On January 17, 2022 Spago Nanomedical reported that interim results from their phase I study with SpagoPix, the tumour selective contrast agent in cancer diagnostics with magnetic resonance imaging (Press release, Spago Nanomedical, JAN 17, 2022, View Source [SID1234605504]). The results show that the candidate is safe, that it accumulates into the tumours, and that it provides clear contrast enhancement in the image analysis. Based on these results the company has decided to expand the study to new indications, in addition to breast cancer. BioStock reached out to CEO Mats Hansen for a comment.

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According to the preliminary results of Spago Nanomedical’s ongoing phase I study, the product candidate SN132D in the company’s SpagoPix project is safe to use also at the higher dose level. In addition, the company can conclude that the tumour selective contrast agent accumulates in solid tumours as intended and that the magnetic resonance imaging (MRI) from patients with breast cancer show clear contrast enhancement.

Expanded phase I with SpagoPix
Spago Nanomedical has initially focused SpagoPix on breast cancer, a disease that, according to the World Health Organization, affects about 2.3 million people each year and where MRI diagnostics are among the standard methods for detection, diagnose and follow-up of the disease.

During the study, it has also been observed that the imaging of the pancreas and the liver has showed clear contrast enhancement. Based on these results, Spago Nanomedical has decided to expand the study to include patients with pancreatic cancer that has metastasised to the liver.

Pancreatic cancer is one of the cancers associated with the highest mortality, thus, the need for improved diagnostic methods is great. In addition, the company will evaluate SpagoPix in other indications with clinical needs.

The SpagoPix progress is positive for Tumorad
The progress with SpagoPix is also important for Spago Nanomedical’s cancer treatment project Tumorad including the drug candidate SN201. The company is developing an individualised radionuclide treatment of cancer tumours, based on the same technology platform as SpagoPix.

The new treatment can be targeted at different cancers and has, in a preclinical model for aggressive breast cancer, indicated that tumour growth can be slowed. The company also conducts preclinical studies in other cancer models.

After successfully having completed the preclinical program last year, the aim is to start a phase I study with SN201 in 2022. Initiating the study, the company will take a first clinical step towards developing a new treatment that can target a variety of tumours and metastases that cannot be treated with external radiation or surgery. Read more.

CEO comments
BioStock reached out to Spago Nanomedical’s CEO Mats Hansen to find out more about the results and what they mean for the company’s projects.

Mats, what do the results mean for SpagoPix’s potential in MRI diagnostics?

– We are very pleased with the results that are in line with the previous interim analysis and clearly confirm that SN132D at the current dose provides clinically relevant contrast enhancement in solid breast tumours and enables us to begin the final phase of the study.

– This is further confirmation that our platform technology for physiological tumour targeting with functional nanoparticles works and opens up for both diagnostic and therapeutic use in different types of solid cancer tumours.

Why did you choose to expand the study with pancreatic and liver cancer?

Mats Hansen, CEO Spago Nanomedical
Mats Hansen, CEO Spago Nanomedical
– On the one hand, we see opportunities to effectively act on the positive signals we have already received regarding contrast in the pancreas and liver, and, on the other hand, we see great value in showing the breadth of the platform, for MRI of course, but also to point to the possibilities of Tumorad.

– Abdominal imaging is already part of the ongoing study and after the fine images with strong contrast in the liver and pancreatic that we have already received, it has been clear that there is a clinical interest in evaluating SN132D further in patients with documented cancer in these organs. It can also easily be done within the framework of the already ongoing study, which means that we have the opportunity already at this stage of development to demonstrate a broader use of SN132D.

– We believe that this is a time- and cost-effective way to increase the value of the project.

In what other indications do you think SpagoPix can be useful?

– We believe that SN132D provides the opportunity for precision simulation with MRI for several solid tumours, and look at the possibilities in other diseases that are distinguished by rapid and unstructured blood vessel growth that can open up for the accumulation of our nanoparticles.

The progress with SpagoPix is also important for Tumorad, what benefits do you see with the latest results?

– This is further confirmation that our platform works to accurately accumulate functional nanoparticles in solid tumours. The particles used in Tumorad are based on the same basic components and principle of physiological tumour targeting.

– The results with SN132D also show a very good correlation between preclinical and clinical data, which, in light of the latest preclinical results with Tumorad, further strengthens us on the path to clinical trials.

