was due to improper use of the stapler, followed by improper function of the stapler.

Today’s issuance of a final order and guidance is the result of our continuous and careful evaluation of surgical staplers and staples for internal use.

An earlier Letter to Health Care Providers was issued in March 2019.

In May 2019, the FDA convened a public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss whether reclassifying surgical staplers for internal use from Class I to Class II would be appropriate.

Manufacturers of surgical staplers for internal use will now be required to meet these special controls outlined in the final reclassification order and be required to submit a 510(k) if they do not already have one.

The FDA does not intend to enforce these requirements until 180 days after issuance of the final order.”

https://www.fda.gov/news-events/press-announcements/fda-issues-final-order-and-guidance-surgical-staplers-and-staples-internal-use

WHO, UN set out steps to meet world COVID vaccination targets

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October 07, 2021: “Working with COVAX, African Vaccine Acquisition Trust and other partners – world can and must meet WHO targets to vaccinate 40% of the population of all countries by the end-2021 and 70% by mid-2022

Vaccine supply gaps to COVAX must be closed immediately for countries to reach the 40% year end target

United Nations Secretary-General and WHO Director-General call on countries and  manufacturers to make good on their commitments without further delays 

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The World Health Organization has today launched the Strategy to Achieve Global Covid-19 Vaccination by mid-2022 (the Strategy) to help bring an end to what has become a two-track pandemic:  people in poorer countries continue to be at risk while those in richer countries with high vaccination rates enjoy much greater protection.

WHO had set a target to vaccinate 10% of every country, economy and territory by the end of September but by that date 56 countries had not been able to do so, the vast majority of these are countries in Africa and the Middle East.

The new strategy outlines a plan for achieving WHO’s targets to vaccinate 40% of the population of every country by the end of this year and 70% by mid-2022.

“Science has played its part by delivering powerful, life-saving tools faster than for any outbreak in history,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

“But the concentration of those tools in the hands of a few countries and companies has led to a global catastrophe, with the rich protected while the poor remain exposed to a deadly virus.

We can still achieve the targets for this year and next, but it will take a level of political commitment, action and cooperation, beyond what we have seen to date.”

“This is a costed, coordinated and credible path out of the COVID-19 pandemic for everyone, everywhere,” said United Nations Secretary-General Antonio Guterres.

“Without a coordinated, equitable approach, a reduction of cases in any one country will not be sustained over time. 

For everyone’s sake, we must urgently bring all countries to a high level of vaccination coverage.”

To achieve the global vaccination targets, there should be a three-step approach to vaccination, with all older adults, health workers, and high-risk groups of all ages, in every country vaccinated first, followed by the full adult age group in every country and lastly extended vaccination of adolescents.

Vaccinating 70% of the global population requires at least 11 billion vaccine doses.   By the end of September, just over 6 billion doses had already been administered worldwide. 

With global vaccine production now at nearly 1.5 billion doses per month, there is sufficient vaccine from a supply perspective to achieve the global vaccination targets provided that there is equitable distribution of those doses. 

Substantial financing has already been invested to procure most of the required vaccine doses for low- and lower-middle-income countries through COVAX, the African Vaccine Acquisition Trust (AVAT) and bilateral contracts. 

There needs to be additional investment to secure the remaining vaccine doses for these countries as well as investment to support in-country delivery.  

The Strategy outlines the priority actions needed from the different actors to achieve the targets.

All Countries must:

  • Establish updated national COVID-19 vaccine targets and plans defining dose requirements to guide manufacturing investment and vaccine redistribution, and financial and programmatic resource needs to guide internal planning and external support;
  • Monitor vaccine demand and uptake carefully to rapidly adapt services and ensure continuity of vaccine supplies;
  • Commit to equitable distribution of vaccines in line with the WHO three-step approach;
  • Revise national vaccination strategies, policies and prioritization as needed to harness emerging evidence to maximize the impact of existing, modified and new vaccines.

Countries with high vaccine coverage must:

  • Swap vaccine delivery schedules, with COVAX and AVAT to enhance coverage in countries in need;
  • Fulfil and accelerate vaccine dose-sharing and donation commitments to COVAX in the near term, for those with existing pledges;
  • Establish new dose-sharing commitments to facilitate progress toward the 70% coverage target in every country.

Vaccine-producing countries must:

  • Allow the free cross-border flow of finished vaccines and raw materials;
  • Enable diversified vaccine production, both geographically and technologically, including through non-exclusive, and transparent licensing and sharing of know-how to allow transfer of technology and scale-up of manufacturing.

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COVID-19 vaccine manufacturers must:

  • Prioritize and fulfil COVAX and AVAT contracts as a matter of urgency;
  • Provide full transparency on the overall monthly production of COVID-19 vaccines and clear monthly schedules for supplies to COVAX, AVAT and low and low-middle income countries, to enable proper global and national-level planning and optimal use of scarce supplies;
  • Actively engage and work with countries that have high coverage and that have contracted high volumes of vaccines to allow the prioritization of COVAX and AVAT contracts, including through delivery schedule swaps, and facilitate rapid and early dose-sharing;
  • Commit to share know-how more rapidly, facilitate technology transfer and provide transparent non-exclusive voluntary licenses, to ensure that future vaccine supply is reliable, affordable, available, and deployed to every country in volumes and timing that achieves equitable access.

Civil society, community organizations, and the private sector must:

  • Advocate locally, nationally and internationally for equitable access to COVID-19 vaccines, tests and treatments, calling for and monitoring in particular the specific actions required of manufacturers, governments and multilateral actors;
  • Mobilize and empower communities, including through social media and community networks, to generate strong vaccine demand and address misinformation and misperceptions that contribute to vaccine hesitancy;
  • Provide support to the in-country delivery of vaccination programmes and services.