On December 17, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (#GI22), taking place in-person in San Francisco, California, and virtually, from January 20 to 22, 2022 (Press release, Eisai, JAN 17, 2022, View Source [SID1234605503]).

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At this symposium, the results of a primary analysis of a prospective clinical study evaluating transcatheter arterial chemoembolization (TACE) therapy in combination strategy with lenvatinib (TACTICS-L) in patients with unresectable hepatocellular carcinoma (uHCC) in Japan (Abstract No: 417), as well as research updates on the Phase IV Study (STELLAR) to evaluate safety and tolerability of lenvatinib in patients with advanced/unresectable hepatocellular carcinoma (Abstract No: TPS485) and results from a clinical study to evaluate the efficacy of lenvatinib for conversion surgery in patients with uHCC (investigator-initiated study in Japan, Abstract No: 458), will be presented.

In addition, trial-in-progress (TiP) posters from the clinical program evaluating the combination therapy of lenvatinib plus pembrolizumab (product name: KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), include the Phase III LEAP-014 Study of the combination plus chemotherapy in patients with esophageal carcinoma squamous cell carcinoma (Abstract No: TPS367), Phase III LEAP-015 Study of the combination plus chemotherapy in patients with advanced/metastatic gastroesophageal adenocarcinoma (Abstract No: TPS369), Phase III Study LEAP-012 of the combination plus TACE in patients with intermediate-stage hepatocellular carcinoma not amenable to curative treatment (Abstract No: TPS494), and Phase II Study of the combination plus belzutifan in patients with advanced solid tumors (Abstract No: TPS669).

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

Eisai positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai poster presentations is below.

Compound
Abstract No. Title / Scheduled Date
Lenvatinib

417
Transcatheter arterial chemoembolization therapy in combination strategy with lenvatinib in patients with unresectable hepatocellular carcinoma (TACTICS-L) in Japan: Primary analysis

January 21 (Fri)
Lenvatinib

TPS485*
A multicenter, observational, phase 4 study (STELLAR) to evaluate the safety and tolerability of lenvatinib (LEN) in patients with advanced or unresectable hepatocellular carcinoma (uHCC)

January 21 (Fri)
Lenvatinib

458
Multicenter prospective study to evaluate the efficacy of lenvatinib to achieve conversion surgery for initially unresectable hepatocellular carcinoma: LENS-HCC trial (Investigator-initiated study in Japan)

January 22 (Sat)
Lenvatinib + pembrolizumab

TPS367*
LEAP-014: an open-label, randomized, phase 3 study of first-line lenvatinib plus pembrolizumab plus chemotherapy in esophageal carcinoma squamous cell carcinoma

January 20 (Thu)
Lenvatinib + pembrolizumab

TPS369*
LEAP-015: A randomized phase 3 study evaluating the efficacy and safety of first-line pembrolizumab plus lenvatinib plus chemotherapy versus chemotherapy in patients with advanced/metastatic gastroesophageal adenocarcinoma

January 20 (Thu)
Lenvatinib + pembrolizumab

TPS494*
LEAP-012 Trial in progress: Transarterial chemoembolization with or without lenvatinib plus pembrolizumab for intermediate-stage hepatocellular carcinoma not amenable to curative treatment

January 20 (Thu)
Lenvatinib + pembrolizumab

TPS669*
MK-6482-016： Phase 2, open-label study of pembrolizumab plus lenvatinib and belzutifan in patients with advanced solid tumors

January 20 (Thu)
* The presentation with TPS (Trial in Progress Submission) attached to the abstract number indicates that the study is in the intermediate stage, and the presentation does not report the final study results.

1．About the Merck & Co., Inc., Kenilworth, N.J., U.S.A. and Eisai Strategic Collaboration

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.

In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.

2. Eisai’s Focus on Cancer

Eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.

On January 17, 2022 AstraZeneca and Daiichi Sankyo reported that they have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen. The application has also been granted Priority Review (Press release, AstraZeneca, JAN 17, 2022, View Source [SID1234605502]).

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Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.1 The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is during the second quarter of 2022.

The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) programme and Project Orbis, two initiatives of the FDA which are designed to bring effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners.

Breast cancer is the most common cancer worldwide, with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally.2 Approximately one in five cases of breast cancer are considered HER2-positive.3 Despite initial treatment with trastuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression.4 More treatment options are needed to further delay progression and extend survival.4-6

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca said: "This review across geographies and the Priority Review in the US as part of Project Orbis is so important because it speaks to the transformative potential of Enhertu based on the unprecedented progression-free survival benefit in this setting. The news reinforces the importance of bringing this potential new option to patients as quickly as possible."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "This regulatory review of Enhertu in the US marks the first time this medicine is participating in both the Real-Time Oncology Review and Project Orbis programmes. The FDA’s prioritisation of our application underscores the potential of this medicine and the continued need to expedite the availability of new treatment options, while making it possible to potentially receive approvals in several countries concurrently."

The sBLA is based on data from the DESTINY-Breast03 trial presented during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021.

In the trial, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1 (hazard ratio [HR] 0.28; 95% confidence interval [CI]: 0.22-0.37; p=7.8×10-22) in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

DESTINY-Breast03 also recorded that nearly all patients treated with Enhertu during the trial were alive at one year (94.1%) compared to 85.9% of patients treated with T-DM1. Confirmed objective response rate (ORR) more than doubled in the Enhertu arm versus the T-DM1 arm (79.7% vs. 34.2%). The safety profile of Enhertu was consistent with previous clinical trials, with no new safety concerns identified and no Grade 4 or 5 treatment-related interstitial lung disease events.

In September 2021, Enhertu received its fourth Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

Enhertu is approved for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in more than 30 countries based on the results from the DESTINY-Breast01 trial.

Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.

Notes

HER2-positive breast cancer
Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths in women worldwide.2 More than two million patients with breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.2 Approximately one in five cases of breast cancer are considered HER2-positive.3

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast, gastric, lung and colorectal cancers.7 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.8

Despite initial treatment with trastuzumab and a taxane, people with HER2-positive metastatic breast cancer will often experience disease progression.4 More treatment options are needed to further delay progression and extend survival.4-6

DESTINY-Breast03
DESTINY-Breast03 is a global head-to-head, randomised, open-label, registrational Phase III trial evaluating the safety and efficacy of Enhertu (5.4mg/kg) versus T-DM1 in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

The primary efficacy endpoint of DESTINY-Breast03 is progression-free survival (PFS) based on blinded independent central review. Secondary efficacy endpoints include overall survival, ORR, duration of response, PFS based on investigator assessment and safety.

DESTINY-Breast03 enrolled approximately 500 patients at multiple sites in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial. A Type II Variation is currently under review by the European Medicines Agency (EMA) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast03 trial.

Enhertu (6.4mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial. A Type II Variation is currently under review by the EMA for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior anti-HER2-based regimen.

Enhertu development programme
A comprehensive development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Enhertu was highlighted in the Clinical Cancer Advances 2021 report as one of two significant advancements in the "ASCO Clinical Advance of the Year: Molecular Profiling Driving Progress in GI Cancers," based on data from both the DESTINY-CRC01 and DESTINY-Gastric01 trials, as well as one of the targeted therapy advances of the year in non-small cell lung cancer (NSCLC), based on the interim results of the HER2-mutated cohort of the DESTINY-Lung01 trial.

Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo) and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and the next-generation oral selective oestrogen receptor degrader (SERD) and potential new medicine camizestrant.

PARP inhibitor Lynparza (olaparib) is a targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease.

Building on the first approval of Enhertu, a HER2-directed ADC, in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings.

To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy Imfinzi (durvalumab) in combination with other oncology medicines, including Lynparza and Enhertu, evaluating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On January 16, 2022 Jacobio reported that it’s self-developed global first-in-class drug Aurora A inhibitor JAB-2485 received IND (Investigational New Drug) from the FDA (Food and Drug Administration) in US (Press release, Jacobio Pharmaceuticals, JAN 16, 2022, View Source [SID1234605499]). Jacobio plans to initiate a Phase I/IIa clinical trial in patients with advanced solid tumors in the US .

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JAB-2485 is a highly selective small molecule Aurora A inhibitor. JAB-2485 can inhibit Aurora A activity at the cellular level, induce apoptosis and inhibit tumor growth. At present, there is no commercialized Aurora A inhibitor globally. Jacobio’s self-developed JAB-2485 is the third Aurora A inhibitor enter into clinical stage in the United States.

JAB-2485 has good anti-tumor activity. Preclinical data show that JAB-2485 is highly selective at biochemical and cellular levels. The inhibitory activity of Aurora A is one thousand times higher than that of Aurora B, and has potential to benefit patients with small cell lung cancer and triple negative breast cancer.