Global and regional multilateral development banks and institutions must:

  • Enable countries to more rapidly access the capital and external support needed for in-country vaccine delivery, prioritizing low-income settings and especially targeting support to the technical, logistics and human resources required;
  • Engage fully with COVAX/ACT-Accelerator and AVAT, with integrated operations and real-time sharing of information to truly support equitable access;
  • Support international procurement and allocation mechanisms to enable all countries to equitably, efficiently and rapidly achieve the COVID-19 vaccine targets;
  • Support vaccine distribution plans and a campaign to convey the life-saving importance of approved COVID-19 vaccinations.

For their part, WHO, Gavi, UNICEF and CEPI must work in close collaboration with World Bank, World Trade Organization, International Monetary Fund, Africa CDC, AVAT, and other key partners to monitor progress, identify changes needed to resolve bottlenecks, coordinate information and prioritize actions; continue to co-lead and manage the COVAX Pillar of ACT-Accelerator; support the equitable allocation of available vaccines, particularly to low-, lower-middle-income and lagging countries; directly support countries to develop and sustain rapid, effective, high-quality COVID-19 vaccine delivery programmes that can achieve the global targets; address key research, policy, safety and regulatory issues that will optimize vaccine impact including effective supply, dosing and vaccine schedules, mixing and matching of products, protection against variants, and other issues; and monitor and report monthly on progress towards the global COVID-19 vaccination goals.”

https://www.who.int/news/item/07-10-2021-who-un-set-out-steps-to-meet-world-covid-vaccination-targets

Novartis will commence Phase III pivotal trials investigating remibrutinib in RMS

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October 7, 2021: “Novartis announced it will present 41 abstracts at the upcoming 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place digitally on October 13-15, 2021.

The data being presented spans a comprehensive MS portfolio, emphasizing the company’s commitment to improving the quality of life for people living with MS at all stages of the disease.

“These data strengthen the role of Kesimpta as a first-choice treatment for relapsing forms of MS, highlighting its long-term safety and efficacy for patients and physicians,” said Lykke Hinsch Gylvin, Neuroscience Global Medical Franchise Head, Novartis Pharmaceuticals.

“With new data across our MS portfolio, Novartis is committed to reimagining medicine by leading on new treatment options, challenging ourselves to focus on unmet needs when managing the disease, and ultimately improving the lives of people living with MS.”

In addition to the data presented at ECTRIMS, Novartis will initiate Phase III pivotal trials to investigate remibrutinib in RMS patients.

Remibrutinib (LOU064) is a highly selective and potent covalent BTK inhibitor with a potential best-in-class profile and has shown favorable safety based on clinical data established to date.

BTK inhibitors are a novel class of therapies that target B-cells and other innate immune cells and prevent inflammation and potentially disease progression in MS.

Novartis key highlights at the 37th ECTRIMS Congress include:

New efficacy and safety data on Kesimpta, the first and only self-administered, targeted B-cell therapy for patients with relapsing forms of MS (RMS), show that Kesimpta is a well-tolerated, high-efficacy therapy in adults, including newly diagnosed patients, with RMS.

The study results will provide a robust picture of safety data for Kesimpta after extended exposure (~ 3.5 years):

  • New findings from the ALITHIOS Phase IIIb open-label extension study look at immunoglobulin M (IgM) and immunoglobulin G (IgG) levels in people treated with Kesimpta over ~ 3.5 years to better understand the potential effect of ofatumumab on these antibody levels as well as any association with risk of serious infection during continuing observation.
  • Safety and efficacy data on Kesimpta from the ALITHIOS Phase III study look at RMS-patients treated with Kesimpta and their risk of a COVID-19 infection as well as its severity.
  • Interim results from a single-center study in the US show the effect of Kesimpta on microglial activation.
  • An open-label multicenter single-arm pilot study in the US will assess the immune response to SARS CoV-2 mRNA vaccine in MS-patients treated with Kesimpta.

New data on Mayzent, the first and only oral treatment studied and proven to slow disability progression as demonstrated in the EXPAND study that included a broad range of secondary progressive MS (SPMS) patients, add to the growing body of evidence that patients treated with Mayzent show delays in disability progression and experience benefits in cognitive performance:

  • An open-label, three-cohort, prospective study based in Germany will present interim data on the immune response after SARS CoV-2 mRNA vaccination in SPMS-patients treated with Mayzent.
  • Findings from the ongoing EXPAND extension study on the long-term outcomes with Mayzent, showing continuing sustained efficacy of the treatment in patients receiving Mayzent.
  • Real world and phase III study data combined to characterize the extent and patterns of activity in ‘active’ and ‘non-active’ SPMS demonstrates that such definitions can be unreliable and may lead to suboptimal management of people living with SPMS.
  • A retrospective real-world study will review patient self-reported and physician-reported information on cognitive symptoms, thus examining the discordance between physician and patient perception of cognition impairment.

Novartis in Neuroscience
At Novartis Neuroscience, we have been tackling neurological conditions for more than 80 years, launching transformative treatments which have made meaningful differences to millions of people worldwide.

We continue to collaborate on industry-leading treatments in multiple sclerosis, pediatric neurology, neurodegeneration and neuropsychiatry because we know through innovation, partnership and community engagement early on, we can improve the standard of care.

To ensure patients everywhere can benefit from these life-changing therapies, we work closely with key stakeholders across the world to ensure rapid and sustainable access to our medicines, with the aim of providing the widest choice of treatments for each person’s unique journey.”

https://www.novartis.com/news/media-releases/novartis-present-broad-range-portfolio-data-ectrims-reinforcing-long-standing-commitment-people-living-multiple-sclerosis