Relevant studies have shown that Aurora A and SHP2 inhibitors may be one of the therapies to solve the drug resistance of KRAS G12C inhibitors, Jacobio has these three self-developed drugs in clinical stage, including SHP2 inhibitors (JAB-3068 and JAB-3312), Aurora A inhibitor (JAB-2485) and KRAS G12C inhibitors (JAB-21822), which has potential to provide more combination therapies to patients.

On January 15, 2022 GlaxoSmithKline (GSK) plc reported that it has received three unsolicited, conditional and non-binding proposals from Unilever plc to acquire the GSK Consumer Healthcare business (Press release, GlaxoSmithKline, JAN 15, 2022, View Source [SID1234605495]). The latest proposal received on 20th December 2021 was for a total acquisition value of £50 billion comprising £41.7 billion in cash and £8.3 billion in Unilever shares. The Consumer Healthcare business is a Joint Venture between GSK and Pfizer, with GSK holding a majority controlling interest of 68% and Pfizer 32%.

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GSK rejected all three proposals made on the basis that they fundamentally undervalued the Consumer Healthcare business and its future prospects.

The Board of GSK is strongly focused on maximising value for GSK shareholders and has carefully evaluated each Unilever proposal. In doing so, the Board and its advisers assessed the proposals relative to the financial planning assessments completed to support the proposed demerger of the business in mid-2022, including the sales growth outlook set out below.

Global leader in Consumer Healthcare
The Consumer Healthcare business has been transformed since 2014 through the successful integrations of GSK’s business with the Novartis consumer health portfolio in 2015 and the Pfizer portfolio in 2019. Importantly, this transformation has also provided a platform to scale and optimise many aspects of the Consumer Healthcare business including divesting lower growth brands, introducing a new R&D/innovation model, optimising the supply chain and manufacturing network, alongside continued investment in new digital, data and analytic platforms and capabilities.

This has resulted in the creation of a leading global consumer healthcare business with annual sales of £9.6 billion in 20211. The business has an exceptional portfolio of world-class, category-leading brands; global scale with footprint and distribution capability to serve more than 100 markets; strong brand building, innovation and digital capabilities; and offers a unique proposition that combines trusted science with human understanding.

The business is led by a highly skilled management team with deep experience in consumer healthcare and FMCG with strong commitment to delivery on its purpose and growth ambitions.

Superior growth and highly attractive financial profile
The business is well-positioned to sustainably grow ahead of its categories in the years to come. The fundamentals for the £150 billion consumer healthcare sector are strong, reflecting an increased focus on health and wellness, significant demand from an ageing population and emerging middle class, and sizeable unmet consumer needs.

Over the period 2019-2021 the Consumer Healthcare business delivered a 4% organic sales growth CAGR2 outpacing its categories and despite the adverse impact of the COVID pandemic.

Superior sales growth for the business is expected to result from a strategy that puts the consumer at the heart of the business to better address every-day health and wellness needs, in particular by increasing household penetration of its leading brands and capitalising on new and emerging growth opportunities arising from innovation and the use of new technologies and digital platforms, all underpinned by continued strong execution and financial discipline. Over the medium term, superior sales growth is expected to be primarily driven by continued momentum of key brands in Oral Care, VMS, and Pain Relief; accelerating innovation in the US and China; and further growth in emerging markets.

Reflecting these trends, and the investments made and planned for the business, the Board of GSK is confident that the Consumer Healthcare business can sustainably deliver annual organic sales growth in the range of 4-6% (CER) over the medium term.

The combination of superior organic sales growth, operating margin expansion and consistent high cash generation will, we believe, offer both existing and prospective shareholders a highly attractive financial profile that facilitates continued investment in growth, the delivery of attractive returns and the opportunity of continued participation in long-term value creation.

Proposals fundamentally failed to reflect the intrinsic value of the business and its potential
The Board of GSK unanimously concluded that the proposals were not in the best interests of GSK shareholders as they fundamentally undervalued the Consumer Healthcare business and its future prospects.

The Board of GSK therefore remains focused on executing its proposed demerger of the Consumer Healthcare business, to create a new independent global category-leading consumer company which, subject to approval from shareholders, is on track to be achieved in mid-2022.

Capital Markets event
GSK intends to share further details of the strategy, brands, capabilities and operations, including detailed financial information and future growth ambitions for the new Consumer Healthcare business at a virtual Capital Markets Day for investors and analysts on Monday 28th February 2022.